What are Dietary Supplements According to the FDA?

Dietary supplements are products that people add to their diets to supplement their nutritional intake. They come in many forms, including tablets, capsules, soft gels, gel capsules, powders, sticks, gummies and liquids. These products contain ingredients such as vitamins, minerals, herbs, amino acids and enzymes. The Federal Food, Drug and Cosmetic Act (FD&C Act) defines a dietary supplement as a product intended to supplement the diet that contains a dietary ingredient such as a vitamin, mineral, herb or other botanical substance, amino acid or dietary substance used by man to supplement the diet by increasing total dietary intake.

The FDA is the federal agency responsible for regulating both supplements and medications. However, the rules for dietary supplements are different from those for prescription or over-the-counter drugs. Dietary supplements are not intended to treat, diagnose, mitigate, prevent or cure diseases. The safety of many supplements has not been well-proven in pregnant women, nursing mothers or children.

The Federal Trade Commission (FTC) requires that information about a supplement be truthful and not misleading. Manufacturers may claim that a supplement promotes health or supports a bodily function (such as immunity or heart health). However, the FDA does not determine if dietary supplements are effective before they are marketed. You're more likely to have side effects from dietary supplements if you take them in high doses or instead of prescription drugs, or if you take many different supplements.

For a list of possible serious reactions to watch out for and how to report an adverse event, see the FDA website. Manufacturers can add vitamins, minerals and other supplement ingredients to the foods you eat, especially cereals and breakfast drinks. Some dietary supplements can help you get adequate amounts of essential nutrients if you don't eat a variety of nutritious foods. Information for consumers on the use of dietary supplements includes updates for consumers, information from other agencies and other educational materials for users of dietary supplements.

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