Since it was formed in 2000, Xlear Inc. (pronounced “clear”), in American Fork, has been recognized as a leading manufacturer of xylitol-based products in North America.

On Thursday, The U.S. Department of Justice, together with the Federal Trade Commission, announced a civil enforcement action against defendants Xlear Inc. and Nathan Jones, CEO and president, for alleged violations of the COVID-19 Consumer Protection Act and the FTC Act.

“According to a complaint filed in the U.S. District Court for District of Utah, the defendants advertised that their saline nasal spray product could prevent or treat COVID-19, without competent or reliable scientific evidence to support those claims. Further, the defendants allegedly made deceptive statements about several scientific studies to bolster their unproven COVID-19 claims,” the department said in a press release on Oct. 29.

Jones repudiates these accusations, noting their 20 year-old nasal spray product has been a popular way customers have kept their nasal passages clean. The nose is a reservoir for germs, including COVID-19.

The COVID-19 Consumer Protection Act, passed by Congress in December 2020, prohibits deceptive acts or practices associated with the treatment, cure, prevention, mitigation or diagnosis of COVID-19.

The complaint also alleges violations of the FTC Act, which prohibits unfair and deceptive conduct, as well as false advertising.

The government seeks civil penalties and injunctive relief to stop the defendants from continuing to make deceptive advertising claims.

“I equate this to David and Goliath,” said Robert Housman, Xlear’s legal counsel. “It’s not a sling shot, Xlear is armed with science.”

On Monday, Jones released the following statement in response to the Department of Justice lawsuit:

“Last year, the government published on the website of the National Institutes of Health the results of a clinical trial performed by researchers at Larkin Community Hospital, Florida. The Larkin clinical trial 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,” Jones said.

Jones added that none of the patients developed severe cases, none required hospitalization.

“Now the Government is suing Xlear, asserting among other things, that when Xlear tells people about scientific studies, even ones republished by the NIH (National Institutes of Health), we are somehow misleading people and making false claims. It’s nonsensical,” Jones said.

“What is more troubling, despite the results of the Larkin trial, and despite the results of a Government-funded Random Clinical Trial done at Vanderbilt University, and despite the findings of yet another Random Clinical Trial done in Georgia, the Government refuses to tell the American people that washing your nose may significantly reduce your risks of getting a severe case of COVID-19, which could result in hospitalization and death,” he added.

As early as February 2020, Xlear and other nasal spray companies met with pulmonologists that told the FTA to look at Xlear nasal spray. It was ignored, according to Jones.

“In the 20 years Xlear has been in business, no one has ever been hurt,” Jones said. “I think there are bad actors supporting big pharma.”

Xlear advertises that its drug-free sinus care provides simple and cost-effective prevention so people can live more healthy lives.

“Growing numbers of in vitro studies find Xlear, and its components, are: antiviral (blocks adhesion — infection — by COVID-19); virucidal (kills and/or deactivates the COVID-19 virus); and, antibacterial (help prevent pneumonia, a leading COVID-19 co-morbidity). This is real science — done and published by independent medical experts. We believe so strongly in the science we are providing links to these studies,” Jones added.

The depths of the complaint and questioning from the government take it down to the time of day a grapefruit was harvested and on what piece of land it was grown, according to Housman. Grapefruit seed extract is in the Xlear nasal spray.

“History is rife with hygiene measures and the establishment’s fights against it,” Jones said.

He referred to the history of cholera outbreaks in London. London obstetrician/anesthesiologist John Snow, conducted a detailed epidemiological investigation of the London cholera epidemic.

Snow believed that if the city would build an underground sewer system it would stop the spread of the disease. After Snow died, the London government put in sewer systems and cholera was handled.

“In sharp contrast to trying to protect the American public, the government is doing all in its power to stop Xlear from simply telling the public about the science,” Jones said. “It is profoundly ironic that the government, which now constantly ignores science for political reasons, suggests that it is taking this action against Xlear to somehow protect the people. From what is the government protecting Americans? From the facts. From the science. From their right to know.”

Jones believes the government seeks to pin blame on Xlear, which he considers a small company trying to help Americans understand there are other things that you can do that may help to provide an additional layer of protection against COVID-19.

“Get vaccinated, wear a mask, social distance, use common-sense, wash your hands — and wash your nose,” Jones added.

“This is a government sweep,” Housman said. “The major burden of proof is on us.”

“The Department of Justice will not tolerate individuals or companies attempting to profit from the current public health emergency by unlawfully and deceptively advertising unproven products,” said Acting Assistant Attorney General Brian M. Boynton of the Department of Justice’s Civil Division in the press release. “The department is committed to working with the FTC to enforce the FTC Act and the COVID-19 Consumer Protection Act against those who unlawfully market unproven COVID-19 treatments.”

“Companies can’t make unsupported health claims, no matter what form a product takes or what it supposedly prevents or treats,” said Director Samuel Levine of the FTC’s Bureau of Consumer Protection. “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 case will be heard in front of a federal judge in Utah. According to Housman the court dockets are backlogged for some time and this will take a while to be heard.

In the meantime, Jones points to scientific findings on Xlear’s nasal spray published with the National Center for Biotechnology Information, multiple different studies published on bioRxiv, The Lancet and more.

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