FDA WARNING_LETTER - xephyr, llc - March 06, 2020
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On March 6, 2020, the FDA and FTC issued a Warning Letter to Xephyr LLC dba N-Ergetics regarding unapproved and misbranded colloidal silver products advertised on www.n-ergetics.com. The FDA determined these products were offered for sale in the U.S. and intended to mitigate, prevent, treat, cure, or diagnose COVID-19, making them unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act.
The letter cited specific website claims establishing the products' intended use for COVID-19, such as "Colloidal Silver 1100 PPM Immune Support" for "Coronavirus 2019-NCoVat, Treatment Has A Home Remedy" and claims that colloidal silver "killed all seven of these Human Coronaviruses." These claims are not supported by competent and reliable scientific evidence.
N-Ergetics was ordered to immediately cease selling these unapproved and unauthorized products for COVID-19. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, including steps to prevent recurrence and supporting documentation. Failure to comply could result in legal action, including seizure and injunction. The firm will be added to the FDA's published list of non-compliant firms. The FTC also advised that
ID · 87e84737-c114-4f0c-939f-bce3ed148c2b
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