Is your product claim a drug claim? [3 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 three of a twelve series discussing those criteria.
Prohibited: Claims suggesting that the product has an effect [using scientific or lay terminology] on characteristic signs or symptoms of a disease.
This one is relatively similar to the first example of prohibited claims. The difference here is that it addresses characteristic signs and symptoms of these specific diseases. In other words, rather than prohibiting the mention of a disease, whether implicitly or explicitly, it prohibits mentioning key symptoms of diseases or states of dysfunction within the body.
Symptoms which are related to diseases (i.e. joint pain is related to arthritis) and symptoms which are specific to diseases (i.e. high cholesterol is specific to hypercholesterolemia) both fall under this classification.
- Lowers cholesterol
- Reduces joint pain
- Prevents bone fragility in post-menopausal women
- Maintains healthy lungs in smokers
Structure / Function Claims
- Helps maintain cardiovascular function
- Supports cartilage and joint function
- Promotes bone health
- Maintains healthy lung function
What's the Difference?
The difference here is similar to the difference in the first guideline. The drug claims identify a specific disease or disorder within the body, whereas the structure / function claims identify ways in which the supplement(s) support the body in its normal state of wholeness.
Rather than naming a disease directly, the drug claim examples above identify diseases by their dominant characteristics. The first claim implies that it can treat hypercholesterolemia. The second implies treatment of arthritis. The third implies treatment of osteoporosis, while the fourth implies prevention of tobacco related lung diseases.
This category may require medical expertise. Some symptoms are associated with both diseased states and with normal states of wellbeing. One example the FDA provides is "relieves stress and frustration." These symptoms are consistent with an anxiety disorder. However, they are also consistent with routine stressors or mood swings, both of which are non-disease states. Therefore, because they are not characteristics of diseased state, they are permitted.
Identifying a disease by its key characteristics is no different then identifying a disease by its medical terminology. If the reader or consumer understands that a specific state of disease or dysfunction is being referenced, you've made a disease claim.