Noble Elements, LLC

Warning LetterOpen

Dr. Calin V. Pop, MD and Nodari Rizun Noble Elements, LLC 1621 Central Avenue Cheyenne , WY 82001 United States orders@coatedsilver.comIssued Jan 30, 2023Center for Food Safety and Applied Nutrition (CFSAN)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateJan 30, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Noble Elements, LLC
Location: Dr. Calin V. Pop, MD and Nodari Rizun Noble Elements, LLC 1621 Central Avenue Cheyenne , WY 82001 United States orders@coatedsilver.com
FEI Number: N/A
Country: United States
Issue Date: January 30, 2023
Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN)
Product Type: Drugs
Status: Open

Summary

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.

Noble Elements, LLC FDA Warning Letter, January 30, 2023