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# FDA Releases ‘Purell’ Warning Letter
- URL: https://www.fdaweb.com/fda-releases-purell-warning-letter/
- Published: 2020-03-17T12:00:00.000Z
- Updated: 2026-09-14T16:07:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146340

FDA has released a 1/17 Warning Letter sent to Gojo Industries, Cuyahoga Falls, OH, asserting that because the firm’s Purell Healthcare Advanced Hand Sanitizer product line is intended for use as consumer and healthcare antiseptics it is considered an unapproved new drug. The [letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gojo-industries-inc-599132-01172020-0?ref=fdaweb.com) contains examples of claims from the firm’s product Web sites that indicate the products are intended to reduce or prevent disease from the Ebola virus, norovirus, and influenza.

“FDA is currently not aware of any adequate and well-controlled studies demonstrating that killing or decreasing the number of bacteria or viruses on the skin by a certain magnitude produces a corresponding clinical reduction in infection or disease caused by such bacteria or virus,” the letter says.

The products also are considered to be new drugs because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling, FDA says. Further, the letter says, although the company suggests its products are marketed under over-the-counter drug review, they do not comply with the relevant tentative final monograph.

Gojo was told to take prompt action to correct the violations and prevent their recurrence and to respond with a list of actions taken, documentation of each action, and a schedule for completion of the actions.