Search Term: " Congress "
Congress Finally Frees Hemp From Jail: Big News For Farmers and CBDIndustry
January 06, 2019 04:20 PM
The Farm Act that was recently passed by Congress allows farmers across the nation to freely grow hemp as they please. Unfortunately, there are still restrictions set on the production of CBD products, which leaves a grey area in terms of what is acceptable and unacceptable. CBD oil is becoming more and more prevalent in treating psychological symptoms without the psychoactive effects that marijuana has. Industry leaders suspect that this bill passing is the first step in the CBD industry ultimately exploding.
"At any rate, the passing of the Farm Bill is sure to have implications on the growing CBD industry."
Read more: https://www.thealternativedaily.com/congress-frees-hemp-from-jail-news-farmers-cbd-industry/
CV Sciences, Inc. to Exhibit at the 25th Annual World Congress on Anti-Aging Medicine in Las ...
December 16, 2017 07:59 AM
The American academy of Anti-Aging (A4M) is having it's annual world conference in Las Vegas and CV sciences, for the fourth year in a row, will be exhibiting there. CV Sciences specializes in natural treatments, using CBD oil to treat the effects of aging naturally, something researchers around the world have been focusing on lately. The CV Sciences booth will have experts available to answer any questions as well as discounts on products for attendees.
"2017 marks the first year A4M has dedicated a specific education track related to cannabis as a modality."
Read more: http://markets.businessinsider.com/news/stocks/CV-Sciences-Inc-to-Exhibit-at-the-25th-Annual-World-Congress-on-Anti-Aging-Medicine-in-Las-Vegas-NV-December-14-16th-2017Company-Continues-to-Expand-Its-Distribution-Network-to-Health-Care-1011085942
Green Gorilla's CBD Oil Line to Present at the International Congress of Orthomolecular Practice in ...
July 14, 2017 11:14 AM
Green gorilla will be at the international congress of orthomolecular practice in Brazil this summer. Green gorilla claims to be some of the purest cbd oil and hemp products available at 99.7% purity. Brazil has recently approved the use of CBD oil for many health issues ranging from ADD to PTSD and many things in between. Green Gorilla, which is USDA approved, is not only striving to have the purest form of CBD available but also the company is striving to keep high ethnically standards across the board in the international marketplace.
Read more: Green Gorilla's CBD Oil Line to Present at the International Congress of Orthomolecular Practice in ...
Cannabidiol Research Expansion Act
June 23, 2017 07:14 PM
The Cannabidiol Research Expansion Act is A bill to require the Attorney General to make a determination as to whether cannabidiol should be a controlled substance and listed in a schedule under the Controlled Substances Act and to expand research on the potential medical benefits of cannabidiol and other marijuana components. The only thing that has been done with this act is that it has been read twice and referred to the Committee on the Judiciary.
Read more: Cannabidiol Research Expansion Act
Members of Congress and Senate in Support of the New CBD Bill
May 13, 2017 06:44 PM
A website for marijuana advocates has issued a story about a new bill working through Congress. This bill would exempt Cannabidiol, or CBD, from being categorized as a controlled substance. CBD has been found to be useful for a form of epilepsy called intractable. Intractable epilepsy does not respond well to conventional medications. Several Republicans have publicly supported this exemption, A YouTube video is included. The video has the support of the Epilepsy Foundation. There were four comments.
Read more: Members of Congress and Senate in Support of the New CBD Bill
Congress Gives Jeff Sessions $0 To Go After Medical Marijuana Laws
May 09, 2017 10:44 AM
Erin Elizabeth summarizes the current political climate as it relates to medical marijuana and the prevailing opinion of lawmakers on Capital Hill. Attorney General, Jeff Sessions, has consistently expressed an emphatically negative view of medical marijuana and has expressed interested in addressing users from his position in the federal government. However, congress, who are simply honoring the wishes of the voters in their home states, have allocated no money to sessions in this effort, solidifying the federal government’s actual stance on medical marijuana: States have the rights to make their own rules and laws to govern the use of this substance for medical purposes.
Read more: Congress Gives Jeff Sessions $0 To Go After Medical Marijuana Laws
5 Things to Know About Genetic Testing Bill
March 24, 2017 02:44 PM
Could you be pressured into submitting to genetic testing in the near future? A proposed piece of legislation could alter the 2008 law that protects us from mandatory genetic testing and or discrimination based on the results of such tests. The proposed changes get around the 2008 law by linking predictive tests to wellness programming and declaring wellness programs exempt from the prior rules. Bioethics experts believe that your genetic health Is nobody’s business and others point out that wellness programs have failed to produce proven results or savings.
"Despite the country's focus on the American Health Care Act, a smaller bill is also working its way through Congress — one that could overturn years of legislative protections for patients."
Read more: http://www.nbcnews.com/health/health-care/nobody-s-business-5-things-know-about-genetic-testing-bill-n733416?cid=public-rss_20170316
Treating Your Allergies With Weed
March 20, 2017 11:44 AM
You can treat your allergies with weed. It can help with seasonal allergies. This is good news for people that like weed. It has already been known for some time now, that weed helps with asthma symptoms. There is no doubt that weed has some very great properties. It's not just a subject for young people that do it for recreation, or Congressman anymore.
"CBD is the compound in cannabis that does not get you high, meaning there’s no reason it can’t serve as a regular treatment for these issues."
DEA Reiterates: Hemp CBD is Illegal
March 19, 2017 03:44 PM
The DEA has reiterated that Hemp CBD is illegal. It does not matter what the sellers of CBD oil tell you, it is illegal. The DEA believes it is illegal in all fifty states. The authority that the DEA has over drugs comes from the Controlled Substances Act. This issue is important to many people.
"The term ”marihuana” means all parts of the plant Cannabis sativa L., whether growing or not."
Here Is Why Congress Believes Marijuana Is The Same As Heroin And Meth
March 12, 2017 11:59 AM
Congressman Garrett is working to get marijuana off the federal controlled substance list, which will put marijuana on a level similar to alcohol rather than heroin. The Controlled Substance Act, passed in 1970 by President Nixon, lists marijuana as a tier 1 substance (the highest possible tier, meaning no acceptable medical use), while only 2 years after it was discovered that marijuana posed no threat to the public. While marijuana is considered highly dangerous to the federal government, twenty-eight state governments so far have passes laws allowing medical marijuana. Even cannabis extracts with no THC are considered schedule 1 drugs. And yet, congress has no plan to reschedule any time soon, with several recent attempts all proving unsuccessful.
"Earlier this week, Congressman Tom Garrett, a Republican freshman from Virginia, introduced legislation aimed at federally decriminalizing marijuana."
Read more: https://www.google.com/url?rct=j&sa=t&url=https%3A%2F%2Fthefreshtoast.com%2Fcannabis%2Fhere-is-why-congress-believes-marijuana-is-the-same-as-heroin-and-meth%2F&ct=ga&cd=CAIyGjViYjkzZDJlODZhNjI0ZWE6Y29tOmVuOlVT&usg=AFQjCNGVMruuanmcWtstgLlU4juLWyStng
Is There a Link Between Diabetes and Pancreatic Cancer?
February 05, 2017 12:59 PM
Diabetes is your body not making or processing insulin properly. Insulin is created in the pancreas. This explains more about that and about a link that might exist between cancer of the pancreas and diabetes. Any health conscious people or those at risk for either condition should check this out.
"Researchers analyzed data from nearly a million patients with type 2 diabetes or pancreatic cancer in Italy and Belgium. Half of all pancreatic cancer cases were diagnosed within a year of patients being diagnosed with diabetes, the findings showed."
What Is Vitamin B-6 And What Is Its Health Benefits?
January 05, 2014 09:19 AM
Vitamin B6 is a water soluble vitamin that is part of the vitamin B complex group that consists of pyridoxal (PL), pyridoxine (PN), pyridoxal 5 phosphate, pyridoxine 5 phosphate, 4-pyridoxic acid (PA), pyridoxamine 5 phosphate, and pyridoxamine. Pyridoxine is the form that is commonly given as a vitamin B-6 supplement. Vitamin B6 is also found in most multivitamin mineral supplements.
The benefits of vitamin B-6 include:
The amount of vitamin B-6 that is needed daily by the body depends on age and sex. Men and women between the ages of 19 and 50 need 1.3mg/day, women who are 51 years and older need 1.5 mg/day, pregnant women need 1.9 mg/day, and men over 51 years need 1.7 mg/day.
Below are some of the foods that contain vitamin B6 (the amount of vitamin B6 they contain is in mg)
Fruits- per carrot juice contains 0.27 mg per 125mls, prune juice contains 0.30mg per 125 mls. and one avocado fruit contains 0.26 mg.
Grains- 30 g of wheat bran contains 0.35 mg of vitamin B6, 30 g of bran contains 0.20 mg
Meats- 75 g of cooked beef liver contain 0.76-0.78 mg, 75g of cooked beef contains 0.14-0.26 mg, 75 g of salmon or tuna contain around 0.67 mg, and other fish (trout, cod, mackerel, snapper, bluefish, and herring contain 0.30-0.39 mg.
Legumes- 0.75 of a cup of soybean contains 0.30 mg, 0.75 of a cup of chickpeas contains 0.84 mg, and 0.75 of a cup of lentils contains 0.26 mg.
The symptoms and signs of vitamin B6 deficiency include:
anemia, depression, convulsion, irritability, morning sickness, and sore tongue.
You can easily meet your daily requirements of vitamin B-6 by taking vitamin B-6 supplements. Athletes who are taking protein and amino supplements should also take vitamin B6 supplements to improve their body’s intake of the proteins and amino acids consumed.
NPA Loby Day
April 29, 2009 04:12 PM
NOW Takes Top Honors in 3 Distinct Categories On March 24th, 2009 a large contingent of individuals from the Natural Products Association (NPA) visited Capitol Hill during Natural Products Day to lobby Congress on behalf of our industry. Among this contingent were seventeen individuals from the state of Illinois, including three from NOW Foods – President Al Powers, Mike Richard, and Truth Advocate Neil Levin. NOW had two goals during Lobby Day; to meet and lobby Illinois legislators and their staffers on important industry matters, and to obtain contact information for House and Senate lawmakers and their staff for the purpose of extending an invitation to visit and tour our Bloomingdale, Illinois headquarters.
During the day Illinois representatives visited the offices of Illinois senator Richard Durbin and Illinois Congressman Bill Foster, and visited with a representative of newly appointed Illinois senator Roland Burris. In regard to legislation, members of the Illinois contingent supported an update to the national school lunch program, which was last revised in 1979, and renewed their support for the Dietary Supplement Health & Education Act (DSHEA), the main body of laws regulating our industry. They also warned Illinois lawmakers that the possible dissolution of the Food and Drug Administration (FDA) into separate Food and Drug agencies could potentially lump natural products regulation together with drug regulation, despite the vastly superior safety record of natural products and dietary supplements.
They also presented information on a number of studies that showed the potential for over $20 billion in healthcare savings over a five year period if consumers were to take certain supplements, including calcium and vitamin D to maintain bone health, lutein and zeaxanthin to support visual function, folic acid to protect from birth defects, and more. Lastly, representatives from NOW Foods opposed new regulations that could hurt businesses that, like NOW Foods, are responble for increasing American exports and creating new jobs for Americans during a protracted economic downturn.
Even though there was no immediate commitment from our representatives in Washington on the key issues discussed, we feel that this Lobby Day was successful in building more personal relationships with our elected officials, and in helping them to understand our industry’spassion and commitment to promoting optimal health for all Americans through the use of safe, high quality natural products.
Interested in learning more about important legislative issues affecting the natural products industry? Visit www.saveoursupplements.organd make sure your voice is heard in the fight to protect American’s access to safe, affordable dietary supplements and natural products.
May 17, 2008 10:17 AM
Recently, the Natural Products Association has experienced a flurry of activity on the legislative front. One month ago, Natural Products Association members went to Washington, D.C. to meet with their representatives and discuss legislation important to the association and the industry. Many who could not visit Washington in person were part of our "virtual march" on Washington that delivered e-mails, petitions, and videos to Congress on the importance of natural products. Natural Products Day was a great success, boasting higher than ever attendance at our evening Congressional reception, and resulting in additional co-sponsors for S. 771, the Child Nutrition Promotion and School Lunch Protection Act sponsored by Tom Harkin (D-Iowa). The bill now boasts co-sponsorship of more than a quarter of the Senate. Its companion bill in the House of Representatives, H.R. 1363, sponsored by Lynn Woolsey (D-Calif.), has gained an additional five co-sponsors as the result of Natural Products Day meetings and now has 140 co-sponsors. These bills continue to build momentum, thanks to your support.
More recently, the Natural Products Association urged supporters to contact their legislators to include an amendment to the "Farm Bill" allowing food stamp recipients to purchase dietary supplements. This provision was similar to free-standing bills that have been introduced in the current and previous Congresses by Sens. Harkin and Orrin Hatch (R-Utah) and have earned the association's support. Although the amendment advanced further than other versions in previous sessions, it did not make the final Farm Bill, which was reported out of conference today. The good news is that the Farm Bill did contain significant increases in nutrition programs and increased funding for organic farming, another supported goal of the Natural Products Association. Because of the strong effort of our supporters on the amendment's behalf, the bill was placed on Congress's radar screens and has greatly improved the chances as stand-alone legislation, S. 770, the Food Stamp Vitamin and Mineral Improvement Act, of seeing passage. We will continue to ask for support on this important bill as this legislative session progresses.
In addition, the Natural Products Association has been leading the fight to protect Dehydroepiandrosterone (DHEA), and to keep this important, safe, and effective supplement available to elderly consumers. The same players behind S. 762, which would wrongly classify DHEA as an anabolic steroid, proposed S. 2470 in late 2007 as a misplaced reaction the release of the Mitchell Report, which chronicled the abuse of steroids by professional baseball players. Although DHEA has no performance enhancing attributes, this bill was proposed to limit the access of minors to DHEA. The Natural Products Association and its supporters have worked hard to inform Congress of the benefits of DHEA, and that it is not an anabolic steroid and should not be classified as one. We have been able so far to prevent any movement on the bill, but the association continues to monitor its progress and make sure that this supplement remains accessible to the seniors who need it most.
