PAPER Topics

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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, ....

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... 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 conditio ...