Product Claim Guidelines [10 of 12]

Is your natural product claim actually a drug claim? [10 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 ten of a twelve series discussing those criteria.

Prohibited: Claims suggesting that a product has a role in the body's response to a disease or vector of disease 

Drug claims are not merely associated with the treatment of a diseased state; they also include the prevention of specific diseases. Therefore, implying that your product helps the body achieve a certain preventive goal constitutes a drug claim. This guideline is similar to previous guidelines addressing the use of specific diseases using medical or lay terminology and addressing specific classifications of treatments. The difference in this guideline is that it includes the human body in the claim.

Drug Claims: 

  • Supports the body's antiviral capabilities
  • Helps the body resist infection
  • Empowers the body to fight disease
  • Helps you stay healthy during the cold and flu season

Structure / Function Claims 

  • Supports the immune system
  • Promotes a healthy immune system

What's the Difference?

The top list of claims refer specifically to preventing a certain disease. These indicate that the product is not a supplement that boosts normal healthy functions but rather that it is a preventive drug for certain conditions. Meanwhile, a product that supports the immune system is not a drug because the immune system is useful for both disease prevention and for healthy bodily function. To ensure claims are compliant, avoid any implication of intended use for disease prevention, treatment, or cure.