SearchBox:

Search Term: " Ruling "

  Messages 1-9 from 9 matching the search criteria.
5 Reasons the DEA's Marijuana Ruling Is Absurd and Indefensible Darrell Miller 12/31/16
Long-Sought Food Labeling Law Underway Darrell Miller 3/19/09
Supplements for Children Darrell Miller 6/26/07
Supreme Court Refused Ephedra Appeal… Darrell Miller 5/17/07
Ban against ephedra supplements at any does upheld. Darrell Miller 8/22/06
Product Resurfaces under a new name - from HSI - Health Sciences Institute Darrell Miller 7/8/06
Federal Court Overturns FDA Ban on Ephedra at Low Doses Darrell Miller 6/9/05
LYCOPENE - Tomatoes Like You’ve Never Seen Them Before ... Darrell Miller 6/3/05
Its not about Ehpedra -- its about DSHEA ... Darrell Miller 5/24/05




5 Reasons the DEA's Marijuana Ruling Is Absurd and Indefensible
TopPreviousNext

Date: December 31, 2016 11:59 AM
Author: Darrell Miller (support@vitanetonline.com)
Subject: 5 Reasons the DEA's Marijuana Ruling Is Absurd and Indefensible





On December 14, 2016, in the Federal Register, DEA Acting Administrator Chuck Rosenberg made cannabis a Schedule I controlled substance by making it illegal to use. People suffering from medical issues often use cannabis (CBD) and CBD oil in their treatment. Opponents to the new classification argue that cannabis should not be included in Schedule 1 drugs. For starters, they say it’s not psychoactive, addictive, or dangerous. Also, the US government has conducted research on the drug and concluded that it has medical benefits. In addition, it has been helpful in treating other coditions, like seizures and schizophrenia.

Key Takeaways:

  • That last bit about treaty provisions? That’s the justification for the move. It’s meant to make the United States more compliant with treaties and agreements involving drug and narcotics control.
  • It’s an extract that has promising medical value, and by placing it under the Schedule I umbrella, the DEA is doing more harm than good.
  • They’re basically taking medicine from sick people with this move. It’s really hard to justify. Maybe even an indefensible move.

"While it’s possible to abuse marijuana (along with anything else), dependence and addiction are rare."



Reference:

https://www.google.com/url?rct=j&sa=t&url=//www.cheatsheet.com/culture/reasons-the-dea-marijuana-Ruling-is-absurd-and-indefensible.html/%3Fa%3Dviewall&ct=ga&cd=CAIyGmM2M2RhZjlmZTVmZDZjMmU6Y29tOmVuOlVT&usg=AFQjCNH3OlhWCT6Ee4sJs2zpnyWswy_1eQ

(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=3723)


Long-Sought Food Labeling Law Underway
TopPreviousNext

Date: March 19, 2009 04:55 PM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Long-Sought Food Labeling Law Underway

Shoppers will have more information about where their food comes from under a new policy, which started this week. Labels on most fresh meats, along with some fruits, vegetables and other foods, will now list where the food originated. In the case of meats, some labels will list where the animal was born, raised and slaughtered.

This is good news to most American that fear they eat foods imported form countries who do not have dumping regulations. Meaning some foods could be grown right next to a land fill that has all kinds of toxins brewing in it. Unhealthy to any who consume these foods.

Commodities covered under COOL must be labeled at retail to indicate its country of origin. For fish and shellfish, the method of production, wild or farm-raised, must be specified. Commodities are excluded from mandatory COOL if the commodity is an ingredient in a processed food item.

Hopefully more manufactures will comply with the new Ruling and go beyond the standards to help Americans make a sound choice at the grocery store.



--
Vitanet ®, LLC

(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=1980)


Supplements for Children
TopPreviousNext

Date: June 26, 2007 09:51 PM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Supplements for Children

Supplements for Children

 

While most parents try hard to make nutritious meals for their family, most children find the appeal of refined, fast, and junk food simply overwhelming. And, sadly, increasingly easy to buy and consume, as well. From kindergarten through 12th grade, in both grade schools and high schools, vending machines offer calorie laden candy bars, sugar-filled soft drinks, and snack foods loaded with fat and salt. Many school cafeterias actually sell fast-food to children for lunch every day. In fact, it seems almost everywhere children go and gather, visually enticing but nutritionally lacking snacks and soft drinks are sure to be available.

