Federal regulators are taking action against a Utah County-based nasal spray company, alleging that it falsely claimed its product could protect users against COVID-19.
In magazine ads, online videos, social media posts and on its website, the American Fork-based company Xlear told consumers that its nasal spray — a mixture of water, the sugar alcohol xylitol and a preservative — can prevent and treat COVID-19 infections if used daily, investigators said.
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The Federal Trade Commission and the U.S. Department of Justice last week sued Xlear and its CEO Nathan Jones in U.S. District Court in Utah, alleging that the company made its promises without scientific evidence.
Since March 2020, Xlear has promoted its nasal spray as a remedy for COVID-19, claiming it offers “up to four hours” of protection against the virus and describing the spray as a “simple treatment” to “help subdue the viral load,” investigators wrote.
Xlear for years has sold its nasal spray through national retailers like CVS, Walgreens, Target and Amazon. Jones founded the company in 2000 to sell the xylitol nasal spray, which was invented by his father, Dr. Lon Jones, as a way to combat repetitive upper-respiratory infections.
In a written statement, Jones said Xlear denies the federal allegations and “will vigorously defend against the Government’s case, and, in doing so, defend the science against politics, paternalism” and dogma.
Research challenged
Xlear’s marketing has cited multiple studies that it claims support the spray’s effectiveness against COVID-19. But investigators said the company has “deceptively” mischaracterized the findings in some of that research.
For example, in a November 2020 news release, the company summarized a recent University of Tennessee study as finding that “Xlear’s components are antiviral — they block viral adhesion in the nose.” But the study only reviewed the effect of xylitol on the virus in monkey cells, not on people.
In an article that appears to have been written for a trade publication in winter 2020, investigators noted, Xlear claimed researchers from the University of North Carolina at Chapel Hill found that treatment through the nose was “the best way to treat COVID-19, especially in its early stages.” But the researchers wrote that their findings actually argued for widespread use of masks and that topical nasal antiviral therapies “might be beneficial.” They said their findings only highlight that nasal tissue should be further investigated as a possible point of infection and treatment.
In the written statement, Jones responded to regulators’ allegations by pointing to a “clinical trial” in which doctors at Larkin Community Hospital in Florida prescribed Xlear to patients who tested positive for COVID-19 in July and September of 2020. Those doctors, Jones wrote, “found people who were already sick with COVID-19, who used Xlear nasal spray — and just Xlear nasal spray — cleared the disease and tested negative in half the time of the average COVID-19 case.”
“None of the patients developed severe cases, none required hospitalization,” Jones wrote.
But the study included only three patients.
To demonstrate a medical intervention is effective — whether it’s a drug, a vitamin, or simply a change in behavior — the results of a clinical trial need to have a high degree of certainty, said Rachel Hess, a professor of population health sciences at the University of Utah.
Researchers take into account a number of factors to calculate a sample size — that is, the number of patients being evaluated — that would demonstrate their outcomes actually are a result of the thing they’re testing, rather than just a matter of chance or some other factor, Hess said.
“Usually when we think about clinical trials, the first thing that we think about is really what the ‘effect size’ is that we’re going to be able to detect, or that would be important to detect,” Hess said. “… How potent [do] you hypothesize your intervention to be, based on preliminary data?”
For example, if researchers want to learn whether a nasal spray reduces the risk of hospitalization for COVID-19 by a large amount, the number of patients they’d need to observe would be different than if they want to learn whether the nasal spray reduces the risk of hospitalization by just a small amount.
Either way, Hess said, “that would be very hard to say with three people.”
Any one of the three patients observed might not have been hospitalized, or might have tested negative for the virus shortly after testing positive, even without the spray. Even high-risk patients like smokers are more likely than not to develop only mild symptoms from COVID-19 — and one of the three patients observed in Florida was a 16-year-old girl whose only risk factor was a history of anemia, which had been treated.
Meanwhile, it’s impossible to know how much a nasal spray reduces the risk of hospitalization or the number of days before clearing a PCR tests, without comparing results for patients who got the spray to results for a similar group who did not get the spray. Preferably, a control group in a clinical trial would receive a placebo instead, so neither they nor the researchers know whether an outcome is tied to the test group or the control group.
“At a minimum, the assessor [of the patients’ results] needs to be ‘blinded’ so they don’t have bias in their ascertainment of outcome,” Hess said.
In studies where human health is concerned, researchers try to figure out how all of those factors could affect the results ahead of time, so they can calculate the sample size they need to make sure the study, if replicated, would produce the same results at least 80% to 90% of the time, Hess said.
Smaller studies may help narrow down whether an intervention is worth testing with a “gold-standard” double-blind, placebo-controlled randomized trial with enough subjects to account for chance, Hess said. But the smaller study alone wouldn’t be evidence that an intervention works.
In fact, the Florida doctors who gave Xlear to three patients wrote that their study “provides a rationale for initiating larger randomized placebo-controlled clinical trials.”
Repeated warnings
Federal investigators first warned Xlear in July 2020 that it was breaking advertising laws by promoting its nasal spray as a COVID-19 treatment, according to the complaint.
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In subsequent exchanges with the FTC, Xlear promised to remove or revise the claims — but Xlear would later post similar claims, the complaint states.
“Over the course of several months and in response to numerous warnings from FTC staff, [Xlear] engaged in a pattern of modifying or removing the unlawful claims, only to reinstate them or add additional deceptive statements later,” regulators wrote.
Investigators said those statements included:
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“Social distancing and wearing masks offers some help, but Xlear nasal spray provides additional tested protection for up to four hours, helping keep you and others around you safe.”
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“Weighing our 20-year safety record, against the risks of this deadly virus, it’s clear Xlear needs to be in widespread use.”
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“If everyone used Xlear, in addition to taking other steps recommended by public health officials, we believe we could help the nation defeat COVID-19 faster.”
There are no published reports of clinical trials that show Xlear can effectively prevent or treat COVID-19, according to the complaint.
“Companies can’t make unsupported health claims, no matter what form a product takes or what it supposedly prevents or treats,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a statement. “That’s the lesson of this case and many others like it, and it’s why people should continue to rely on medical professionals over ads.”
The complaint also lists social media posts and Amazon reviews from consumers who say they purchased Xlear’s nasal spray because they believed it could treat COVID-19.
One customer wrote: “I bought after reading this nasal spray would kill ‘noticeable’ amounts of covid 19. [sic] All a scam. Fraud item.”
The FTC has sent warnings to multiple Utah companies to stop advertising unproven COVID-19 remedies. In April 2020, regulators sent warnings to doTerra in Pleasant Grove, Modere in Springville, and Lehi-based Tranont for claiming their products improved immunity against COVID-19, with a similar letter sent in May 2020 to a Park City ozone therapy company called The Stern Method. In March 2021, the FTC and U.S. Food and Drug Administration sent a warning to Salt Lake City-based Ageless Global, LLC.
A Cedar Hills man, Gordon Pedersen, also was indicted on criminal charges that he posed as a doctor to market colloidal silver, which has been touted — without clinical evidence — as a homeopathic treatment for the coronavirus. The American Fork company he used to own also was tied to a criminal charge; its operators are now participating in Pedersen’s prosecution.
