On May 14, 2020, the Hon. Ronald A. White, a federal judge in the United States District Court for the Eastern District of Oklahoma, issued a Temporary Restraining Order (“TRO”) against Xephyr LLC (doing business as N-Ergetics) and three associated individuals (Brad Brand, Derill J. Fussell, and Linda Fussell) (collectively, “Defendants”), ordering them to immediately cease labeling, holding, and/or distributing any drugs, including colloidal silver products.

The Defendants marketed their colloidal silver products online, claiming to cure, mitigate, treat, and prevent COVID-19, as well as other coronaviruses (such as SARS and MERS), and various other diseases such as cholera, diabetes, cancer, and AIDS. Colloidal silver is a liquid product marketed for oral use that contains microscopic suspended silver particles, and is not generally recognized as safe and effective by qualified experts for any of the Defendants’ promoted uses.

As previously reported in this blog, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued a joint warning letter to Defendants on March 6, 2020, challenging the marketing and distribution of Defendants’ colloidal silver products. The agencies were particularly concerned that products claiming to cure, mitigate, treat or prevent serious diseases like COVID-19 could cause consumers to delay or forego appropriate medical treatment, leading to serious and life-threatening harm. There are currently no vaccines or drugs approved by FDA to treat or prevent COVID-19, and in any event, none of the limited drugs currently granted Emergency Use Authorizations by FDA for the treatment of COVID-19 (e.g., remdesivir, hydroxychloroquine, etc.) contain colloidal silver.

The civil Complaint, filed by the U.S. Department of Justice (DOJ) at FDA’s request, alleges the products are unapproved new drugs; that the disease-related claims are not supported by adequate substantiation in the form of competent and reliable scientific evidence; and that the products lack adequate directions for use and are misbranded. The Complaint seeks to permanently restrain and enjoin the Defendants from labeling, holding, and distributing any unapproved and/or misbranded new drugs, such as colloidal silver, in interstate commerce. The TRO expires on June 4, 2020, and the court will hear argument on the government’s request to extend the injunction on May 21, 2020.