Regulatory Report
AusarHerbs - Corona Destroyer Tea - Unapproved and Misbranded Products Related to COVID-19, USA
5 years ago •source fda.gov
United States
The FDA observed the website offers “Corona Destroyer Tea” for sale in the United States in two options, “Prevention” and “Reversal,” and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19[1] in people.Based on FDA review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and d. Some claims on the website and product label establish the intended use of the product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19
For more information click here: www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ausarherbs-610976-01122021
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