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The Controversial Future of Lab-Grown Meat   
Date:
June 07, 2024 12:10 PM
The Controversial Future of Lab-Grown MeatLab-grown meat, also called cultured or cell-based meat, is a new tech stirring hope and controversy in food. This method produces animal meat without slaughtering, offering an alternative to livestock farming. It could revolutionize protein thinking by reducing environmental impact and addressing ethical concerns. However, as with any new technology, there are significant debates surrounding its safety, health implications, and overall viability.
How Lab-Grown Meat is ProducedThe process of producing lab-grown meat begins by taking a small sample of animal cells, often through a harmless biopsy. These cells, typically muscle cells, are then placed in a nutrient-rich culture medium that mimics the environment within an animal's body. The culture medium contains essential nutrients like amino acids, sugars, and growth factors that encourage the cells to divide and grow. Over time, these cells multiply, differentiating into muscle tissue, which can then be harvested, processed, and formed into meat products. This process, often taking place in bioreactors, aims to replicate the natural muscle growth seen in animals. By controlling the environment meticulously, scientists can produce meat that is structurally and nutritionally similar to conventionally farmed meat. Despite the technological advancements and potential benefits, there is still a wave of skepticism and resistance against lab-grown meat, primarily centered on health risks and the idea of naturalness.
Health Risks: The Skeptics' ViewpointCritics of lab-grown meat often argue that these products are unnatural and potentially harmful. They highlight the use of a synthetic culture medium and artificial scaffolding materials to structure the tissue as primary concerns. One common criticism is that the long-term health effects of consuming lab-grown meat are unknown. Since this technology is still relatively new, there hasn't been enough time to study the impact it may have on human health comprehensively. Another significant concern revolves around the additives and growth factors used in the culture medium. Skeptics claim that consuming these substances, some derived from non-food-grade sources, could lead to unintended side effects over time. Moreover, contaminants introduced during the production process may pose risks absent in naturally grown meat. Some also point to the lack of regulatory standards and oversight for lab-grown meat as a potential risk. Since this is a new industry, the guidelines for safety, production, and labeling are still evolving. This uncertainty contributes to the fear and resistance among certain consumer groups and policymakers.
Regulatory Response: States Banning Lab-Grown MeatIn light of these concerns, some states have taken a firm stance against lab-grown meat. Florida and Arizona, for example, have enacted bans prohibiting the sale of cultured meat products. These states argue that there is insufficient evidence to guarantee the safety and health benefits of lab-grown meat. They also see these bans as a way to protect consumers and promote traditional agriculture practices. Florida's legislative body expressed concerns about the potential economic impact on the state's agriculture sector, which relies heavily on cattle farming. By Banning lab-grown meat, they aim to safeguard the livelihoods of local farmers and ensure the sustainability of rural communities. Similarly, in Arizona, legislators emphasized the naturalness and cultural significance of traditionally farmed meat, viewing lab-grown alternatives as a threat to their state's heritage. These bans have sparked debates on innovation in our food system and if regulators overlook new technologies too hastily. Lab-grown meat supporters argue that these bans impede progress and limit consumer choice for ethical, eco-friendly products.
Why Naturally Grown Meat is Better and HealthierDespite the potential benefits of lab-grown meat, many still advocate for naturally grown meat as the superior option. First and foremost, naturally grown meat has a long history of consumption, providing a well-documented track record of its health effects. Unlike lab-grown meat, which relies on new and untested methods, natural meat comes from animals that have been bred and raised for generations. One of the key arguments in favor of naturally grown meat is the lack of artificial additives and synthetic processes. Animals on well-managed farms have open pastures, a varied diet, and humane living conditions, resulting in meat free from artificial additives. Natural meat can be organic and free-range, meeting consumers' health and ethical standards. Nutritionally, naturally grown meat offers high levels of essential nutrients, including vitamins, minerals, and healthy fats. Grass-fed and pasture-raised animals, especially known for producing meat with higher omega-3 fatty acids and lower saturated fat content, have well-documented nutritional benefits supported by extensive research, giving health-conscious consumers peace of mind. Another argument for naturally grown meat is its cultural and environmental significance. Traditional farming practices contribute to biodiversity, support local economies, and maintain rural landscapes. Lab-grown meat, on the other hand, often involves centralized production that may not offer the same level of environmental benefits.
In The FutureThe future of lab-grown meat remains a contentious topic, with passionate arguments on both sides of the debate. This innovative technology shows promise for changing our food system, tackling ethical issues, and lessening environmental impact. However, it sparks questions about health risks, regulations, and long-term sustainability. With some states considering bans on cultured meat, the dialogue on food values evolves. Choosing between lab-grown and naturally raised meat will hinge on personal preferences, values, and emerging scientific evidence.
