By Kevin Stawicki

Law360 (May 15, 2020, 6:40 PM EDT) -- A federal judge has blocked Xephyr LLC from selling colloidal silver products that purport to treat coronavirus, saying the Oklahoma company's distribution of the unapproved alternative drugs threatens public safety.

U.S. District Judge Ronald A. White on Thursday granted the federal government's request for a temporary injunction, saying it showed how Xephyr, or N-Ergetics, violated the Food, Drug, and Cosmetic Act by continuing to sell colloidal silver, and that "there is a cognizable danger that defendants will continue to do so in the future" without the order.

"No specific finding of irreparable harm is necessary, no showing of any inadequacy of other remedies at law is necessary, and no balancing of interests of the parties is required prior to the issuance of a temporary restraining order in this case," Judge White wrote.

The U.S. Food and Drug Administration and the Federal Trade Commission sent a joint letter to Zephyr in March ordering it to stop marketing their colloidal silver products as being able to cure COVID-19, and to change their websites or face legal action.

When Zephyr failed to comply, the FDA said it had no choice but to sue Oklahoma federal court.

"Xephyr's claims that their unapproved colloidal silver products can cure, mitigate, prevent or treat COVID-19, or other diseases like cholera, diabetes, cancer and AIDS, will not be tolerated," the FDA's chief counsel Stacy Amin said in a statement on Thursday. "Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective, especially during this ongoing pandemic."

Representatives for Xephyr did not respond to requests for comment on Friday, but the company's website read: "Due to the FDA and the DOJ's requests, this site has been removed," and it told customers that they can seek refunds for recently purchased items.

Xephyr promoted products containing colloidal silver as being able to boost immune system support and their ability to protect against COVID-19, the government said in the lawsuit. The National Institutes of Health maintains that colloidal silver isn't a useful dietary supplement, and the FDA has taken action against companies that made misleading statements about its effectiveness.

Thursday's order is the latest salvo in the FDA's crackdown on companies misleading consumers about their products' performance, only heightened in recent months in response to the pandemic.

In addition to going after Xephyr, the FDA sent warning letters to other supplement companies and televangelist Jim Bakker, demanding they stop selling or advertising teas, essential oils and other alternative therapies such as colloidal silver as products that can treat COVID-19.

After the FDA told Gojo Industries Inc., the maker of Purell, in January to stop marketing its hand sanitizer as reducing or preventing diseases — including the Ebola virus and the flu — consumers across the country filed lawsuits claiming consumer protection violations.

A California federal judge on May 4 barred hand sanitizer maker Innovative BioDefense Inc. from marketing its products as protecting against a range of infectious diseases after a bench trial shot down its affirmative defenses.

The government is represented by Rachel E. Baron and Adam E. Lyons of the U.S. Department of Justice's Civil Division, Michael O'Malley of the U.S. Attorney's Office for the Eastern District of Oklahoma, and Stacey C. Amin and Annamarie Kempic of the FDA.

Counsel information for Xephyr was not immediately available.

The case is U.S. v. Xephyr LLC et al., case number 6:20-cv-00140, in the U.S. District Court for the Eastern District of Oklahoma.

--Additional reporting by Mike LaSusa. Editing by Adam LoBelia.

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