Is your natural product claim actually a drug claim? [1 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 one of a twelve-part series discussing those criteria.
Is this claim a structure / function claim or a drug claim? And what's the difference?
Natural product claims come in many forms ranging from health claims to drug claims. Most natural product claims, however, are structure / function claims which are unique to dietary supplements. The differences in these claims are relatively straightforward.
Structure and function refer to the body as a whole. The goal is to maintain the body in this normal working state of wellbeing. Supplements maintain health.
Drugs or pharmaceuticals prevent, treat, and cure. The goal is to restore the body to health from a diseased state of dysfunction.
Therefore, structure / function claims will describe the role(s) of a formulation or its ingredients on the normal structure and function of the human body, not related to a specific disease. Whereas drug claims will describe the role of a formulation or its ingredients on an abnormal state of health aka disease.
Structure Function Claim Examples:
- supports the immune system
- keeps kids healthy
- supports healthy digestion
- natural mood elevator
- great source of energy
Drug Claim Examples:
- lowers cholesterol
- treats and prevents joint pain
- prevents heart attack
- for cold and flu symptoms
Guidance: Dossier substantiation data must be available when they ask. If you do not have one BEFORE you start the claim, you are breaking the law. General rule of thumb, have it available within 15 minutes.
Structure / function claims exclusively maintain health status. They do not describe a relationship with a disease, which is defined as damage to an organ, part, structure, or system of the body in such a way that it does not perform properly.
If I avoid stating directly that my product cures a specific disease, I have avoided making drug claims.
This is a dangerous belief. Drug claims do not have to be explicit. You can avoid directly stating that your product has an effect on a disease and still be penalized for making drug claims.
Structure / Function claims are alternatives to drug claims that I can freely add to my products or website.
This is also a risky approach. Structure / function claims represent a class of potential claims that can be made regarding dietary supplements, but are not a grab-bag of marketing slogans. Before making a structure / function claim, the claim must be sufficiently substantiated with a professionally compiled or reviewed dossier, registered with the FDA, and accompanied by a disclaimer. See more on S-F claim requirements here.
The FDA disclaimer will protect me from the appearance of drug claims.
The FDA disclaimer is a required accompaniment for structure / function claims. It is not a "get out of jail free" card and does not excuse or cure an otherwise unauthorized marketing claim or ad. Statements made on packaging and on websites cannot be undone by dropping a disclaimer at the bottom of the page.
How do I ensure my claims are compliant?
The FDA provides criteria for clarifying the difference between structure / function claims, which are legal for dietary supplements provided they are substantiated, registered, and accompanied by the FDA disclaimer, and drug claims, which are reserved for authorized drug products.
This 12-part series dives deep into these criteria, providing clarity for claim requirements and helping you to protect your brand from expensive regulatory action.