Why aren't nutritional supplements regulated by the FDA?

Dr. Michael Roizen, MD
Internal Medicine
Why doesn't the Food and Drug Administration (FDA) regulate the safety and sale of nutritional supplements? Because they're classified as food products, not medicines, so they aren't regulated by the strict standards governing the sale of prescription and over-the-counter drugs.

The FDA has very little authority to mess with nutritional supplement companies because they're not drug manufacturers; they're selling foodstuffs or nutraceuticals (natural substances believed to have health benefits), according to some decision made decades ago.

Further, the FDA can't even inspect the company's manufacturing process unless it has reasonable evidence that its products are harming people -- and this means some people need to be harmed before the FDA can step in. That's a little late, if you ask me.

This lack of regulation can lead to wildly inconsistent quality -- and there's even no guarantee that the ingredient touted on a bottle's label will be in the supplement at all.
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Before 1994 dietary supplements were subject to the same regulatory requirements as were foods by the FDA. That changed when Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. Whatever their form may be, DSHEA places dietary supplements (DS) in a special category under the general umbrella of "foods," and therefore the FDA still has the responsibility to help regulate the industry albeit a lesser role. The FDA (Center for Food Safety and Applied Nutrition) and the Federal Trade Commission (FTC) are both involved. Also as of 2011 all dietary supplement manufacturers must follow Current Good Manufacturing Practices (cGMPs), which means testing is required for all raw materials and finished products. Supplements are often now marketed without proving they work as claimed making the FDA or FTC catch up with them after they have been distributed. If there are frequent reports of adverse reactions the FDA will investigate and if they find fault with product, they have the power to pull it from the market, levy fines, etc. The FTC cracks down on false claims and can also remove the product and/or fine the company at fault.

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Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.