The Consumer Healthcare Products Association (CHPA) released the following statement today after submitting a Citizen Petition to the U.S. Federal Trade Commission (FTC) urging it to withdraw the Notice of Penalty Offenses Concerning Substantiation of Product Claims it sent to nearly 700 marketers of over-the-counter (OTC) medicines, dietary supplements, homeopathic products, and functional foods in April 2023, warning recipients of the possibility of incurring significant civil penalties if they fail to adequately substantiate their product claims in ways that run counter to litigated decisions of prior FTC administrative cases:
CHPA and five co-petitioners* are requesting FTC withdraw its Notice for three reasons: (1) the Notice attempts to impose a substantiation standard which is prohibited by law and inconsistent with DSHEA and long-standing regulatory guidance; (2) the Notice does not establish the ‘actual knowledge’ necessary to seek civil penalties under Section 5(m)(1)(B) of the FTC Act; and, (3) 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," said CHPA Deputy General Counsel Carolyn Hermann, "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."
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.
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.
The Dietary Supplement Health and Education Act (DSHEA) of 1994, in addition to long-standing guidance from the FTC and the U.S. Food and Drug Administration (FDA), all make clear that claims for nonprescription drugs and supplements do not require drug-level clinical trials. Relying on this regulatory framework, thousands of companies have created and sold consumer healthcare products, helping millions of consumers live happier and healthier lives. CHPA is the leading voice fighting to ensure Americans have access to beneficial consumer healthcare products that deliver new and better ways to get and stay healthy.
Unfortunately, over time, the FTC began to depart from these well-settled principles and began trying to impose a drug-level randomized controlled clinical trial requirement, as it again stated in its December 2022 guidance. In April 2023, the Commission took its guidance one step further, sending notices to almost 700 companies across the consumer healthcare product industry – including many members of CHPA – challenging the bases that the companies use for making “product claims,” particularly “health claims.” Recipients were warned they could face significant civil penalties if they fail to adequately substantiate their product claims.
*Co-Petitioners: CHPA is joined by the following organizations in support of the Petition: (in alpha order) American Herbal Products Association (AHPA), The Food Industry Association (FMI), Natural Products Association (NPA), Personal Care Products Council (PCPC), United Natural Products Alliance (UNPA).