Thanks to your help, the Natural Products Association continues to have an active presence on Capitol Hill that is felt by legislators. We could not do it without the help of you, our supporters, who know how important it is to stand up for natural products. The impact of your messages to legislators continues to help the Natural Products Association to ensure all natural products - from natural and organic foods to dietary supplements and health and beauty aids - are accessible to Americans. With your continued support we will continue to be known as a vocal group with a wide base of support through the rest of this legislative session and beyond.
To get involved, please visit our action center at www.capwiz.com/nnfa/issues/
On Tuesday, April 8, the Natural Products Association - 11th Annual Natural Products Day
April 10, 2008 04:46 PM
On Tuesday, April 8, the Natural Products Association and our sponsors will be hosting the 11th Annual Natural Products Day in Washington, D.C. This day is an important way for natural products advocates to reach out to Congress and discuss the issues that matter. For more information on Natural Products Day or to register, please visit www.NaturalProductsAssoc.org/npd08.
Among the many healthy policies we’ll be asking members to promote on Capitol Hill, bill S. 770, Food Stamp Vitamin and Mineral Improvement Act, will be at the top of our list.
S. 770 would give needy food stamp recipients the choice of purchasing certain vitamin and mineral supplements with their benefits, in the same way they are free to make other dietary choices. If the stamps can be used to buy a soda or snack cake, why not use them to buy a supplement to improve your health? These select supplements could improve appetite and growth rates in poor children; decrease infectious disease in the elderly; prevent neural tube birth defects; protect against heart disease and stroke; protect against some cancers; maintain cognitive function in the elderly; and build bone mass in the young and decrease bone loss in the old.
But, you don’t have to go to the Hill to make a difference! If you can’t join us in Washington, D.C., you can still e-maiL your elected officials and tell them to support S. 770! Don’t miss this chance to put your stamp of approval on this important bill! Take Action Now!
Click here to e-mail your elected officials
Big Pharma Plays God, Stealing and Altering Pant Compounds making Synthetic Drugs
January 02, 2008 02:24 PM
It has been claimed by the Nutritional Health Alliance (NHA) that the pharmaceutical companies are formulating their pharma drugs using natural plant-derived substances. This is not totally groundbreaking news, of course, since the whole pharmaceutical industry was based on natural products such as aspirin, derived from willow bark, and antibiotics derived from the penicillin mold.
While there is nothing wrong with them doing this, there are signs of their increasing lobbying to limit the supply of supplements so that Big Pharma can monopolize the production and supply of all supplements and remedies, natural or synthetic. What is disturbing is that bills such as the Adverse Event Reporting Bill, passed by Congress in February 2007 as the Dietary Supplement and Nonprescription Drug Consumer Protection Act, could conceivably place greater powers into the hands of the large pharmaceutical companies to restrict the sales of natural products that are not part of their ‘approved’ prescription range.
This Act requires users and distributors of over the counter and non-prescriptive natural remedies to report any adverse effects that they believe have been caused by the remedy they are using. What this does is to require untrained people to make medical decisions as to what is causing their adverse reaction.
A patient taking several prescription drugs and a vitamin supplement might naturally assume that it is the vitamin that is causing their reaction, since they will believe the drugs to be safe. Hence they will report the vitamin supplement as being the cause. Since the act does not oblige them to report reactions from prescription drugs, then this opens the door for Big Pharma to hijack plant compounds, and then alter them to make synthetic drugs.
The position of the FDA in all of this is dubious since that body has already made many decisions that favor the large pharma companies rather than the consumer, or producers of herbal remedies.
However, there is also the opposite view that the supplement industry is unregulated, and some degree of control is long overdue. While it is difficult to argue against this, it is the form of control that is in question and also the reasons behind it.
The pharmaceutical companies have long gained through America’s ill health, and it is to their advantage for Americans to become ill or suffer from the chronic diseases that come with a sedentary lifestyle and a diet of fast foods. The industry’s short-sighted approach has been to wait until people become ill and then treated them with expensive drug, rather than prevention that would ultimate lose them customers for their products.
A happy and healthy community, regularly taking supplements that keep them fit and well, is not to the advantage of pharmaceutical companies that prefer a depressed, unfit and sick American population to which they can sell their products. Hence the smear campaigns in the press regarding ‘uncontrolled’ natural remedies, untold bills in Congress, and what could end up as the ultimate revocation of our freedom to consume the natural products of our choice.
If we are taking two or three prescription drugs for a heart condition or to reduce the cholesterol levels in our body, and also an Omega-3 fatty acids capsule, we are urged to report the capsule if we have any side effects from the cocktail. Presumably on the basis that the drugs have been approved by the FDA, and so cannot possibly cause any side effects in us. A fish oil capsule is hardly likely to cause a heart attack, but many prescription drugs can if badly prescribed. However, it is the capsule that is likely to be fingered, banned and then included in a pharmaceutical product that is cleared by the FDA.
Those that take over the counter supplements, vitamins and herbal remedies are a threat and it is difficult not to become cynical about the intentions of such Acts of Congress and the people behind them. True, the supplement and herbal industry probably does require some form of regulation, but to phrase this in such a way as to require medically untrained people to report what they perceive as being the adverse effects of supplements rings of an intention to regulate by restriction or even banning.
When that occurs, Big Pharma will take these products and fashion them into expensive prescriptive drugs that are then approved for use by the FDA. What we were at one time able to purchase from our local health store we would now have to purchase at several times the price through prescription.
The health benefits of natural nutritional supplements are well documented, and the industry are now using methods to ensure standardization of the active ingredients where possible. However, this is not always possible with foodstuffs that do not always grow in standardized ways.
The Dietary Supplement Health and Education Act (DSHEA) was passed by Congress in 1994 to protect and preserve our rights to healthy supplementation of our diets with natural products of our choice. The FDA has systematically failed to enforce this and prosecute synthetic manufacturers who have not kept to the law. The FDA does not need new powers, but the funding to implement those already in existence.
Lobbying in Congress by interested parties should not be allowed to undermine the rights of all Americans of the freedom to consume the products that will provide them with a healthier lifestyle. The DHSEA is all that is needed to preserve this and to protect consumers from Big Pharma and their need to create conditions conducive to an increasing need for their products.
Yes, the health supplements industry likely needs some form of regulation to ensure standardization of products as far as is possible, but the way to do this is not to place medical decisions into the hands of the untrained. Do not forget that these are natural products, available freely from nature in fruit, vegetable and animal products, and are not synthesized in a laboratory as many of today’s drugs are.
However, give them a free rein, and Big Pharma will hijack these natural products, change them and then sell them to us at highly inflated prices to do the job that already do for us: keep us healthy.
Supreme Court Refused Ephedra Appeal…
May 17, 2007 01:39 PM
Supreme Court Refused Ephedra Appeal…The U.S. Supreme Court on Monday refused to consider an appeal by Nutraceutical International Corporation, which sought to overturn a federal ban on the dietary supplements containing ephedrine alkaloids. The court’s decision, issued without comment, lets stand a 2005 ruling by a federal appeals court that upheld the Food and Drug Administration’s (FDA) 2004 ban. David Seckman, executive director and CEO of the Natural Products Association commented on the refusal. “Obviously we were concerned about the consequences of the circuit court’s ruling on the risk benefit standard the FDA used in removing ephedra from the market, which is why we filed our amicus brief. As we clearly stated in the brief, we believe Congress did not intend for such a standard to be used. But, since the Supreme Court decides to take up only between five and ten percent of cases brought to it, it is not a shock that they’ve decided not to hear it. We should note, however, that the denial of the Nutraceutical petition is not an affirmation by the Supreme Court that they agree with the lower court’s decision,” Seckman said. In April, the Natural Products Association had filed a “friend of the court” or amicus brief with the U.S. Supreme Court that challenged the lower court ruling on the standard used by the FDA to impose a 2004 ban on ephedrine alkaloids in dietary supplements.
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NHA/Washington Update - Statistics Lie
April 06, 2007 04:57 PM
The mass media targets antioxidants with misleading stats.
The smear campaign against nutritional supplements continues in 2007, with headlines such as the following: “Antioxidants Don’t help You Live Longer,” “Antioxidants Might be Dangerous,” “Antioxidants Do Not Prevent Disease and May Increase Mortality.” Do you notice a theme? Antioxidants are the latest target for media manipulators seeking to steer the public away from life-enhancing nutrition.
The study that spawned these alarmist headlines, first published in the Journal of the American Medical Association, is a “meta-analysis”; this means it draws its conclusions from a number of different studies. In this case, 68 studies involving 232,606 people were analyzed. Meta-analyses are an example of how easily statistics can lie.
Like 2004’s infamous vitamin E-bashing meta-analysis (which proclaimed vitamin E to be deadly, even though it focused on elderly patients who were already stricken with disease), the recent meta-analysis of antioxidants has a preordained outcome—results are determined by which studies are chosen for analysis. Experts have pointed out significant flaws in the execution of this meta-analysis; for example, it includes studies that administered many different combinations of antioxidants, and in varying doses. In addition, these Hitler-skelter antioxidants and dosages are scattered across a wide range of people, everyone from male doctors to elderly nursing home patients. Finally, this meta-analysis neglected to include the most significant antioxidant study ever conducted in its findings. The china study, which in surveying 800 million people was one of the most comprehensive studies of its kind, verified antioxidants effectiveness in fighting cancer, heart disease and stroke. Why was it not included in the meta-analysis?
Even a junior high school science student would question this meta-analysis’s statistical significance. So how can mass media transform this flawed study into headlines that proclaim antioxidants will kill you?
The answer is because the media gets away with it. In our fast paced world, where celebrity rehab stints are front page news, fact-driven journalism is fading—and distracted news readers are enabling its demise. The solution? Consider media reports with awareness and intelligence, and never assume that headlines speak truthfully.
The recent antioxidant bashing study crumbles when subjected to awareness and intelligence. In addition to the obvious study flaws, and even more telling: stories coving the study with headlines proclaiming “antioxidants may increase mortality” are grievously misleading; as it turns out, the study did not identify any causes of death—which were surely diverse given that the study tracked over 200,000 diverse people. Believe the headlines, however, an antioxidants causing all the deaths when in fact they probably caused none—an example of the absurd “association with out causation” logic that may destroy our right to take safe, natural supplements.
Continue investigating and you will find that Denham Harman, MD, PhD, the “father of the free radical theory of aging,” antioxidants pioneer and professor emeritus at the University of Nebraska Medical Center, is able-bodied and active at age 91. Harman takes antioxidants vitamin C, vitamin E and selenium daily—a revelation with more credibility than any antioxidant bashing hatchet-job study.
Educate yourself about antioxidants and other supplements that Congress is trying to take away from you. Fight to keep your health under your own control, always. Patronize the natural health food store that are committed to providing you with quality products and reliable knowledge. For more information, visit www.nha2007.com
Barking Up The Wrong Tree – Dietary Supplements are targeted while foods sicken millions.
November 09, 2006 11:54 AM
The FDA and our enemies in Congress want you to believe that non-causal Adverse Event Reporting (AER, as presented in the S.3546 bill in Senate and the HR.6168 now in the House of Representatives) for supplements should be implemented to protect our health. The latest nationwide E.coli outbreak casts a shadow of doubt on S.3546/HR.6168 supporters’ motives, however-because these bills are treating safe, natural supplements as dangerous threats while foods wreak havoc on our nation’s health.
By the time this issue went to press, 187 people had been sickened and as many as three people had died from toxic E.coli bacteria found in contaminated bags of spinach. Tragically, this is nothing new; the Centers for Disease Control and Prevention estimate that food borne disease cause approximately 76 million illnesses, 325,000 hospitalizations and 5,000 deaths in the United Stages each year. More than 200 known diseases are transmitted through bad food.
Despite these staggering figures, there is no adverse event reporting system in place for foods. So if our enemies in Congress truly want to protect us, why are they pursuing non causal AER for safe, natural dietary supplements and not foods? The unfortunate answer is that non-causal AER supporters are either ignorant or in pursuit to non-disclosed political agendas. The latter is extremely disturbing especially when these self serving political agendas, promoted in the name of “protecting health,” will actually harm public health by taking away our supplements.
Not only are AER supporters barking up the wrong tree, but the AER bills that they have constructed are totally destructive. S.3546/HR.6168 is based on association and not causation. That’s right—S.3546/HR.6168 disregard what actually caused an adverse event, and instead use “guilt by association.” These poorly constructed bills are impotent when it comes to protecting people, but nonetheless are poised to devastate the nutritional supplements industry. If passed, S.3546/HR.6168 will unleash a barrage of frivolous lawsuits that will make trial lawyers rich while bankrupting the entire nutritional supplement industry and taking away our vitamins forever.
It is hard to imagine why some elected officials, the FDA and certain nutritional supplement industry groups are channeling so much money and energy into AER for harmless supplements while potentially deadly pathogens are tainting our food supply and sickening millions. If our elected officials truly wish to help the American people and protect public health, they should leave safe, natural dietary supplements alone and focus their AER efforts on foods—but only if they take the time to draft an intelligent, functional AER bill that is based causality.
Don’t Give Up the Fight
Adverse events with supplements are practically nonexistent. Adverse events with food are abundant. Elected officials who support S.3546/HR.6168 and the non-causal AER they espouse are clearly misguided, with an imbecile’s grasp on prioritization. If you agree that non-causal AER for supplements is an unwarranted waste of time and will destroy the industry by guilt by association, then please voice your opinion, before it’s too late!
