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March 6, 2020: FDA and FTC Issue Warning Letter to Xephyr, LLC d/b/a N-Ergetics for Unapproved and Misbranded Products Related to COVID-19

N-Ergetics Warning Letter News – The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued a joint warning letter to Xephyr, LLC d/b/a N-Ergetics (N-Ergetics)for listing and promoting colloidal silver products on its website for sale in the United States, intended to mitigate, prevent, treat, cure or diagnose COVID-19 (coronavirus) in people.

N-Ergetics Warning Letter Information

On March 6, 2020, the FDA and FTC jointly issued a warning letter to N-Ergetics for selling misbranded and unapproved products on its website intended to treat or prevent COVID-19.

Per the FDA and FTC’s warning letter:

FDA has determined that these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352. The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

The FDA advised N-Ergetics that it is the company’s responsibility to be in compliance with the FD&C Act. N-Ergetics was given forty-eight (48) hours to respond to the warning letter with specific steps they plan to take to remedy the situation.

Officials caution that there are currently no vaccines, prescriptions, etc. known to treat or cure COVID-19. Anyone aware of suspected fraudulent medical products for COVID-19 are asked to contact the FDA on their reporting site or at: FDA-COVID-19-Fraudulent-Products@fda.hhs.gov

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