The U.S. Food and Drug Administration has gone to court to stop an Atoka company from allegedly selling products containing colloidal silver as a remedy for COVID-19.
The FDA, in a civil lawsuit filed Wednesday, claims Xephyr LLC, doing business as N-Ergetics, asserts on its company website and on product literature that colloidal silver “cures, mitigates or treats coronavirus and other diseases,” according to a complaint filed in Muskogee federal court.
The lawsuit names company owners Brad Brand, Derill J. Fussell and Linda Fussell as defendants along with the company.
The lawsuit alleges N-Ergetics offers on its website colloidal silver products for sale in the U.S. that it claims are intended to cure, mitigate, treat, or prevent coronaviruses, including COVID-19 and other diseases, including urinary tract infections, yeast infections and pink eye.
The lawsuit describes a web page with the heading “Human Coronavirus” on the N-Ergetics website as evidence of the alleged unlawful claims.
Colloidal silver, according to the U.S. Department of Health and Human Services, “consists of tiny silver particles in a liquid that is sometimes promoted on the Internet as a dietary supplement. However, evidence supporting health-related claims is lacking. In fact, colloidal silver can be dangerous to your health.”
The company website page lists various afflictions including various flu types, cholera and smallpox, calling them “non-pharmaceutical intervention viruses,” saying that they can only be controlled by “running their course,” according to the lawsuit.
A vaccine eradicated smallpox in the U.S. in the 1970s.
The web page claims there is an over-the-counter supplement used to treat pathogens for 123 years and follows with a question mark that acts as a link that takes the reader to the company’s colloidal silver page if clicked, according to the complaint.
The company sometime Wednesday afternoon replaced the text on its colloidal silver website page with the following: “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 firstname.lastname@example.org within the next 20 days.”
The FDA claims it conducted comprehensive searches of publicly-available medical and scientific literature for colloidal silver and determined that there was no published, adequate and well-controlled studies demonstrating that N-Ergetics’ colloidal silver products are safe and effective for use under the conditions prescribed, recommended or suggested in their labeling.
“Because there are no published adequate and well-controlled studies for the intended uses of defendants’ colloidal silver products to cure, mitigate, treat or prevent coronavirus or any other disease, qualified experts have not come to the consensus of opinion that the products are effective for such uses,” according to the complaint.
The FDA claims it issued a warning letter to the company and its owners on March 6, advising them that they were violating federal law by distributing unapproved new drugs and misbranded drugs in interstate commerce.
The lawsuit claims the company responded by posting the warning letter on its website with a news release that stated “we sell several products including colloidal silver, an ex-prescription since 1938. This now, over-the-counter supplement has been laboratory, university and doctor tested to kill 650 pathogens in vitro.”
The website also includes a disclaimer that N-Ergetics products do not mitigate, prevent, treat, diagnose or cure any virus or disease in people.
The lawsuit seeks a preliminary and permanent injunction restraining and enjoining Xephyr LLC/N-Ergetics from introducing or delivering new drugs into interstate commerce or taking part in activities related to misbranding drugs.
The lawsuit asks a judge to authorize the FDA to inspect the business and its records related to its allegations and to make restitution to all purchasers of its colloidal silver products and recall their unapproved new drugs and misbranded drugs.
YouTube has terminated N-Ergetics’ account due to what it describes as multiple or severe violations of YouTube’s policy against spam, deceptive practices, and misleading content or other violations of its terms of service.
Xephyr LLC/N-Ergetics responded to a request for comment with an email noting the take down of the colloidal silver page.
“To the best of our knowledge, we are in compliance,” the email stated.
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