FDA WARNING_LETTER - KetoKerri LLC - August 09, 2020

The FDA issued a Warning Letter to Kerri Rivera regarding the sale of unapproved and misbranded products related to COVID-19. Between March 12 and August 9, 2020, the FDA reviewed Rivera's websites (www.kerririvera.com, www.ketokerri.com), Amazon storefront, and Facebook page. The review found products like "KK Black Seed Oil," "KK Breakthrough Vitamin D," "Stonebreaker," "KK EDTA," "Zeolite," "Ultra Liquid Zeolite," and "DR. FITT FIRE FIGHTERS" were offered for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products were deemed unapproved new drugs under 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). The introduction of such products into interstate commerce violates sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)). The letter notes that while some claims have been removed and the Facebook page is down, the violations are serious public health concerns.

Rivera is required to email COVID-19-Task-Force-CFSAN