Medical Mikes, Inc.

Warning LetterOpen

Mike Vanacoro Medical Mikes, Inc. 3393 Nutly Circle Yorktown Heights , NY 10598 United States hello@medicalmikes.comIssued Jan 10, 2023Center for Drug Evaluation and Research | CDER

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

Violations1

Issue DateJan 10, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Medical Mikes, Inc.
Location: Mike Vanacoro Medical Mikes, Inc. 3393 Nutly Circle Yorktown Heights , NY 10598 United States hello@medicalmikes.com
FEI Number: N/A
Country: United States
Issue Date: January 10, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Medical Mikes, Inc. was cited for selling unapproved CBD products on its website that claimed to mitigate, prevent, treat, diagnose, or cure COVID-19, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act by marketing unapproved new drugs. The products were also found to be misbranded under section 502 of the FD&C Act, and their introduction into interstate commerce violated sections 301(a) and (d) of the Act. The FDA took action during the declared public health emergency and national emergency related to COVID-19 to protect consumers from unauthorized products making disease claims without FDA approval.

Medical Mikes, Inc. FDA Warning Letter, January 10, 2023