Blue Willow Biologics

Warning LetterOpen

Chad Costley, MD/MBA President and Chief Executive Officer Blue Willow Biologics 2311 Green Road Ann Arbor , MI 48105 United States nanobio@bluewillow.comIssued Aug 3, 2021Center for Drug Evaluation and Research

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateAug 3, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Blue Willow Biologics
Location: Chad Costley, MD/MBA President and Chief Executive Officer Blue Willow Biologics 2311 Green Road Ann Arbor , MI 48105 United States nanobio@bluewillow.com
FEI Number: N/A
Country: United States
Issue Date: August 03, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

Summary

Blue Willow Biologics was warned for marketing an unapproved non-alcohol-based nasal antiseptic product intended to mitigate, prevent, treat, or cure COVID-19 without FDA approval, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act. The product was found to be misbranded under sections 502(a) and (ee) of the FD&C Act and was being sold through the company's websites and retail partners including CVS. These violations—introducing an unapproved new drug into interstate commerce—were particularly serious given the concurrent public health emergency declaration for COVID-19, which prompted FDA to take urgent enforcement measures against unauthorized products making pandemic-related claims.

Blue Willow Biologics FDA Warning Letter, August 3, 2021