During the 1990’s, intense lobbying by the dietary supplement industry resulted in the United States Congress passing the Dietary Supplement Health and Education Act of 1994 (DSHEA). DSHEA made dietary supplement manufacturer responsible for ensuring their supplements were safe before they are marketed. Unlike prescription drugs that can not be sold without FDA approval, under DSHEA the FDA is responsible for taking action against any unsafe dietary supplement after it reaches the market. Dietary supplement manufacturers do not need to register their products with the FDA nor get FDA approval before producing or selling them. Manufacturers are not required to prove their products work, but must assure product label information is truthful and not misleading. To that end manufactures can state, based on published clinical studies, a product may lower cholesterol or decrease joint pain but they cannot claim the products will work. Dietary supplement claims that crossover that threshold becomes a drug requiring FDA approval.

The FDA's is post-marketing responsibilities include monitoring the safety of dietary supplements or as they put it “voluntary dietary supplement adverse event reporting.” In plain English, the FDA monitors reports of adverse side affects from taking dietary supplements (heart attacks, stroke, liver and kidney failure, nerve damage, death) and takes appropriate action when necessary including banning the product. The FDA also monitors product information, such as labeling, claims, package inserts, and accompanying literature.

Claims made by manufacturers of diet supplements in television and radio ads also come under the jurisdiction of FTC. If the FTC rules advertising claim or claims are misleading or deceptive, they have the authority to fine the manufacturer and order them to stop making the misleading or deceptive claims. Usually a manufacturer will admit no wrong doing and stop making the claims. Occasionally, a State Attorney General may do the same after substantiating complaints filed against a supplement manufacturer. What you have is an unregulated industry policing itself. With continuing budget cuts, neither the FDA nor the FTC has sufficient funding to police the industry’s claims and rely on consumer complaints to protect the public from unsafe products. There is a growing movement to grant the FDA authority to regulate the diet supplement industry. Even if the FDA is given authority, it must have the budget and people to monitor the industry.

Claims sounding too good to be true probably are. Avoid products with the following disclaimers:

Ø  “Results not typical”