FDA has authorized three types of claims for dietary supplement labeling (1) nutrient content claims; (2) FDA approved health claims; and (3) descriptive claims which are neither nutrient content claims nor health claims.
A nutrient content claim is a claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling. An expressed nutrient content claim is any direct statement of the level of a nutrient in the dietary supplement, e.g. “low sodium.” An implied nutrient content claim is any claim that: (1) describes the dietary supplement or an ingredient therein in a manner that suggests that a nutrient is absent or present in a certain amount, e.g. “high is oat bran;” or (2) suggests that the dietary supplement, because of its nutrient content, may be useful in maintaining healthy dietary practices and is made in association with an explicitly claim or statement about a nutrient, e.g. “healthy, contains 3 grams of fat.”
Only those nutrient content claims, or their synonyms, that are specifically defined in FDA's regulations may be used. The claim may be no more than two times the font size of the statement of identity. Whether a nutrient content claim may state “contains,” “good source of,” “high,” “low,” “free” or any other related claim must be addressed on a case by case basis depending on the level of the nutrient in question.
A health claim is an explicit or implied characterization of a relationship between a substance and a disease or a health-related condition. Health claims are permitted only if they have been authorized by an FDA finding that there is a “significant scientific agreement” to support the claim. The Food and Drug Administration Modernization Act of 1997 (“FDAMA”) also now allows health claims that are based on “authoritative statements” from certain federal scientific bodies, such as the National Institutes of Health (“NIH”) and the National Academy of Sciences, these are referred to as qualified health claims.
Aside from these authorized claims, dietary supplement marketers are prohibited from making any labeling claim about the diagnosis, mitigation, treatment, or cure of a disease. A health claim may take the form of a written statement, a third-party reference, a symbol, or a vignette. They describe the effect a substance has on reducing the risk of or preventing a disease.
Qualified health claims are supported by less scientific evidence than an authorized health claim. FDA must approve the qualified health claim and the claim must be accompanied by an agency-approved disclaimer, which is a statement that discloses the level of scientific evidence used to substantiate the health claim.
FDA will permit the use of a qualified health claim provided that (1) FDA has issued a letter stating the conditions under which we will consider exercising enforcement discretion for the specific health claim; (2) the qualified claim is accompanied by an agency approved disclaimer; and (3) the claim meets all the federal requirements for health claims in 21 C.F.R. § 101.14, except for the requirement that the evidence for the claim meets the validity standard for authorizing a claim, and the requirement that the claim be made in accordance with an authorizing regulation.
Structure/function claims refer to representations about a dietary supplement's effect on the structure or function of the body for the maintenance of good health and nutrition. A structure/function claim describes the role of a substance intended to maintain the structure or function of the body. A structure/function claim does not require pre-approval by FDA. The difference between a health claim and a structure/function claim is that a health claim describes the effect a substance has on reducing the risk of or preventing a disease, e.g., “calcium may reduce the risk of osteoporosis” and a structure/function claim describes an effect on the body, e.g., “helps maintain a healthy cardiovascular system.”
The following statements are considered structure/function claims:
A statement that claims a benefit related to a classical nutrient deficiency disease and that discloses the prevalence of such disease in the U.S.;
A statement that describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, or characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function; or
A statement that describes the general well-being from the consumption of a nutrient or dietary ingredient.
Structure/function claims must (1) have substantiation that such statement is truthful and not misleading; (2) include the disclaimer; and (3) notify FDA no later than 30 days after the first marketing of the product that these claims are being made in accordance with 21 C.F.R. § 101.93.
The disclaimer must read “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease;” or “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The disclaimer must be boldface type and placed in a box and linked to the statement by a symbol (e.g. an asterisk) placed at the end of each statement that refers to an identical symbol placed adjacent to the disclaimer.