Please call and fax Joe Barton, Chairman of the Committee on Energy and Commerce, and other key AER players at the following numbers (fax numbers second): Barton at 202-225-2002, 202-225-3052; Chairman of the Judiciary Committee F. James Sensenbrenner, Jr. at 202-225-5101,202-225-3190; House Majority Leader John Boehner at 202-225-6205, 202-225-0704; Speaker of the House J. Dennis Hastert at 202-225-2976,202-225-0697; and Congressman Nathan Deal a member of the Energy and Commerce Committee, at 202-225-5211, 202-225-8272.
Don’t let self-serving political skullduggery take your vitamins and supplements away from you! Visit www.NHA2006.com and take advantage of online tools that allow you to easily send faxes to Congress. Please do not delay—without swift and decisive action, we may all lose our health freedom forever!
*This editorial is a public service announcement sponsored by the Nutritional Health Alliance (NHA).
Crucial bill S.3546 may soon land in the House of Representatives.
September 19, 2006 11:24 AM
By the time you read this Washington Update, Senate Bill 3546 (S.3546), “The Dietary Supplement and Nonprescription Drug Consumer Act,” may have already passed the Senate. As S.3546 advances to the House for implementation, non-casual Adverse Event Reporting (AER) looms on the horizon. This bill will wrongfully associate safe and beneficial dietary supplements with millions of adverse events that supplements did not cause. As S.3546 targets supplements, it ignores foods that have been linked to millions of annual adverse events—calling into question whether this bill is truly designed to keep us safe. With our right to take vitamins hanging in the balance, we must take immediate action in the House to head off S.3546 as the pass.
S.3546 offers no protection to American people. Instead, this bill appears to inexplicably punish supplement manufacturers and those who choose nutrition as a path to health and well-being. S.3546 attacks our fundamental freedom of choice through guilt by association and will destroy our core freedom to decide how and through which means we pursue health.
Along the way to revoking our health freedom, S.3546 will impose unreasonable reporting requirements that will drain supplement manufacturers’ resources and finances until they collapse. The non-causal AER that S.3546 proposes will unleash a wave of junk lawsuits that will deliver the fatal blow to the supplement industry—making trial lawyers rich while America’s health sinks in the murky waters of malnutrition and sickness.
Association, Not Causation
S.3546 proposed AER for supplements is based on association and not causation—a baldy misguided approach under which supplements will be reported for adverse events even if they did not cause, and had nothing to do with, those adverse events.
Non-causal AER encourages the scourge of our society-junk lawsuit purveyors and ambulance-chasing trial lawyers-to continue exploiting out legal system for their own selfish gains. If S.3546 is implemented, this scourge will blame vitamins for everything from acne to obesity. Americans are already paying for the actions of junk lawsuit scammers, facing ever increasing insurance premiums. With S.3546, Americans will pay an even greater price for junk lawsuits-losing their freedom, their health and their very lives when health-enhancing nutrition is taken away.
Why are safe, natural supplements being singled out, anyway? Dietary supplements rarely, if ever, cause any serious adverse events. The centers for disease control (CDC) estimate that foods cause approximately 76 million illnesses, 325,000 hospitalizations and 5,000 deaths in the United States each year. Despite these figures, no one in Washington is proposing AER for foods. That S.3546 does not include foods is incriminating; it suggests that public safety is not the bill’s ultimate goal. Our enemies in Congress are pushing S.3546, not to protect us, but to destroy supplements-because supplements keep us healthy and healthy people make no money for Big Pharma.
Sending Faxes to the House
After S.3546 is passed in the Senate, it will land in the House of Representatives’ Committee on Energy and Commerce. We must voice our AER opposition to Rep. Joe Barton, the chairman of this key committee, because he will hold the greatest leveraging power when non-causal AER is discussed in the House. Please fax and call Barton (emails and letters are ineffective) and urge him to abolish S.3546 in the name of health freedom.
Please call and send faxes to Barton and other key AER players at the following numbers (fax numbers second): Barton at 202-255-2002, fax:202-225-3052, chairman of the judiciary committee F. James Sensenbrenner, Jr. at 202-225-5101, fax: 202-225-3190; House Majority Leader John Boehner at 202-225-6205, fax: 202-225-5117; Speaker of the House J. Dennis Hastert at 202-225-2976, fax: 202-225-0697; and Congressman Nathan Deal, a member of the Energy and Commerce Committee, at 202-225-5211, Fax: 202-225-8282.
Join the Nutritional Health Alliance (NHA). Visit www.NHA2006.com and take advantage of online tools for easily sending faxes to Congress. Time is running out-please fax and call today and fax and call again tomorrow! With your help, we can preserve the American legacy of health freedom-and keep safe, beneficial nutritional supplements in our lives for generations to come.
An Interview with Congressman Sam Farr, Representing California’s Central Coast.
May 30, 2006 02:36 PM
Ambassador to Health Profile
An Interview with Congressman Sam Farr, Representing California’s Central Coast.
Congressman Sam Farr, a fifth-generation Californian, represents the state’s beautiful central coast. His district encompasses the length of the big Sur coastline in Monterey County, the Monterey Bay National Marine Sanctuary, the Salinas Valley “Salad bowl,” the redwoods, mountains and beaches of Santa Cruz County, and the majestic rural landscape of San Benito County. The health and wealth of this region has been strengthened by Rep. Farr’s focus on the environment, education and the economy. Rep. Farr was raised in Carmel, California and graduated from Willamette University with a BS in biology. He later attended the Monterey Institute of International Studies and the University of Santa Clara. He is fluent in Spanish. As a tough advocate for the health food industry, he has lobbied for strict federal organic standards.
Todd: Congressman Farr, thank you for taking the time to speak with us! Id also like to thank you for all the great things you’ve done for our community, form funding marine sanctuaries and authoring the Ocean’s Act to expanding Pinnacles national Monument. The League of Conservation Voters and others have recognized you as an “Environmental Hero”. And, you’ve worked hard to support the economic vitality of central coast’s $3 billion agriculture industry which includes a substantial organic segment. Our backyard here is also the home of a robust group of nutritional supplement manufacturers. An estimated 187 million Americans are currently taking dietary supplements as part of their daily healthy diet. In California, we’ve got 792 natural product manufacturers and distributors. Where do you stand on the state of our industry?
Congressman Farr: Well, thank you for the introduction and for asking to talk to me about nutritional supplement issues. I am very supportive of this industry and include myself in the 187 million Americans taking dietary supplements. I think supplements offer many safe and viable tools to maintain your health. The continued growth of this industry is an indication of both consumer confidence in the products and the products’ ability to fill the gaps where conventional medical care falls short.
Todd: It is estimated that by 2030, more than 70 million Americans will be over the age of 65 and the cost of health care could reach $16 Trillion per year. A recent study by the Lewin Group showed that by taking certain dietary supplements, seniors can lead healthier, more productive, independent lives while saving billions in reduced hospitalizations and physician services. Do you share our view that a Wellness Revolution is needed to counter the dilemma of an aging population versus shrinking health care support in the future?
Congressman Farr: Our health care system is definitely facing a challenge, especially as the Baby Boomers hit their 60’s and Americans are living longer than ever before. As a Baby Boomer myself, I am well aware of America’s aging population and the impact that will likely have not only on our social institutions but also our fiscal well-being. I agree that dietary supplements do play and will play an even larger role in the future as more seniors look for a way to augment their diets in order to stay healthy and active longer than past generations.
Todd: Our industry is regulated by DSHEA (the Dietary Supplement Health and Education Act), which was passed unanimously by Congress in 1994 to create a reasonable regulatory framework for access to, information about, dietary supplements. But many say that the FDA and DSHEA weren’t adequately funded to do the job as tasked. “Supplements are unregulated” is a false argument we sometimes hear. To ensure that the FDA is able to carry out the law as Congress intended, Representatives Dan Burton (R-Ind.) and Frank Pallone (D-N.J.) introduced H.R. 2485, the DSHEA Full Implementation and Enforcement Act of 2005. Did you support this bill and where does it stand today?
Congressman Farr: I think the DSHEA is a critical law and was proud to support it when Congress considered it in 1993 and 1994. I would certainly support H.R. 2485 if it came up for a vote in Congress. Unfortunately this bill has not moved since it was first introduced and referred to the Subcommittee on health in the house energy and commerce committee. Since this is an election year we have a tight schedule with only about 60 legislative days scheduled before we adjourn. That means it’s likely Congress will only finalize bills such as the appropriation bills that fund government before adjournment.
Todd: Our business climate has included some valid and rigorous challenges to improve our industry, from good manufacturing practices (GMP), to allergy labeling, to implications of Prop-65 in California. It’s disconcerting that a new bill, H.R. 3156 The Dietary Supplement Access and Awareness Act would try to capitalize on misconceptions about the industry. In an era of declining health care and declining insurance coverage, this bill would regulate supplements as prescription drugs. Among other things, it would also require adverse event reports to be turned over to the FDA, even though other foods, including those with identical ingredients, do not have the same requirements. This has the potential to be the next Prop-65-like Lawsuit mill. The result of H.R. 3156 would be chilling. It will knock smaller producers out of the market. It will result in higher prices for all supplements. It will decrease the availability of health-giving supplements to the public. What’s your feeling on this?
Congressman Farr: I am similarly concerned about H.R. 3156 and would oppose it if it came up for a vote in Congress. Like H.R. 2485, this legislation has been referred to a subcommittee on Health in the House Energy and Commerce Committee without any further action. The supplement industry has worked in good faith with the FDA since passage of DSHEA and H.R. 3156 would re-invent a wheel that isn’t needed. Instead, adequate funding as proposed in H.R. 2485 would provide ample oversight for the industry.
Todd: According to a recent study, 72% of the general population believe the government should fund more research on health benefits of nutritional supplements. Do you agreen and what can be done to meet this need?
Congressman Farr: I definitely agree that the federal government should play a bigger role in support of research regarding the health benefits of nutritional supplements. As a member of the House Appropriation Committee, I sit on the subcommittee that has jurisdiction over the FDA’s budget and I know the tight fiscal restraints the agency is under. I’ve worked with my colleagues to provide adequate funding, but it’s an uphill battle especially when we’re in a “robbing Peter to pay Paul” kind of situation. I recommend that people within the industry organize and use your consumer base to actively lobby Congress for additional funds. I’m fond of reminding people that the squeaky wheel gets grease – so let every Congress member and Senator know how much this issue matters to you.
Todd: When there is overwhelming scientific evidence that nutritional supplements provides relief for a disease condition, it currently takes a lawsuit to get the FDA to relent and allow the claim. Even then, the FDA strictly limits the claim and requires a disclaimer that does more harm than good in communicating this important information to the public. There is a new bill, H.R. 4282, The Health Freedom Protection Act that would end FDA and FTC censorship of health information. As an example, the 50% of all adult males who suffer from an enlarged prostate could receive relief from that condition by consuming a simple and safe ingredient, saw palmetto derived from the fruit of the dwarf American palm tree. The FDA censors that information. The public deserves a better opportunity to be informed about omega-3 EFA and heart disease, folic acid and birth defects, phosphatidylserine and cognitive impairment. Do you agree and do you support this bill?
Congressman Farr: I agree the public needs to access to the best information possible so they can make well informed choices about their health. I likely would support H.R. 4282 if it came up for a vote in Congress. Unfortunately this bill is in a similar situation as other we’ve mentioned in this interview – and again because of the tight schedule of an election year, it’s unlikely action will happen this year.
Todd: According to the barometer study, 85% of the US population is currently using some type of dietary supplement. Do you? Looking at your busy schedule from co-chairing the House Oceans Caucus to your seat on the Travel and Tourism Caucus, you are one busy Congressman! Are you popping nutritional supplements please tell us!
Congressman Farr: I do take some nutritional supplements, though they vary and since Ginkgo Biloba isn’t among them I cant remember their names off-hand! One product I do use faithfully is Airborne to help me combat germs and colds that I might get from sitting on an airplane. But, like many Americans my life is over-scheduled and combined with the amount of air-travel I do, I find nutritional supplements helpful as I try to stay healthy despite my hectic lifestyle.
Todd: Thank you Congressman Farr! Live long and prosper!
DSEA Release of Health/Cost Impact Study Conducted by the Lewin Group, Initial Results, Wash DC; Nov. 2, 2005
NNFA database. Adam.F on 3-15-06.
DSEA Nutritional Supplement Barometer Study, 2005 Report, Prepared by the Natural Marketing Institute (NMI).
Todd Williams; Source Naturals Marketing Programs Manager.
Fight for supplements now—it’s a matter of life and death.
May 20, 2006 01:15 PM
More than 100,000 people a year die from obesity. More than 100,000 people a year die from synthetic drugs’ side effects. These staggering numbers are a direct result of food and drugs. Isn’t there a governmental agency that monitors our food and drugs? Oh yes—it’s called the Food and Drug Administration (FDA). Judging by the numbers, the FDA needs to immediately start improving the quality of our food supply and imposing stricter safety regulations on the pharmaceutical industry. It’s a matter of life and death.
The mortality numbers associated with obesity and drugs are conservative, the tip of a massive iceberg. All signs indicate that the US, like the Titanic, is on a course for a disastrous collision with an unhealthy food supply and increasingly ubiquitous drugs. At the helm is the FDA, navigating like a dangerously distracted captain. The iceberg looms but instead of steering away, captain FDA scrutinizes a harmless ice cube in his glass—the nutritional supplement industry.
As the Iceberg draws closer, the captain is joined by his crew: Senators Dick Durbin, Tom Harkin and Orrin Hatch. Oblivious to the threat they gather around the captain’s ice cube: “this ice cube could be dangerous. How can we minimize the treat? Ice cubes should probably be controlled by the FDA. Let’s draft legislation that treats this ice cube like a iceberg, just in case.” Meanwhile, we are about to crash full speed into the real danger.
Headed for Disaster
This analogy reflects reality: Durbin, Harkin, and Hatch are drafting non-causal Adverse Event Reporting (AER) legislation that could destroy our health freedom. Under AER, supplements will be associated with adverse events like heart attacks and strokes—even if they had nothing to do with, and did not cause, those events. Treating safe, natural supplements as if they are drugs makes about as much sense as treating an ice cube like an iceberg.
