Dietary Supplements

Some manufacturers are marketing supplements that have substances and effects similar to drugs. The FDA is attempting to impose drug status on these supplements and is being challenged in the courts by supplement manufacturers. In this article, I examine the legal debate surrounding the definition and regulation of substances - whether as a drug or a dietary supplement. First, I outline some key differences in the regulation of drugs and supplements and examine the two provisions of DSHEA that blur the distinction. Second, I describe recent attempts by the FDA to clarify the guidelines for defining supplements and their associated health claims, as well as court actions challenging these attempts. Third, I discuss future litigation and other regulatory actions regarding the drug or dietary supplement debate and its implications for marketers, consumers, and policy makers.

Supplements are not required by the FDA to have premarket approval or safety testing, as are necessary for new drugs and food additives. For example, prior to release, a new drug must obtain FDA drug approval through an extensive process that involves preclinical testing on animals, three phases of investigational new drug testing, a new drug application review, and postmarketing surveillance research. Conversely, product testing is not required for any supplement with ingredients that have been present in the food supply prior to October 15, 1994, or that have a history of use or other safety evidence in labeled conditions.

Many supplements were not required to submit evidence because the ingredients were found in food or had been used safely prior to the passage of DSHEA. For those supplements that do not meet these requirements, evidence of safety must be submitted to the FDA 75 days prior to market release. However, this safety information, which could include any citation to a published article may be of questionable quality potentially biased study conducted by the manufacturer, an in vitro rather than human. As a result, the FDA has been put in a policing. Furthermore, DSHEA has made market removal of unsafe supplements more difficult for the FDA.

To be a dietary supplement adulterated and attempt to remove it from the market, the FDA must prove that the product's ingredient poses a significant or unreasonable risk of illness or injury, whereas previously, it simply had to show that the ingredient was not generally recognized as safe. In all cases, the FDA now bears the burden of proof on each element to demonstrate that a supplement is adulterated. Furthermore, the safety of a supplement can be judged only against its labeled conditions of use and not unintended or actual consumer uses. If no suggested uses are printed on the supplement label, the FDA must try to prove actual conditions of usage in its enforcement actions.