Kleenhanz, LLC

Selected passages from the FDA letter

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

Passage 1

Based on the above claims, your Kleenhanz® Towelettes hand sanitizer products are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. § 321(g)(1)(B), because they are intended for use in 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 they are intended to affect the structure or any function of the body.

Passage 2

No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. § 355, are in effect for these drug products, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your Kleenhanz® Towelettes are GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. §§ 355(a) and 331(d).

Passage 3

However, your Kleenhanz® Towelettes products do not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rubs Proposed Rule and the 2015 Healthcare Antiseptics Proposed Rule, nor any other TFM, proposed rule, or final rule and do not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.

Passage 4

Benzethonium chloride is not a permitted active ingredient, either as a sole ingredient or in combination with other ingredients like benzalkonium chloride, for use in consumer antiseptic hand rub drug products under the 1994 TFM. Consumer antiseptic rub drug products with this active ingredient do not conform to the TFM. In addition, the use of more than one active ingredient is not consistent with the 1994 TFM for either consumer antiseptic rub drug products or healthcare topical antiseptic drug products.

Passage 5

In addition, your labeling includes claims that your Kleenhanz® Towelettes products are effective in preventing infection or disease from the coronavirus that causes COVID-19. Your website located at www.kleenhanz.com also contains claims that your Kleenhanz® Towelettes products are effective in preventing disease or infection from other pathogens, including but not limited to, "...Human immunodeficiency virus (HIV) type 1… Hepatitis type B & C…Herpes simplex type 1 & 2…Influenza A (H1N1) …MRSA… Staphylococcus aureus…Enterococcus VRE… Neisseria gonorroheae [sic]…Influenza A2… Norwalk… Rotavirus…Candida albicans… E Coli MG1655 type…Chlamydia trachomatis…" Such indications go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings.

Passage 6

Your Kleenhanz® Towelettes are also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. § 352(ee), because they are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. § 355h, but do not comply with the requirements for marketing under that section and they are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. § 355.