While these senators target natural supplements, American citizens continue to die at alarming rates because of deadly pharmaceutical drugs and an unhealthy food supply. Where are the priorities of these misguided senators and the FDA? Dietary supplements are part of the solution to this problem, helping to support health and ensure proper nutrition.
AER is a health emergency! Durbin’s legislation could be introduced any day now. We the people, the passengers on this poorly navigated ship , must mutiny, storm the helm, fight against non-causal AER and steer towards health freedom.
We must Take Control!
If we want safe, beneficial nutritional supplements, we must exercise democratic power of the people. AER is poised to implementation. We must rise up together and tell our elected officials that we demand the right to take vitamins! Send Fax today, and send another fax tomorrow to make your voice heard! Fax vitamin adversary Senator Dick Durbin at 202-228-0400, and let him know you will never vote for an enemy of health freedom. Fax key vitamin players in Congress, Senators Tom Harkin at 202-224-9369 and Orrin at 202-224-6331. Let these senators know that their support of non-causal AER will forever tarnish their legacies. Fax Senator Michael Enzi, Chairman of the senate Subcommittee on health, Education, Labor and Pensions, at 202-228-0359. Tell Senator Enzi in no uncertain terms that dietary supplements help keep you and your family healthy, and it is your right to take them.
Visit //www.NHA2006.com/ and use revolutionary technology to enable visitors to rapidly and easily compose letters and faxes to Congress. For health, freedom and liberty, join the NHA.
A toxic by-product of industrial waste.
April 21, 2006 04:34 PM
Imagine a government permitting industry to dump toxic waste products into the drinking water supply, denying the public the right to make an informed choice by censoring the press and dissenting experts. Meanwhile, influential leaders disseminate misinformation and hoodwinked people demand community acess to the dangerous chemical.
Although it might seem like science fiction, this scenario has been playing in America since 1940’s. the toxic chemical? Fluoride. Today, 170 million Americans, approximately two thirds of the population, have fluoridated drinking water issuing from their taps.
A 1998 Gallup poll showed that the majority of Americans—a whopping 70% --support water fluoridation. Dissenters are seen as crackpots and conspiracy theorists.
EPA Unions Call for a Moratorium
In august 2005, eleven Environmental Protection Agency employee unions under the umbrella of NTEU Chapter 280, primarily scientists, researchers, doctors, submitted a request to Congress for a moratorium on drinking water fluoridation, based on scientific evidence that fluoride is a proven carcinogen.
Dr. William Hirzy, Vice President of Chapter 280, explains that the biggest misperceptions about fluoridated water are “that its safe and effective, that basically there are no adverse effects, and that it does this magic of lowering dental decay rates.”
A Profitable By-Product
Although the American Dental Association explains that fluoride is a naturally occurring compound, the form used in drinking water, hydrofluorosilicic acid is, in fact, a product of man.
Today’s fluoride is a by-product of the phosphate fertilizer industry. Air filtration vents, called “Wet-Scrubbers,” trap fluoride, which is a gaseous by-product of manufacturing. For many years, the gas was vented into the sky, where it caused lawsuits by farmers for burnt crops and sickened animals. Now, the fluoride is sold to American communities as well as developing countries, Dr. Hirzy calculates the fertilizer industry makes about 100 million a year from their toxic by-product.
Fluoride’s Tainted History
Fluoride’s effect upon teeth was first observed in children who were overexposed to ingested fluoride. Their teeth turned pitted and brown, a condition recognized as dental fluorosis. According to the American Dental Association, fluoride damages only the body’s tooth-forming cells, buy many scientists are concerned that other cells are damaged as well.
According to Phyllis Mullenix, Ph.D., a prominent toxicologist, animal research shows that fluoride crosses the blood-brain barrier, causing defects in the brain region devoted to memory and learning. In humans, the behavior evidenced in rats would qualify as motor dysfunction, deficits or learning disabilities.
Is Fluoride Good for Poor People?
Many argue that fluoridation is needed by economically disadvantaged populations with inadequate access to dental care. In fact, these are the people at greatest risk from fluoride, which wreaks its most hazardous effects on those who are malnourished. Calcium deficiency, in particular, is linked with fluorosis.
Is It Good For Anything?
Ironically, many dental authorities acknowledge that ingested fluoride has little to no effect on preventing cavities in the pits and fissures of the teeth, where most cavities occur. Many researchers acknowledge that only topical fluoride can stop cavities. The largest nation wide study, conducted in 1989 by the national institute of Dental Research, showed that children in fluoridated and non-fluoridated communities have approximately the same cavity rate.
Fluoridation and the Wellness Revolution
The Fluoridation controversy is another example of our health care system’s approach of throwing chemicals at problems, rather than solving them through improved public hygiene and better nutrition. In addition, calcium and vitamin D supplementation can help build strong teeth, while vitamin C is essential for healthy gums.
Source: www. Fluoridealert .org, www. Fluoridedebate .org, www. Nteu280 .org/issues/fluoride/fluoridesummary.htm
Nutritional Supplements Could Save U.S. $6.5 Billion.
January 07, 2006 12:26 PM
Health Care Crisis Bankrupting U.S. Budget
Nutritional Supplements Could Save U.S. $6.5 Billion.
You probably never heard about it on the radio, nor saw its actions reported on CNN. Others can’t guess what its acronym stands for. The United States Government Accountability Office (GAO) is an investigative arm of Congress examining the receipt and payment of public funds. This government office exists for the sole purpose of communicating to Congress those facts and figures which we, as a society, can’t afford to overlook.
And they are saying that the healthcare system is going to bankrupt us. The agency recently issued a special report called 21st Century Challenges, which concludes that current U.S. fiscal policies are unsustainable and, unless radical changes are initiated relatively soon, will “result in large, escalating, and persistent deficits.
The Money Pit
According to the GAO report, the United States spends more than 15% of our gross domestic product on health care, and that figures growing fast. We spend a larger percentage than is spent by any other industrialized country. What’s even more suprising is how little we get for the money. An estimated 45million Americans are uninsured. The United States continues to compare abysmally to the other industrialized nations in critical areas like infant mortality, life expectancy, and premature and preventable deaths.
Medicare and Medicaid together devour 20% of the federal budget. With the baby boomers—individuals born between the end of WWII 1960—hitting retirement age this year, those figures will only grow larger with each passing year. Unless, as the GAO report says, something is done quickly.
A report released just weeks ago by the Dietary Supplement Education Alliance (DSEA) demonstrates that the government can save at least 6.5 billion in health care cost reductions if nutritional supplements are integerated into the healthcare system.
The Lewin Group, a market research firm, developed a report, entitled: Increasing Quality of Life While Minimizing Costs. It focused in on just two supplements, both of which concern reduction in disease prevention for people over age 65. Omega-3 oil, popular for its reduction in coronary heart disease, is projected to save 3.1 billion dollars. Lutein and Zeaxanthin, which supports healthy vision, will save 2.5 billion dollars if this supplement is added to health care plans, according to the study. Savings would come from reduced hospitalizations and doctor’s fees, as well as reduced nursing home use for those who in good health, could remain independent rather than needing to transfer to live-in care facilities.
Early last month, a bipartisan caucus on dietary supplements kicked off. It will be co-chaired by Rep. Chris Cannon (R-Utah), and Rep. Fran Pallone (D-N.J.), and its goal will be to examine the manner in which nutritional supplements may become a component of healthcare reform, such as part of an individual flexible Spending Account or health Saving account. As the GAO report indicates, the government interest is reaching critical mass and nutritional supplements are on the verge of entering a new era. As Congressman Cannon said during a November 2nd press conference, government needs to develop a sound policy supporting nutritional supplements “As more and more Americans start taking responsibility for their own health.”
Sources/Links for Further Reading:
Visit the website of the United States Government Accountability Office. //www.gao.gov/
House Government Reform Subcommittee on Human Rights Wellness. //reform.house.gov/
For more information about the Lewin Group’s Health Impact Study, please visit: //www.supplementinfo.org/
Court Rules for FDA in Lane Labs Appeal
December 12, 2005 09:44 AM
A federal appeals court has ruled that Lane Labs (Allendale,NJ) may be ordered to pay back consumers for selling what the food and drug administration (FDA) considered unapproved new drugs. The three-judge panel upheld the 2004 decision by U.S. district Judge William G. Bassler of the District of New Jersey, which stated that FDA may demand that Lane Labs pay back every consumer who had bought the company’s top selling products—shark cartilage supplements that were allegedly marketed as treatments for diseases including cancer and HIV. The restitution amount is estimated at 109 million. The appeals court rejected the argument that FDA cannot demand restrictions because the Federal Food, Drug, & Cosmetic Act (FDCA) does not expressly provide for such a remedy. “Whether or not Congress specifically contemplated restitution under the FDCA, the ability to order this remedy is within the broad equitable power granted to the district courts to further the economic protection purposes of the statute,” 3rd Circuit Judge Marjorie O. Rendell wrote in an opinion joined by Judges Maryanne Trump Barry and Edward R. Becker.
In its appeal, Lane Labs was supported by an amicus brief from the Washington Legal Foundation (WLF, Washington, DC) urging the court to reverse Bassler’s decision, on the grounds that restitution is not authorized anywhere in the text of the FDCA.
WLF attorneys Daniel J. Popeo and Richard A. Samp, joined by attorney Jeffrey A Lamken of Baker Botts in Washington, DC, argued that the FDCA gives courts the power to “restrain” violations, but does not allow FDA to seek “Backward-looking monetary relief.”
WLF argued that FDA, throughout most of its history, never asserted a right to seek restitution until recently, when it began asserting that power in order to have “a big club with which to intimidate manufacturers who might otherwise seek to challenge FDA directives,” including large pharmaceutical companies. However, the court upheld FDA’s authority to seek restitution on the grounds that the FDCA’s grant of authority to restrain violations of the Act should be read broadly to include all forms of equitable relief.
FDA cannot be allowed to get away with this power grab,” said Samp after reviewing the Third Circuit’s decision. “The American economy suffers, and public safety and health are jeopardized, when FDA seeks to exert power beyond its authority, upsetting to delicate balance struck by Congress in its attempt to both preserve the public welfare and encourage valuable pharmaceutical innovations.” He added that WLF has pledged to continue to litigate the issue and to support Lane Labs in any further appeals the company may file.
Bird Flu Vaccine in short supply !!
November 26, 2005 02:23 PM
U.S Unprepared for Bird Flu Pandemic
Vaccine in short supply.
Officials worldwide are preparing for the worst, as bird flu spreads through asia and into Europe, resulting in the death of 140million chickens and ducks. Meanwhile waterfowl travel their migratory paths, shedding virus contaminated feathers, droppings and saliva into the water, air and soil.
Human cases of avian flue have so far been limited to individuals who had direct contact with sick birds. Experts, however, believe the virus could mutate into a form easily transmitted from human to human. The current strain, known as H5N1, is particularly lethal; it has killed 61 people—half of those infected.
A few times each century, flu pandemics sweep the world. One of the worst, the 1918 flu, killed 50 million people; it was also a bird flu, which jumped directly to humans. The grimmest forecast today is a pandemic that could kill millions. And, among developed nations, the united states is one of the least prepared.
After Delay, U.S. Must Wait in Line.
Congress and the President are considering spending billions to buy the drub tamiflu, which has been shown to reduce the duration and severity of bird flu. A few months ago, the manufacturer could have delivered much of this supply; now, orders placed by other countries have exhausted production capacity for the next two years, according to the New York Times. U.S. health agencies have 2 million doses on hand, enough to treat 1% of the population.
A Military Response?
Anticipating a crisis, President Bush asked Congress to consider using the military to enforce a quarantine, and requested a review of the Posse Comitatus Act of 1878, which prohibits the armed forces from engaging in domestic policing. Critics question the effectiveness of a military response to a health problem, and point out that authorities can already call in the National Guard to deal with civil disorders.
Contagious Disease and the Wellness Revolution.
Concentrations of poverty, especially in Asia; huge, crowded farms and factories; poor hygiene; insufficient public health facilities; companies that refuse to produce unprofitable vaccines—all must be addressed to prevent future pandemics.
Meanwhile, individuals must do all they can to protect themselves. Wash your hands often and keep them away from your eyes and nose. Avoid contact with people who have respiratory illnesses. Clean surfaces used to prepare raw poultry with hot, soapy water, and cook poultry thoroughly. With so many potential assaults on your health, a wise strategy that is at the very core of the wellness revolution is to strengthen your immune system. Get enough sleep, take good daily multiple, and visit your health food store for a wide range of immune-boosting herbs and special nutrients to help you stay well this winter.
Sources: After Delay, U.S. Faces Line of Flu Drug, New York Times, 10/7/05; U.S. Warns of Future Flu Pandemic, Associated press, 10/10/05; Review of the monster at our door: the global threat of avian flue by Mike Davis.
Bird Flu Facts:
Symptoms: fever, cough, sore throat, aches, pneumonia.
Virulence of current strain: kills 100% of birds, 50% of humans.
Projected U.S. Pandemic Death toll: ½ million.
August 30, 2005 01:22 PM
Kiss Herbal Supplements Goodbye
Healthful herbal therapies face a new attack in Congress.
If people let government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls of those who live under tyranny. – Thomas Jefferson
Our third president recognized the devastating health and liberty implications of allowing governments to dictate what people eat. One can only imagine the disgust with which Jefferson would regard elected officials who are currently betraying core American freedoms by working to revoke our rights to choose what foods we put in our bodies.
In 1994, the Dietary Supplement Health and Education Act (DSHEA) estabilished that dietary supplements are foods. Its passage was a shinning moment of democracy that resonated with Jefferson’s beliefs on health freedom, as millions of Americans raised their voices to preserve our right to safe, natural supplements.
