The Department of Justice earlier this week ordered an Orange County-based company to stop distributing its hand-sanitizer products until it received U.S. Food and Drug Administration approval or removed certain claims from its labeling that its products could protect against norovirus, rhinovirus, rotavirus, flu and Ebola.
As of Thursday morning, the product’s website was processing orders.
U.S. District Judge David O. Carter of the Central District of California instructed Innovative BioDefense Inc. of Lake Forest, Calif., on Monday to stop distributing its Zylast products until stipulations were met.
But Carter also admonished the FDA for a lack of enforcement against a more well-known company that made similar claims, Purell-maker GOJO Industries. Purell products have been purchased in droves over the past few months as concerns over the coronavirus have prompted people to seek out ways to protect themselves in addition to washing their hands.
Attorneys for BioDefense Inc. argued that the case was brought at the persistent urging of GOJO Industries.
Zylast owner Hotan Barough refrained from commenting on the matter until consulting a lawyer. Attorney Kirby Behre, who represents Innovative BioDefense, previously said the company was “happy to comply with Judge Carter’s order.”
In a 2018 complaint, the United States alleged that the distributors of Zylast products had violated the Federal Food, Drug, and Cosmetic Act by claiming that its goods — antimicrobial antiseptics, antiseptic lotions and antiseptic foaming soaps — could protect against certain diseases, despite a lack of proof or approval from the FDA.
“Consumers are entitled to drug labeling that complies with the law,” said Assistant Atty. Gen. Jody Hunt of the Department of Justice’s Civil Division. “The Department of Justice works closely with the FDA to ensure that manufacturers lawfully comply with the drug approval process.”
The company made headlines in late 2014 after it won USAID’s “Fighting Ebola Grand Challenge” and was touted as a product that could help prevent the spread of Ebola.
But in a letter to company Chief Executive Colette Cozean roughly six months later, the FDA warned Zylast to address violations of misbranding and unsubstantiated advertising of an unapproved new drug.
“Although all three Zylast products have stated purposes as topical ‘antiseptics’ the product labeling states intended uses that cause the products to be unapproved new drugs,” the letter states.
In January, the FDA served a similar letter of warning to GOJO, instructing the company of violations pertaining to statements suggesting its Purell hand sanitizers could be effective against diseases such as the Ebola virus, norovirus and influenza. Samantha Williams, corporate communications senior director for GOJO, said the company took “immediate action,” updating its website and other digital content marketing the product.
But according to Carter, the FDA’s action against GOJO should have occurred sooner.
As for Zylast, its original website, which stated it was for “educational purposes,” on Thursday morning included the following line: “The Company does not make, and the FDA does not allow, efficacy claims against specific pathogens or general claims of reducing illness.”
The site linked to a customer portal, which was operating. A 2-ounce bottle of antiseptic, for example, cost a customer $12.45. That included a $7.50 charge for priority shipping.
It did not appear that the site currently mentioned its former claims.
City News Service contributed to this report.