U.S. Food and Drug Administration issued the following announcement on May 14.
A federal court has entered a temporary restraining order against Xephyr LLC, doing business as N-Ergetics, and three individuals associated with the entity, requiring them to immediately stop distributing colloidal silver products. The defendants offered these products for sale to treat coronavirus, which includes Coronavirus Disease 2019 (COVID-19) and many other diseases. In granting the government’s request for relief, the court found that the United States has demonstrated that Xephyr and the associated individuals named in the injunction are violating the Federal Food, Drug, and Cosmetic Act (FD&C) by unlawfully distributing colloidal silver products that are unapproved new drugs and misbranded drugs. The court also found that there is a danger that the defendants will continue violating the law without the temporary restraining order.
“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 Deputy General Counsel of the Department of Health and Human Services and Chief Counsel of FDA Stacy Amin. “The FDA will continue our efforts to make sure that this and other like-minded sellers comply with the law.”
The FDA, jointly with the Federal Trade Commission (FTC), previously issued a warning letter to Xephyr about its colloidal silver products. The FDA and FTC requested that the company respond within 48 hours describing the specific steps it has taken to correct the violations. While the sellers removed their COVID -19-related webpages for a time, by the end of April 2020, they had resumed marketing their colloidal silver products as a treatment for COVID-19 in violation of the law.
On their website, www.n-ergetics.com, Xephyr markets their colloidal silver products to cure, mitigate, treat or prevent COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), among other diseases. Labeling accompanying the purchased product also includes claims that colloidal silver can cure, mitigate, treat or prevent cholera, diabetes, cancer and AIDS. There is a lack of adequate data to establish the safety and effectiveness of Xephyr’s colloidal silver products for use in the treatment or prevention of any disease, and the FDA has not approved the defendants’ colloidal silver products for any use.
As a result of these violations, today, U.S. District Judge Ronald A. White for the U.S. District Court for the Eastern District of Oklahoma, entered the temporary restraining order against Xephyr and the individual defendants Brad Brand, Derill J. Fussell and Linda Fussell. The Order expires on June 4, 2020. There will be a hearing on the government’s request to extend the injunction on May 21, 2020. The complaint, filed by the U.S. Department of Justice (DOJ), against the Atoka, Okla. seller and the seller’s most responsible individuals, seeks to restrain and enjoin all defendants from labeling, holding and distributing unapproved new drugs and misbranded drugs, in interstate commerce on a permanent basis. The FDA requested that DOJ to bring this case on behalf of the U.S. Government. 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 Xephyr.
The FDA is particularly concerned that products that claim to cure, mitigate, treat or prevent serious diseases like COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. There are currently no vaccines or drugs approved to treat or prevent COVID-19. The only drugs authorized for emergency use do not contain colloidal silver. The FDA reminds the public to seek medical help from their health care providers and urges people to talk to their health care provider about treatment options, as well as follow advice from other federal agencies about how to prevent the spread of COVID-19. Additionally, the FDA advises all consumers to consult with a health care professional before deciding to take any medication, and consumers should carefully read the labels of any product they are thinking of using.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of COVID-19 products to the FDA’s MedWatch Adverse Event Reporting program.
The FDA continues to monitor social media, online marketplaces and incoming complaints to help ensure that sellers do not continue to sell fraudulent products related to COVID-19.
Original source can be found here.