Determined to counteract this disturbing trend, parents everywhere are urgently seeking solutions to help their children get the nutrition they need. One answer is supplemental multivitamins. There are certainly plenty of multivitamins formulated for children currently on the market. However, these products vary considerably in quality and content. Some lack certain vital nutrients. Some taste terrible. Still others are loaded with sugar and artificial flavorings. The good news is that there are superior multivitamins and exceptional immune boosting products formulated specifically for children that actually taste great. In this issue of Ask the Doctor, we will discuss childhood nutrition and how to help ensure your children’s health with high quality, 100% natural flavored nutritional supplements.

 

Q. Do children really benefit from vitamin supplements? Can’t I make sure they get the vitamins and minerals they need from meals?

A. Even the most nutritionally vigilant parent cannot be 100% certain what nutrients are in the food they serve their children. That’s because there’s so much variability in the food we prepare. For instance, fat-soluble vitamins can withstand normal cooking, but vitamins A and E are gradually destroyed by exposure to air. Water-soluble vitamins such as B1, B6, folic acid, and pantothenic acid are destroyed by heat. Vitamin B2 is destroyed by light and heat, while light and air destroy vitamin C. Certain food preservatives and preparation methods also destroy the vitamins in food. To further complicate matters, some fruit and vegetables are grown and harvested in such a way that does not promote nutrient content – so even raw foods may be lacking.

Then there are those crazy food phases all children seemingly go through. While these phases are generally harmless in the long run, a recent alarming exception was in the news. A five-year old boy ate nothing but cheese pizza, Pop-tarts, biscuits, and water, refusing fruits, vegetables, juices and vitamins. He slowly developed limp, swollen gums, and small purple spots appeared on his skin. After five months of this extremely deficient diet, he was unable to walk or get out of bed because the pain was so severe. Doctors diagnosed the boy as having a severe vitamin C deficiency after Ruling out other ailments such as leukemia. Within a week of getting vitamin C supplements, the boy’s pain and other symptoms were completely resolved. Obviously, this little boy’s story is unusual. However, even mild food phases (such as “If It’s Green It Must Be Yucky” or “The Only Good Crust Is A Cut-Off Crust”) can result in awfully lop-sided nutrition.

 

Q. Can multivitamins help my child’s performance in school?

A. Most teachers firmly believe that nutrition and learning go hand in hand. They are convinced that children who are well nourished possess the mental stamina that’s needed to learn and retain even difficult concepts. But can multivitamins help children become better students?

Two independent research teams recently conducted randomized trials to find the answer. The researchers followed 245 school-children aged 6 to 12 years for three months. They gave half of the children multivitamin tablets every day, and half of the children placebos. When the children were tested, the children in the multivitamins group showed an increase in their nonverbal intelligence scores. Nonverbal intelligence is closely associated with academic performance.

 

Q. I can’t get my children to take 100% natural flavored multivitamins because they don’t taste very appealing. Isn’t there some way to make a 100% natural multivitamin taste good enough for my children to willingly take?

A. Yes, there is! Because most children need chewable multivitamins, manufacturers need to contend with the truly terrible taste of certain minerals. Magnesium, iodine, copper, and iron are probably the worst tasting. Some solve this dilemma by skimping on the amounts of these minerals in their children’s formulas. Others cover up the bad taste with either massive amounts of sugar or artificial flavors, or both.

However, a select few multivitamin makers have discovered how to offer a natural flavored, great tasting children’s multivitamin that contains these vital minerals. The best children’s vitamins are prepared in a base of natural fruit that provides both antioxidants and other healthy phytonutrients. Children’s multivitamins made in such a fruit base have very low sugar content, as well, providing as little as four calories a day. Fructose – fruit sugar – is the preferred sweetening agent, in addition to the fruit content.

