What You Need to Know about Dietary Supplements | FDA

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Dietary Supplements can be beneficial to your health but taking supplements can also involve health risks. The U.S. Food and Drug Administration (FDA) does not have the authority to review dietary supplement products for safety and effectiveness before they are marketed.

Youve heard about them, may have used them, and may have even recommended them to friends or family. While some dietary supplements are well understood and established, others need further study. Read on for important information for you and your family about dietary supplements.

Before making decisions about whether to take a supplement, talk to your healthcare provider. They can help you achieve a balance between the foods and nutrients you personally need.

Dietary supplements include such ingredients as vitamins, minerals, herbs, amino acids, and enzymes. Dietary supplements are marketed in forms such as tablets, capsules, softgels, gelcaps, powders, and liquids.

Some supplements can help assure that you get enough of the vital substances the body needs to function; others may help reduce the risk of disease. But supplements should not replace complete meals which are necessary for a healthful diet so, be sure you eat a variety of foods as well.

Unlike drugs, supplements are not permitted to be marketed for the purpose of treating, diagnosing, preventing, or curing diseases. That means supplements should not make disease claims, such as lowers high cholesterol or treats heart disease. Claims like these cannot be legitimately made for dietary supplements.

Yes. Many supplements contain active ingredients that have strong biological effects in the body. This could make them unsafe in some situations and hurt or complicate your health. For example, the following actions could lead to harmful even life-threatening consequences.

Note: These examples do not represent either an endorsement or approval by FDA.

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FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.

The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market.

If the dietary supplement contains a NEW ingredient, manufacturers must notify FDA about that ingredient prior to marketing. However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness.

Manufacturers are required to produce dietary supplements in a quality manner and ensure that they do not contain contaminants or impurities, and are accurately labeled according to current Good Manufacturing Practice (cGMP) and labeling regulations.

If a serious problem associated with a dietary supplement occurs, manufacturers must report it to FDA as an adverse event. FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.

Dietary supplement labels must include name and location information for the manufacturer or distributor.

If you want to know more about the product that you are taking, check with the manufacturer or distributor about:

Be a savvy supplement user. Heres how:

Notify FDA if the use of a dietary supplement caused you or a family member to have a serious reaction or illness (even if you are not certain that the product was the cause or you did not visit a doctor or clinic).

Follow these steps:

Learn more about dietary supplements.

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What You Need to Know about Dietary Supplements | FDA