(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=6614) Natural Sweeteners Vs. Artificial Sweeteners 
Date:
April 30, 2009 10:16 AM
Artificial sweeteners are food additives intended to replace the sweetness of sugar without the calorie intake. There are also natural sweeteners that can replace sugar, so which should you choose? Natural sweeteners such as sugar, honey and grape juice are well known, although there are also the less well known, but much more effective, sucanat and stevia. Sucanat is dried unrefined cane sugar, and unlike refined sugar retains the molasses. Stevia, on the other hand, is a shrub, native to Paraguay, the leaf of which contains a non-sucrose sweetener, 300 times the sweetness of sugar, and which is not absorbed by the body. It is a sweetener pure and simple, with no proven health issues. It is also Japan's most popular sugar substitute. Artificial sweeteners have been known for many years, the first and best known being benzoic sulfanide, known to you as saccharin. The health risks of saccharin have been the subject of debate for over 100 years and have yet to be resolved. Studies had shown it to cause cancer in rats, and it was placed on a list of known or suspected carcinogens. It has been banned for use in the USA, but that was lifted by the FDA in 1991, and in 2000 saccharin has no longer required a health warning label. The issue appears to have been resolved by rats metabolizing saccharin in a way not possible in humans. However, many are still suspicious of it, and if you don't trust a food additive then do not voluntarily consume it. The top two artificial sweeteners in the USA are sucralose and aspartame. Sucralose, discovered in the UK in 1976, is the less emotive of the two, and is chemically the chlorocarbon trichlorogalactosucrose, produced by chlorination of sucrose and 600 times as sweet. It should be stressed that a chlorocarbon is totally different to a chlorinated hydrocarbon. It is generally considered safe to use, although it is very slow rate of degradation in waste water has raised concerns that concentrations could increase with increasing popularity of the sweetener. According to' Sweet Deception', the book states sucralose to be discovered during the search for an insecticide, and is produced when sugar is treated with acetic anhydride, hydrogen chloride and trityl chloride among others in the presence of toluene, MIBK and dimethyl formamide among other solvents. Although marketed as coming from a natural source, it is anything but natural. Aspartame was developed by G.D. Searle, and its approval by the FDA has been a matter of concern for many years. Promoted by Donald Rumsfeld, then CEO of Searle, he "called in his markers" to have the substance approved, which was not one of the more glorious moments in America's history. It is used in over 6,000 products, most household names, yet was based on "inconclusive and incompetent science" according to detractors. In 1981, on the day of his inauguration, Ronald Regan suspended the powers of the FDA on aspartame, and then a month later appointed a new FDA head, Arthur Hayes, who immediately licensed the substance. Donald Rumsfeld was on President Regan's team. There is a strong body of evidence that aspartame is toxic to humans, although the official evidence has discredit such studies. Recent evidence that linked aspartame to cancer has been stated as irrelevant to humans. In spite of the concerns, the substance has been approved, not only in the USA but also by the European Union. This might call into question the relevance of studies to humans, but many still believe that commercial considerations are behind these decisions. In fact, an extensive study carried out by the Italian European Ramazzini Foundation, showed that aspartame can cause a significant increase in cancers and leukemias in rats at well below the doses allowed by the EU or the US. This substance required further study by bodies with no vested interest in the outcome. Those that believe so point to the stevia situation. This natural sweetener is banned for use as a food additive in the EU, and cannot be sold as sweetener due to the FDA not recognizing it as such. It has also been banned in Hong Kong, even though it is the sweetener of choice in Japan, with no apparent side-effects becoming endemic in that country. The USA might not approve stevia as a sweetener, but it is considering lifting its ban on cyclamate. Cyclamate was banned by the FDA due to tests on rats indicating a possibly carcinogenic effect, but no more positive than those on aspartame. Cyclamate is permitted in Canada, where saccharin is not, and also in the UK, but not throughout the EU. It is obvious, then, looking at the various claims and counter-claims, and the conflicting legislation between civilized countries, that the artificial sweetener industry is wrought with uncertainty. In the past, it is almost certain that commercial considerations have come before the health of the nation, and that does not engender confidence. In fact, the only sane approach to take at this time would be to avoid artificial sweeteners altogether, and stay natural. That is not to claim that natural products are safe to eat - far from it! Many of the most virulent poisons are natural, but the well-used natural sweeteners appear to be safer at this time than any of those artificially manufactured. There might be objections to this where diabetes is concerned, and Canada, while Banning saccharin for normal use, still allows it for use by diabetics. This is the one of the two major bodies that promotes the use of artificial sweeteners: the diabetic lobby and the weight loss lobby. It is difficult to question the obesity and weight problem that America has while at the same time arguing against the use of artificial sweeteners. However, don't forget that stevia is widely used in Japan with no reported health problems, and stevia is a natural sweetener that is permitted for use as a food additive, and that is not absorbed by the body. However, there is also a recent 2005 study that has indicated that diet drinks containing artificial sweeteners might fool your body into believing that the sweet taste is promising energy, and when it doesn't materialize, you feel hungry and eat more. This has been supported by animal studies. These have shown convincingly that the sensation of sweetness induces the production of insulin with resulting hypoglycemia because there is no actual increase in blood sugar. This induces increased food intake. This has been proved with rats, and also proved was the fact that the natural response of eating less at the next meal, after sugary food, was gradually diminished in animals fed non-calorific sweeteners. The choice is yours, but it would seem advisable to stick to natural sweeteners for the time being, at least until the studies carried out are in concurrence as opposed to offering conflicting results depending upon who is doing the testing.