DSHEA Under Attack
But now, as countless people use supplements to enhance their health, some officials are tampering with the DSHEA. HR 3156, the dietary supplement access & awareness act introduced by representative Susan Davis (D-CA), is designed to deny Americans access to the supplements they rely upon for good health. Should HR3156 pass, herbal supplements will be subject to risk benefits analysis, under which adverse event reporting will empower the FDA to ban herbal supplement sales.
Inexplicably, the bill pays no heed to the amount of herbal supplement associated with an adverse event. In other words, if someone ingests an unreasonably excessive amount of a herbal remedy, and as result experiences an adverse event, that would be enough for the FDA to ban that supplement—even if the overwhelming majority of consumers experienced positive benefits by using the supplement properly. This caveat, in addition to the relative ease with which an adverse event could falsely be linked to herbal supplements, has the potential to enable widespread, groundless bans of these health-enhancing, time-tested therapies.
Fight Back, Right Now!
We must act now to prevent the passage of HR 3156. For America’s sake, we must fight the forces in Congress that wish to ban our access to herbal supplements. In the name of democracy we must ensure that our elected officials are representing our interests and not furthering their own agendas. Without your immediate support, America’s health will be compromised as herbal supplements, one by one are banned under false pretenses.
To Quote Jefferson once again, “Never put off ‘till tomorrow what you can do today.” The need for your support is urgent, so please fax your representatives in Congress today and urge them to oppose that passage of HR 3156. Contacting elected officials is fast and easy; visit www.NHA2005.com and use revolutionary technology that helps you compose faxes to Congress. Become a good health ambassador; educate your friends on this gross impingement on our health freedom and encourage them to join the fight against health tyranny!
Fax the architects of HR 3156, Susan Davis (Fax: 202-225-2948), John Dingell (Fax: 202-226-0371) and Henry Waxman (Fax: 202-225-4099), and let them know that if they revoke your health freedom, you’ll vote for your health-care interests in the next election! It is only with your help that we can win the fight to keep safe, healthy supplements in our lives. For health, Freedom and liberty, visit www.NHA2005.com and Join the NHA Today.
ARTIFICIAL SWEETENERS: CAUSE FOR WORRY
July 15, 2005 12:26 PM
ARTIFICIAL SWEETENERS: CAUSE FOR WORRY
Among some of the most troubling food additives that we routinely ingest are artificial sweeteners, also referred to as non-nutritive sweeteners. Having received the FDA stamp of approval, they are liberally ingested with little thought to what their actual health risks may be. Andrew Weil, M.D., in his book Natural Health Natural Medicine, writes: More worrisome than preservatives are artificial sweeteners. Saccharin, a known carcinogen, should be avoided. Cyclamates, banned some years ago for suspected carcinogenicity, are not being reconsidered for use in food. They taste better than saccharin but cause diarrhea in some people. Avoid them too. Recently, aspartame (NutraSweet) has become enormously popular. The manufacturer portrays it as a gift from nature, but, although the two component amino acids occur in nature, aspartame itself does not. Like all artificial sweeteners, aspartame has a peculiar taste. Because I have seen a number of patients, mostly women, who report headaches from this substance, I don’t regard it as free from toxicity. Women also find that aspartame aggravates PMS (premenstrual syndrome). I think you are better off using moderate amounts of sugar than consuming any artificial sweeteners on a regular basis. A natural sweetener that may cause some people problems is sorbitol, originally derived from the berries of the mountain ash tree. Sorbitol tastes sweet but is not easily absorbed form the gastrointestinal tract and is not easily metabolized. It is a common ingredient of sugarless chewing gums and candies. If you eat a lot of it, you will probably get diarrhea. People with irritable bowel syndrome or ulcerative colitis should avoid sorbitol.
Ann Louise Gittleman, in her book, Super Nutrition for Women, writes: In 1977, a Canadian study indicated that when pregnant rats were fed large doses of saccharin, their male offspring developed bladder cancer. As a result, the Canadians banned saccharin and the U.S. Congress ordered warning labels on all saccharin products like Sweet ‘N Low. The national Academy of Sciences in 1978 evaluated the evidence and concluded that saccharin was primarily a promoter of other cancer-causing agents, a cocarcinogen. In the meantime, G.D. Searle developed aspartame, a combination of two amino acids and methanol (wood alcohol) . . . Few long-term studies of the effects of aspartame have been done. However, reports to the Food and Drug Administration and the Centers for Disease Control indicate that, as more people consume the substitute in large quantities, health may be affected. In some circumstances, individuals may be getting high levels of methanol; for example, it is estimated that on a hot day after exercise, an individual drinking three 12-ounce cans of diet cola could easily consume as much as eight times the Environmental Protection Agency’s recommended limit for methanol consumption. The most common complaints are dizziness, disorientation, tunnel vision, ear buzzing, loss of equilibrium, numbing of hands and feet, inflammation of the pancreas, high blood pressure, eye hemorrhages and seizures. Artificial sweeteners can stimulate hunger or cause additive allergies, just as sugar does. In other words, we get the disadvantages of sugar, along with the proven or suspected disadvantages of artificial sweeteners. While thousands of Americans continue to consume aspartame in unprecedented amounts, controversy surrounding its safety lingers. Dr. Richard Wurtman of the Massachusetts Institute of Technology (MIT) has reported that abnormal concentrations of neurotransmitters developed when he fed laboratory animals large doses of aspartame. He believes that the phenylalanine content of the sweetener actually manipulates and alters certain brain chemicals which could initiate behavioral changes and even seizures. He also purports that while small quantities of aspartame may be safe, the cumulative effects of the compound—particularly if consumed with high carbohydrate, low protein snacks—could be serious (Wurtman I, 799-801, Wurtman II, 429-430, Wurtman III, 1060).
In spite of serious concerns, saccharine and aspartame packets sit in restaurant sugar bowls all over our country, while in Japan, natural stevia powder enjoys popularity as one of the best and safest non-caloric sweeteners available.
FDA & Congress: Stop The Madness- Let the natural health revolution enhance our lives.
July 14, 2005 09:24 AM
FDA & Congress: Stop The Madness!Let the natural health revolution enhance our lives.
Here's a memo to the Food and Drug Administration and Congress: Enough is Enough. The American people are fed up with backroom politics. We are sick and tired of having our God-given right to natural health threatened by attempts to "protect" us from the very natural therapies that can help ensure our national health. You do not have the power to dictate or control our pursuit of natural health. First and foremost, end your attempts to regulate or even ban nutritional supplements! Americans choose to take supplements because we believe they contribute to optimal health and vitality. Who are the FDA and Congress to trample on our beliefs and pursuit of health and happiness?
Next, our enemies need to open their narrow minds to the sublime power of nature. We must embrace nature to evolve in body, mind and spirit. Our understanding of the healing power of natural elements has progressed significantly over the past century. We are on the cusp of a natural health revolution that will enhance the well-being of millions.
Natural supplements can change the world for the better. And yet, there the governments stands like an ignorant behemoth attempting to block our access to natural supplements. Step aside, we say. This is America, and we have the right to choose our own path to health.
Plant a seed and watch it grow. This is nature's most basic miracle. Part of this miracle is nature's inherent ability to create, perpetuate and enhance life. Science has proven that thousands of plants have healing powers, including powerful benefits for depression and pain management; that scientific knowledge affirms the wisdom employed by indigenous healers for centuries. These plants were placed on earth to comfort and relieve people suffering from painful, degenerative diseases of body and mind.
Who presumes to deny us nature? Look no further than to Congress and the FDA-for they are doing this right now. We must stop this behavior. The health and healing of all our people must take priority over all other interests.
Washington Update readers, rise up and unite! If the phiosophies in this column resonate with your own beliefs, then join the health freedom revolution! To uphold our freedom to take natural supplements, we must support like-minded souls and revolt against those working to rip our rights away.
Facing the right senators is an easy, effective way to help save supplements. Fax encouragement to key vitamin advocates, Senators Tom Harkin at 202-224-9369 and Orrin Hatch at 202-224-6331. Fax your disapproval to Senator Dick Durbin, a key figure in the movement to ban supplements, at 202-228-0400. Fax Senator Michael Enzy, Chairman of the Senate Subcommittee on Health, Education, Labor, and Pensions, at 202-228-0359. Tell Senator Enzi that you demand the freedom to take natural supplements. If you have already sent a letter or fax, please send another fax. Our health freedom depends on this fax campaign.
You can take action by visiting www.NHA2004.com and taking advantage of revolutionary technology that lets you rapidly and easily compose faxes to Congress. With your help, we can win the fight to keep safe, healthy supplements in our lives! For health, freedom, and liberty join NHA today!
June 25, 2005 10:21 AM
In 1990, the First World Congress on the Health Significance of Garlic and Garlic Constituents was held in Washington, D.C. Forty-six presentations were heard by fifty scientists on the health benefits of garlic. Topics addressed included garlic’s ability to fight infection, especially Candida albicans, and to prevent cardiovascular disease and cancer. Finally, ancient medicinal practices regarding garlic are being vindicated by twentieth-century scientists who, for a long period of time, literally turned up their noses at the prospect of garlic as a viable therapeutic agent. Today, both scientific and herbalist tradition support the fact that garlic, in its various forms can provide extraordinary health benefits.
Unquestionably, it can significantly reduce the risk of cardiovascular disease and certain kinds of cancer. Taking garlic in certain dosages can help protect human cells from oxidation, free radicals and certain types of radiation. Garlic is an effective immune system booster and has anti-bacterial, anti-viral and anti-fungal properties. Garlic promises to emerge once again, as a powerful medicinal agent which will most certainly impact 21st-century health practices.
GARLIC AS A NATURAL BLOOD THINNER
June 25, 2005 10:03 AM
GARLIC AS A NATURAL BLOOD THINNER
Blood clots pose a significant threat to one’s health and longevity and substantially raise the risk of heart attack or stroke. Blood clots consist of platelets and fibrin. The amount of fibrin in the body is believed to be significantly related to heart attack or stroke risk. In fact, new medical tests are currently being developed to test more carefully for fibrinogen levels in the blood as a predictor for heart attacks and stroke.
The chemical constituents of garlic can actually reduce fibrin formation and help to decrease fibrin that already exists in the blood. Some researchers have even gone as far as to state that Garlic is more effective at preventing blood clots than aspirin therapy.17
Ajoene, a sulfur compound contained in garlic seems to be responsible for its anti-clotting effect. Because ajoene is only viable at room temperature or above, it is not present in raw or freeze-dried garlic. It is believed that adding garlic to the diet can help to increase the breakdown of fibrin from 24 to 130 percent in people who have cardiovascular disease.18
Researchers reported at the First World Congress on garlic that ajoene is such a powerful anti-clotting agent that may prove valuable in cardiac surgeries, including balloon angioplasty, in which blood vessels are artificially dilated to facilitate better blood flow.19
Europeans routinely used garlic as a natural blood thinner which has none of the side-effects associated with synthetic drugs. It should be noted, however, that anyone who suffers form a hemorrhagic disorder (bleeding) should not take commercial garlic products which contain significant amounts of ajoene.
June 25, 2005 09:58 AM
For thousands of years amazing magical and medicinal powers have been attributed to garlic. Prized as a legendary protectant against vampires in Transylvania, it has also been used to enhance sexual prowess and fight off infections. Referred to as “the stinking rose,” it is mentioned in Bible, the Talmud, and in the Odyssey by Homer as well. The Egyptians looked to garlic as a tonic which boosted physical strength and consumed it while building the pyramids. The Greeks utilized its laxative properties, and the Chinese prescribed it for high blood pressure. Vikings and Phoenicians alike extolled the virtues of garlic and used it both for flavoring foods and treating disease.
Garlic is a hardy, perennial bulb which is native to the Mediterranean regions of Africa and Europe. Along with onions, leeks, chives and shallots, garlic is a member of the lily family. The botanical name for garlic, allium sativum may have been derived from the celtic word all which refers to “pungent.” The edible portion of the garlic plant grows underground and consists of a cloved bulb.
Hippocrates believed that garlic could treat uterine cancer and Native Americans used it for stomach cancer. During the Bubonic Plague years in Europe, garlic was used to boost immunity against the infectious organism responsible for so many deaths. Several accounts relate that survivors of the plague were frequently those who had routinely ingested large amounts of garlic. A sixteenth- century herbalist writes, referring to garlic, “The virtue of this herb is thus. It will unbind all wicked winds within a man’s body.”1
During the eighteenth century, Russians utilized garlic to treat influenza. Eventually, garlic would become known as “Russian penicillin.” American colonists regarded garlic for its ability to kill parasites.
In the nineteenth century, Louis Pasteur finally proved scientifically that garlic contains antibiotic properties. His discovery led to the initiation of hundreds of studies which have substantiated his findings. What was thought to be nothing more than a culinary ingredient has medicinal value. Garlic can effectively kill bacteria, fungi, viruses and parasites. In the late nineteenth century, garlic was routinely used by physicians as an effective treatment for typhus, cholera and whooping cough. It was highly recommended by medical practitioners and considered as staple treatment for infection. Albert Schweitzer used garlic for treating amebic dysentery in Africa. Early in this century, tuberculosis was treated with garlic and it was also used as an antibiotic/antiseptic for wounds during World War II. American and European doctors alike noted a remarkable high cure rate in tuberculosis patients treated with garlic.
2 Septic poisoning and gangrene, which can so quickly develop in battlefield wounds were prevented to a significant degree by using garlic. During the 1950’s Chinese scientists used garlic to successfully treat influenza. Subsequently, western studies found that garlic was an effective treatment for the common cold. Today the widespread use of antibiotics have relegated garlic to the back burner of medicinal therapies for infection. The discovery of penicillin resulted in classifying garlic as nothing more than a folk remedy. Unfortunately, for several decades its medicinal potential was no longer taken seriously by scientists. Over the last decade, scientific interest in garlic has dramatically escalated. In 1990, the First World Congress on the Health Significance of garlic and Garlic Constituents was held in Washington D.C. Herbalists have always considered garlic as an effective treatment and preventative agent against colds, flu and other infectious diseases. The present focus on garlic as a medicinal agent promises to support the notion that garlic should be utilized by medical practitioners much more than it currently is.
