FDA Regulation of Nutritional Supplements

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers of nutritional supplements are responsible for ensuring that their products are safe before they are marketed. Manufacturers of nutritional supplements do not need to provide information to the Food and Drug Administration Board, before they can get a product out on the market. They also do not need the board’s review and approval of the supplement’s ingredients before selling these products.

FDA regulation of nutritional supplements is different from those covering “conventional” foods and drug products; it takes on a post-marketing responsibility by way of monitoring safety and product information.

1. Monitoring safety

FDA regulation of nutritional supplements involves monitoring the safety of a supplement product that is out on the market. Before the FDA can take action to restrict the use of a nutritional supplement, it has to show the hazards associated with the use of the said nutritional supplement.

FDA regulation of nutritional supplements can be initiated in the form of studies, reviews, reports, scientific literature, and public comments. This was what happened in 1997, when the FDA proposed to limit the amount of ephedrine alkaloids (also known as ephedra, Chinese ephedra, Ma huang, and epitonin) in dietary supplements, as it was found to cause a range of side effects such as dizziness, nervousness, changes in heart rate and blood pressure, chest pain, stroke, hepatitis, seizure, psychosis, and even death. For more information on other potentially dangerous dietary supplements, you can visit the FDA website.

2. Product information

FDA regulation of nutritional supplements also includes, to an extent, the monitoring of the truthfulness of label claims. FDA regulation of nutritional supplements requires that the labels of dietary supplements include the statement of identity, the net quantity of contents, the structure-function claim: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease," the directions for use, the Supplement Facts panel (includes serving size, amount, and active ingredient), the other ingredients in descending order of predominance and by common name or proprietary blend, the name and place of business of manufacturer, packer or distributor, and the address to write to for more product information.

3. Best practices

FDA regulation of nutritional supplements also includes establishing good manufacturing practices, or GMPs, for manufacturers of nutritional supplements. To be sure that the ingredients packed inside the marketed nutritional supplement product are the right ingredients and amount, choose a manufacturer that is GMP-compliant.

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