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A legal challenge filed by dietary supplement manufacturer Xlear against the Federal Trade Commission could fundamentally reshape how companies market health products in the United States. The lawsuit, reported by KFF Health News, seeks to eliminate the FTC's longstanding requirement that companies provide substantial evidence backing health claims about their products—a standard maintained since 1984.
Nathan Jones, founder of Xlear, manufactures products containing xylitol, including chewing gum, nasal spray, and other items. While Jones expresses strong beliefs about xylitol's potential benefits against tooth decay, covid, heart disease, and Alzheimer's disease, current FTC regulations prevent him from making such claims in advertising without substantial supporting evidence.
The company filed its lawsuit in June after the FTC dropped a 2021 case against Xlear over marketing its sinus rinse as a covid preventive and treatment. Jones reported spending $3 million fighting that case before it was dismissed. Xlear attorney Rob Housman indicated the company hopes the suit will be considered under the Supreme Court's 2024 Loper Bright ruling, which gave courts greater authority to question federal agencies' interpretation of governing laws.
For decades, the FTC has required companies to substantiate medical claims about their products with convincing evidence, typically including clinical trials. The agency has taken action against hundreds of products making unproven health claims. Jessica Rich, who served as the FTC's director of consumer protection from 2013 to 2017, characterized these actions as targeting "bogus health cures."
Mary Engle, associate director of the FTC's advertising practices division from 2001 to 2020, described the potential impact of Xlear's lawsuit as "a complete game changer" for health product regulation.
The Alliance for Natural Health USA, which includes alternative medicine practitioners, vaccine skeptics, and proponents of natural remedies, joined Xlear with a separate petition in May demanding the FTC drop its requirement for substantial evidence backing health claims. The alliance also seeks withdrawal of 2022 guidelines that generally require companies to run randomized clinical trials to prove their claims.
Attorney Jonathan Emord filed the petition on behalf of the alliance. Emord has successfully fought FDA and FTC regulation of supplements in previous cases and unsuccessfully ran for Virginia governor as a Republican in the 2024 primary. His petition seeks to flip the burden of proof, requiring the government to prove health claims are false rather than requiring manufacturers to prove claims are true.
"If an advertiser throws caution to the wind and makes a health-related product claim without resort to any supporting evidence, the FTC is powerless" to stop it under Emord's proposed framework, the petition states. Claims would be "tested in the idea and information market free of government constraint."
The Trump administration has not announced new enforcement actions against supplement makers since taking office, though it has distributed proceeds from previous fraud settlements to consumers. In March, the Department of Justice also closed a case brought on behalf of the FTC and FDA against a company claiming its Earth Tea could cure covid.
Serena Viswanathan, who retired as FTC associate director in June, reported that the agency's Division of Advertising Practices has lost at least a quarter of its staff since Trump took office. The Department of Justice has reorganized its consumer protection unit, which previously backed the FTC in many actions, moving some lawyers to immigration and other areas.
Xlear attorney Housman observed that with Health and Human Services Secretary Robert F. Kennedy Jr.'s administration including numerous proponents of nontraditional health products, "there's been a downtick of enforcement."
Kennedy warned before Trump's reelection that the FDA would face consequences for what he characterized as "aggressive suppression" of vitamins, peptides, nutraceuticals, and other products from a supplement industry seeking greater freedom to make product claims.
The FDA maintains authority to recall dangerous products and check health claims, though the agency lacks sufficient workforce to comprehensively police the vast $70 billion supplement industry. The FTC has traditionally demonstrated stronger enforcement capabilities, successfully suing companies making unsubstantiated claims. Last year, for example, the agency won a judgment against a company advertising a supplement as "clinically shown" to improve memory.
Jones argues that pharmaceutical industry monopolistic control limits consumer healthcare choices. He characterizes government restrictions as preventing his company from discussing what xylitol does, noting that stating "xylitol can help prevent tooth decay" constitutes a drug claim that requires FDA approval.
The FDA approved xylitol as a food additive in 1963 and regulates it as a cosmetic ingredient. Jones founded Xlear 25 years ago; the company now employs approximately 110 people and sells to 70,000 retailers.
According to Jones, xylitol reduces gum inflammation by blocking adhesion of Streptococcus mutans bacteria to mouth cells. In Finland, where water is not fluoridated, dentists have long recommended xylitol-imbued chewing gum for children.
Three ear, nose, and throat specialists interviewed by KFF Health News stated that xylitol effectively moisturizes nasal cavities, perhaps slightly better than simple saline solution. While no evidence supports its use preventing or curing covid, xylitol—like saline nose washes—may reduce symptoms when used early in viral upper respiratory infections, according to Christine Franzese, professor of otolaryngology at the University of Missouri Medical Center and chair of the American Academy of Otolaryngology-Head and Neck Surgery's allergy, asthma, and immunology committee.
The American Academy of Pediatric Dentistry deems xylitol safe when used at recommended doses in sprays, candies, chewing gum, and other products, though it notes evidence is mixed on whether xylitol fights cavities effectively. At higher doses, xylitol can cause diarrhea and other gastrointestinal problems. A National Institutes of Health-funded study published last year found that regular use of xylitol as a sweetener could exacerbate heart disease, though quantities consumed by study participants far exceeded amounts in a few sticks of chewing gum.
Recent policy shifts may benefit Xlear's business prospects. On May 21, Jones and pediatric dentist Mark Cannon of Northwestern University testified before the Utah Legislature supporting a pilot project to provide Xlear's gum to students and prisoners as a replacement for fluoridated water, which the state banned in March. Florida ordered fluoride removed from state water starting July 1, and other states are considering similar bans.
Jones indicated the company would provide gum for the Utah pilot at cost, but if governments promote it and public awareness increases, "that's where we see us being able to grow."
FTC Chairman Andrew Ferguson has not publicly addressed the Xlear lawsuit. However, at a July 9 workshop titled "The Dangers of 'Gender-Affirming Care' for Minors," Ferguson defended the agency's traditional practice of requiring health claims to be backed by reliable scientific evidence and maintaining high standards of scientific substantiation.
Former FTC official Rich noted that under that logic, "Ferguson has to defend against the Xlear lawsuit," adding that allowing companies to market health products without any basis creates serious issues when customers spend money on unproven products instead of seeking proper care.
Regardless of how courts rule on the Xlear lawsuit, supplement manufacturers face complex compliance challenges across federal and state jurisdictions. Even in potentially deregulated environments, maintaining comprehensive quality management systems, rigorous testing protocols, and detailed documentation provides business advantages including enhanced consumer trust, stronger merchant processing relationships, and competitive differentiation.
Companies that implement voluntary quality standards—including third-party testing, standardized manufacturing processes, and transparent labeling practices—position themselves favorably with retailers, financial institutions, and consumers regardless of evolving regulatory frameworks.
Operating in the dietary supplement industry requires sophisticated quality management infrastructure to demonstrate product safety and manufacturing consistency. Qredible's Q-Trust system provides supplement companies with comprehensive quality management tools, secure documentation systems, and transparent supply chain oversight. Contact our team today to learn how our platform can help your business maintain rigorous standards in changing regulatory environments.
Source: This article is based on reporting by Arthur Allen for KFF Health News, published August 25, 2025.
