FDA WARNING_LETTER - NovaBay Pharmaceuticals, Inc. - October 27, 2020

The FDA and FTC issued a Warning Letter to NovaBay Pharmaceuticals, Inc. on November 2, 2020, following reviews of their websites (novabay.com, avenova.com, saniteyesmore.com) and social media (Facebook, Twitter) between September 22-24, 2020, and October 27, 2020. The letter also noted product availability on Amazon and Walmart.

The letter identifies AVENOVA® ANTIMICROBIAL LID & LASH SOLUTION, PURE HYPOCHLOROUS ACID, 0.01%, 20 ml, as an unapproved new drug and a misbranded drug. The product is marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, which violates sections 505(a) and 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a) and § 352. The 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).

The FDA and FTC demand immediate cessation of sales for these unapproved and unauthorized COVID-19 related products. NovaBay