Product Claim Guidelines [9 of 12]

Is your natural product claim actually a drug claim? [9 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 nine of a twelve series discussing those criteria.

Prohibited: Claims that the product or ingredient belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease. 

"A picture is worth a thousand words." Which means the use of pictures, images, or symbols in your marketing may communicate as much as, if not more than, the words and text in your materials.

These images and symbols, just like the rest of your materials, must clearly communicate your product's role in supporting and maintaining healthy structure and function of the human body. If your images communicate diseased states or drug-related actions, you are making a drug claim.

Images and their interpretation are highly subjective, based on cultural context. This can make it difficult as you may perceive a symbol to have one meaning, but the general public may have a different interpretation. According to the FDA and the FTC, you are responsible for the "net interpretation" of your materials and if there is more than one reasonable interpretation, both must be substantiated.

Which means your images need to be compliant.

Drug Claims: 

  • antibiotic
  • antiviral
  • antimicrobial
  • antidepressant
  • analgesic
  • anti-inflammatory*

Structure / Function Claims 

  • energizer
  • adaptogen 
  • tonic
  • revitalizer
  • calmative
  • anti-inflammatory*

What's the Difference?

Claiming that an ingredient or formulation belongs to certain classes of products is often sufficient to constitute a drug claim. These classifications, such as antibiotic or antiviral, are strongly associated with diseased states. For example, marketing an herbal supplement during the Covid-19 pandemic under the label "antiviral" implies to consumers that the supplement may prevent or treat Covid-19. Marketing any product as antibacterial implies to consumers that the product may be an alternative to doxycycline or amoxicillin.

What about anti-inflammatory, which appears under both headings? The FDA identifies certain classes which would be dependent on the overall context of the label, website, or marketing materials. These include diuretic, laxative, and anti-inflammatory. In these instances, the term could imply drug activity associated with a disease but it could also imply structure or function support in a normal state of wellbeing.

Using one of these phrases requires clear clarification that the intended use is for health maintenance and not treatment or prevention of a disease. This will typically make the claim longer as it must include the clarification. Examples of compliant phrases include "Laxative for relief from occasional constipation" or  "Diuretic to relieve temporary water-weight gain."