B4B Corp.

Warning LetterOpen

B4B Corp. 40 Remsen Ave, Brooklyn , NY 11212 United States (b)(6)Issued Feb 18, 2021Center 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.

Letter Details

Firm: B4B Corp.
Location: B4B Corp. 40 Remsen Ave, Brooklyn , NY 11212 United States (b)(6)
FEI Number: N/A
Country: United States
Issue Date: February 18, 2021
Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN)
Product Type: Drugs
Status: Open

Summary

B4B Corp. was cited for selling "Earth Tea Extra Strength," an unapproved new drug that violated section 505(a) of the Federal Food, Drug, and Cosmetic Act by making claims to mitigate, prevent, treat, diagnose, or cure COVID-19 without FDA approval or authorization. The product was also found to be misbranded under section 502 of the FD&C Act and was marketed through the company's website and social media channels. The FDA issued this warning during the declared public health emergency and national emergency related to COVID-19, prioritizing consumer protection from unauthorized products making pandemic-related health claims.