Washington, D.C.—As WholeFoods Magazine has reported, in December 2022, the Federal Trade Commission (FTC) Bureau of Consumer Protection issued a revised version of its business guidance for health products. The new Health Products Compliance Guidance represents a "substantial" update to the 1998 guide Dietary Supplements: An Advertising Guide For Industry. And in April 2023, FTC put approximately 670 brands (see the full list, which includes many prominent industry companies, here) on notice that they should "avoid deceiving consumers with advertisements that make product claims that cannot be backed up or substantiated." Hundreds of companies were sent notifications from the agency, which said it "will not hesitate to use its authority to target violators with large civil penalties." 

In September 2023, the Consumer Healthcare Products Association (CHPA) released a statement after submitting a Citizen Petition to the FTC urging it to withdraw the Notice of Penalty Offenses Concerning Substantiation of Product Claims. CHPA was joined by American Herbal Products Association (AHPA), The Food Industry Association (FMI), Natural Products Association (NPA), Personal Care Products Council (PCPC), United Natural Products Alliance (UNPA) in support of the petition.

The associations requested FTC withdraw its Notice for 3 reasons: 

  • The Notice attempts to impose a substantiation standard which is prohibited by law and inconsistent with DSHEA and long-standing regulatory guidance;
  • The Notice does not establish the "actual knowledge" necessary to seek civil penalties under Section 5(m)(1)(B) of the FTC Act; 
  • Enforcing the Notice would violate due process, as it is so vague, it fails to provide any company with fair notice of what is prohibited.
  • “While the Commission’s viewpoint is not new or surprising, what is surprising is to see FTC take its stance one step further by placing hundreds of companies on notice through standardless form letters that fail to provide any basis for imposing the civil penalties they threaten," said CHPA Deputy General Counsel Carolyn Hermann. “First, the Notice attempts to impose a substantiation standard prohibited by DSHEA and inconsistent with long-standing FDA and FTC guidance. Despite this, and several court opinions holding that a more balanced, multi-factored standard remains the law, FTC has continued to push a ’drug-level’ substantiation standard and is now moving forward with its viewpoint by circumventing Congress and the formal rulemaking process. Second, the Notice fails to establish that any company had ‘actual knowledge’ its conduct was unlawful, which is required to obtain civil penalties under the FTC Act and already recognized by the courts in FTC’s previous attempts to obtain civil penalties. Finally, enforcing a Notice that has distributed vague, unclear, and contrary regulatory guidance would violate due process, because it fails to provide any company with fair notice of what is prohibited."

    Hermann added, “Since the Notice has no legal effect, it is merely threatening companies for engaging in permissible and truthful promotion of products. The chilling effect caused by the Notice thus keeps true and not misleading scientific information away from consumers, which is exactly what Congress intended to prevent through DSHEA. To stop this unlawful chilling effect, CHPA urges FTC to immediately withdraw the Notice.”

    Related: FTC: Nearly 700 Companies Warned Over Product Claims

    FTC's New Business Guidance for Marketers & Sellers of Health Products