Washington, DC—Citizens for Health (CFH) and the National Health Federation (NHF) have filed an Amici Curiae brief in support of Xlear, Inc., in the Federal Trade Commission (FTC) enforcement action United States v. Xlear. The brief (alsocalled a Friends-of-the-Court Brief) was submitted to the United States District Court for the Central Division of Utah. It requests the dismissal of FTC’s complaint based on the Supreme Court’s recent decision in Loper Bright Enterprises v. Raimondo.
Related: The Supreme Court Finally Tells the Alphabet Agencies That They Are Not Legislators
FTC’s lawsuit against Xlear, which was initiated in 2021, alleges that the company violated the FTC Act by promoting its saline nasal spray as a preventive and treatment option for COVID-19 without adequate substantiation through randomized controlled trials (RCTs). The brief argues that such requirements exceed the statutory authority granted to the FTC.
Regulatory Overreach?
The Amici Curiae brief emphasizes that the FTC Act, as written, does not mandate RCTs to substantiate health claims. The brief draws on the Loper Bright decision to argue that federal agencies cannot impose requirements not explicitly authorized by Congress.
“NHF and Citizens for Health filed our amici brief to ensure the District Court was aware of the perspective of American consumers as it considers this vital question—whether RCTs are necessary to show that health claims meet the legal standard that they be truthful and not misleading,” said Betsy Lehrfeld, Secretary and Treasurer of CFH, and Scott Tips, President and Counsel for NHF, in a joint statement.
Impact on Consumer Access and Innovation
The organizations also highlighted the broader implications of the FTC’s actions. “The FTC is supposed to be a consumer watchdog,” said Lehrfeld and Tips. "However, the FTC’s actions here disempower and hurt American consumers. The FTC’s requirement for RCTs limits consumer information and choice, stifles innovation, and drives up prices for consumers, making products less available to low-income Americans. By preventing truthful and not misleading information about less expensive, effective, natural, non-pharmaceutical options from reaching consumers, it compels them to rely on costly ‘Big Pharma’ products. The Court needs to know what is at stake in this case for American healthcare consumers.”
For more information, access the full amici brief here and read additional background on Loper Bright Enterprises v. Raimondo.
Experts say this case is particularly significant in addressing the broader debate about the FTC's authority in regulating health claims for natural and non-pharmaceutical products.
