Dietary Supplement Labeling and Claims

The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) work together to regulate dietary supplement labels and claims. FDA has primary responsibility for claims on product labeling, including packaging, inserts, and other promotional materials distributed at the point of sale. The FTC has primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs, and similar direct marketing materials.

FDA Guidance

Guidance for Industry: Dietary Supplement Labeling Guide -- Prepared by the FDA to help assure that the dietary supplements sold in the United Stated (U.S.) are properly labeled.

Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act -- This guidance describes the amount, type, and quality of evidence FDA recommends a manufacturer have to substantiate nutritional deficiency, structure/function, or general well-being claims made for dietary supplement products.

Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims - Final (July 2007; Revised January 2009)

FTC Guidance

Dietary Supplements: An Advertising Guide for Industry -- This guide clarifies how long-standing FTC policies and enforcement practices relate to dietary supplement advertising.

Gut Check: A Reference Guide for Media on Spotting False Weight Loss Claims -- This is part of FTC's efforts to educate the media and consumers about misleading weight loss advertising.

Advertising FAQ's: A Guide for Small Business -- This guidance does not specifically refer to supplements, but the principles underlying FTC's guidance is relevant to any company that advertises.