Kegan Wellness – FDA Warning Letter, Jul 14, 2020

This FDA Warning Letter, dated July 13, 2020, addresses Aarohi Verve (Kegan Wellness) regarding the sale of unapproved and misbranded products related to COVID-19. The FDA and FTC reviewed the company's website (https://www.keganwellness.com) and social media (Twitter, Facebook) on June 30 and July 9, 2020.

The violations identified include offering "She Vitamin C Tablets," "She+ Tablets," and "Giloe+ Tablets" for sale in the U.S., with claims that they mitigate, prevent, treat, diagnose, or cure COVID-19. These products are 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 these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).

The letter cites the public health emergency and national emergency declarations for COVID-19 as context for urgent FDA action. Kegan Wellness is required to immediately cease the sale of these unapproved and unauthorized products. Within 48 hours, the company must