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

Source: https://www.keypedia.com/records/warning_letter/novabay-pharmaceuticals-inc/3ed50718-3418-4b99-927b-b06b8907bed0

> FDA WARNING_LETTER for NovaBay Pharmaceuticals, Inc. on October 27, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: NovaBay Pharmaceuticals, Inc.
- Inspection Date: 2020-10-27
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/novabay-pharmaceuticals-inc/2546fcc0-fd18-4b23-9873-efcf1ed14b27

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c