When a structure-function claim is used, what accompanying note is required?

When a structure-function claim is used, what accompanying note is required?

• A. FDA disclaimer
• B. Third-party certification
• C. Not necessary
• D. Prescription requirement

Answer: (A)

When labeling a dietary supplement with a structure-function claim, you must include an FDA disclaimer. This type of claim describes how a nutrient or ingredient may affect the body’s structure or function, but it does not claim to diagnose, treat, cure, or prevent disease. The required note states that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease. This disclaimer makes clear that the FDA has not approved the claim and helps distinguish dietary supplement claims from drug claims or FDA endorsements. Other options, like third-party certification or a prescription requirement, are not required for this kind of claim, so they don’t fit the regulatory rule.

When labeling a dietary supplement with a structure-function claim, you must include an FDA disclaimer. This type of claim describes how a nutrient or ingredient may affect the body’s structure or function, but it does not claim to diagnose, treat, cure, or prevent disease. The required note states that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease. This disclaimer makes clear that the FDA has not approved the claim and helps distinguish dietary supplement claims from drug claims or FDA endorsements. Other options, like third-party certification or a prescription requirement, are not required for this kind of claim, so they don’t fit the regulatory rule.