S.O.S. from the FDA: a cry for help in the world of unregulated dietary supplements.

• Author: Dier, Joseph K.

1. 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. This would thereby require pre-market approval of all dietary supplements in order to protect consumers from potentially hazardous side effects, reduce supplement-related litigation, and instill confidence in the dietary supplements industry once again.

   Part II of this comment will examine the numerous American statutes and regulatory framework surrounding the dietary supplement industry. Part III will examine the FDA's Adverse Event Reporting System, giving statistics of injuries allegedly caused by dietary supplements as reported by manufacturers as well as by the American public. Part IV will analyze foreign systems of dietary supplement regulation. Part V will outline the roles played by the FDA as well as the Drug Enforcement Agency ("DEA") in these matters. Part VI will discuss a report created by the United States Government Accountability Office that calls for several changes to the current regulatory system. Lastly, Part VII will examine why there is a need for new legislation and solutions, and identify the drawbacks to such an approach.

2. THE HISTORY OF DIETARY SUPPLEMENT REGULATION

   Over the past one hundred years, the food, cosmetic, drug, and dietary supplement industries have seen countless laws and regulations come and go, and have dealt with numerous legislative acts and amendments. (11) In 1938, Congress passed the Food, Drug and Cosmetic Act ("FDCA") (12) "which gave the FDA the power to not only remove dangerous products from the market, but also to require pre-market approval from the FDA before certain products were placed on the market." (13) Under the FDCA, dietary supplements were classified as drugs. (14) The FDCA makes it illegal to introduce "into interstate commerce . . . any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded." (15) Under the FDCA, "a food shall be deemed to be adulterated... [i]f it is a dietary supplement or contains a dietary ingredient that presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling." (16) Notably, during the reign of the FDCA, regardless of whether a supplement was classified as a drug or a food additive, the manufacturer was required to have the product pre-approved, and if "experts did not regard the product as safe ... the manufacturer was then assigned the burden of proving the safety of the product." (17)

   While [section] 342 of the FDCA deals with adulterated food, [section] 343 describes misbranded foods. The statute states that "[a] food shall be deemed to be misbranded ... [i]f ... its labeling is false or misleading in any [manner]."is Included in this section are regulations for the labeling of dietary supplements. (19) Additionally, a food will be considered misbranded if the product is a dietary supplement and "the label or labeling of the supplement fails to list the name of each ingredient of the supplement that is described in [the dietary supplement section] of this title." (20) Furthermore, "representations in the labeling of a food which render such food misbranded is a false or misleading representation with respect to another food or a drug, device, or cosmetic." (21) Section 343 goes on to state that "nutrition information shall first list those dietary ingredients that are present in the product in a significant amount and for which a recommendation for daily consumption has been established." (22) However, "a dietary ingredient shall not be required to be listed if it is not present in a significant amount, and shall list any other dietary ingredient present and identified as having no such recommendation." (23)

   The next major step for the dietary supplement industry came in 1962 with the Kefauver-Harris Amendments. (24) These changes to the FDCA required manufacturers to "prove effectiveness for the products' intended use, and not simply product safety." (25) Around the same time, the FDA attempted to pass new regulations (26) "aimed at loosening the restrictions on safer supplements provided in small dosages, while at the same time retaining and strengthening its authority to regulate other supplements as drugs." (27) The final regulations were published in 1973. (28) Unfortunately for the FDA, after spending nearly eleven years finalizing these regulations, notwithstanding over a million objections, (29) subsequent federal court decisions hindered major parts of the new regulations. (30) The next in a long line of significant blows to the FDA came with the passage of the Vitamin-Mineral Amendments of 1976, better known as the Proxmire Amendments. (31) Lastly, new attempts by the FDA to change the 1973 regulations were rebuffed, but this time due to improper procedure on the part of the FDA. (32)

   The dietary supplements regulatory scene was relatively quiet until the profound changes that occurred in the 1990s. First, the Nutrition Labeling and Education Act of 1990 ("NLEA") (33) was passed in order to "clarify and to strengthen the [FDA's] legal authority to require nutrition labeling on foods, and to establish the circumstances under which claims may be made about nutrients in foods." (34) Furthermore, under NLEA, "It]he Secretary (35) shall promulgate regulations authorizing claims of the type described in [this Act] only if the Secretary determines ... that there is significant scientific agreement ... that the claim is supported by such evidence." (36) While this appears to be a plus for the FDA, a massive lobbying effort once again took hold and opposed the FDA's authority in "implementing any regulations regarding health claims appearing on the labels of dietary supplements." (37)

   These lobbying efforts led to the passage of the Dietary Supplement Act of 1992 ("DSA"). (38) Congress found that "prompt approval of safe and effective new drugs is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease." (39) This prompted the belief that the...