Labeling of Dietary Supplements
Please Check Dates for Latest InformationGeneral Labeling Issues | Health Claims | Structure Function Claims | Claims Based on Authoritative Statements
See also: Label Claims (includes conventional foods & dietary supplements)
Dietary Supplement Claims
FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media and printed materials. There are three categories of claims that can be used on foods and dietary supplement labels: health claims, structure/function claims, and nutrient content claims. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, or, in the case of advertising, with the Federal Trade Commission.
Health claims describe a relationship between a food substance and a disease or health-related condition. There are three ways by which FDA exercises its oversight in determining which health claims may be used on a label or in labeling for a food or dietary supplement: 1) under the 1990 Nutrition Labeling and Education Act (NLEA), FDA can authorize a health claim for a food or dietary supplement based on FDA's careful review of the scientific literature; 2) under the 1997 Food and Drug Administration Modernization Act (FDAMA), upon successful submission of a "notification," a health claim may be made for a food based on an authoritative statement of a scientific body of the U.S. government or the National Academy of Sciences; and 3) under a 1999 court decision in the case of Pearson v. Shalala, certain qualified health claims may be used for a dietary supplement. The differences between these three methods of oversight for health claims are summarized below. For those health claims that have been approved for use on food and dietary supplement labels, see: http://www.cfsan.fda.gov/~dms/flg-6c.html.
DSHEA created another category of statements, generally referred to as "structure/function" claims, that may be made for dietary supplements. These statements may claim a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States. Structure/function claims may also describe the role of a nutrient or dietary ingredient intended to affect a structure or function in humans, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity," or they may describe general well-being from consumption of a nutrient or dietary ingredient. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.
For more information see the January 6, 2000 Federal Register (65 FR 1000) that describes the types of claims that can and can not be made for dietary supplements. It can be found on the Web at: http://www.cfsan.fda.gov/~lrd/fr000106.html.
Manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim.
Nutrient Content Claims
Under NLEA, foods and dietary supplements can use claims called "nutrient content claims." These claims describe the level of a nutrient or dietary substance in the product, using terms such as "good source," "high," or "free." Nutrient content claims may only be made if FDA has a regulation specifying the criteria that a food must meet in order to use the claim. With few exceptions, nutrient content claims can only be made for nutrients or dietary substances that have an established daily value. The requirements that govern the use of nutrient content claims help ensure that descriptive terms, such as "high" or "low," are used consistently for all types of food products and are thus meaningful to consumers. Examples of nutrient content claims can be found on the Web at: http://www.cfsan.fda.gov/~dms/flg-6a.html and http://www.cfsan.fda.gov/~dms/flg-6b.html.
Like it did for health claims, the Food and Drug Administration Modernization Act (FDAMA) of 1997 provided a second way for a nutrient content claim to be used on foods. FDAMA allows certain nutrient content claims to be made based on an "authoritative statement" as discussed above for health claims. However, these claims may be made for both conventional foods and dietary supplements. There is a separate guidance document, posted on FDA's Web site (http://www.cfsan.fda.gov/~dms/hclmguid.html), that explains how a firm can make these types of nutrient content claims.
Percentage claims for dietary supplements represent yet another category of nutrient content claims. These claims are used to describe a percentage level of a dietary ingredient for which there is no established Daily Value. Examples include simple percentage statements such as "40% omega-3 fatty acids, 10 mg per capsule," and comparative percentage claims, e.g., "twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)." (See 21 CFR 101.13(q)(3)(ii), which can be found on the Web at http://www.cfsan.fda.gov/~lrd/cf101-13.html.)