B4B Corp. – FDA Warning Letter, Jan 29, 2021
On February 18, 2021, the FDA and FTC issued a Warning Letter to B4BCorp regarding the unapproved and misbranded product "Earth Tea Extra Strength" sold on their website, https://www.b4bcorp.com, and promoted via social media, https://www.twitter.com/b4bcorpusa.
The agencies reviewed the websites on January 25 and 29, 2021, and found that the product was offered for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. This renders "Earth Tea Extra Strength" 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). The introduction of this product into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).
The FDA emphasized the public health emergency declared for COVID-19 and its urgent measures to protect consumers from unauthorized products. B4BCorp was instructed to immediately cease the sale of all unapproved and unauthorized products for COVID-19 mitigation, prevention, treatment, diagnosis
ID · e80c47b2-2bc1-45e6-bac3-68711488d638
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