FDA WARNING_LETTER - Applied Biological Laboratories Inc. - March 31, 2022
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The FDA issued a Warning Letter on March 24, 2022, to the company at 760 Parkside Ave., 317 Brooklyn, NY 11226, following reviews of their websites, https://www.biovanta.com and http://www.appliedbioinc.com, and social media in February and March 2022. The Federal Trade Commission (FTC) also reviewed these sites.
The FDA found that "Biovanta Dual Action Throat Spray" and "Biovanta Triple Action Lozenges" were offered for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). Their introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).
The letter demands immediate cessation of sales for these unapproved and unauthorized COVID-19 related products. The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective
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