S.O.S. from the FDA: A Cry for Help in the World of Unregulated Dietary Supplements

By Dier, Joseph K. | Albany Law Review, Fall 2010 | Go to article overview

S.O.S. from the FDA: A Cry for Help in the World of Unregulated Dietary Supplements


Dier, Joseph K., Albany Law Review


I. INTRODUCTION

   The FDA is responsible for protecting the public health by assuring
   the safety, efficacy, and security of human and veterinary drugs,
   biological products, medical devices, our nation's food supply,
   cosmetics, and products that emit radiation. The FDA is also
   responsible for advancing the public health by helping to speed
   innovations that make medicines and foods more effective, safer,
   and more affordable; and helping the public get the accurate,
   science-based information they need to use medicines and foods to
   improve their health. (1)

The above-quoted mission statement of the Food and Drug Administration ("FDA") highlights several duties that the Agency must juggle. First, it must protect the nation's health. Second, it must do its part to advance the public health by helping to make medicine and food more effective, safe, and affordable for the public. In 1994, Congress muddied the waters by forcing the FDA to refrain from interfering with the public's access to dietary supplements. (2) In a perfect world, there would never be a conflict between these duties. Unfortunately, since this perfect world does not exist, what is the FDA to do when faced with the growing reality of dangerous dietary supplements being marketed when it has its hands tied by legislative action requiring it to allow largely unencumbered access to these products?

While the possibility of health problems is clearly the most important issue discussed in this comment, there also exists an interesting, and extremely relevant, side issue. "Somebody has to be accountable for this.... [I]f somebody's doing something illegal with supplements sold over the counter, they need to be accountable for their actions and be penalized.... [W]e have to do the right thing so the youth don't go to stores and buy dirty supplements." (3) This statement, made by J.C. Romero, the Philadelphia Phillies pitcher who was suspended for fifty games after testing positive for the banned substance Androstenedione, highlights an important issue in the sports world--both professional and amateur--as well as in the general public. Not only are Americans being persuaded by dietary supplement manufacturers to purchase potentially harmful products, but professional and collegiate athletes are also taking supposedly legal products, only to later discover that the product was either adulterated or misbranded. In certain cases, as with J.C. Romero, this mistake or carelessness could lead to suspension, loss of pay, or loss of athletic eligibility. (4) In other cases, the results can be much more serious.

In a 2006 study, researchers discovered that seventy-three percent of adults over the age of eighteen had used dietary supplements within the past year. (5) These numbers are a fairly significant increase from the Congressional findings in 1994 which concluded that "almost 50 percent of the 260,000,000 (6) Americans U.S. & World Population Clocks, U.S. CENSUS BUREAU (Oct. 3, 2010), regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition," (7) and the increase in use does not appear to be stopping anytime soon. While United States legislators were hopeful that decreasing the amount of regulation surrounding dietary supplements would "improv[e] the health status of the United States," (8) there exist a number of negative effects that were not considered to be significant when this deregulation of dietary supplements was quickly pushed through Congress. (9)

In response to a growing concern for greater regulation of the dietary supplement industry, Congress should pass new legislation, such as the proposed Dietary Supplement Safety Act of 2010, (10) which would repeal the Dietary Supplement Health and Education Act. Further, it should adopt a new system that mimics that of the European Union's Food Supplements Directive and Canada's Natural Health Products Regulations. …

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