 

Q. What vitamins should be in a multivitamin for children?

A. There are several vitamins and minerals that children need to take each and every day. They include biotin, folate, niacin, pantothenic acid, vitamins B12, B1, A, B6, C, D, E, and K. Let’s review a few. We’ll start with folate, one of the B vitamins. This vital vitamin helps the body use protein, helps make DNA, helps cells grow and divide, and keeps the nervous system healthy. In fact, folate is so important to children that the Food and Drug Administration (FDA) mandated that folate must be added to many foods most children eat daily. Since 1998, cereal, enriched bread, flour corn meal, rice, and pasta have been folate-fortified with this B vitamin.

One of folate’s vital actions is the reduction of homocysteine levels in the blood. Homocysteine is an amino acid (the building block of protein) that is normally produced in the human body. Research has shown that high levels of homocysteine can irritate blood vessels, make blood clot more easily than it should, and cause blockages in arteries increasing the risk of heart attacks and strokes .

However, study after study has proven that taking folate reduces harmful homocysteine levels. While most of this research has been in adults, a recent study looked at children’s homocysteine levels. Researchers examined over 3500 children and discovered that high homocysteine levels increased the risk for heart disease in these children, especially as they grow. The researchers leading this study reinforced how critical folate is for all children.

Other critical vitamins for children are the vitamins C and E. The rates of childhood asthma have increased significantly here in the US. There seem to be several reasons for this troubling trend, including environmental pollution and changes in the earth’s atmosphere. However, when vitamin C and vitamin E are given to children with asthma, they are able to breathe better and feel much better, too. It seems C and E, both antioxidants, keep asthmatic bronchial tubes from constricting which results in wheezing less and breathing better.

 

Q. Which minerals do children need?

A. It is absolutely crucial that children get calcium, chromium, iron, magnesium, manganese, selenium, zinc, and phosphorus every day. Sadly, however, the majority of our children are not getting the recommended amounts of many of these vital minerals. Children in America today drink more carbonated soft drinks than milk and are in the midst of a calcium crisis. Green leafy vegetables, another good calcium source, are also negligible in teen diets.

According to statistics from the National Institutes of Health, only 13.5 percent of girls and 36.3 percent of boys age 12 to 19 in the United States get the recommended daily amount (RDA) of calcium. Because almost 90 percent of adult bone mass is established by the end of this age range, children today are in danger of being part of an osteoporosis epidemic in the future as they enter late adulthood.

Lack of adequate calcium has immediate consequences for children, as well. The number of fractures among children and young adults has increased as a direct result of poor calcium intake. Pediatricians are also seeing children with rickets, a bone disease caused by low levels of vitamin D. Rickets became almost nonexistent after vitamin D was added to milk in the 1950s, but, due to lower milk consumption, is now appearing at greater rates around the country. And milk itself can be problematic for some children. Aside from alarming reports of hormones and herbicides in commercial dairy factory milk, even organic milk is not tolerated by all because of lactose intolerance and allergies.

Zinc is another mineral that’s vital for children. Because zinc is critical for normal growth and development, children need to take it every day. A study published in the Journal of the American Dietetic Association, however, found more than half of US children ages two to 10 years fail to get the recommended daily allowance (RDA) for zinc. What’s even more troubling is that zinc is vitally connected to children’s ability to process information, pay attention, as well as remember and retain new information

Zinc does a lot to keep children healthy. More than 200 enzymes in our bodies rely on zinc. However, it’s zinc’s ability to connect with our immune systems to help fight infections that is crucial for children. While researchers are not certain how zinc precisely boosts a child’s immunity, they think that zinc might fight pneumonia and other infections by either enhancing the body’s immune status, preventing the infection from establishing itself, or improving the immune system’s ability to rid itself of the infecting organism. It’s possible that zinc does all three.

 

Q. No matter what I do, my children seem to come down with bad colds each year. Besides giving them a multivitamin, are there other nutritional supplements that can keep my children healthy?

