(Regulatory Focus) Label Claims for Supplements (PMPN archive, Mar 02)

Originally Published PMPN March 2002

REGULATORY FOCUS

Label Claims for Supplements

FDA helps companies determine acceptable claims for nutritional supplements.

Erik Swain

FDA's Center for Food Safety and Nutrition has released a guidance, geared to small businesses, containing simple explanations of the regulations outlining acceptable and unacceptable label claims for dietary supplements.

The guidance, published January 9, 2002, can be found at http://www.fda.gov/OHRMS/DOCKETS/98fr/98n-0044_gdl0001.pdf. It focuses on the difference between structure/function claims, which are allowed, and disease claims, which are not allowed. The guidance also covers basic legal requirements for structure/function claims, how to comply with the regulation, and how to determine whether something is a disease claim or a structure/function claim. Existing inventory labeled before the rule went into effect had to be relabeled by January 7, 2001, for large businesses and by July 7, 2001, for small businesses.

The regulation states that dietary supplement labels can "describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function." The guidance notes that claims about nutrient deficiency diseases are also acceptable, as are those that describe the effect of the dietary supplement on general well-being. To use any claims, a firm must substantiate that they are truthful and not misleading, notify FDA that a claim is being made within 30 days of first marketing a product, and include the mandatory disclaimer statement that no claims are being made about specific diseases. Disease claims are not allowed unless the claim has undergone premarket review and been authorized by FDA.

The guidance offers explanations of the 10 criteria the agency uses to distinguish disease claims from structure/function claims. It also notes that the context of the statement, decided from information in all labeling, is a major factor in determining whether something is a disease claim, and FDA reserves the right to deem something a disease claim on that basis, even if not covered by the specific criteria in the rule. The criteria are:

Anything that mentions a specific disease or class of diseases is a disease claim. A description of a disease state implying that a product has an effect on a specific disease or class of diseases is also a disease claim.
Claims of an effect on "characteristic signs or symptoms" of a disease are not allowed. Claims that can be characteristic of nondisease states can often be appropriate structure/function claims. For claims that always imply disease, there are contexts that can make them allowed structure/function claims, such as removing inferences to an effect on a structure/function that was abnormal.
References to a "natural state or process" can be considered disease claims if the condition is uncommon or can cause significant or permanent harm.
Product names should not contain the name (or a recognizable portion thereof) of a disease, nor any terms that suggest treatment or prevention of a disease.
Stating that a product belongs to a class of products intended to treat or prevent a disease is not allowed, unless there is context that makes it clear that the intended effect of the product is on structure/function and not disease.
Claiming that a product is a substitute for a drug or other therapy for disease is not allowed, unless the drug in question is not intended to treat or prevent disease.
A claim that a nutritional supplement can augment a therapy or drug intended to diagnose, mitigate, treat, cure, or prevent a disease is not allowed.
A claim that a supplement fights a disease or enhances the disease-fighting functions of the body is not appropriate.
Claims to treat, prevent, or mitigate adverse events associated with a disease are not permitted.
A claim may be a disease claim based on its wording or the context in which the claim appears on the product's label or labeling, even if not covered by the other nine criteria.