(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=2001) Big Pharma Plays God, Stealing and Altering Pant Compounds making Synthetic Drugs
Date:
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.
(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=1684) Ban against ephedra supplements at any does upheld.
Date:
August 22, 2006 11:48 AM
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.
(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=1354) Sugar Overload....
Date:
July 07, 2005 04:22 PM
Sugar Overload My kids are getting completely overloaded on sugar at school from meals and treats -- my daughter comes unglued and cant study. When i went to grade school, there was no lunch and no sweets available. What a change in society... Amanda Shrewsbury - Spring City, Utah... You're right to be concerned about school food programs, especially since budget restrictions have led a number of districts to use major fast-food companies as food service providers -- and even worse, to let soda companies stock school beverage machines. Fortunately, the tide is starting to turn. Los Angeles is just one of a number of cities that are Banning soda from their school buildings. Other districts are going so far as to offer organic lunches to there students. you may want to contact your school superintendent, as well as members of your local school board and let them know how you feel about what's best for your children.
(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=561) Home on the Range
Date:
June 13, 2005 03:52 PM
Home on the Range by Janis Jibrin, RD Energy Times, September 5, 1999 Got chicken? Americans can't seem to get enough of this bird. Last year each of us ate, on average, just about 80 pounds of chicken, a whopping increase over the 49 pounds we each devoured in 1980 and an eight-pound increase from 1995. Part of this food's popularity comes from its lean image as a healthier, less fatty alternative to red meat (don't forget to take the fatty skin off). Chicken's also a cheap protein source: At many popular supermarkets you'll find weekly specials at about a dollar a pound. But at health food markets, chicken can cost upwards of $1.69 a pound. These birds may be touted as raised in an organic, stress-free environment and on a vegetarian diet, free of antibiotics. For many people, this poultry is a better buy. The Alternative Chicken Most of the supermarket chicken you pick up in grocery refrigerated cases are broilers, birds bred to mature in about eight weeks. In comparison, in the '60s, chickens needed 14 weeks to become adult poultry. Conventionally-raised broilers eat grain mixed with whatever's cheapest on the market, such as recycled cooking oil that's been used to fry fast foods and animal parts. These birds reside in chicken coops the size of football fields and don't see the light of day until transported to the slaughterhouse. On the other roost, alternatively raised chickens are brought up in a variety of ways (see box), but usually enjoy a more relaxed life and diet. Chickens on the farm receive antibiotics for two reasons: To fight off the diseases that can run rampant through a crowded chicken coop and to encourage faster growth. Antibiotics Stimulate Growth Mark Cook, PhD, professor of animal science at the University of Wisconsin at Madison, explains, "Gut bacteria trigger an immune system assault, which makes chickens a little feverish, suppresses appetite and slows growth. Antibiotics stimulate growth indirectly, by keeping bacteria levels down, and preventing the immune reaction." When birds get sick, they often get dosed with even more antibiotics. This widespread antibiotic use has come home to roost and may contribute to the growth of bacteria that, frequently exposed to chemicals, have evolved ways to keep from being killed by pharmaceuticals. This development threatens human health. Bacterial infections that people contract, once easily cured by penicillin or other drugs, are now tougher to eradicate. For instance, campylobactor, a common bacteria found in chicken, and responsible for some food poisonings, now demonstrates signs of resistance to drugs like floroquinolones. A powerful class of antibiotics, floroquinolones used to dependably conquer this infection. "Floroquinolones are an extremely important class of antibiotics, used to treat many types of infections such as urinary tract infection, a wide variety of gastrointestinal illnesses, pneumonia, almost everything," says Kirt Smith, DVM, PhD, epidemiologist, acute disease epidemiology section, Minnesota Department of Health. A study by Dr. Smith, published in the New England Journal of Medicine (340, 1999: 1525-32), showed that the percent of floroquinolone-resistant campylobactor appearing in infected people in his state-Minnesota-climbed from a little over 