Slaying the Hydra: The History of Quack Medicine, the Obesity Epidemic and the FDA's Battle to Regulate Dietary Supplements
Indiana Health Law Journal, Vol. 6, pp. 203-251, 2009
49 Pages Posted: 13 Aug 2009 Last revised: 2 Aug 2012
Date Written: July 7, 2009
The United States' obesity crisis is gaining momentum. Studies released in 2008 project that, in only fifteen years, eighty percent of Americans will be either overweight or obese. Being overweight or obese places an individual at significant risk of developing hypertension, Type II diabetes, heart disease, stroke and cancer. The obesity epidemic has triggered a correspondingly massive growth in the weight loss supplement industry. Overweight consumers desperate to lose weight are being lured by 'magic bullet' claims into purchasing 'quick-fix' weight loss supplements in order to lose weight and decrease their risk for disease. However, the majority of these products are ineffective. The Federal Trade Commission ('FTC') reports that more consumers are defrauded by weight loss products than any other product it has examined. Thus, U.S. consumers are being thwarted in their weight loss and disease reduction efforts and the obesity crisis continues to mushroom.
Why isn’t the FDA using its premarket approval authority to keep these sham products from entering the market in the first place? Not surprisingly, the weight loss supplement industry is marketing its products as dietary supplements and is claiming the safe haven protections from FDA regulation offered under the Dietary Supplement Health Education Act ('DSHEA') and the National Labeling Education Act of 1990 ('NLEA'). What is surprising is that the FDA appears to agree. Are the weight loss supplement industry and the FDA correct?
In order to answer this question, this Article reviews the history of the regulation of quack medicines under the Food, Drug and Cosmetic Act ('FDCA') and outlines the events and legislative history that preceded the passage of DSHEA and NLEA. In conducting this inquiry, this Article examines the historical relationship between the state of scientific uncertainty over the effectiveness and safety of new products intended to treat abnormal health conditions and predatory commercial practices. This investigation informs the debate over the proper regulatory balance between the protection of individual choice in matters involving self-regarding behavior, such as making food choices, and the need to protect vulnerable consumers from harm from third parties who are marketing health care products, including weight loss supplements. This Article concludes that NLEA and DSHEA were only intended by Congress to deregulate dietary supplements to the extent that they target healthy populations to maintain or improve a normal state of health and outlines how the FDA can assert its premarket approval process to prevent sham weight loss supplements from reaching the market.
Keywords: obesity, weight loss, supplement, FDA
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