Avoid Pitfalls when Sharing Scientific Research about Dietary Ingredients
Ingredient suppliers, and brands responsible for finished products, want to highlight clinical studies supporting product claims. Questions about DSHEA’s scientific literature exemption, part of the FD&C Act, come up frequently for our SupplySide and Natural Products Expo exhibitors. While DSHEA does carve out an exception for scientific literature, it must be used with care.
Here are some best practices MarketReady recommends:
- Intended Use Doctrine. Be aware that the FDA’s primary consideration is “intended use.” It considers whether the literature is evidence that the manufacturer intends the ingredient or product to be used like a drug. See, for example, FDA’s warning letter to ChromaDex in November 2020.
- Physical Separation. Literature must be separated from the point of sale. Remember, the scientific literature exemption was drafted with brick-and-mortar stores in mind, not websites and social media posts. The informal approach to providing virtual separation, the “two-clicks rule,” separates the material from the products with an intervening page (two links, not a “double-click”) between the scientific literature and the page on which the product is promoted.
- In Its Entirety. In addition to separating the material, the scientific literature must appear in its entirety. We commonly see only excerpts from scientific literature placed in materials describing a product.
- Not Misleading. The information cannot be false or misleading and must be presented as part of a balanced view. If conflicting studies exist, a business may need to acknowledge them as well.
- Branded Information. One of the most challenging aspects of the exemption is that no information may be appended to the scientific literature. Businesses focused on transparency want to include their brand and contact information on these materials, but when they do so, they can convert scientific literature into promotional materials.
Consumers want to see the science. Businesses should consider separately posting scientific information in digital libraries earmarked for scientific literature and educational material.
MarketReady Insights helps business share scientific literature within the DSHEA exemption.