Is your natural product claim actually a drug claim? [8 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 eight of a twelve series discussing those criteria.
Prohibited:. Claims suggesting that your product is a substitute for a product that is a treatment for a disease or augments a treatment for disease
Some ingredients are prohibited from inclusion in dietary supplements because they have been authorized as a drug prior to being marketed as a dietary supplement. In that instance, you may not include that ingredient in the formulation.
Ingredients, like aspirin, cannot be found in the ingredient list. Likewise, claims may not imply that such an ingredient is found in the formulation, even if it is not in the ingredient list.
- Herbal Prozac
- Contains willow bark, a precursor to aspirin
- An aspirin alternative
- Nature's Xanax
- Use as part of your diet when taking insulin
- Combats effects of antibiotics
Structure / Function Claims
- Use to support mood balance
- Provides a natural boost
- Promotes glucose metabolism
- Supports healthy gut flora
What's the Difference?
Whether you are promoting the product as a drug-free alternative to popular prescription products, as a side-effect free alternative, or a way to reduce side effects from drugs, the end result is a claim that your product is an alternative to a drug product. Linking a natural product to a pharmaceutical drug tells your consumers that the two are interchangeable. It implies equivalency. This is contradictory to the entire purpose of dietary supplements. Dietary supplements are not drug products; they support the natural wholeness of the body.
What if you want to market your product as a drug-free alternative? There are no legal claims for drug-free solutions to disease states or conditions. If you have developed a product with the ability to treat or cure disease, the product not a supplement even if it is 100% plant based and natural. It is a drug if it is intended to treat disease. The FDA has a botanical drug pathway for this exact scenario. This pathway requires clinical research to confirm safety and efficacy.