TABLE 9-3FDA Regulation of Foods, Drugs, and Dietary Supplements

StatusDietary SupplementsFoodsaFood AdditivesNew Drugsb
Premarket approval requiredNocNodYesYes
Risk-benefit analysis conducted by FDA before marketingNoNoNoYes
Postmarketing reporting or surveillance by industry requiredNoNoRarelyYes
Burden of proof for demonstrating safety or lack thereofFDAFDAManufacturerManufacturer

Foods (including conventional foods and dietary supplements), unlike drugs, are considered safe (reasonable certainty of no harm), and thus risk-benefit analysis is not applicable.


This description applies to “new” drugs. Many over-the-counter drugs are regulated under FDA's Over-The-Counter Drug Review procedures, which do not provide for postmarketing surveillance.


A 75-day premarketing notification, but not premarketing approval, is required for dietary supplements containing ingredients not marketed before 1994.


In 2001, FDA proposed a rule requiring marketers of food developed through biotechnology to notify the agency at least 120 days before commercial distribution and to provide information to demonstrate that the product is as safe as its conventional counterpart (FDA, 2001).

SOURCE: Adapted from IOM (2005).

From: 9, Dietary Supplements

Cover of Complementary and Alternative Medicine in the United States
Complementary and Alternative Medicine in the United States.
Institute of Medicine (US) Committee on the Use of Complementary and Alternative Medicine by the American Public.
Washington (DC): National Academies Press (US); 2005.
Copyright © 2005, National Academy of Sciences.

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