Is your natural product claim actually a drug claim? [11 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 eleven of a twelve series discussing those criteria.
Prohibited: Claims that a product augments a therapy or drug used to diagnose, mitigate, treat, cure, or prevent disease OR claims that a product treats, prevents, or mitigates adverse effects or side effects associated with a therapy for a disease
What if the goal of your formulation is not to treat a disease itself, rather to supplement the usual treatment for that disease? For example, perhaps you have an essential oil blend that is known to potentiate the effects of antibiotics? Or perhaps you have an anti-nausea blend that helps chemotherapy patients? Or you have a probiotic formulation that is beneficial for people taking antibiotics?
Linking a product, ingredient, or formulation to a therapy or drug associated with a disease is considered a drug claim. Naming any pharmaceutical or medical treatment or procedure links your product with the effects of that product or procedure, implying drug-related effects for the condition being treated.
- Reduces chemotherapy-induced nausea
- Soothes skin irritated by radiation therapy
- Mitigates diarrhea caused by antibiotics
- Resolves headaches caused by nitrates
Structure / Function Claims
- Relief of upset stomach
- Supports skin health
- Promotes healthy gut flora
- Promotes relaxation
What's the Difference?
Identification of a specific drug, treatment, or procedure constitutes a claim related to your product and the underlying state of disease or dysfunction. This is contradictory to the overall purpose of natural supplements, which exist to support the body in a state of health and wellbeing.
Indicating that a formulation can help to relieve upset stomach does not constitute a drug claim because an upset stomach often occurs in a healthy body for reasons unrelated to a cancer diagnosis or chemotherapy.