In April 2023, the FTC sent over 700 warning letters to wellness brands, including pharmaceutical producer AstraZeneca PLC, retailer CVS Health Corp., General Mills Inc., supplement company BrainJuice LLC, Goop, and many beloved medium-sized supplement brands.
While the letters stated that the recipient's actions could subject the company to civil penalties of up to $50,120 per violation, the letters did NOT identify
any actual unlawful conduct
which products the letters addressed
the “unsubstantiated” claims
Companies had no way to remedy the concerns expressed in the letter.
Now, the Consumer Healthcare Products Association (CHPA) and several co-petitioners have taken a stand against the FTC’s recent actions. They have submitted a Citizen Petition to the FTC, urging it to withdraw the Notices sent to hundreds of marketers of over-the-counter medicines, dietary supplements, homeopathic products, and functional foods.
CHPA and its co-petitioners cite three primary reasons for their request.
First, they argue that the Notice attempts to impose a substantiation standard that is prohibited by law and inconsistent with established regulatory guidance.
When Congress enacted the Dietary Supplement Health and Education Act (DSHEA), the public was promised access to safe dietary supplements, foods, over-the-counter medication, and other health-focused consumer products. This guaranteed that consumers could obtain truthful and non-misleading information about these products, without the need for new drug-level clinical trials.
So, according to both DSHEA and long-established FTC guidance, non-drugs are NOT required to undergo drug-level randomized controlled clinical trials, yet the FTC seems to be penalizing these brands for this.
Susanne Mitschke, CEO and Co-founder of Citruslabs voiced her perspective.
"The FTC guidelines appear somewhat excessive. They advocate for drug-standard substantiation, yet supplements are prohibited from making 'treatment' claims. I believe that supplements should remain just that – supplements. I would welcome a regulatory framework that recognizes the vast array of insights that clinical research can provide. While randomized controlled trials (RCTs) are widely regarded as the gold standard, single-group studies focusing on biomarkers also establish robust substantiation and, in my view, should be prioritized over questionnaire-based RCTs."
Second, they contend that the Notice does not establish the 'actual knowledge' required to seek civil penalties under Section 5(m)(1)(B) of the FTC Act.
The FTC must prove that the companies had “actual knowledge” that their conduct was unfair or deceptive. The 700 Notices were almost identical for each recipient, containing a general and vague list of five acts that were generic statements from previous cases. The Notices never mention anything specific to the brands.
Lastly, they argue that enforcing the vague and unclear Notice would violate due process, as it fails to provide clear guidelines on what is prohibited.
The Notices didn’t tell the companies anything factual about what they were doing wrong. It never identified product claims, or substantiation, or lack thereof. The FTC didn’t explain how these 700 companies were selected or whether they conducted any prior investigation.
Carolyn Hermann, CHPA Deputy General Counsel, expressed concern about the FTC's approach.
“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."
The co-petitioners believe that the FTC's actions are causing a chilling effect, preventing companies from sharing truthful scientific information with consumers, which goes against the intent of Congress through the Dietary Supplement Health and Education Act (DSHEA).
The CHPA urges the FTC to withdraw the Notice, asserting that it has no legal effect and is causing unwarranted fear among companies engaged in the lawful promotion of their products. They emphasize the importance of maintaining access to beneficial consumer healthcare products while ensuring transparency and fairness in regulatory actions.