Muskogee, Oklahoma - A federal court in Muskogee, Oklahoma, entered a temporary restraining order halting the sale of an unapproved colloidal silver product to treat COVID-19, the Department of Justice announced Thursday.
The U.S. District Court for the Eastern District of Oklahoma entered the temporary restraining order in response to a civil complaint and accompanying court papers filed by the Department of Justice. In its complaint, the department alleges that Xephyr LLC, doing business as N-Ergetics, and its owners Brad Brand, Derill J. Fussell, and Linda Fussell, sell and distribute a colloidal silver product claiming that it will cure, mitigate, or treat coronavirus and its resulting disease, COVID-19, as well as other diseases including pneumonia, AIDS, and cancer. Colloidal silver is a suspension of silver particles in a liquid, and it is not generally recognized as safe and effective by qualified experts for any of the uses for which defendants promote it.
“The Department of Justice takes swift action to protect consumers from unsafe products that are unlawfully sold as COVID-19 treatments,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “We will continue to work closely with the Food and Drug Administration to prevent harm to consumers from unlawful products during this pandemic.”
“The facts leading to this civil action underscore the importance of exercising extreme caution when dealing with people making claims to have a cure-all,” said U.S. Attorney Brian J. Kuester for the Eastern District of Oklahoma. “National disasters bring out the best of many Americans. Unfortunately there are those who seek to take advantage of the fear and anxiety caused by widespread disasters, such as the Coronavirus, that may cause people to be more vulnerable to fraudulent claims.”
The department’s complaint alleges that defendants are introducing unapproved new drugs into interstate commerce and that their disease-related treatment claims are unsupported by any well-controlled clinical studies or other credible scientific substantiation. Additionally, the complaint asserts that, because defendants’ products do not have adequate directions for lay users, the products are misbranded.
On March 6, 2020, FDA, jointly with the Federal Trade Commission, issued a Warning Letter to defendants notifying them that they are violating federal law (including the Federal Food, Drug, and Cosmetic Act) by, among other things, distributing unapproved new drugs and misbranded drugs in interstate commerce. After receipt of this warning, the complaint alleges, the defendants attempted to cloak their claims to prevent liability, while continuing to make the same substantive claims and to sell colloidal silver as a cure, mitigation, or treatment for coronavirus and COVID-19.
“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. Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective, especially during this ongoing pandemic,” said Stacy Amin, FDA Chief Counsel. “The FDA will continue our efforts to make sure that this and other like-minded sellers comply with the law.”
This enforcement action is being prosecuted by Trial Attorneys Rachel E. Baron and Adam E. Lyons of the Department of Justice, Civil Division’s Consumer Protection Branch, and Assistant U.S. Attorney Michael O’Malley of the U.S. Attorney’s Office for the Eastern District of Oklahoma, with assistance from Associate Chief Counsel for Enforcement Jaclyn Martínez Resly of the FDA, Office of the General Counsel, Department of Health and Human Services.
The claims made in the complaint are allegations that, if the case were to proceed to trial, the government must prove to receive a permanent injunction against the defendants.
In response to the department’s filing, defendants immediately took down their sales site. In addition, they have posted a message offering refunds to their customers: “Due to the FDA and the DOJ’s requests, this site has been removed. Anyone who has ordered in the last 90 days, and would like a refund, please email...” The department will continue to seek complete relief against defendants.