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Noble Elements, LLC was warned for selling Coated Silver, an unapproved new drug product that violated section 505(a) of the Federal Food, Drug, and Cosmetic Act. The company's website made disease claims establishing the product as a drug, including antimicrobial and antibacterial benefits, while lacking FDA approval or authorization. The product was also misbranded under section 502 of the Act. Given the declared mpox public health emergency, the FDA specifically requested that the company cease selling unapproved products claiming to mitigate, prevent, treat, diagnose, or cure mpox.