It’s been more than 15 years since FDA published final regulations describing the types of statements that can be made regarding the effect of a dietary supplement on the function or structure of the body. The regulations are an important resource for the dietary supplement industry—including marketers of joint health products—because they cite concrete examples of allowable claims, distinguishing them from prohibited statements that regulators would consider an express or implied claim to treat a disease.
Under the 1994 Dietary Supplement Health and Education Act (DSHEA), FDA does not approve structure/function claims. But the claims must be truthful and not misleading, and companies must submit a notification of the claim within 30 days of marketing the dietary supplement. However, FDA doesn’t invariably respond to a structure/function notification. But if FDA does respond, don’t ignore the agency.
In selling dietary supplements to address joint health and inflammation, it’s important to qualify the claims to make clear they aren’t intended to treat a disease such as arthritis, industry lawyers said.
In the final regulations, FDA referenced a number of statements related to joint health that would be interpreted as claims to treat a disease. While the examples cited by FDA remain important for industry, it’s important to recognize the agency has evolved its position on certain structure/function claims, such as inflammation.
When making joint health claims on a new dietary supplement, submit the required notification to FDA. Avoid statements—express or implied—of treating a disease such as arthritis. If it’s unclear whether regulators would consider the statement a structure/function claim, consult qualified counsel. Finally, if FDA responds to a structure/function notification, follow up with the agency in a timely manner.
For additional insights from legal experts on structure/function claims and other details about the joint health market, download the “Bolstering Joint Health” Digital Magazine.