Dietary supplement regulation is one of the most complex areas of FDA compliance. Below are answers to the questions we hear most frequently from supplement manufacturers, distributors, and brand owners.
Are dietary supplements regulated by the FDA?
Yes. Dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994 and FDA regulations at 21 CFR Parts 101 and 111. Unlike drugs, dietary supplements do not require pre-market FDA approval, but manufacturers must comply with Current Good Manufacturing Practice (cGMP) requirements, proper labeling standards, and adverse event reporting obligations.
What claims can I legally make on my dietary supplement label?
The FDA permits three types of claims on dietary supplement labels: (1) Nutrient content claims, which describe the level of a nutrient (e.g., “high in vitamin C”); (2) Health claims, which link a nutrient to a disease and require FDA authorization; and (3) Structure/function claims, which describe how a nutrient affects the body’s normal structure or function (e.g., “supports immune health”). Structure/function claims must be truthful, not misleading, and accompanied by the disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Do I need to register my dietary supplement manufacturing facility with the FDA?
Yes. Under 21 CFR Part 1, domestic and foreign facilities that manufacture, process, pack, or hold dietary supplements for U.S. consumption must register with the FDA. Registration must be renewed every two years during the October through December registration window. Failure to register is a prohibited act under the Federal Food, Drug, and Cosmetic Act and can result in significant penalties.
What are Current Good Manufacturing Practices (cGMPs) for dietary supplements?
cGMP regulations for dietary supplements (21 CFR Part 111) require manufacturers to establish and follow written procedures for production, quality control, and record-keeping. Key requirements include testing the identity of incoming ingredients, establishing product specifications for purity, strength, and composition, investigating consumer complaints, and retaining batch records for at least one year. Non-compliance can result in FDA Warning Letters, product recalls, and injunctions.
What should I do if the FDA inspects my dietary supplement facility?
If the FDA contacts you to schedule an inspection, you should immediately notify your regulatory counsel. During an inspection, FDA investigators may review your cGMP records, manufacturing processes, labeling, and complaint files. At the conclusion of the inspection, investigators may issue an FDA Form 483 listing observations of possible violations. You have the right to respond to a Form 483, and a well-prepared response can significantly affect the outcome. Capote Law Firm assists clients throughout the inspection process and in preparing 483 responses.
Have more questions about dietary supplement compliance? Capote Law Firm provides personalized regulatory guidance for businesses at every stage. Contact us today or call (786) 207-1174 to schedule a consultation.