Noble Elements, LLC – FDA Warning Letter, Jan 31, 2023

The FDA issued a Warning Letter to Coated Silver (www.coatedsilver.com) after reviewing their website in October 2022. The FDA determined that the company's "Coated Silver" product is an unapproved new drug and a misbranded drug, violating sections 201(g)(1)(B), 505(a), and 502(f)(1) of the Federal Food, Drug, and Cosmetic Act.

The product is deemed a drug because website claims establish its intent for use in the cure, mitigation, treatment, or prevention of disease, specifically citing claims related to mpox, viruses, bacteria, and fungi. Examples include blog posts stating "Colloidal silver has antimicrobial properties" and is "effective against viruses, bacteria, and even fungi," including "Monkeypox."

As an unapproved new drug, it lacks FDA approval based on scientific data for safety and effectiveness. It is also misbranded because it fails to bear adequate directions for use by a layperson, as it is intended for conditions requiring supervision by a licensed practitioner.

The FDA, noting a public health emergency for mpox, requested the company cease selling unapproved and unauthorized products for mpox mitigation, prevention, treatment, diagnosis, or cure. The company must respond within fifteen working days, outlining corrective actions and prevention measures, or provide reasoning if they believe no violation occurred. Failure to comply may result in legal action, including seizure and