by Marc Saleme

Created on: August 16, 2009   Last Updated: August 17, 2009

Dietary 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.

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