
Originally Posted by
Nortier et al., 2000
The 1994 Dietary Supplement Act does not require that dietary supplements (defined broadly to include many substances, such as herbs and amino acids, that have no nutritive value) be shown to be safe or effective before they are marketed. The FDA does not scrutinize a dietary supplement before it enters the marketplace. The agency is permitted to restrict a substance if it poses a "significant and unreasonable risk" under the conditions of use on the label or as commonly consumed.
The safety standard may sound as if the FDA has all the authority it needs to protect the public. The problem is that the burden of proof lies with the FDA. Even when the agency is able to act, how is it supposed to know which products contain [a known carcinogen], and who sells them? What is the agency supposed to tell people who may have consumed these herbs? Congress has put the FDA in the position of being able to act only after the fact and after substantial harm has already occurred.