Recently, medical research has focused on garlic’s potential value in treating cardiovascular disorders and as an anti-cancer agent. This renewed interest in garlic has contributed to the development of the “Designer Foods Program” which is sponsored by the National Cancer Institute.3 This agency investigates foods that may be effective cancer preventatives. Garlic is one of those foods which may have profound cancer prevention potential.
7-Keto - The Key to Healthy Aging
June 21, 2005 05:05 PM
The global population is aging at an alarming rate and causing an explosion in health care costs, insurance premiums, cosmetic surgery and more. In the U.S. alone, more than one million baby boomers are expected to live to 100 years of age or older. This increased life expectancy presents a whole new set of health concerns that the medical community has not had time to address, since there is a greater need to care for age-related health problems in this ever-growing elderly population.1
Aging and the Decline in Vital Nutrients
We all grow old at the same rate but people age at different rates. Aging is a process of gradual changes that occur to varying degrees in each of us. Interestingly, the aging process is composed of different components and interactions, some of which can be impacted. One such component is the declining level of essential biological compounds, which causes our bodily functions to slow and become dysfunctional. Our organs don?t work efficiently, our immune system becomes lazy, we lack energy, our metabolism drops and we gain weight easily.1 7-oxo DHEA (7-Keto™) is a naturally occurring compound that declines with age.2 Replacing this key metabolite helps promote a healthy immune system and maintains resting metabolic rate at levels that accelerate weight loss during standard weight reduction programs.
Aging and a Healthy Immune System
Numerous changes occur in the immune system with advancing age, probably contributing to decreased immune responsiveness. Although all segments of the immune system are affected, investigators have most consistently identified declines in cellular or T-cell mediated immune function in the elderly. The decline in T-cell immune function is generally associated with an increased susceptibility to foreign organisms. For example, individuals with age-related declines in cellular immunity have an impaired response to vaccinations, making them more susceptible to health imbalances even though they have had their shots. In a clinical study presented at the Federation of American Societies for Experimental Biology meeting in April 2004, the effect of 7-Keto on elderly immune function was evaluated. Healthy elderly adults were given 7-Keto orally twice daily over a period of one month. The study revealed that 7-Keto augmented several key T-cell mediated immune function parameters compared to placebo administration.4
Age-Related Weight Gain
Age-related weight gain and obesity are approaching epidemic proportions in our country.5 Weight gain is a disorder of energy balance involving energy intake and/or expenditure. Low energy expenditure, a drop in resting metabolic rate (RMR), is a challenge during most weight loss attempts due to age, calorie restriction, lack of physical activity or a combination of factors. RMR represents 60% of total daily energy expenditure. Maintaining a higher RMR as we age and during weight reduction programs helps us achieve and maintain a normal weight. Furthermore, compounds with the thermogenic potential to achieve even minimal increases in daily energy expenditure of 2-3% may have clinical relevance in preventing the decline in RMR with calorie restricted diets or weight loss, and in decreasing the risk of regaining weight. 7-Keto, a non-stimulant thermogenic compound, has been shown to significantly increase energy expenditure in humans.6 A recently completed clinical study, also presented at the Federation of American Societies for Experimental Biology 2004 meeting, revealed that administration of 7-Keto to overweight adults in conjunction with a calorie restricted diet effectively reversed the decline in RMR normally associated with dieting. Obese participants following a calorie-restricted diet demonstrated a 5.4% increase in daily RMR with 7-Keto.7 The magnitude of the increase in RMR by 7-Keto is clinically relevant, and represents a promising agent for enhancing thermogenesis and weight loss in obese individuals on calorie-restricted diets. Additionally, 7-Keto has been shown in two confirmatory published clinical studies to result in three times more weight loss compared to diet and exercise alone. It has a favorable side effect profile and is easy and convenient to take.8,9 Our life expectancies will likely be longer than those of our parents, and our quality of life during those years will depend on how well we take care of our bodies now. Undoubtedly, the science of aging will give rise to new and exciting technologies to help us age more gracefully and healthfully. Maintenance of healthy immune function is keenly needed for improved quality of life in the elderly. Dietary manipulation and supplementation has been identified as a method of immune system renewal, and supplements such as 7-Keto may play an important future role as immune system modulators. Moreover, the addition of 7-Keto to any weight loss program will offer vital support of energy expenditure and help with the attainment of a manageable and healthy weight into our older years.
1. 1995 White House Conference on Aging, ?Executive Summary: The Road to an Aging Policy for the 21st Century," February 1996: 17-18. 2. Marenich LP. Secretion of Testosterone, Epitestosterone, Androstenedione, and 7-Keto-Dehydroepiandrosterone in Healthy Men of Different Ages. Prob Endokrinol. 1979; 25(4): 28-31. 3. Ginaldi L, De Martinis M, D?Ostilio A, Marini L, Loreto MF, Quaglino D. Immunological Changes in the Elderly. Aging 1999; 11(5): 281-286. 4. Zenk JL, Kuskowski MA. The Use of 3-acetyl-7-oxo-dehydroepiandrosterone for Augmenting Immune Response in the Elderly, Abstract Presented at the meeting of the FASEB, April 17, 2004, Manuscript submitted for publication. 5. Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and Trends in Obesity Among US Adults. 1999-2000. JAMA 2002;288:1723-1727. 6. Astrup A. Thermogenic Drugs as a Strategy for Treatment of Obesity. Endocrine 2000;13(2):207-212. 7. Zenk JL, Leikam SA, Kassen LJ, Kuskowski MA. A Prospective, Randomized, Double Blind Study to Evaluate the Effect of HUM5007 and 7-oxo DHEA on Resting Metabolic Rate in Overweight Adult Men and Women on a Calorie Restricted Diet, Abstract Presented at the meeting of the FASEB, April 17, 2004, Manuscript submitted for publication. 8. Kalman DS, Colker CM, Swain MA, Torina GC, Shi Q. A Randomized, Double-Blind, Placebo Controlled Study of 3-Acetyl-7-Oxo-Dehydroepiandrosterone in Healthy Overweight Adults. Current Therapeutic Research 2000;61: 435-442. 9. Zenk JL, Helmer TR, Kassen LJ, Kuslowski MA. The Effect of 7-Keto Naturalean on Weight Loss: A Randomized, Double-Blind, Placebo-Controlled Trial. Current Therapeutic Research 2002; 63:263-272.
John L. Zenk, M.D., is Chief Medical and Scientific Officer for Humanetics Corporation and President and Medical Director of Minnesota Applied Research Center, both located in Eden Prairie, MN. He has spoken nationally and internationally on the subjects of integrating conventional and complementary medicine, anti-aging technologies, evaluating the effectiveness of alternative medicine, and dietary supplement research and development. He is author of the book Living Longer in the Boomer Age, and co-author of the book Age Wise and is a frequent contributor to national media. He has served as Principal Investigator for 15 controlled clinical studies, three of which were recently published in national peer-reviewed journals, and has presented abstracts at the 11th World Congress for Food Science and Technology and the Federation of American Societies for Experimental Biology.
Building the Burn
June 14, 2005 12:09 PM
Building the Burn by Marjorie Flakowitz Energy Times, June 11, 2004
When was the last time you exercised? During the past decade, the number of obese Americans has jumped by 50%. A big factor in this increase: lack of physical activity.
Today, technological society seems to make everyday life effortless: car windows retreat at the push of a button, remote controls keep couch potatoes from budging off the cushions and video games have replaced non-cyber ball playing. Americans don't move around and burn off the calories they eat. Instead, our sedentary ways are causing big stomach bulges and a big bulge in health problems linked to being overweight.
Want to lose those pounds? Consuming the right nutrients and pounding the pavement are a great start.
Number of Large Americans Grows Larger
Fifty-five out of every 100 Americans are now overweight. And the numbers continue to surge. To take yourself out of these alarming statistics, plan a consistent exercise program. If the thought of sweating during strenuous workouts at the gym scares you, relax. You don't have to do that much. According to a long list of research, a few half-hour walks a week can put you on the road to weight loss.
For instance, researchers at Duke found that walking a total of only 12 miles a week can help you control your weight even if you're not dieting (Archives of Internal Medicine 1/12/04). Of course dieting and taking the right supplements will help you lose weight a little faster, but walking burns off the pounds.
In the study at Duke, scientists gathered about 180 overweight, sedentary people and assigned them to one of four groups. The first group had to jog about 20 miles a week. The second group jogged 12 miles a week. The third group walked 12 miles, and the last group didn't do a thing.
" We found that the two low-exercise groups lost both weight and fat, while those in the more intensive group lost more of each in a 'dose-response' manner," says Cris Slentz, PhD, one of the researchers. " Simply put, the more you exercise, the more you benefit. Just as importantly, the control group of participants who performed no exercise gained weight over the period of the trial."
Everybody who was exercising lost weight; their stomachs and hips shrank. The folks who did nothing didn't just stay at the same weight; their weight went up.
Dr. Slentz adds, "From the perspective of prevention, it appears that the 30 minutes per day will keep most people from gaining the additional weight associated with inactivity. Given the increase in obesity in the US, it would seem likely that many in our society may have fallen below this minimal level of physical activity required to maintain body weight."
Of course, limiting the carbohydrates you consume and eating more protein at the same time as you exercise can help you lose weight more effectively. To help your body utilize protein more fully to fuel your exercise, many experts recommend taking enzyme supplements.
One of the most valuable enzyme combinations in this process is Aminogen(r), an all-natural, patented plant enzyme that assists the digestive tract in liberating the amino acids that are the building blocks of dietary protein. By helping separate these amino acids, absorption is boosted through the walls of the small intestines and your metabolism is better able to take up proteins and use them.
Add Chromium to Exercise
The mineral chromium is another supplement found helpful in aiding weight loss. An eight-week study at the University of Texas, Austin, compared weight loss among obese women who exercised and took chromium with the number of pounds that were lost by women performing the same amount of exercise without taking supplements (Medicine & Science in Sports & Exercise 1997; 29:992-8).
The result: women taking chromium lost a significantly greater amount. How does chromium work? A study at the University of Vermont found that chromium may help muscles take blood sugar (glucose) out of the blood more effectively by improving what's called insulin sensitivity (18th International Diabetes Federation Congress, Paris, 8/03).
Insulin is released by the pancreas to help cells take in glucose. By exercising and keeping your weight down, and becoming more insulin sensitive, you potentially reduce your chances of getting diabetes. The cells quickly respond to insulin and blood sugar stabilizes.
On the other hand, when insulin sensitivity drops significantly, the body may suffer what's called insulin resistance, a pre-diabetic condition that complicates and slows the removal of sugar from the blood. The Vermont researchers found that chromium increases the activity of a protein called Akt phosphorylation. This is a natural substance made by the body that makes cells more sensitive to insulin and speeds the movement of blood sugar into cells, where it can be burned for energy. So, in combination with exercise, which also helps the body become more responsive to insulin, chromium may help keep blood sugar under control.
As Sandra Woodruff points out in her book Secrets of Good Carb, Low Carb Living (Avery/Penguin), "[P]hysical activity boosts the body's ability to process carbohydrate and helps reduce insulin resistance....Exercise acts much like an insulin-sensitizing drug to make the body's cells more responsive to insulin, which enables them to remove sugar from the blood more efficiently." The results of exercise and getting sufficient chromium can help support weight loss and healthy blood sugar levels. The Vermont research team found that the exercising chromium takers boosted their insulin sensitivity by almost 9%.
Building a Lean Body
A prime benefit of exercising while you lose weight is that physical activity builds muscle tissue. Muscle tissue, even at rest, burns more calories than fat cells, so having extra muscle means you can eat more and still maintain or lose weight. An aid in this process is Coleus forskohlii root, Benth., a plant that originated in India. Research shows that forskohlii furthers molecular energy processes within cells that support the development of lean body tissue (muscle) and the enzymatic reactions that break down fat.
In a study of about two dozen women who took forskohlii extract, researchers found that taking this supplement was associated with feeling more energetic and less hungry (Experimental Biology meeting, 2002). According to Vladimir Badmaev, PhD, who has studied forskohlii, this herb's help in supporting lean body tissue is crucial to maintaining a healthy weight.
" In highly overweight individuals, fat tissue can constitute up to 70% of body weight. The remaining proportion of body composition corresponds to the lean body mass. Lean body mass is composed of muscle, vital organs, bone, connective and other non-fatty tissues in the body," says Dr. Badmaev.
" The body's metabolic rate is in direct proportion to the amount of lean body mass. Therefore, safely maintaining or increasing lean body mass is an important consideration for any weight-loss strategy."
The Skinny on Calcium
Calcium, long known for its ability to strengthen bones, is now turning out to play a key role in weight maintenance as well. In one study, obese mice who were put on calorie-restricted diets lost body fat when fed extra calcium (Experimental Biology meeting 2000). Both supplemental calcium and low-fat dairy proved effective. What's more, low-fat dairy's ability to burn fat and provoke fat loss have been confirmed in additional research (Obesity Research 4/04; 12:582-90).
Fat cells contain calcium, and scientists believe that the more of this mineral a fat cell contains, the more fat will be burned off. This action is especially important when you cut back on calories, since that often gives your body the idea that it's starving, leading your metabolism to slow and making weight loss extremely difficult.
A Complete Program
To lose weight efficiently, stay in top shape and retain your feelings of energy, you also have to make sure you get enough of the vitamins and minerals necessary for good health.
For those eating a high-protein diet who are limiting their fruits and vegetables, taking a supplement that incorporates nutrients from fruits and vegetables can help restore your feelings of well-being and help maintain your motivation for dieting and losing weight. (Supplements are available that deliver these nutrients without carbohydrates.)
