The promise of DSHEA (the Dietary Supplement Health and Education Act of 1994) included the opportunity to educate consumers about the benefits of dietary supplements and dietary ingredients. This was carved out in structure/function claims.
Before a brand can educate, it must have knowledge to share. This is identified in the realm of structure/function claims as “substantiation."
Looking at substantiation from FDA’s perspective, we are left with a guidance document from December 2008 on the topic. In “Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act," FDA generally defers to FTC case law while further stating it will base its evaluation of substantiation on:
1. The meaning of the claim(s) being made;
2. The relationship of the evidence to the claim;
3. The quality of the evidence; and
4. The totality of the evidence.
Examples in this guidance describe what FDA’s current thinking is on each of these criteria.
To achieve something that acknowledges FDA’s current thinking as expressed in the guidance document, the best approach is to compile multiple studies that at least meet the full criteria described in the guidance.
Learn more about FDA’s thinking on joint health claim substantiation as well as ingredient research and market data in INSIDER’s Joint Health Digital Magazine.
As chief operating officer, Jim Lassiter oversees all consulting operations at Ingredient Identity [Link to ingredientidentity.com]. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.