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WARNING LETTER
•SilveryGuy•August 12, 2020

SilveryGuy – FDA Warning Letter, Aug 12, 2020

Record Details

On August 14, 2020, the FDA and FTC issued a Warning Letter to Silveryguy.com, an Amazon Associate, for promoting and participating in the sale of "Colloidal Silver" with unproven COVID-19 claims. The FDA reviewed the company's website (www.silveryguy.com) and Facebook page (www.facebook.com/silveryguy/) on August 5 and 12, 2020.

The violations include marketing Colloidal Silver with claims implying it can mitigate, prevent, treat, diagnose, or cure COVID-19. This causes the product to be an unapproved new drug under Section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and a misbranded drug under Section 502 (21 U.S.C. § 352). Introducing or delivering these products into interstate commerce is prohibited under Sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)), and misbranding a drug held for sale after interstate shipment is prohibited under Section 301(k) (21 U.S.C. § 331(k)).

The letter cites the public health emergency and national emergency declarations related to COVID-19. Sil

Company
SilveryGuy
Inspection date
August 12, 2020
Product type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Donald D. Ashley (Director)
  • Serena Viswanathan (Associate Director)
View Company Profile

ID · b6a70a82-d025-484b-9f8c-4dd2bf619e4d

Violation Codes5
21.U.S.C. 355(a)21 U.S.C. 35221 U.S.C. 331(d)21 U.S.C. 331(k)21 U.S.C. 331(a)

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