Regulatory Compliance Resources and Guidance

Regulations for Herbal Products

AHPA advocates for effective regulation of herbal products and provides information and resources to help member understand and comply with all relevant regulations.

U.S. Federal Regulations

FDA regulates both finished dietary supplement products and dietary ingredients. Dietary supplement manufacturers must register their facilities with FDA and must comply with the Dietary Supplement Current Good Manufacturing Practice (cGMP) requirements. Manufacturers and distributors must make sure that all claims and information on the product label and in other labeling are truthful and not misleading. FDA regulates dietary supplement labels and other labeling, such as package inserts and accompanying literature. The Federal Trade Commission (FTC) regulates dietary supplement advertising.

cGMP -- Current Good Manufacturing Practice

NDIs -- New Dietary Ingredients

SAERs -- Serious Adverse Event Reporting

FDA has primary responsibility for claims on product labeling, including packaging, inserts, and other promotional materials distributed at the point of sale. FTC has primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs, and similar direct marketing materials. Internet marketing is subject to regulation in the same fashion as promotions through any other media.

All companies – including marketers of dietary supplements – must comply with truth-in-advertising standards. FTC's truth-in-advertising law can be boiled down to two common-sense propositions: 1) advertising must be truthful and not misleading; and 2) before disseminating an ad, advertisers must have adequate substantiation for all objective product claims.

Pesticide Databases

Pesticide Resources

  • Presentation (2013): U.S. Pesticides Regulations: Relevance to Herbal Dietary Supplement Manufacturers (free to AHPA Members)

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