Product Claim Guidelines [2 of 12]

Is your natural product claim actually a drug claim? [2 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 two of a twelve series discussing those criteria.

Prohibited: Claims suggesting that your product has an effect on a disease or class of diseases. 

The first guideline is straightforward. Don’t reference a disease in your claim. This is more broad than merely avoiding medical terminology. Diseases can be identified using medical terminology, lay terminology, or even slang. Furthermore, don’t identify a class of diseases or use the terms disease or diseased. Again, this isn't an issue of semantics. Using lay terminology or slang is the same as using medical terminology. 

Drug Claims: 

  • Prevents insomnia
  • Reduces the pain and stiffness of arthritis 
  • Protects from viral infections 
  • Alleviates stomach ulcers 
  • [this product] promotes health and prevents disease

Accepted Structure / Function Claims 

So what can you say? Provided you have a professionally compiled or reviewed substantiation dossier, you can make claims like this:  

  • Nighttime sleep aid 
  • Supports healthy joints  
  • Supports healthy immune function 
  • Helps maintain intestinal flora

What’s the difference?

The drug claims specifically identify a state of disease or dysfunction within the body, linking it to your product. Addressing disease is the realm of pharmaceuticals. Supplements maintain a state of normal health within the body. They support systems, structures, and functions of the body.

So the goal here isn’t merely to avoid stating the name of a disease specifically. The difference is more fundamental than semantics. The goal here is to describe how the supplement supports the body in its state of normal health and wellbeing. Helping someone sleep is a normal bodily function. Insomnia, however, is a medical condition which represents a dysfunctional state of the body.