Product Claim Guidelines [12 of 12]

Is your natural product claim actually a drug claim? [12 of 12]

The FDA provides criteria for determining whether your product claim is a structure / function claim (which is permitted provided that you have a substantiation dossier) or a drug claim. This is part twelve of a twelve series discussing those criteria.

Final Criterion: Anything not mentioned previously which otherwise implies or suggests that a product has an effect on a disease or diseases

The final criterion for avoidance of drug claims is a catch-all approach to address any potential loopholes not previously specifically covered. It is entirely possible to meet all previous criteria and still provide an overall message in marketing materials which implies prevention, treatment, or the cure of a disease.

This goes back to the overarching dividing line between dietary supplements and drugs. Supplements are designed to support systems, structures, and overall function of the human body. They may target naturally occurring and normal states of discomfort, such as occasional sleepiness or post-exercise pain, but they do not target abnormal states of wellbeing aka diseased states. Supplements are marketed featuring what they do (i.e. supports immune function) rather than what they treat (i.e. prevents viral infections).

If the net impression of your marketing materials implies that your product is useful for preventing or treating a diseased state of the body, it's a drug. The FDA and FTC both look at the entirety of your marketing to evaluate whether or not your product is a drug. Images, associated links, social media messages, and even affiliate or sales claims are all part of this context. The FDA and/or FTC have the authority to take corrective action for inappropriate claims. This can include warning letters, federal action (often with multi-million dollar settlements), freezing your merchant account, state investigations, and more.

Other Requirements

In addition to ensuring that your claims are structure / function claims rather than drug claims, structure / function claims must be properly substantiated with a claims dossier and registered with the FDA 30 days prior to use. They must also include the FDA 2-part disclaimer which reminds consumers that the claims have not been evaluated by the FDA for accuracy and that the product is not intended to prevent, diagnose, or treat any disease." This disclaimer does not override the need for claim substantiation or registration, it is a third requirement.