FDA Guidance for Brands, E-tailers, and Retailers
Compliance with FDA regulations is a critical part of the dietary supplement industry. It protects consumers, ensures market stability, and preserves the company's reputation. Businesses that prioritize formula reviews, accurate labeling, substantiated claims, and rigorous verification processes are better positioned to succeed in this competitive and highly regulated market.
Formulation Reviews
A formula review ensures that the ingredients and their concentrations are safe for consumption and compliant with FDA regulations. The Dietary Supplement Health and Education Act (DSHEA) permits certain ingredients but prohibits others. New dietary ingredients (NDIs) require a pre-market notification to the FDA with evidence of safety. Introducing unapproved or unsafe ingredients can result in legal and financial repercussions and endanger consumer health.
Structure/Function Claims Substantiation
Structure/function claims describe the product's role in supporting normal body structure or function (e.g., "supports immune health"). These claims must be truthful and not misleading. Claims must be substantiated by credible scientific evidence. The FDA requires notification within 30 days of marketing a product with such claims. Unsupported claims can result in regulatory enforcement and damage to the company’s reputation
Labeling
Accurate and compliant labeling informs consumers and avoids misleading claims. Labels must include a Supplement Facts panel, ingredient list, net quantity, and appropriate warnings. Manufacturers must also adhere to allergen labeling requirements. Misbranded products can be seized by the FDA, and companies can face lawsuits for misleading consumers.