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On September 14, the Consumer Healthcare Products Association (CHPA) sent a citizen petition to the Federal Trade Commission (FTC), calling for an immediate withdrawal of the penalty claim notices sent to around 700 consumer health companies.
The notices were sent in April 2023 and warned of civil penalties and potential litigation if marketers fail to “adequately substantiate their product claims.”
“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.
CHPA and five other co-petitioners (American Herbal Products Association, The Food Industry Association, Natural Products Association, Personal Care Products Council and United Natural Products Alliance) are calling for the FTC to withdraw the notices for three reasons.
First, CHPA argues the notices attempt to impose a substantiation prohibited by and inconsistent with the Dietary Supplement Health and Education Act (DSHEA).
“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, CHPA said in a statement.
The DSHEA, which was an act passed in 1994, in addition to long-standing guidance from the FTC and the Food and Drug Administration (FDA) make clear that nonprescription drugs and supplements do not require drug-level clinical trials, according to CHPA.
“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 said in a statement.
Second, CHPA also argues that the 700 companies had no “actual knowledge” as to whether their conduct was unlawful, which is required by FTC standards to obtain civil penalties. This standard is already recognized by the courts.
Finally, CHPA argues the notice was worded in a contradictory, unclear and vague manner that would violate due process because it provides little to no information or fair notice as to what is prohibited.
“Since the notice has no legal effect, it is merely threatening companies for engaging in permissible and truthful promotion of products,” CHPA said in a statement. “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 read the full petition, visit CHPA’s website.
