The New England Journal of Medicine (NEJM) recently published an article about the government’s lack of oversight in dietary supplements, appropriately titled, “American Roulette – Contaminated Dietary Supplements“. Dietary supplements (which include botanical products, vitamins and minerals, amino acids and tissue extracts) are  regulated by the FDA under the 1994 Dietary Supplement Health and Education Act (DSHEA).

According to the Food and Drug Administration’s own web site, “Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.”

There is a caveat in here: food products must be appropriately labeled. Regardless, prior to the 1994 DSHEA act, all dietary supplements were regulated under the same regulatory requirements as food products. Why on earth the Clinton administration changed these regulations giving manufacturers the authority to oversee their own products seems to me to be foolish. It’s like having the fox guard the chicken coop.

Given that about half the adult population in this country use some form of dietary supplements, given that the FDA has identified 140 contaminated products and given that the estimates of adverse events from these supplements totals 50,000, isn’t it about time this regulation changed?

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