In addition, supplements of what are called ketogenic amino acids-the natural substances that form protein's building blocks-can also help fuel your weight-loss program. These special nutrients can be efficiently used for the body's energy needs, a process that helps you lose weight.
And don't forget to keep moving! Soon you may have the kind of results researchers produced at the University of Pittsburgh when they studied women who exercised 40 minutes, five times a week (Journal of the American Medical Association 9/10/03). Those women lost 25 pounds in six months.
Your results may be just as good or better!
Marilu Henner: Energy Personified!
June 14, 2005 11:50 AM
Marilu Henner: Energy Personified! by Stephen Hanks Energy Times, January 3, 2005
Marilu Henner is an actress, dancer and author, a health, fitness and cooking guru and a devoted mom. Now she's also an advocate for nutritional supplements. In this revealing interview, she offers her thoughts on the battle to support consumer rights and to create a better health care system in America.
"So, you want to know what my schedule is after I finish talking with you?" Marilu Henner says, in an almost breathless voice. "Today's Tuesday, right? Tomorrow morning I leave Los Angeles [where she lives] for New York City so I can do the Tony Danza Show first thing Thursday morning, Then, I take a 9 am flight back to LA because my son has a sleepover birthday party. I have a 7 am flight to New Jersey the next morning because I'm speaking about mental health at a conference at a big country club. The next morning, I catch a 7 am flight back to LA for my son's soccer games, one at noon and the other at 2. Whew!"
Trying to keep up with Marilu Henner would make anybody feel out of breath because the woman is energy personified. At 52, her schedule includes acting in movies, on television and in the occasional Broadway show, writing books (she's authored seven, including Total Health Makeover and Healthy Life Kitchen), teaching online diet and exercise classes through her website (marilu.com), taking Pilates classes three times a week and raising two sons, Nicholas (10) and Joseph (8).
But now, on top of all that, the former star of the TV show Taxi has become a health and nutrition activist, speaking out in favor of the use of dietary supplements whenever she can. This past September, Henner testified at a hearing of the House Subcommittee for Human Rights and Wellness to advocate increased funding for research and full implementation of the Dietary Supplement Health and Education Act (DSHEA). During her testimony, Marilu described why she believes consumers should have access to more information about supplements and why the products should be made more accessible through both government initiatives and private health plans. "I believe that dietary supplements should be part of a campaign to improve our nation's health," Henner testified.
Energy Times recently caught up with Marilu at her Los Angeles home for a freewheeling conversation. Here, this vibrant yet down-to-earth celebrity displays her passion for health, nutrition and consumer issues.
Energy Times: You've become one of the most high profile celebrities to advocate a consumer's use of dietary supplements. What was your motivation to get involved in such a public way?
Marilu Henner: As a teenager, I had been a yo-yo dieter. I could be around 135 pounds and balloon up to 174. I knew I needed a different way of looking at my life. I couldn't concentrate on those stupid diets where I could lose 20 pounds in a week and then gain it all back over a weekend. But after my mom died at 58 in 1978, I said to myself, "It's not really about my body anymore, it's really about my health." I just became obsessed with health. I read everything I could get my hands on. I starting taking human anatomy classes, going to medical libraries and seeing nutritionists and doctors. And I started experimenting on myself, turning myself into my own guinea pig. It took me about eight years to put together a program. I always say that my health birthday was 1979, but it wasn't until 1987 that I could say I was living a completely healthy lifestyle.
ET: Were you ever really heavy when you were performing in a show? MH: Sure. When I first performed the role of Marty in "Grease" more than 30 years ago I weighed about 175 pounds. But I hid it well. When you wear those 1950s clothes you can get away with it.
ET: When did you start incorporating supplements into your health program? MH: Before I became pregnant with my first son in 1993, I had never been a supplement taker. But I started taking prenatal vitamins and dietary supplements when I was breastfeeding and they made me feel really good. After the pregnancy, I just kept taking them because I was getting the essential nutrients that I couldn't get from food alone. I was getting great stuff from my food, but with all the travel I do-you know, the eating on planes and in restaurants-I couldn't always shop for organic food. I had a doctor who understood the value of dietary supplements and encouraged me to use them. I've taken them ever since and I recommend them to my family and friends, as well as to people through my books and classes.
ET: What supplements other than vitamins do you find helpful in your total nutrition program? MH: I take vitamin E, omega-3 fish oils, antioxidants, garlic, coral calcium and echinacea supplements.
ET: So let's get back to why you decided to testify before Congress in support of supplement use. MH: I know that as soon as you put a celebrity face on an issue, people tend to pay a little more attention. When I was in Washington, I was able to tell Congress the personal stories I've heard about people who turned their lives around-from debilitating illness to vibrant health-when they got the information they need to make good choices. By good choices, I mean rejecting the manufactured foods of our society, with their over-reliance on sugar, meat and dairy, and the chemicals, hormones and steroids that usually accompany these products. Instead, we should be moving towards an organic, vegan diet that produces a sense of physical health. I also believe that a healthy diet includes the use of appropriate dietary supplements.
ET: Do you think that government is moving fast enough to reduce the restrictions on safe supplements? MH: Things could always move faster. But I remember years ago writing letters on behalf of people who wanted supplements without needing a prescription. When I would tell people about the benefits of soy products or supplements, they'd think I was nuts. Now those ideas are mainstream. The floodgates are open and people want to know more. You can't even keep up with all the information. I think that the government knows they're not going to get away with making people have a prescription to take their vitamins.
ET: What is the citizen's responsibility in all this? MH: We're in a real transitional phase and people should take responsibility to educate themselves. You have to question your doctors and recognize when something is or isn't working. You have to find a health practitioner who really knows their stuff.
ET: As you said, there's so much information out there, how do you decipher it all? How can someone be an educated information consumer?
MH: I know it's very difficult because there are so many options. Believe me, I've been doing this a long time and I'm glad I did the research. I think you have to read everything. You have to find a nutritionist/herbalist/doctor who's the real deal and knows what they're talking about. You have to recognize the symptoms in your own body and try to figure it out. I think if you start out with a good multivitamin, a calcium supplement, fish oils and vitamin E, that can be your base and you can't go wrong.
ET: Isn't a diet built on buying organic foods much more expensive? MH: Sure, it's a little more expensive. But there's nothing more expensive than bad health. There's nothing more expensive than food being thrown away because it doesn't taste right. Organic fruit tastes so much better than the perfect-looking fruits and vegetables sprayed with pesticides.
ET: What's your advice to people who want to start a workout and weight-loss program? MH: I'm always saying to people, "Look, you walk your dog, your cat stretches, your hamster runs on a hamster wheel. You're an animal, too, so go move, go do something." I know a lot of people believe that when you want to lose weight you have to go on these 1,200-calorie-per-day diets.
Well, my weight is always between 120-124 pounds and I eat close to 2,000 calories a day, but everything I eat is of quality. And I burn a lot of calories because I wear comfortable shoes and I move around in my life. I'm always strong, I never get sick and I feel like an animal.
ET: How do you view the future of healthcare policy in this country and where do you think nutritional supplements fit in? MH: I strongly believe that the general public needs more access to dietary supplements to maintain essential good health. American research and development has come up with really great products, but the American Medical Association and the drug companies have stigmatized supplements. So what's the result? Most Americans don't have access to safe supplements because they are not covered by their health plans, nor recognized as effective by the federal government. This really needs to be changed.
I think we should take 90% of what we're spending on drugs that barely keep people alive and start spending it on prevention, nutrition and changing lifestyle habits. In this country we're all about curing the disease rather than curing the patient. We don't look at the patient holistically and try to find out how the disease developed. Your doctor should be in charge of keeping you well, not keeping you in that strange state of, what I call, "dis-ease." It's like the medical and pharmaceutical establishment wants to keep you just sick enough so you'll continue to be a paying customer. They've convinced people to think they've got to take a pill to cure themselves rather than use their own bodies.
ET: Do you think medical schools will start training doctors to treat patients holistically and focus more on preventative medicine?
MH: I think we're seeing a lot more nutrition and alternative medicine specialists these days. And the general public is becoming more aware of health and nutrition issues then they were years ago. There's this groundswell of people saying "Wait, I need more information. Wait, my doctor's no longer God. I can't just keep taking these pills and trying to figure out all these warning labels and side effects."
ET: Do you plan on becoming more politically active on these issues? MH: Absolutely, I want to work with any organization that wants to improve school lunch programs, improve the healthcare system and get people more involved in understanding nutrition and disease prevention.
Bone Power - Natures Plus
June 11, 2005 04:41 PM
Bone Power by no author Energy Times, May 1, 1997
Patricia Q. stopped smoking 20 years ago. At 61, she is active, tries to exercise regularly, eats properly and takes a multivitamin. Most would consider Patricia's lifestyle a sufficient safeguard against the diseases of aging. But one debilitating possibility still concerns her: Osteoporosis-bone thinning. She worries that her bones may have begun weakening almost a decade ago. Although her good health habits can slow the demineralization of her bones, osteoporosis may still take its toll. And as her neck and back begin to obviously round, a possible sign of bone weakness, Patricia frets about her future.
The weakening of bones brought on by age makes them more prone to fracture. One of every two women older than age 50 suffers an osteoporosis-related fracture during her lifetime. Osteoporosis literally means "porous bones," bones that deteriorate and particularly increase the risk of damage to the hip, spine and wrist. In extreme cases, everyday activities assume danger: fractures can result from simply lifting a bag of groceries or from what would otherwise be a minor fall. Some women, fearful of fractures, eliminate many seemingly innocuous activities from their daily lives. Their fear is well founded. Complications from these fractures are a major killer of women.
As women grow older, the risk grows, too. Ten million individuals already have the disease, and 18 million have low bone mass, placing them at risk for osteoporosis.
But research shows that osteoporosis may be preventable and controllable. Regardless of age, eating right, getting enough calcium and performing weight-bearing exercises, can lower your risk for this disease.
Understanding Your Bones
Bones are not static structures but living tissue constantly reformed in a process called remodeling. Every day old bone is removed and replaced with new bone tissue. When more bone is broken down than is replaced (demineralization), bones weaken. When the structure loses sufficient density, you face eminent danger of a fracture.
Generally speaking, bones continue to increase their density and calcium content until you reach your 30s, at which point you probably have attained your peak bone mass. Afterward you may either maintain this mass or begin to lose calcium yearly, but you rarely can increase bone density. The loss of bone density can increase at menopause, when your body ceases producing estrogen, a hormone required to improve bone strength. In addition, some medications, used for a long period, compromise bone density.
Stop Calcium Loss
Eating a diet rich in nutrients that help your bones stay strong should be the first step in stopping or slowing the process of osteoporosis. Calcium, magnesium, vitamin D, phosphorus, soy-based foods and fluoride compose the major nutrients that strengthen bone.
At this moment, 98 percent of your body's calcium resides in your bones, the rest circulates in the blood, taking part in metabolic functions. Because the body cannot manufacture calcium, you must eat calcium in your daily diet to replace the amounts that are constantly lost. When the diet lacks sufficient calcium to replace the amount that is excreted, the body begins to break down bone for the calcium necessary for life-preserving metabolic processes.
Calcium in the diet can generally slow calcium loss from bones, but it usually doesn't seem to replace calcium already gone. The National Institutes of Health recommend 1000-1200 milligrams of dietary calcium per day for premenopausal women and 1200-1500 milligrams for menopausal and postmenopausal women
Good sources of calcium include milk and milk products, yogurt, ricotta, cheese, oysters, salmon, collard greens, spinach, ice cream, cottage cheese, kale, broccoli and oranges.
If you cannot tolerate dairy products, calcium supplements are an easy way to consume calcium. Take supplements with a meal to aid absorption of calcium from the stomach.
In Total Health for Women, Dr. Kendra Kale, clinical assistant professor of medicine at the University of Pennsylvania School of Medicine, urges women to read supplement labels. Scrutinize the fine print to see how many grams are considered "elemental"or "bioavailable"-the form of calcium your body will absorb. If you're taking a 750 milligram supplement, chances are only 300 milligrams are elemental. You should also check that the pill will dissolve within 30 minutes and meets the United States Pharmacopoeia (USP) standards. If tablets do not break down within 30 minutes, they may pass through you unabsorbed and you won't digest the calcium from them that you need.
Absorbing calcium from your digestive tract also requires the presence of vitamin D. Ten to 15 minutes of sun exposure daily usually satisfies vitamin D requirements since most people's bodies can use sunlight to manufacture this substance. So walking to work, or going outside for lunch should supply sufficient ultraviolet light to facilitate calcium absorption.
As we age, however, our body's ability to produce vitamin D gradually diminishes. Our diets can make up the difference: Good dietary sources of vitamin D include egg yolks, liver and fish or nutritional supplements. Many foods, like milk, are supplemented with vitamin D.
Magnesium is another mineral that helps to build bones. Found in leafy, green vegetables, nuts, soybeans, seeds and whole grains, your daily requirement of magnesium should be about half of your calcium intake.
Absorbing calcium for bone health also requires phosphorus, but be careful not to get too much of a good thing: excess phosphorus can actually increase your body's need for calcium. This can present a problem for people who drink bottle after bottle of cola soft drinks or who eat an abundance of processed foods which are often high in phosphorus.
New Soy Research
New research suggests that soy foods, like tofu or soy milk may be vital for preserving bones. A study of more than 60 postmenopausal women who consumed either diets rich in soy's isoflavones or milk protein found that eating soy restored calcium to some of the women's bones. Even though the researchers didn't think such a replacement due to soy was even possible!
The researchers at the University of Illinois believe that isoflavones behave in the body in some of the same ways that estrogen does. The study measured bone density at the lumbar spine, a part of the body at the small of the back that is liable to fractures due to osteoporosis.
