The FDA has released final guidance on “Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act,” which discusses the amount, type, and quality of evidence that FDA recommends a dietary supplement manufacturer have to substantiate a nutritional deficiency, structure/function, or general well-being claim. FDA has adopted the FTC standard for substantiation and, among other things, will expect statistically significant clinical studies to support structure/function claims.
- How-to guide How-to guide: How to avoid liability for defective products in supply of goods agreements (USA) Recently updated
- How-to guide How-to guide: How to develop a vulnerability disclosure program (VDP) for your organization to ensure cybersecurity (USA) Recently updated
- Checklist Checklist: Anti-bribery and corruption risk assessment (UK)