Dietary Supplements: Background Information

Written by Office of Dietary Supplements

Detailed information on dietary supplements, what they are and claims made about safety and effectiveness of dietary supplements.

Table of Contents

• What is a dietary supplement?
• What is a new dietary ingredient?
• Are dietary supplements different from foods and drugs?

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• What claims can manufacturers make for dietary supplements and drugs?
• How does FDA regulate dietary supplements?
• What information is required on a dietary supplement label?
• Does a label indicate the quality of a dietary supplement product?
• Are dietary supplements standardized?
• What methods are used to evaluate the health benefits and safety of a dietary supplement?
• What are some additional sources of information on dietary supplements?

What is a dietary supplement?

As defined by Congress in the Dietary Supplement Health and Education Act (http://www.fda.gov/opacom/laws/dshea.html#sec3), which became law in 1994, a dietary supplement is a product (other than tobacco) that

• is intended to supplement the diet;

• contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;

• is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and

• is labeled on the front panel as being a dietary supplement.

What is a new dietary ingredient?

A new dietary ingredient is a dietary ingredient that was not sold in the United States in a dietary supplement before October 15, 1994.

Are dietary supplements different from foods and drugs?

Although dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) as foods, they are regulated differently from other foods and from drugs. Whether a product is classified as a dietary supplement, conventional food, or drug is based on its intended use. Most often, classification as a dietary supplement is determined by the information that the manufacturer provides on the product label or in accompanying literature, although many food and dietary supplement product labels do not include this information.

What claims can manufacturers make for dietary supplements and drugs?

The types of claims that can be made on the labels of dietary supplements and drugs differ. Drug manufacturers may claim that their product will diagnose, cure, mitigate, treat, or prevent a disease. Such claims may not legally be made for dietary supplements.

The label of a dietary supplement or food product may contain one of three types of claims: a health claim, nutrient content claim, or structure/function claim (http://www.cfsan.fda.gov/~dms/hclaims.html). Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product. A structure/function claim is a statement describing how a product may affect the organs or systems of the body and it can not mention any specific disease. Structure/function claims do not require FDA approval but the manufacturer must provide FDA with the text of the claim within 30 days of putting the product on the market (http://www.cfsan.fda.gov/~dms/ds-labl.html#structure). Product labels containing such claims must also include a disclaimer that reads, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."

How does FDA regulate dietary supplements?

In addition to regulating label claims, FDA regulates dietary supplements in other ways. Supplement ingredients sold in the United States before October 15, 1994, are not required to be reviewed by FDA for their safety before they are marketed because they are presumed to be safe based on their history of use by humans. For a new dietary ingredient—one not sold as a dietary supplement before 1994—the manufacturer must notify FDA of its intent to market a dietary supplement containing the new dietary ingredient and provide information on how it determined that reasonable evidence exists for safe human use of the product. FDA can either refuse to allow new ingredients into or remove existing ingredients from the marketplace for safety reasons.