A. Absolutely! In fact, there are 100% natural flavored children’s immune formula nutritional supplements that contain their good buddy zinc, vitamins B6, C, and A (as beta carotene), plus elderberry extract. Elderberry extract has been used as a traditional medicine for hundreds of years to treat colds and flu. And as it so often happens, scientific research has validated this use. In fact, scientists have discovered that elderberry keeps viruses from invading other cells and replicating. It also spurs important immune cells into action to fight invading germs.

While we previously discussed vitamin C’s ability to help children with asthma breathe easier, it also provides powerful immune protection. It speeds up the healing of wounds, such as those knee and elbow scrapes so common in childhood. However, vitamin C is a water-soluble vitamin and can’t be stored in the body. It must be replenished every day. When children are under increased stress (like when they get sick with a cold or flu), their vitamin C levels are more rapidly depleted.

Vitamin B6 is also water-soluble and can only work in children’s bodies for eight hours. Then more B6 must be obtained. Vitamin B6 strengthens the immune system by helping white blood cells make antibodies. Vitamin A helps make lysozymes, important anti-infectious agents found in tears, saliva, and sweat. It also stimulates the thymus gland, an important immune organ, especially in children, to work better.

 

Q. Should children take an immune formula every day or only when they are sick?

A. It can be taken several ways. Some parents may want to give the formula when school first starts or other times that their children are exposed to lots of germs. For a child who suffers from asthma or seasonal allergies or just seems to get sick frequently, parents could provide the immune formula every day, increasing the dose when needed. And still others might feel it’s best to give their children the immune formula only whey they do catch a cold or have the flu.

No matter how it is given, the 100% all natural flavored, immune boosting nutritional supplement can provide powerful protection against all those disease-causing germs your children are exposed to every day.

 

Conclusion

The nutritional choices we make for our children today will have a profound effect on their health tomorrow. Recent research has revealed that diabetes, heart disease, obesity, osteoporosis, and cancer in adults often result form nutritional deficiencies that occurred in childhood.

Thankfully, the reverse is just as true. This means that children who are well nourished with an optimal intake of minerals, vitamins, and helpful herbs can grow into healthy and happy adults. Providing high quality multivitamins and immune boosting nutritional supplements for our children can be an important part of that process.

 



--
Vitanet, LLC

(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=1578)


Supreme Court Refused Ephedra Appeal…
TopPreviousNext

Date: May 17, 2007 01:39 PM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Supreme Court Refused Ephedra Appeal…

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.

Nutraceutical Line Brands:
Solaray - Ultimate Nutrition - Actipet Pet supplements - Action Labs - Sunny Greens - Thompson nutritional - Natural Sport - Veg Life Vegan Line - Premier One - NaturalMax - Kal

(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=1538)


Ban against ephedra supplements at any does upheld.
TopPreviousNext

Date: August 22, 2006 11:48 AM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Ban against ephedra supplements at any does upheld.

A three-judge panel of the 10th U.S. Circuit Court of Appeals in Denver late last week overturned a 2005 Ruling by a Utah district court that had allowed the sale of low-dosage ephedra dietary supplements containing 10 milligrams or less of ephedrine alkaloids.

The appellate decision, which is effective immediately, supports FDA’s original determination that no dosage of ephedra is safe for consumption and means that it is unlawful to manufacture and sell any supplements containing ephedra, even products containing low doses of the herb.

The original ban was challenged in a May 2004 lawsuit by Nutraceutical Corp, and its subsidiary Solaray Inc., which said dried whole-herb ephedra sinica - the type of supplement in their products – had been safely used for thousands of years.

The U.S. district judge in Utah blocked any enforcement action against Nutraceutical for selling supplements containing 10 milligrams or less of ephedra per daily dose. The Utah District Judge said FDA’s process in banning ephedra improperly shifted the burden of proving product safety from the government to supplement manufacturers.

While noting that the Dietary Supplement Health and Education Act of 1994 (DSHEA) categorized dietary supplements as foods and are not, therefore, subject to premarket approval by FDA, the appellate panel found that the Utah district court had interpreted this basic provision to narrowly.

The panel said that the Food, Drug and Cosmetic Act (FDCA), of which DSHEA is a part, should not be interpreted “too restrictively” but should instead be read in a manner “consistent with the statute’s overwhelming purpose to protect public health.”

