My wife is back in school and she was looking for a topic for her public policy paper. I sent her the “Do it for the Children” article to start a debate (arguement)with her. She instead decided that ephedra would be a good topic for her upcoming paper. I am reviewing the paper but I am not that enlightened to be honest. Any suggestions would be appreciated.
----------------------------------------Potential Regulatory Action on Dietary Supplements Containing Ephedra
On February 28, 2003, the Department of Health and Human Services (HHS) announced it was taking a series of actions designed to further examine the potential risks associated with dietary supplements containing ephedra . This action followed the results of a RAND Corporation study, which suggested ephedra might pose significant health risks to the public. In addition, the RAND study produced no evidence to support claims by manufacturers that supplements containing ephedra can induce long-term weight loss and athletic performance enhancement. At issue is whether to pursue regulatory action of these dietary supplements, and perhaps removal from the market.
Under the Federal Food, Drug and Cosmetic Act (FDCA) of 1938, the Food and Drug Administration (FDA) was granted authority to regulate drugs, devices, foods and cosmetics to an appropriate degree. The FDCA also indicated that the FDA could not require pre-market approval for dietary supplements. The law only requires that
manufacturers of dietary supplements submit data to the FDA prior to marketing if the product contains a dietary ingredient that is not already present in the food supply. Throughout the 1980?s and the early 1990?s, the FDA was widely suspected of exploiting its authority under FDCA. Congress, as well as a series of federal court decisions, supported the notion that the agency had repeatedly abused its authority in an attempt to prevent the marketing of safe and proper dietary supplement products. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which clearly defined the FDA?s authority over dietary supplements. Under the DSHEA, dietary supplements can only be removed from the market if they are found to ?pose a significant and unreasonable risk, contain poisonous or deleterious substances, are unfit for food, make drug claims, or lack truthful and informative labeling.?
In the June 4, 1997, Federal Register, the FDA first attempted to regulate products containing ephedra by opening a comment period to gather evidence under the DSHEA clause that the supplement posed a ?significant and unreasonable risk? to the public. The proposed regulations included a warning statement on the label and a reduction of the potency of the supplements. In the April 3, 2000, Federal Register, the FDA withdrew the proposed regulations of the supplements.
In addition to the RAND Corporation report, there are a number of scientific studies which indicate that ephedra poses a health risk. However, there is also significant literature that suggests the efficacy of ephedra in weight loss, which is a primary claim by ephedra manufacturers. A 2002 article in the International Journal of Obesity concluded that supplements containing ephedra ?may be beneficial for weight reduction without significant adverse effects.?
The FDA?s current comment period will end on March 31, 2003, at which time the agency will compile information and issue a conclusion to ensure the safety of the general public.
There is sufficient evidence to suggest that ephedra does pose a ?significant health risk,? to the public, and as such, it would be prudent to support strict limitation on the marketing and production of ephedra. This is a well-publicized issue, given the deaths of several professional athletes which have been attributed to the use of ephedra, most recently that of Baltimore Orioles pitcher Steve Bechler in February. A public opinion poll conducted by Gallup on March 18, 2003, concluded that a majority of Americans support the banning of ephedra. This follows Congressional testimony by the American Medical Association, which suggested a complete ban, as well as bans imposed by the U.S. Military, the National Football League, the International Olympic Committee, and the National Collegiate Athletics Association.
There is a substantial population, which does not support regulation of supplements containing ephedra. These individuals include the majority of the athletic community, as well as a contingent which feels the FDA is being hypocritical by proposing regulation of ephedra, while tobacco causes more documented harm than all dietary supplements combined. The Small Business Administration has also gone on record as opposing regulation, due to the number of small businesses that would be adversely affected. Finally, it is important to note the history of abuse of regulatory laws on the part of the FDA and the public perception of the agency in this regard.
Based upon this information, it is my recommendation that the FDA and HHS conclude that dietary supplements containing ephedra be regulated, but not banned. The FDA?s proposed restrictions in the June 1997 Federal Register provide an adequate framework for new regulation.