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A temporary restraining order was entered against Xephyr LLC, doing business as N-Ergetics requiring the company to immediately stop distributing colloidal silver products.
In another case of companies falsely claiming to sell products that prevent and/or treat COVID-19, FDA announced on May 14, 2020 that US District Judge Ronald A. White for the US District Court for the Eastern District of Oklahoma entered a temporary restraining order against Xephyr LLC, doing business as N-Ergetics, and three individuals associated with the company for violating the Federal Food, Drug, and Cosmetic Act (FD&C). The order requires the company to stop distributing colloidal silver products it claims to treat coronavirus, including COVID-19. The US Department of Justice (DOJ) filed the complaint, which 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.” According to FDA, “the court also found that there is a danger that the defendants will continue violating the law without the temporary restraining order.” A hearing to extend the injunction past its expiration of June 4, 2020 will be held on May 21, 2020.
A previously issued warning letter to Xephyr was sent in March 2020 by FDA and the Federal Trade Commission. In response to the warning letter, the company temporarily removed the products from their webpages but resumed marketing the products by the end of April 2020.
The company’s website markets colloidal silver products with the claim that the products cure, mitigate, treat, or prevent COVID-19, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). The product’s labeling also claims that colloidal silver can cure, mitigate, treat, or prevent cholera, diabetes, cancer, and AIDS. FDA has not approved these products for any use and state that there is a lack of adequate data to establish their safety and effectiveness.
“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, in a press release. “The FDA will continue our efforts to make sure that this and other like-minded sellers comply with the law.”