Nutraceutical’s attorney has indicated that the company would appeal the Ruling to the full appeals court.



--
Vitanet keeping you up to date on supplement Laws!

(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=1354)


Product Resurfaces under a new name - from HSI - Health Sciences Institute
TopPreviousNext

Date: July 08, 2006 01:55 PM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Product Resurfaces under a new name - from HSI - Health Sciences Institute

You may remember the outrageous Ruling resulting scandal surrounding Lane Labs MGN3 product back in july 2004. essentially, the FDA forced the company to stop selling the product—not because it was dangerous or ineffective but because the FDA felt that Lane Labs marketing language made disease clams allowed only for FDA-approved drugs.

When that happened, everyone who had experienced great results with this immune system booster (including many HSI members) suddenly found themselves without a safe and effective product they could rely on. So we promised that we would keep a lookout for a natural and effective therapy that would provide similar benefits to the outlawed MGN3 formula.

But we’re officially calling off the search. A new product called PeakImmune4 was introduced in july 2005. but as it turned out, Peakimmune4 really isn’t new at all. It actually contains the same active ingredients as MGN3—it’s just being sold by a different company under a different name.

When products change names and hands, it can be co concerting. And I have to admit that at first, this seemed kind of fishy to me. so I did some digging to find out if Peakimmune4 was really all it was cracked up to be. What I realized at the end of this winding trail was that to best understood the story, you need to start at the beginning.

Connecting the dots

In 1992, Daiwa Pharmaceutical began developing Rice Bran Arabinoxylan Compound (RBAC). RBAC does right to the source of ultimate health: your immune system. Human clinical studies have proven that RBAC can more than triple the activity of Natural Killer cells, the body’s first line of defense against disease like cancer, HIV, and hepatitis. Studies also show that RBAC increases two other vital immune system cells: T cells and B cells.

Daiwa, which is based in Tokyo, Japan, licensed this patented formula to Lanes Labs, which sold it in the U.S. under the trademark MGN3. (We first told you about it back in 1999 in the June Issue of your Members Alert). But then in July 204, the government stepped in and barred Lane Labs from selling MGN3 (in addition to two other products). The FDA did not, however outlaw RBAC, the compound from which the product was make.

Daiwa, was left with a great product but no way to market it in the U.S. that’s when they decided to branch out and open their own company in the states, Daiwa Health Development, so they could continue to offer RBAC and introduce other Daiwa supplements to the market.

In July 2005, Daiwa launched Peakimmune4. it may be hard to find a connection between these two products because you wont find MGN3 mentioned in any of Peakimmune4’s promotional materials. That’s because the court did more than just forbid Lane Labs from selling MGN3. it also stipulated that the MGN3 brand name could not be used in marketing and promotion of supplements made from the same active ingredient, and that products could not be promoted as a replacement or substitutes for MGN3.

However, you can rest easy knowing that this product uses the same active as MGN3, which means the same solid research backs it up.

Recommendations for healthy immune system

Many immune system products require you to cycle on and off. But since Peakimmune4 does not lose effectiveness over time and doesn’t cause the immune system to attack itself, you can take it regularly without worrying about side effects.

Dr, Martin Milner, medical adviser to HIS, has used the RBAC compound for years. He has monitored its effectiveness in his own patients by testing their NK cell response. Milner confirmed clinically that his patients have retained increased levels of NK cell activity even when they used the product for prolonged periods of time.

For the best results, you should follow two simple steps: first, take four capsules three times a day for four weeks (before or after a meal). Then, after four weeks reduce dosage to the maintenance level of four capsules daily. You can find Peakimmune4 at most health food and vitamin stores. And don’t be surprised when it pops up in your doctor’s office under the name BRM4.

