The US Federal Trade Commission (FTC) has released a crucial notice on substantiating product health claims and ensuring fair endorsement and testimonials practices. Over 700 recipients – mostly marketers of any health-related products – were informed that non-compliance could lead to civil penalties of up to $50,120 per violation. The notice is part of the FTC’s continued efforts to clearly define the regulatory framework of the FTC’s authority over ads for health-related products.

The Health Products Compliance Guidance, released December 2022, interprets and explains the FTC’s advertising laws specifically regarding expressed and implied claims of dietary supplements and other health-related products. Overall, the FTC’s policy requires advertising to be truthful and not misleading, and expressed or implied claims be adequately substantiated with “competent and reliable” scientific evidence.

The FTC defines that the following acts and practices are considered unlawful:

  • Lack of adequate support for: objective product claims, claims relating to the health benefits or safety of a product, disease-like claims that indicate a product can cure, mitigate, or treat any serious disease.
  • Any false or misrepresented endorsements that may be untruthful and/or deceptive and mislead consumers. Positive consumer reviews are considered endorsements and will be subject to the same standards.

As such, it’s expected that anyone participating in the marketing efforts of dietary supplements or other health-related products be aware of the requirements needed to comply with FTC advertising laws as anyone involved in deceptive marketing and promotion could be liable and subject to financial remedies such as civil penalties.

Lumanity has extensive experience developing substantiation dossiers for dietary supplements and various other health products. Our team offers robust regulatory and scientific support services for over-the-counter (OTC) drugs, medical devices, dietary supplements, cosmetics, and foods. We recommend that all applicable companies develop and maintain thorough substantiation dossiers containing “competent and reliable” scientific evidence that meets FTC standards. Starting early is key so contact us to learn more about the FTC’s advertising law and how we can support your compliance efforts.