When does a supplement become a drug?
July 1, 1998 less than 1 minute read
When does a supplement become a drug?
Pharmanex's Cholestin, a Chinese red yeast rice, is marketed as a dietary supplement that reduces cholesterol levels, but it contains lovastatin, the agent in Merck's Mevacor, according to the Food and Drug Administration (FDA). At issue in an ongoing turf battle is not whether Cholestin, or hong qu, is dangerous, but rather that the product has crossed the line between supplements and drugs.
As such, should it be subject to the rigorous testing that drugs must undergo? Should its manufacturer be allowed to advertise its potential, but untested, benefits? For now, such food supplement companies cannot claim that their products prevent or treat disease, but can claim that they promote health. As Cost Management in Cardiac Care goes to press the score is Pharmanex - 1; FDA - 0.
A federal judge ordered the agency to permit Pharmanex to continue to manufacture the herbal remedy for now. A final decision is pending.
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