If you decide to try Peakimmune4 to support your immune system health, you should work with your health care professional, especially if you are pregnant, are nursing, are being treated for any medical condition, are currently taking medications, or have been diagnosed with a health disorder. And if you are taking immunosuppressant drugs for an organ transplant, you should NOT take a product with RBAC in it, each capsule contains 250mgs of Rice Bran Arabinoxylan Compound (RBAC). HSI www.HSIBaltimore.com

(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=1329)


Federal Court Overturns FDA Ban on Ephedra at Low Doses
TopPreviousNext

Date: June 09, 2005 08:41 AM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Federal Court Overturns FDA Ban on Ephedra at Low Doses

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 rakesh@amin-law.com.

References

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

(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=243)


LYCOPENE - Tomatoes Like You’ve Never Seen Them Before ...
TopPreviousNext

Date: June 03, 2005 10:51 AM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: LYCOPENE - Tomatoes Like You’ve Never Seen Them Before ...

Lycopene

It’s hard to imagine that the ancestor of the beefsteak tomato was a tiny yellow fruit first harvested by the Incas. Tomatoes have come a long way since their origin in the Andes, becoming more popular than any other fruit or vegetable in America. (Botanically, the tomato is really a fruit, despite the Supreme Court’s 1893 Ruling that it’s a vegetable.) Today, our appreciation of this dietary staple is entering a new chapter. Modern nutrition science has delved into the biochemistry of the tomato and discovered unique phytonutrients with powerful influences on the human body. Utilizing this research, Source Naturals has introduced a concentrated form of the tomato’s most vital nutritional compound: Lycopene.

Tomatoes and their Healthy Red Color

Lycopene is the pigment that gives tomatoes, watermelons and some grapefruits their healthy red color. Found most abundantly in tomatoes (Lycopersicon esulentum), lycopene is a member of the carotenoid family. This group of phytonutrients are major contributors to the health of the human race. (Phyto is derived from the Greek word for plant.)

Over 500 different carotenoids have been identified by science, and almost 10% of them are found in human blood and tissue. Best known is beta-carotene, whose important benefits have been well-documented. Other familiar phytonutrients include allicin from garlic, and capsaicin from chili peppers. Lycopene, lutein, alpha-carotene and betacarotene are the most abundant of the carotenoids present in human blood and tissues. Human breast milk has been found to contain 19 carotenoids, including lycopene. Like many carotenoids, lycopene has evolved as an integral part of human biochemistry, with many benefits to our well-being. Since mammals cannot synthesize it, lycopene must be obtained from the diet.

Lycopene and Prostate Function

One of the most interesting aspects of the way phytonutrients interact with the human body – beyond their broad spectrum antioxidant activity – is their tendency to be “organ specific.” Different carotenoids have an affinity for different organs in the body! In the case of lycopene, it’s the most plentiful carotenoid in the prostate gland. Studies have explored the link between diets high in lycopene and proper prostate function.

Lycopene Protects Cells

Research has shown that lycopene may protect DNA by its powerful antioxidant activity against singlet oxygen free radicals, dangerous forerunners to cellular damage. Lycopene was found to be the most efficient biological carotenoid to neutralize singlet oxygen – almost 3 times more powerful than beta-carotene. Also, lycopene has a “sparing effect” for beta-carotene: lycopene sacrifices itself to free radicals so that beta-carotene can be reserved for conversion to vitamin A. Lycopene has another ability that has excited further investigation. It increases gap junctional intercellular communication, which is the chemical and electrical coupling between neighboring cells. This enables a healthy exchange of the signals that regulate normal growth – thereby offering a protective influence on cellular reproduction.

Getting the Most From Tomatoes

Until recently, lycopene was not commercially available, and hasn’t been studied as extensively as has beta-carotene. But now, thanks to a unique (non-chemical) proprietary process, lycopene can be obtained from specially bred and cultivated tomato varieties that are rich in lycopene, and very red. Source Naturals LYCOPENE is standardized to 5% lycopene in a base of vegetable oil. It also contains small amounts of other carotenoids, naturally present in tomatoes. While it’s important to continue eating fruits and vegetables, we can also benefit from the fruits of nutritional research. This is especially important since so much of our food supply has become denatured, lacking the traditional nutrition our bodies require. Source Naturals LYCOPENE is a significant step toward reclaiming the nutrients we need to help create a life of health and vitality. Get a taste of the 21st Century – Source Naturals LYCOPENE.

