By Curtis Walcker, M.S.
December 9, 2015
Communicating the features and benefits of your dietary supplements is a critical success factor. Although this can be done in several ways, the most powerful is usually through the use of structure/function claims. A common misnomer about these claims is that virtually anything can be said as long as the FDA disclaimer language is added to the label or labeling. Unfortunately, this is far from the truth. There are regulations that put significant limitations on what can be said, and it is truly an art to not only saying things compliantly, but also in ways that are meaningful to consumers. Here are some of the most basic aspects of structure/function claims.
What are structure/function claims?
Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of humans, or characterize the documented mechanism(s) of action by which a nutrient or dietary ingredient acts to maintain such structure or function. Importantly, they cannot be disease claims. Structure/function claims may also relate to nutrient deficiency diseases, or describe the effect of the dietary supplement on general well-being.
What are disease claims?
Dietary supplements and their ingredients cannot be marketed with the intentions to diagnose, mitigate, treat, cure, or prevent diseases (other than classical nutrient deficiency diseases). Doing so creates disease claims. By the definition given in 21 U.S.C. 343(r)(6), “disease” is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.
Q: Which of the following is the disease claim?
1) Product X treats diabetes.
2) Product X promotes healthier blood sugar.
A: Both are very likely to be considered disease claims. Did you choose 1? Disease claims can be explicit or implied. They need not mention specific disease names such as diabetes.
What laws and regulations govern structure/function claims?
The Dietary Supplement Health and Education Act of 1994 (DSHEA) added section 403(r)(6) to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law states that a dietary supplement may bear structure/function claims and provides their requirements. Further, 21 CFR 101.93 also restates these requirements.
What are the requirements for using structure/function claims?
- You must have substantiation that the claims are truthful and not misleading, and you must have this substantiation before you make the claims.
- Refer to the FDA and FTC guidance documents for preparing competent and reliable claims substantiation, or get help from someone who can prepare these files for you. You do not want to be caught without them.
- You must notify the FDA that you are using the claims within 30 days of first marketing your product.
Q: Do you really need to do this?
A: Yes. Many companies overlook this important requirement for making structure/function claims.
- You must include the mandatory disclaimer for structure/function claims.
- Text for the disclaimer when one claim is present: 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.
- Text for the disclaimer when more than one claim is present: 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 placed adjacent to the claim(s) with no intervening material or linked with a symbol (e.g., an asterisk) at the end of each claim that refers to a symbol placed adjacent to the disclaimer.
- On product labels and labeling, the disclaimer must appear on each panel or page where structure/function claims are made.
- The disclaimer must be set off in a hairline box when it is not adjacent to the claim(s).
- The disclaimer must be in bold type and no smaller than one-sixteenth inch.
While these basics do not cover everything you must know when making structure/function claims, they give you a good start towards regulatory compliance. For a bit more, see our April, 2015 article Supplements Claimed to Treat 100+ Diseases. It highlights some places claims exist, as well as some of the most prevalent claims cited in FDA Warning Letters.