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Add to FavoritesDietary supplements evade FDA consumer protection measures
In 1933, Vanguard press released Kallet and Schlink's 100,000,000 Guinea Pigs, decrying the abuses of the American public by unscrupulous food and drug manufacturers, and lamenting the inability of the Food and Drug Administration to protect citizens from toxic food ingredients and ineffective or mislabeled drugs. Soon after that, Ruth deForest Lamb wrote The American Chamber of Horrors, describing how industry leaders would politically stymie any amendment to the FDA's ability to regulate these industry practices. Because of these forces molding public interest into a spearhead of political import, the 1938 Food, Drug, and Cosmetic Act was passed, forcing accountability of industry for its practices, and allowing the FDA the necessary avenues to bring civil and criminal action against violators of the act. However, the act reserves the strictest regulations for the manufacture and sale of drugs. Dietary supplements are not required to prove efficacy or safety before their presentation to the public market.
Under the Dietary Supplement Health and Education Act of 1994, the responsibility of determining safety of, and that no false or misleading statements of efficacy are made in marketing a dietary supplement, is that of the manufacturer, and not the FDA. Unless the dietary supplement contains a novel component, the manufacturer of a dietary supplement is not required to register the new product with the FDA, nor undergo any product screening. Recently, problems with this inability of the FDA to proactively screen dietary supplements have been coming to light.
On July 27th, 2009, the FDA issued a warning letter to American Cellular Labs in Alameda, California that its muscle-building products were not dietary supplements as described in Section 201(ff)(1) of the Food, Drug, and Cosmetic Act, but actually prescription drugs as defined at section 503(b)(I)(A) of the Act [21 U.S.C. 353(b)(1)(A)]. Prescription drugs are defined as such "because of their toxicity or other potentially harmful effect..." Health problems in conjunction with ACL products have been reported since late 2007.
In a letter to Iovate Health Sciences, April 30, 2009, the FDA declared that after seven years of receiving complaints of liver-related illness associated with the use of their product Hydroxycut, the product was declared adulterated under section 402(f)(1)(A) of Act [21 U.S.C. 342(f)(1)(A)]. In those seven years there were a total of 23 cases of liver toxicity including at least one case requiring a liver transplant and one case of death. The cause of liver toxicity was undetermined.
Other bodies of world government do not entrust the safety of dietary supplements to manufacturers. The World Trade Organization recognizes the Codex Alimentarius, a compendium of food safety data which includes food additives and dietary supplements, as an authority standard for resolving disputes regarding consumer protection. The Codex Alimentarius is developed by the Food and Agriculture Organization of the United Nations and the World Health Organization. Germany's Federal Institute for Drugs and Medical Devices requires absolute proof of safety for plant medicines, but only reasonable certainty of efficacy. In the United States, watchdog groups such as consumerwatch.org serve to aid the FDA in the role of protecting consumers from hidden dangers and scams in dietary supplements. The fact that such privately run organizations need to exist to supplement the FDA proves that the government provision for consumer protection is not sufficient.
Learn more about this author, Marc Saleme.
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No
by Karlin Brock
Are you aware of the fact that Congress is contemplating an overthrow of The Dietary Supplement Health and Education Act? This may sound paranoid and inflammatory but it is nothing short of the truth.
The DSHEA was created in response to the FDA attempting to regulate nutritional supplements as if they were drugs in 1994. The Nutritional Health Alliance and the public stopped them and the DSHEA was the result. It protects us from the FDA interfering with the sale of nutritional supplements. But they are sneaking in the back door and most people are failing to notice.
The FDA won its case against ephedra and its use has been banned. Studies show that ephedra use is safe when used as directed, but because it had the potential to be abused, the FDA was successful in its case. With this new ruling, the FDA has created two back doors allowing them to treat supplements as drugs.
The Risk/Benefit Analysis is an approach used to test the safety and efficiency of synthetic drugs with possibly lethal side effects. Supplements are not synthetic and they are not drugs. They have been classified as foods, which they are. The FDA is attempting to apply this approach to our supplements.
The Adverse Event Reporting is another approach used to test the safety and efficiency of synthetic drugs with possibly lethal side effects. Again, supplements are not synthetic, nor are they drugs. They are food.
It makes no more sense to test our supplements under these approaches than it would to test the garlic or rosemary in our pantries, or the dandelions growing in our yards. Perhaps they will be testing our potatoes and our broccoli next. It doesn't make sense. The testing would cost taxpayers millions of dollars or more. It would give the FDA the power to ban more of our supplements that many of us depend on daily.
Many over the counter drugs have the potential for abuse. Because they are synthetic, produced by a pharmaceutical company and FDA approved, we do not see them banned. This does not mean that you can't die from an overdose. It simply means that all the right fingers are in all the right pies. Everyone is getting their cut of the profits. If every over the counter drug was held to the same tests as ephedra was, we would not have over the counter drugs at all.
The FDA has already used unscrupulous means to ban ephedra. The FDA is obligated to allow the public to review and comment on any final rule in its entirety prior to enactment. The FDA never indicated that it was utilizing a Risk/Benefit analysis for a dietary supplement prior to the final Ephedra Rule. Our legal rights were denied; therefore the Rule should not stand.
It's very interesting how many current FDA agents are former pharmaceutical company employees. It's also interesting how many have continued to receive pay from the pharmaceutical company they worked for while working for the FDA. The conflict of interest is obvious. The pharmaceutical industry has a huge lobby in Washington. The fewer alternatives that Americans have the more we will have to buy from them. Whether its healthy or best for us or not, they will make their money.
For more information on this subject visit the NHA website at www.nha2004.com. You can also e-mail your Representatives in Congress to speak out against this attempted coup by the FDA. It doesn't have to be a long or fancy letter. Simply tell them to stop the FDA from attempting to regulate or control our supplements. It's that simple.
Learn more about this author, Karlin Brock.
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