A nasal spray company wants to make it harder for the FTC to police health claims

In the midst of the covid-19 pandemic, a health products company called Xlear began advertising its saline nasal spray to people desperately searching for ways to protect themselves from a new virus. In its marketing, Xlear pointed to studies that it said supported the idea that ingredients in the spray could block viruses from sticking to the nasal cavity. Based on its interpretation of the science, Xlear promoted the product as one part of a “layered defense” against contracting covid.

In 2021, the Federal Trade Commission, in a bipartisan vote, decided to sue Xlear for making allegedly “unsupported health claims,” saying the company had “grossly misrepresented the purported findings and relevance of several scientific studies” in its advertising. Earlier this year, the Trump Justice Department, on the FTC’s behalf, asked for the lawsuit to be dismissed with prejudice, though it didn’t explain its reasoning. But Xlear still wanted its day in court. Now, it’s suing the FTC because it wants a court to make it harder for the agency to attempt to go after health claims.

Xlear is filing the lawsuit at a time where the government’s standard operating procedures around both science and administrative law have been upended. Health and Human Services Secretary Robert F. Kennedy Jr. recently expelled all the members of the Centers for Disease Control and Prevention’s vaccine policy advisory committee, a simultaneously radical and predictable outcome given his career in spreading anti-vaccine falsehoods. Meanwhile, the current FTC is engaged in helping President Donald Trump undermine the agency’s long-standing independence from the White House. After Trump purported to fire its two Democratic commissioners, the FTC has even openly taken up long-standing conservative grievances over alleged censorship in the digital sphere.

Like Kennedy, Xlear is advocating for a path that could open up the health products space to alternative — and possibly less-tested — upstarts. “There’s a tension here between the reform movement of MAHA [Make America Healthy Again] and the old-guard approach of the FTC,” Xlear’s lead counsel, Rob Housman, tells The Verge. “If you want to break our focus on drugs and pharmaceuticals, one of the things you have to do is make space for innovation and things like hygiene and other approaches.”

Xlear insists it’s not trying to lower the bar for health marketing claims, but simply hold the FTC to a reasonable legal standard. Housman believes the Supreme Court’s decision to strike down Chevron deference last year — removing long-standing precedent telling courts they should often defer to federal agencies’ expertise — makes the case even easier. “We don’t want people to think we’re trying to reduce the burden of science,” he says. “We, in fact, want to up the burden of science. We just want to make sure that companies are complying with the law — not the law as the FTC says it is.”

As Xlear sees it, the FTC has stepped beyond its authority to enforce the law against false and misleading claims, coming up with arbitrary standards of what kinds of evidence should be considered adequate to justify a health claim. Housman points to the agency’s 2022 guidance that says randomized controlled trials (RCTs), especially when replicated at least once, are most reliable to substantiate health claims. There’s no magic number for the number or kinds of studies, according to the guidance, but it says “randomized, controlled human clinical trials (RCTs) are the most reliable form of evidence and are generally the type of substantiation that experts would require for health benefit claims.” The FTC did not immediately respond to a request for comment on the lawsuit.

Xlear says this is far too high of a hurdle, especially for smaller companies that may not have the money to conduct such resource-intensive trials. Housman compares it to an adage about how there’s no RCT trials to prove parachutes work — the punchline being that no one would conduct a study where a control group jumped out of a plane without a parachute. (It’s unclear how removing this high hurdle would “up the burden of science.”)

Xlear says that 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, which Kennedy wants to strip from the water supply. Fluoride is a mineral that prevents tooth decay. A recent study from the National Toxicology Program found that very high levels of fluoride (atypically high in the US) are linked to slightly lower IQ scores for kids, but fluoride has been the subject of conspiracy theories for almost a century, even making an appearance as a comedic bogeyman in the movie Dr. Strangelove, in which General Jack D. Ripper refers to it as “the most monstrously conceived and dangerous communist plot” to “sap and impurify all of our precious bodily fluids.”

Housman says that even if Xlear wins its lawsuit on every count, “this doesn’t allow people to make up bogus marketing claims.” The FTC will still have the authority to take down truly false and misleading claims, just not by the allegedly arbitrary standard it has been. He adds that the threat of private lawsuits is effective to keep egregious marketing claims at bay. “We don’t believe anybody should be making bogus claims,” Housman says, “but we also believe that the agency has the responsibility to do the work.”