Amid the covid-19 pandemic, Xlear, a health products manufacturer, initiated a campaign promoting its saline nasal spray. The company targeted individuals seeking protective measures against the novel virus, claiming, based on its interpretation of existing research, that the spray’s ingredients could hinder viruses from adhering to the nasal cavity. Xlear characterized its product as part of a “layered defense” system against covid transmission.
In 2021, the Federal Trade Commission (FTC) moved to initiate a lawsuit against Xlear, alleging the company made “unsupported health claims.” This bipartisan decision highlighted the FTC’s position that Xlear had “grossly misrepresented” the significance and relevance of various scientific studies in its marketing materials. Earlier this year, the Trump administration’s Department of Justice sought to dismiss the case, yet Xlear has since opted to sue the FTC to challenge the agency’s ability to regulate health marketing claims.
The timing of Xlear’s lawsuit coincides with significant alterations in governmental protocols relating to science and administrative law. Recently, Health and Human Services Secretary Robert F. Kennedy Jr. removed all members of the CDC’s vaccine policy advisory committee, a decision viewed as both radical and expected given his history of disseminating anti-vaccine narratives. Concurrently, the FTC is undergoing pressures from the Trump administration, impacting its traditional independence and addressing longstanding conservative critiques regarding censorship in digital platforms.
Xlear’s position, much like that of Kennedy, seeks to broaden the health products sector, potentially paving the way for innovative — albeit less rigorously tested — alternatives. Rob Housman, Xlear’s lead counsel, expressed to Technology News that “there’s a tension here between the reform movement of MAHA [Make America Healthy Again] and the old-guard approach of the FTC.” He emphasized the necessity of creating space for new solutions beyond traditional pharmaceuticals.
“There’s a tension here between the reform movement of MAHA and the old-guard approach of the FTC”
Xlear maintains it is not aiming to lower the standards for health marketing claims; rather, it seeks to ensure that the FTC adheres to reasonable legal benchmarks. Housman argues that the recent Supreme Court ruling abolishing Chevron deference — which previously guided courts to defer to the expertise of federal agencies — strengthens their case. “We don’t want to imply that we’re trying to lessen the scientific burden,” he clarified, “but rather, ensure that compliance is based on the law, not on the FTC’s interpretation of it.”
According to Xlear, the FTC has exceeded its jurisdiction in regulating misleading claims, imposing arbitrary standards for the type of evidence required to substantiate health assertions. Housman referenced the FTC’s 2022 guidelines, which suggest that randomized controlled trials (RCTs) are the most reliable method for validating health claims. While there is no specified number of studies required, the guidance emphasizes that RCTs are expected for health benefit assertions. The FTC did not respond to inquiries concerning the lawsuit.
Xlear argues that the current standards create insurmountable challenges, particularly for smaller entities lacking resources for extensive trials. Housman likened the situation to an adage regarding parachutes, suggesting that conducting RCTs for their efficacy is impractical, as no one would test parachute performance in a study where control participants jumped without one. The rationale behind advocating the removal of such strict criteria remains debatable.
One reason it’s bringing the lawsuit is so that it can freely make health claims about another product it sells, which it believes can be an alternative to fluoride
Further motivating the lawsuit is Xlear’s interest in promoting another product, which it asserts can serve as an alternative to fluoride. The company is particularly concerned given that Kennedy proposes removing fluoride from the water supply. Fluoride, known for its role in preventing tooth decay, has faced scrutiny as highlighted by a recent study from the National Toxicology Program, which linked high fluoride levels to lower IQ scores in children. Despite ongoing debates, fluoride has been at the center of conspiracy theories for decades.
Housman concluded that even a favorable outcome for Xlear in this lawsuit would not permit companies to make unsubstantiated marketing claims. The FTC would retain the power to act against genuinely false and misleading assertions, but would need to do so based on the established legal standards rather than the perceived arbitrary ones in place. He emphasized that private lawsuits can effectively deter misleading marketing practices, asserting, “We don’t believe anybody should be making bogus claims, but we also believe that the agency has the responsibility to do the work.”