Fluoride: Not Just For Teeth
Although most people associate the mineral fluoride with strong teeth, fluoride is just as important for bone strength. Surveys report that osteoporosis is reportedly less common in communities that drink fluoridated water. Fluoride combines with calcium in the bones to slow mineral loss after mid-life. Good sources of this mineral include fish, tea and most animal foods.
Cut Back on Alcohol and Coffee
According to the National Osteoporosis Foundation, consuming lots of caffeine is thought to increase the calcium excreted in your urine. In addition, high levels of protein and sodium in your diet are also believed to increase calcium excretion. And although more studies of protein and sodium are needed to precisely determine how these substances influence calcium loss you should limit the caffeine, protein and salt you take in.
On top of those findings, researchers say that the diuretic action of alcohol and caffeine speed skeletal calcium loss. They believe alcohol may interfere with intestinal absorption of calcium.
Along with a bone-friendly diet, your exercise program should also be designed to preserve bone. Weight-bearing exercise-exercise that places stress on the bones-strengthens bone density and wards off osteoporosis. Weight-bearing exercises include weight lifting, walking, jogging and jumping rope.
Exercise possesses many benefits for preserving bone, according to Miriam Nelson, Ph.D., author of Strong Women Stay Young. Among them: exercise can help you retain the balance necessary to resist falls and strengthen the muscles that keep you erect. Studies performed on women of all ages found that by doing strength training exercises two times a week for a year, without use of estrogen or hormone replacement therapy (HRT), women, on average, added three pounds of muscle and lost three pounds of fat. They were also 75 percent stronger with improved balance and bone density.
Although strength training can be performed by anyone at any age, Nelson recommends that if you have an unstable medical condition or if you have recently undergone surgery, wait until you recover and speak with your doctor before beginning an exercise program. If you have not exercised in a long time, consult a health practitioner knowledgeable in sports medicine before beginning an exercise program.
Drug therapies are now available to combat osteoporosis. One of the most popular is HRT, which supplies estrogen to women undergoing menopause. However, medical experts are still arguing over HRT 's possible role in increasing your risk of cancer, particularly breast cancer.
According to Jan Rattner-Heilman, co-author of Estrogen, the Facts Can Change Your Life, the conflicting studies that balance the benefits and risk of HRT are bound to confuse the average consumer. Estrogen is recommended to prevent bone loss and forestall heart disease and possibly Alzheimer's disease. Most women take estrogen to ease the discomforts of menopause such as hot flashes, and many experts do not believe that it unduly increases the risk of breast cancer for those at low risk.
Heilman warns, however, that estrogen probably should not be taken by women especially at risk for breast cancer risk or those who are already suffer the disease.
Patricia Q. is reluctant to try HRT. "I'm at risk for breast cancer-my mother had it-so I won't take estrogen. I'd rather do what I can without medications. My preference is to watch my diet and exercise as much as I can. That gives me my best chance to avoid osteoporosis."
Doctor Nelson agrees with this perspective She believes that exercise possesses enough benefits to make it the treatment of choice. "The difference between estrogen and strength training is that strength training has a huge spillover effect; you aren't just decreasing one type of disease. You become stronger with more muscles and less fat, and you become more fit. This decreases your chances for many types of diseases, not just osteoporosis. It can decrease risks for heart disease, diabetes, sleep disturbances, hypertension and more."
If you believe you are at risk for osteoporosis, ask your doctor about the benefits of bone mineral density screening. DEXA scan (dual energy x-ray absorptiometry) measures the bone density in a 15-minute test. But the test is expensive: the cost of this test ranges from $75-200 or more and may not be covered by your health insurance. But financial help may be on the way. A Bone Mass Standardization Act has been introduced in Congress to ensure that the cost of bone mass measurement is covered under Medicare and that standards for coverage are clear and consistent for anyone with medical insurance.
Fighting Osteoporosis at Different Ages
Childbearing years (30-40): These years are particularly important for preserving bone through exercise and good nutrition. Eat plenty of low-fat dairy products, vegetables and soy. Perform weight-bearing exercise such as walking, jogging and weight lifting to attain the greatest amount of bone and muscle possible. Being active reduces risk of injury and makes you stronger. If you smoke, now's the time to stop.
Menopausal years (late 40s-50s): During this time, muscle, bone and estrogen decreases. Minimize loss through diet, walking and weight lifting. Your exercise intensity may have to be decreased but you should not stop being physically active.
Post Menopause (over 60): Focus on reducing your risk of falling. Minimize balance problems and increase muscle strength through exercise.
Federal Court Overturns FDA Ban on Ephedra at Low Doses
June 09, 2005 08:41 AM
Federal Court Overturns FDA Ban on Ephedra at Low Doses
by Rakesh M. Amin and Mark Blumenthal
A Utah Federal District Court recently limited the scope of a year old Food and Drug Administration’s (FDA) Final Rule1 banning the sale of all ephedrine-alkaloid dietary supplements.2 The Court’s ruling has a limited affect on the ability of companies to sell ephedrine nationally, but is important regarding FDA procedure for creating rules and enforcement powers. Ephedrine alkaloids are found primarily in the controversial herb ephedra (Ephedra sincica Stapf., Ephedraceae).
The District Court determined that the FDA’s use of a risk-benefit analysis was against the intent of Congress in passing the Food, Drug and Cosmetic Act,3 which presumes all foods are safe and requires the FDA to prove the existence of a significant or unreasonable risk. The court held that to require food producers to establish a benefit before selling their product places an improper burden on them and was inconsistent with Congress’s intent when it passed the Dietary Supplement Health and Education Act of 1994 (DSHEA) to clearly place the burden of proof of safety of a dietary ingredient on the FDA.4
Secondly, the court determined the FDA had to show by a preponderance of the evidence “a significant or unreasonable risk of illness or injury.”5 Therefore, in order to ban all sales of a given product, the FDA must first prove that the dosage amount in the product presents an unreasonable risk.6 Prior to this ruling, the FDA was not required to consider dosage size before banning a substance.
This ruling has limited effects at the moment since the FDA may appeal this decision. Additionally, the ruling has no effect on the laws of several states (including California, Illinois and New York) which have banned all sales of ephedrine alkaloids in dietary supplements. The ruling also only applies to products containing 10 mg or less of ephedrine alkaloids per daily dosage. Any product exceeding that amount is still banned and will continue to be enforced under the FDA rule.7
The court, in its ruling, specifically precluded the FDA from taking any enforcement action against Nutraceutical Corporation, the company that filed the lawsuit, for its sale of products containing 10mg or less of ephedra and for the FDA to consider further rulemaking “consistent with this Order”.8 However, the court did not specifically instruct the FDA to refrain from taking enforcement action against other brands containing less than 10mg of ephedrine.9 As such, companies considering launching new products containing ephedrine alkaloids are advised to do so carefully.
Nutraceutical Corporation president Bruce Hough was cited in The New York Times as saying that the company’s reason for filing the suit was not based on ephedra and that his company had no plans to begin marketing ephedra supplements in the near future.10 Hough was quoted as saying, “We filed it [the lawsuit] because the FDA established rules that could cause problems to the rest of our business.” Hough was referring to the legal basis upon which the FDA banned the sale ephedra. He told the American Botanical Council that the FDA was applying a drug standard of risk vs. benefit to herbs and dietary supplements – technically foods under the law. [Hough B. Personal communication to M. Blumenthal, Apr. 27, 2005.] His company filed the lawsuit in an attempt to deter FDA’s new procedure for creating what he considered arbitrary rules which contradict the plain meaning of existing federal law (DSHEA).
The American Herbal Products Association (AHPA) issued a statement on April 26 clarifying its policy on the sale of ephedra in dietary supplements.11 AHPA has notified all its members that at this time it is the organization’s policy that none of its members should be selling low doses (10 mg or less) of ephedra in dietary supplements until the FDA has clarified its position on the Court decision. At this time it is not clear whether FDA plans on appealing the decision or will implement the new policy set by the Court.
The court decision does not affect the sale of the herb ephedra in traditional formulations intended for use that is consistent with traditional uses, e.g., pulmonary complaints, and are dispensed by licensed healthcare practitioners.
As might be expected, court’s decision has stimulated a new round of media and Congressional criticism of the relative safety of herbs and dietary supplements as well as DSHEA. For example, a highly critical article by Chris Mooney was posted on the website of the American Prospect on April 25.12 The Prospect is relatively influential in Democratic and progressive political circles in Washington. The article uses language such as the court decision is a “scandal” and a “disturbing ruling”, refers to DSHEA as “a terrible law” and a “peculiar and misguided law” and the “wrongheaded standards encoded in the DSHEA”, and repeats the often-cited media mantra about “unregulated herbal supplements” and that the “FDA has been hamstrung and effectively rendered impotent.”
More information regarding the sale of ephedrine products or FDA regulations in general is available from the law offices of Rakesh M. Amin at (312) 327-3382 or firstname.lastname@example.org.
1 21 C.F.R. Pt. 119, Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (Published February 11, 2004) (Effective April 12, 2004) available at /dockets/98fr/1995n-0304-nfr0001.pdf
2 Nutraceutical Corporation and Solaray, Inc. v. Lester Crawford, D.V.M., Acting Commissioner, U.S. Food and Drug Administration, et al., Case No. 2:04CV409TC, U.S. District Court for the Central District of Utah; available at gov/reports/204cv409-28.pdf
Its not about Ehpedra -- its about DSHEA ...
May 24, 2005 08:58 AM
On april 14th 2005, a federal court in UTAH Ruled against the FDA's ban on low dose ephedra products. The plaintiffs were Nutraceutical Corporation and its subsidiary Solaray. They sued not just to protect their ephedra product, but to protect your access to other supplements. Why did they sue and what does this mean for you?
Media and Political Rhetoric Vs. Real Science
Protecting DSHEA and your access to dietary supplements
Why did Nutraceutical challenge FDA's actions?
Why did FDA Ban Ephedra?
What did the court Decide?
How does the Decision affect me?
Does the ruling mean that ephedra is safe?
What's Next for Ephedra?
What can I do to protect my access to supplements?
Let your Congressman and Senators know that access to supplements is important to you. A useful website for contacting them is: www.saveoursupplements.org
contact Nutraceutical by email at: Savesupplements@nutracorp.com
Note: Solaray® Whole herb ephedra was formulated to have 10mg or less ephedrine alkaloids per daily dose(two servings). © Nutraceutical corporation...
Study Says Supplements Could Save Billions in Health Care Costs
May 09, 2005 05:52 PM
Study Says Supplements Could Save Billions in Health Care Costs
A study released at a House subcommittee hearing in late September on the cost savings and health benefits of selected dietary supplements projected a $15 billion reduction in health care costs over a five-year period from calcium and folic acid.
The study, commissioned by the Dietary Supplement Education Alliance (DSEA) and conducted by the Lewin Group, found that the five selected supplements—omega-3 fatty acids, glucosamine, and saw palmetto along with calcium and folic acid—could make a significant impact on health care costs while positively affecting consumers’ health status. DSEA asked the Lewin Group to put a dollar figure on the benefits of calcium and folic acid because the Food and Drug Administration (FDA) allows health claims on products containing these nutrients.
Since the study began, FDA also authorized qualified health claims on omega-3s, and the National Institutes of Health has implemented large-scale studies of saw palmetto and glucosamine.
“Many industry experts have long believed that dietary supplements provide consumers with long-term health benefits by reducing the incidence of debilitating health problems, and this study proves it,” said Elliott Balbert, president and CEO of Natrol, Inc. (Chatsworth, CA) and president of DSEA. “The findings provide evidence to support both the cost savings and quality-of-life benefits of these particular supplements.”
DSEA commissioned the Lewin Group to critically review the research literature on the five supplements for consistency, validity, and impact (i.e., size of the effect; to develop estimates of the potential health care expenditure savings that could result from daily use of two of the supplements; and to suggest areas of future research for supplements where there is emerging evidence. The Lewin Group arrived at the $15 billion figure by focusing on two specific health issues: hip fractures (including hospital and nursing facility expenses) in the case of calcium along with vitamin D, and neural tube defects in the case of folic acid. Joan DaVonzo, vice president of the Lewin Group, said at a news teleconference following the Sept. 22 hearing that the savings in health care costs from supplementing calcium intake might be even larger than the projected $13.9 billion if other types of fractures were included.
Dr. Jeffrey Blumberg, professor of nutrition at Tufts University and one of the witnesses who testified before the House Subcommittee on Human Rights & Wellness chaired by Rep. Dan Burton (R-IN), told reporters the health benefits—and potential cost savings—of folic acid supplementation went far beyond the $1.1 billion estimate for neural tube defects. He said folic acid has been shown to help prevent other types of birth defects as well as reducing the risk of cardiovascular disease and certain types of cancer. “It’s not a one nutrient/one disease relationship,” Blumberg said.
“Research shows that the typical American diet does not always provide a sufficient level of nutrients. This study just reveals the tip of the iceberg in the ability of supplements to contribute to a healthier America,” said Elwood Richard, president and founder of supplement manufacturer NOW Foods (Bloomingdale, IL), in response to the study.
DaVonzo acknowledged that the potential for the five supplements studied went beyond the dollar figures projected in the study. For instance, in the case of saw palmetto and its reported prostate health benefits, “The impact could be huge,” she said.
“It’s no surprise to anyone in the industry that dietary supplements are safe, affordable, and effective, and this study not only confirms that statement, but will, more importantly, reach an audience well beyond industry,” said David Seckman, executive director and CEO of the National Nutritional Foods Association. “An even more critical finding is the fact that dietary supplements can dramatically cut health care costs if used regularly—a point that won’t be lost on any American consumer, the media, and lawmakers aware of the staggering—and rising—cost of health care in this country.”
To help spread the message beyond the halls of Congress, DSEA prepared an audio news release and was organizing a satellite media tour. DSEA vice chairman Jon Benninger said the hope was to commission followup studies on other nutrients “as funding allows.” Vitamin Retailer Magazine, Inc., 431 Cranbury Road, East Brunswick, NJ 08816 //www.oprmagazine.com/