A Utah company is celebrating being in business for 25 years while attempting to stand up to the Federal Trade Commission with a federal lawsuit.
Nathan Jones, the founder and CEO of American Fork-based Xlear, said at a press conference Tuesday celebrating the anniversary that the idea of washing one’s nose is as simple as washing hands.
“It actually makes more sense to wash our nose than it does to wash our hands or brush our teeth,” he said.
But he said federal regulators don’t allow him to say that.
Jones said nasal hygiene could have played a bigger role during the COVID-19 pandemic if public health agencies had embraced it — and if the FTC hadn’t been suing Xlear and sending them and other competitors warning letters.
Now, the company is claiming that the same chemical compound in Xlear’s nasal spray, xylitol, can make a difference in oral care. However, Xlear’s lawsuit states that the company is unable to advertise this due to fear of possible FTC action.
Xlear asks courts to stop FTC enforcement
Xlear sells xylitol-based hygiene products, not pharmaceuticals, in Walmart, Target, CVS, Rite-Aid, Walgreens, health food stores and online. On June 18, it requested that the U.S. District Court of Utah eliminate sections of the FTC Act regarding false advertising and deception, and require the FTC to prove that a company’s claim is false, rather than merely citing a business’s lack of evidence.
In the lawsuit, Xlear argues that the FTC Act does not require a company making a marketing statement to be able to substantiate the statement, so the FTC should not be able to require that, either.
The company said now that Utah and Florida have banned fluoride in drinking water, it should be educating people about xylitol-based dental hygiene, both for commercial and public interest purposes — but it is not because it fears enforcement from the FTC. It said this has infringed upon its First Amendment rights.
Xlear claims that during the pandemic, it found evidence that its nasal spray blocked the adhesion of the virus that causes COVID-19, as it had previously found it blocked bacterial adhesion, and would lessen the effects of the virus. It said in this month’s lawsuit there is research showing saline-based nasal sprays reduce the risk of respiratory infections like COVID, and there are decades of scientific research showing xylitol fights bacteria in tooth decay.
But that evidence and research are not sufficient for them to appease the FTC regulations, so the company is instead working to fight its way past them.
The FTC was issued a summons on Monday in the new lawsuit and has not yet had the opportunity to officially respond to it — but it did make comments in its own lawsuit against Xlear in October 2021.
It alleged Xlear violated the COVID-19 Consumer Protection Act by falsely advertising that its nasal spray was an effective way to both prevent and treat COVID-19. It asked the company to pay financial penalties and be stopped from continuing to make false claims. That lawsuit was dismissed in March at the agreement of both parties with prejudice, meaning the FTC agreed not to file the same claims again.
None of the other terms of the agreement were disclosed in the court documents.
Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a 2021 statement that it filed the lawsuit because “companies can’t make unsupported health claims.”
The lawsuit said Xlear and its founder said its nasal sprays provide four hours of protection from COVID-19, when there were no clinical trials to support that. It said the company continued making those claims after warning letters were sent by the FTC.
The research
Dr. Lon Jones, the inventor of Xlear and father of its CEO, Nathan Jones, said Tuesday that he learned about xylitol after his wife, a special education teacher, told him if he cared about children, he would find a way to prevent their ear infections. He said at the same time, his granddaughter was getting ear infections after starting to go to day care.
He said he found a study about children in Finland chewing xylitol-based gum to prevent tooth decay, and talked to the doctors involved in the study about how it prevented bacteria. He said his granddaughter was too young to chew gum, so he tried the nasal spray. He claims that instead of a 40% reduction in ear infections, as the children chewing gum in Finland experienced, he saw a 95% reduction in his study.
Lon Jones said he talked to the FDA about his efforts and started trying to file for a new drug, but the studies needed to be completed would have cost him millions. Because the main ingredient, xylitol, was so readily available and could not be patented, he said pharmaceutical companies weren’t interested in funding the studies. That is why he decided to sell a nose wash, later giving the business idea and name to his son.
Most nose washes have a 5% solution of xylitol, but he said that is the same concentration a human body produces. He says Xlear’s 11.5% concentration can pull water into the airway and optimize the body’s cleaning system. He claims using Xlear’s nasal spray can restore the optimal humidity levels in the nose, and what xylitol does is “negotiate” with microbes rather than trying to kill them.
“We’re also involved in a war with microbes — a war that we’re not winning, a war that we can’t win because microbes are the titans of life on this earth. It’s a cosmic war,” he said.