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# FDA Wants Food Handler Antiseptic Product Info
- URL: https://www.fdaweb.com/fda-wants-food-handler-antiseptic-product-info/
- Published: 2018-12-06T12:00:00.000Z
- Updated: 2026-09-15T00:48:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142973

FDA says it has established a docket to obtain data, information, and comments to aid it in assessing the safety and effectiveness of food handler antiseptic drug products (antiseptic hand washes or rubs intended for use in food handling settings) for over-the-counter human use. A *Federal Register* [announcement](https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-26561.pdf?ref=fdaweb.com) says that manufacturers of food handler antiseptics and other interested parties are being asked to submit safety and effectiveness data on OTC food handler antiseptics marketed for use by food handlers in commercial or regulated environments where growth harvest, production, manufacturing, processing, packaging, transportation, storage, preparation, service, or consumption of food occurs.

Comments and data are sought on definitions, eligibility, and current conditions of food handler antiseptics; safety and effectiveness criteria; and test methods to demonstrate food handler antiseptic effectiveness. “In general,” the notice says, “we are seeking input on current use conditions of antiseptics used in the food handler setting and recommended testing to establish the effectiveness of OTC food handler antiseptics.”

FDA says it has tentatively concluded that food handler antiseptics may differ from antiseptic products addressed in other rulemakings. It says that determination is based on the current categorization of other antiseptic products and considers factors that may include specific microorganisms of concern in food handling environments, as well as the safety of repeated-exposure use patterns. It also considers issues raised by the public health consequences of foodborne illness, differences in frequency and type of use, and contamination of the hands by dirt, grease, and other oils.

Industry and other interested parties have supported the idea of an OTC food handler antiseptic category, the agency says. Some information and data have already been submitted to FDA in support of establishing such a category. FDA says it believes more information is needed to assist it in evaluating the safety and effectiveness criteria appropriate for food handler antiseptics.