Patheon Manufacturing Services LLC – FDA Warning Letter, Jan 25, 2022

The FDA issued a Warning Letter to Mr. Voloshin on January 18, 2022, concerning the distribution of "Hand Sanitizer" as an alcohol-based over-the-counter (OTC) hand sanitizer. The primary violation identified is that the product is misbranded under section 502(i)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(i)(1), because its container is misleading.

Specifically, the "Hand Sanitizer" is packaged in 8.45-ounce bottles that resemble beverage containers customarily purchased by U.S. consumers, such as drinking water bottles. This packaging may mislead consumers, increasing the risk of accidental ingestion, which the FDA previously warned against in an August 27, 2020, news release. The product is classified as a "drug" under sections 201(g)(1)(B) and 201(g)(1)(C) of the FD&C Act due to its intended use as a topical antiseptic, with claims like "Fights over 99% of most common germs within seconds."

The introduction or delivery of this misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). The