Federal Trade Commission (FTC) only published Its Health Product Compliance Guide (“Guide”), which it issued to replace an advertising guide from 1998 focused on dietary supplements. For this new guidance document, the FTC explains:
“Like the 1998 guidance, this document provides guidance from FTC staff on how to ensure that health-related product benefit and safety claims are true, not misleading, and supported by science. Since 1998, the FTC has settled or litigated more than 200 cases involving false or misleading advertising claims about the benefits or safety of dietary supplements or other health-related products, including foods, over-the-counter drugs ( OTC), homeopathic products, health devices, diagnostic tests and health related applications. This update builds on the issues raised in those cases to illustrate how the FTC identifies express and implied claims conveyed in advertising and how the agency evaluates the scientific support for those claims. While most examples involve the advertising of dietary supplements, the same legal principles apply to the marketing of any health-related product.
The guidance begins with the basic principles that (1) advertising must be truthful and not misleading; and (2) advertisers must have adequate substantiation for all objective product claims made to consumers. The guidance then provides an overview of the regulatory framework (eg, the FTC’s authority over the marketing of dietary supplements, foods, drugs, devices, and other health-related products and the relationship of the FTC Act to the FDA Act for such products ), an application of the FTC Act to the advertising of health-related products (e.g., an explanation of health claims and disclosures and the requirement of substantiation), and a discussion of other advertising issues (e.g., use of testimonials and approvals). In its conclusion, the FTC writes:
“Marketers of health-related products, including dietary supplements, must be familiar with the requirements under FDA law and FTC law that labeling and advertising claims be true, not misleading, and substantiated. The FTC approach generally requires that health claims be supported by competent and reliable scientific evidence that the representations are true. To ensure compliance with the FTC Act, marketers of any health-related product must follow two important steps: 1) Consider what explicit and implicit messages consumers are likely to receive from your advertising. When appropriate, carefully qualify your claims – in other words, clearly explain the limited circumstances in which the advertised benefits or results apply; 2) Carefully review the support for each claim to ensure that it is scientifically sound, appropriate in the context of the surrounding evidence, and relevant to the specific product and advertising claim.“
The full Guidance document is available here.
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