In December 2022, for the first time in nearly 25 years, 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 now, FTC has but brands on notice that they had best look at the updated guidance and conduct a compliance review of their own messaging.

On April 13, FTC put approximately 670 advertisers (see 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." An announcement from FTC  noted that the agency is using its penalty offense authority "to remind advertisers of the legal requirement to have a reasonable basis to support objective product claims." And if they don't have that backing, FTC is hoping this action will deter advertisers from making deceptive claims in the future.

“The requirement for advertisers to have adequate support for their advertising claims at the time they’re made is a bedrock principle of FTC law,” said Sam Levine, Director of the FTC’s Bureau of Consumer Protection, in the announcement. “The prospect of steep civil penalties will help ensure that advertisers don’t play fast and loose with the truth.” 

"Significant civil penalties" for companies that don't comply

The notices of penalty offenses were sent to companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, or functional foods. These companies were warned that they could incur "significant civil penalties" if they fail to substantiate product claims "in ways that run counter to the litigated decisions of prior FTC administrative cases." The notices of penalty offenses allow the agency to seek up to $50,120 per violation against companies that engage in conduct that "it knows has been found unlawful in a previous FTC administrative order, other than a consent order." Those violations could add up to significant penalties.

Unlawful acts and practices outlined in the notices include: 

  • failing to have a reasonable basis consisting of competent and reliable evidence for objective product claims; 
  • failing to have competent and reliable scientific evidence to support health or safety claims; 
  • failing to have at least one well-controlled human clinical trial to support claims that a product is effective in curing, mitigating, or treating a serious disease; 
  • misrepresenting the level or type of substantiation for a claim;
  • misrepresenting that a product claim has been scientifically or clinically proven.

In an FTC Business Blog discussing the issue, Lesley Fair explained: "Receiving a Notice isn’t an indication that the FTC thinks the company has violated the law. Rather, the goals are to ensure that marketers understand their legal obligations and to establish a basis for civil penalties for any future violations. Furthermore, although the initial recipients are companies making health claims, the Notice isn’t limited to that sector. The caselaw cited in the Notice covers all objective efficacy or performance representations."

Fair also had a recommendation for the industry at large:  "Whether or not your business received the Notice of Penalty Offenses, savvy marketers will take it as a cue to conduct a compliance check. A good place to start: the FTC’s Health Products Compliance Guidance."

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

Regulatory and Enforcement Update on Notable Action in the Active Aging Space

Ensuring Regulatory Compliance When Bringing a Product to Market