References:

  • • Khachik, F., et al. (1995). Lutein, Lycopene, and their oxidative metabolites... Journal of Cellular Biochemistry, Suppl. 22, 236-46.
  • • Mascio, P., et al. (1989). Lycopene as the most efficient biological carotenoid singlet oxygen quencher. Archives of Biochemistry and Biophysics, 274(2), 532-38.
  • • Zhang, L., et al. (1991). Carotenoids enhance gap junctional communication... Carcinogenesis, 12(11), 2109-14.



    --
    VitaNEt ®
    VitaNEt ® Staff

    (https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=165)


    Its not about Ehpedra -- its about DSHEA ...
    TopPreviousNext

    Date: May 24, 2005 08:58 AM
    Author: Darrell Miller (dm@vitanetonline.com)
    Subject: Its not about Ehpedra -- its about DSHEA ...

    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?

  • We wanted to make sure the FDA followed DSHEA (The Dietary Supplement Health And Education Act) and uses sound science to stop the sale of ingredients at dose levels that cause harm.
  • We were concerned about a new concept -- a "Risk-benefit" test -- that caused all supplements to be treated like drugs and gave FDA the power to ban any dietary supplement at its discretion.
  • Dietary supplements should not be treated like drugs. Supplements are typically natural food products. Treating them like drugs -- with pre-market approval and clinical studies required -- would mean an end to consumer access to supplements.
  • We believed our low-dose ephedra product was safe. It was not designed for weight loss, but for traditional uses, like respiratory support.
  • Why did FDA Ban Ephedra?

  • Over eighty years, FDA proposed, withdrew and re-proposed limits on dietary supplements with ephedrine alkaloids. Until the final rule, all the proposed rules exempted low-dose ephedra products.
  • During those eighty years, FDA took few actions against manufacturers who sold high-dose ehpedra. The Result? Negative and often inaccurate publicity surrounding ephedra supplements.
  • In the final Rule, FDA announced to ban all dietary supplements containing any ephedrine alkaloids, but did not ban them in foods like chinese herbal teas.
  • What did the court Decide?

  • Under DSHEA, dietary supplements are to be regulated as foods.
  • Like other foods, Dietary supplements are "presumed to be safe."
  • FDA's "risk-benefit" test is contrary to what Congress intended when they passed DSHEA in 1994.
  • To ban a dietary supplement, FDA must establish that the specific dose recommended in the label presents a significant or unreasonable risk of illness or injury. FDA didnt do that for low-dose ephedra. FDA cant stop Nutraceutical and Solaray from selling their low-dose ephedra product.
  • FDA has to rewrite its Ephedra rule.
  • How does the Decision affect me?

  • The courts rulling protects your access to dietary supplements. FDA cant arbitrarily ban them.
  • The Ruling requires FDA to pay attention to dosage in determining if a supplement is dangerous.
  • The rulling prohibits FDA from Treating dietary supplements like drugs -- it must treat them like foods, as DSHEA specifies.
  • Does the Ruling mean that ephedra is safe?

  • Nutraceutical's case only involved Solaray® Ephedra, a low-dose whole food product.
  • The court said FDA did not have adiquate scientific evidence that low-dose ephedra is unsafe.
  • Since low-dose ephedra is a food, it is presumed to be safe.
  • The court did not analyze scientific evidence about the safety of ephedra producs at higher doses.
  • What's Next for Ephedra?

  • FDA Must exempt low-dose ephedra at 10mg or less of ephedrine alkaloids per day. FDA must reopen the rulemaking to establish the precise dose level above 10mg ephedrine alkaloids at which ephedra presents a significant or unreasonable risk or illness or injury.
  • FDA can also choose to appeal the court's Ruling.
  • We are evaluation the reintroduction of Solaray® ephedra. We want to do it in a way that is consistent with our obligations to our customers and in compliance with the law and the recent court decision.
  • 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...



    --
    VitaNet ®
    VitaNet ® Staff

    (https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=97)



    VitaNet ® LLC. Discount Vitamin Store.