Nasal spray company said its product prevents, treats COVID. Now regulators are suing

A company sued by federal regulators over products it says could prevent or treat COVID-19 accused the government of “doing all in its power to stop Xlear from simply telling the public about the science.”

Xlear Inc. was sued last week by the Department of Justice and Federal Trade Commission, which said it falsely claimed its nasal spray could prevent and treat COVID-19.

According to the complaint, filed in the U.S. District Court for the District of Utah, the company violated the COVID-19 Consumer Protection Act and the FTC Act, both of which are intended to prevent individuals or corporations from making deceptive or misleading claims about their products’ uses.

That includes false claims that products can treat, cure, prevent, mitigate or diagnose COVID-19, a statement from the DOJ said.

Xlear Inc. is a Utah-based company that manufactures xylitol-based products, including nasal sprays, dental care products and sweeteners. Investigators said that the company claimed in magazine ads, social media posts, online videos and its own website that daily use of its nasal spray could prevent and treat COVID-19 infections, The Salt Lake Tribune reported.

Specifically, the complaint alleges that the company said its products could “provide four hours of protection against infection from the coronavirus and therefore are a simple, safe, and cheap option that could be an effective solution to the pandemic,’” ABC 4 reported.

“Companies can’t make unsupported health claims, no matter what form a product takes or what it supposedly prevents or treats,” Director Samuel Levine of the FTC’s Bureau of Consumer Protection said in the DOJ 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 FTC sent Xlear Inc. a warning letter in July 2020 saying that the company had made “unsubstantiated claims for coronavirus prevention or treatment,” including claims that the xylitol-based nasal sprays would reduce the viral load of COVID-19 to “an undetectable amount” when used to wash out the nose and that the sprays were “a simpler, cheaper way to deal with COVID-19.”

Federal regulators said that the company promised to remove the claims at the time, but instead continued making them, ABC 4 reported.

Xlear Inc. said in a March 23, 2021 Facebook post that it “removed a number of scientific studies and posted disclaimers on our website and social media” at the insistence of the FTC. However, the company also said that it believes “the FTC has no authority to stop us from giving you accurate scientific information” and that “moreover, the FTC lacks the scientific/medical expertise to evaluate such data.”

However, the company’s website still said, as of Nov. 5, that nasal sprays “can help” and asks visitors to “tell the CDC to encourage their use” by signing a petition. The petition is titled “Help fight COVID-19: CDC must issue guidance on nasal sprays.”

On Nov. 1, Nathan Jones, founder and president of Xlear Inc., said in a statement that a clinical trial showed that individuals who used Xlear nasal spray “cleared the disease and tested negative in half the time of the average COVID-19 case” and that none of the patients developed severe cases or required hospitalization, The Salt Lake Tribune reported.

The study Jones referred to only included three patients with COVID-19. Most researchers would say that sample size is too small to be conclusive, the Tribune reported.

“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,” Rachel Hess, a professor of population health sciences at the University of Utah, told the Tribune.

“That would be very hard to say with three people,” Hess said.

According to the Mayo Clinic, there’s no evidence that the use of saline nasal wash can prevent or treat COVID-19.

This story was originally published November 5, 2021 at 10:51 AM.