# FDA WARNING_LETTER - Blue Willow Biologics - March 24, 2021

Source: https://www.keypedia.com/records/warning_letter/blue-willow-biologics/51ab5c51-b1ef-41f6-931f-a08bcdc4e369

> FDA WARNING_LETTER for Blue Willow Biologics on March 24, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Blue Willow Biologics
- Inspection Date: 2021-03-24
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On August 3, 2021, the FDA issued a Warning Letter to the company operating nanobioprotect.com and bluewillow.com, following a March 24, 2021, review of their websites. The FDA found the company was selling "NanoBio Protect Nasal Antiseptic Solution," a non-alcohol-based consumer antiseptic nasal product, with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 and other conditions.

The FDA determined this product is an unapproved new drug, violating section 505(a) of the FD&C Act, and a misbranded drug under sections 502(a) and (ee). The product's labeling and website claims, such as "The Nanodroplets optimize the ability of the antiseptic to kill germs. The droplets sit on skin after application, enabling protection for up to 8 hours (in lab testing)," establish its intended use as a drug.

The product is considered a "new drug" because it is not generally recognized as safe and effective (GRASE) for its intended uses, and no FDA-approved application is in effect. Furthermore, it does not conform to the 1994 Tentative Final Monograph (TFM) for topical antimicrobials or its amendments, specifically regarding extended efficacy claims and its intended application inside and around the nostrils. These claims create a false sense of security, potentially

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Company: https://www.keypedia.com/companies/blue-willow-biologics/d99a92bb-2799-40ed-a75b-f2cf8771f021

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