Product Claim Guidelines [5 of 12]

Is your natural product claim actually a drug claim? [5 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 five of a twelve-part series discussing those criteria.

Prohibited: Certain claims made through the use of images, pictures, symbols, or the like. 

"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: 

  • An image of a child with a rash
  • Electrocardiogram tracings
  • Images of diseased lungs
  • Heart symbol
  • Brain scan imaging

Structure / Function Claims 

  • An image of a healthy child smiling
  • Pictures of adults exercising
  • Images of organs which are clearly healthy
  • Icon of healthy human body

What's the Difference?

Images and symbols are used to convey the intended use of a product. When the image or symbol communicates a diseased state, the consumer takeaway is that this product has the ability to prevent or treat disorders related to the image.

In the first example, the image of a child with a rash communicates that a product is intended to prevent or alleviate dermal conditions. The second example of an EKG tracing implies the presence of heart disease. Images of diseased lungs convey that the intended consumer is at high risk for, or is suffering from, lung disease. Finally, the heart symbol is widely understood to refer to cardiovascular-related prevention.

What if the brain scan image or EKG tracings are healthy? The catch here is that the average consumer does not have the background expertise to interpret such images and determine whether or not they are diseased. These images imply diagnostic testing, which is associated with disease. While a clinician or technician may clearly comprehend that tracings indicate absence of disease, the net impression is what matters.