Blue Willow Biologics

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

This product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).

Passage 2

This consumer topical antiseptic product was also misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because the labeling was false or misleading. Specifically, labeling for this product claimed that the product “adheres to the OTC monograph system for topical skin antiseptics.” As noted above, this product does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.

Passage 3

This consumer topical antiseptic products is also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

Passage 4

Based on the above claims, your topical antiseptic product is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. § 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. § 321(g)(1)(C), because it is intended to affect the structure or any function of the body.

Passage 5

This consumer topical antiseptic is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling.

Passage 6

However, your consumer topical antiseptic product does not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, nor any other TFM, proposed rule, or final rule, and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.

Passage 7

Your claims on the product label, suggesting your consumer antiseptic provides all day efficacy against infection, and your claims on your websites, which suggested all day protection against serious-disease related pathogens including the novel coronavirus that causes COVID-19, do not conform to the 1994 TFM or any of the amendments to the TFM discussed above. Time-specific extended efficacy claims, especially when related to serious-disease related pathogens, endanger the public health by creating a false sense of security for the general public that may result in infrequent hand washing or the substitution of these products for protective gloves and clothing, which are the principal methods for protecting against the spread of diseases caused by pathogenic microorganisms.

Passage 8

In addition, according to the product labeling, NanoBio Protect Nasal Antiseptic Solution is intended to be applied inside and around the nostrils. Consumer antiseptic products intended for administration inside and around the nostrils are not permitted under the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rubs Proposed