The Federal Trade Commission regulates advertising for dietary supplement products. The U.S. Food and Drug Administration and FTC share responsibility for the oversight of dietary supplements and related promotion.
FDA is generally responsible for labeling, safety and quality, while FTC is generally responsible for advertising. Both agencies have authority to take action against dietary supplements and companies if they identify violations of law and applicable regulations.
FDA and FTC coordinate their enforcement and regulatory efforts via a memorandum of understanding — often called the “FDA-FTC Liaison Agreement” — that governs the basic division of responsibilities between them.
In December 2022, FTC announced new business guidance (“Health Products Compliance Guidance”) for marketers and sellers of health products, including dietary supplements. The guidance represents a substantial update to FTC’s 1998 “Dietary Supplements: An Advertising Guide for Industry.” While the guidance doesn’t have the force or effect of law, it interprets and explains FTC advertising law under the FTC Act, and as set out in case law and FTC policy statements.
Per the guidance, FTC’s broad mandate is to prevent “unfair or deceptive acts or practices.” That includes ensuring the accuracy of information that marketers provide about the benefits and safety of dietary supplements and other health-related products, enabling consumers to make informed decisions.
Based on sections 5 and 12 of the Federal Trade Commission (FTC) Act and FTC’s policy statements on deception and advertising substantiation, FTC has distilled its truth-in-adverting law to two principles: Advertising must be truthful and not misleading; and before disseminating an ad, advertisers must have adequate substantiation for all objective product claims conveyed — expressly or by implication — to consumers acting reasonably under the circumstances.
According to FTC, a deceptive advertisement is one that contains a material misrepresentation or omission that is likely to mislead consumers acting reasonably under the circumstances. The type of substantiation needed for a claim depends on many factors, including the product being marketed and the nature of the claim.
Generally, however, it is FTC’s position that claims about the health benefits or safety of dietary supplements and other health-related products require “competent and reliable scientific evidence” to show the representations are true. FTC has more specifically defined that standard as “tests, analyses, research, or studies that (1) have been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function to which the representation relates; and (2) are generally accepted in the profession to yield accurate and reliable results.”
FTC further requires that the research must be “sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.”
Sources
- “Questions and answers on dietary supplements” (FDA reference)
- “Memorandum of understanding between the Federal Trade Commission and the Food and Drug Administration”
- “Health Products Compliance Guidance” (FTC reference)
- FTC announces new business guidance for marketers and sellers of health products” (December 20, 2022, FTC news release)