1% in infected people during 1992 to 10.2% in 1998. He and other scientists strongly suspect that the rise is a direct consequence of the Food and Drug Administration's (FDA) decision to allow floroquinolones in poultry feed beginning in 1995. Although it was nearly impossible for Dr. Smith to trace the precise origin of campylobactor poisoning, he believes chicken was usually the source-and not just U.S. chicken. Many of the infected people had returned from Mexico and other countries. "Sales of floroquinolones for poultry use in Mexico has increased dramatically," notes Dr. Smith. Many alternative chicken producers do not use any antibiotic-laced feed at all. Other farmers adjust the feed to lower gut pH, making it more acidic and lowering chances of bacteria. At the U. of Wisconsin, Dr. Cook is developing antibodies to suppress the immune response to bacteria so chickens won't need antibiotics to spur growth. Buying and dining on chicken raised with little or no antibiotics could beneficially lower your risk of contracting a hardy bacterial infection. Better to catch campylobactor from an antibiotic-free chicken than a conventional chicken, speculates Dr. Cook. "There's less likelihood the bug will be resistant, and a better chance your problem can be cured with antibiotics," he explains. And, looking beyond your own immediate health risk, buying antibiotic-free chicken makes a small contribution to stopping the spread of antibiotic resistant bugs. A Matter of Taste Conventionally raised chickens get little exercise and live only eight weeks, so they're tender but bland. "There's not much taste in a modern chicken. Free range or organically grown, older birds usually have more taste," notes Dr. Cook. The days of barnyard chickens happily clucking and strutting around in picturesque nature have disappeared with the family farm. Today, chickens lead a meager existence. After hatching, baby chicks are tossed into a gigantic hen house that is home to up to 30,000 birds. Their short lives are lived within the United States Department of Agriculture (USDA) mandated 3/4 square foot per chicken. In that squeeze, birds can catch "chicken influenza," especially in winter when it's too cold to let in much fresh air. Laying hens don't experience much more of a peaceful existence. These birds live their years with about five other hens, so crowded they can't flap their wings. Cages, suspended in the air, let eggs roll into a holding area. So they don't peck each other, hens are often debeaked, a painful process that can cause infection. Hens go through natural laying and "dry" cycles. Growers manipulate this cycle by "forced molting," depriving hens of food for four to 14 days to keep them constantly laying. By the end of two years, hens are worn out. Their inactivity weakens their bones enough that electrical stunning, the usual method for knocking chickens out before slaughter, shatters their bones. So some wind up being plucked and boiled alive, according to Mary Finelli, program director for farm animals and public health at the Humane Society of the United States. The meat from these hens, tougher than other birds, was probably in your deli lunch sandwich. It's also used in the school lunch program or may end up in dog food. "Generally, organically-grown broilers and hens have it better because room to move is part of the organic certification process," says Finelli. Finelli suggests visiting chicken suppliers to find out how chickens are treated. Or, she advocates a Humane Society book listing reliable firms. For a local producer call the society: 202-452-1100. According to a Consumer Report report, some growers force chickens out the last week of their lives to brand them "free range." So free range isn't a prime standard for choosing a decently raised chicken. However, turkeys thrive outdoors, so choosing free-range turkey is often a good idea for better tasting poultry. In any case, organic is your best bet for chicken without pesticides. Make it your main choice for your 80 pound yearly consumption! To fight cruel treatment of poultry: • Forced Molting Ban. Forced molting is shocking hens for more eggs. To support petitions Banning forced molting write: Docket Manage-ment Branch, FDA, Dept. Health & Human Serv-ices, 12420 Parklawn Drive, Room 1-23, Rock-ville, MD 20857. Include docket # 98P-0203/CP • Downed Animal Protection Bill (House Bill 443, Senate Bill S515) spares some animals from the tortuous journey from chicken house to slaughterhouse. Mandates humane euthanization.
(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=331) Federal Court Overturns FDA Ban on Ephedra at Low Doses 
Date:
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 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
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