How does the FDA regulate dietary supplements?

A report from the American Association of Liver Diseases tied one-in-five cases of chemical-induced liver damage to dietary supplements. Even though the Food and Drug Administration (FDA) regulates dietary supplements and pharmaceutical drugs, both products face different standards. This post will explore how the FDA regulates dietary supplements and how supplement recalls work.

The Dietary Supplements Health and Education Act of 1994 defines a supplement as a vitamin, herb, or enzyme that comes in a tablet, powder or liquid form. These supplements may provide extra nutrients that the body needs to function and may help reduce the risk of disease. Dietary supplements cannot claim that they treat diseases or act as a complete meal replacement.

Unlike prescription drugs, the FDA is not authorized to review supplements for safety or effectiveness before they are available for purchase. The FDA does provide manufacturing guidelines and labeling regulations that dietary supplement manufacturers must follow. Supplement manufacturers are legally required to produce safe supplements that do not contain contaminants or impurities.

Dietary supplements can remain on the market until a producer tells the FDA of a problem or the FDA proves that a supplement is unsafe. Alternatively, prescription drugs must go through a review process and clinical trials before they become widely available. Recalls of dietary supplement and pharmaceutical drug happen, but the FDA can only take action after a dietary supplement is available to consumers.

Although dietary supplements and pharmaceutical drugs may seem similar, they face different regulations. Even if a dietary supplement or pharmaceutical drug does not get recalled, the manufacturer may be negligent for not including warnings or following proper legal guidelines. If you become sick because of a supplement or prescription drug, speak to a lawyer and see if you can file product liability claim.

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