The US Food & Drug Administration (FDA) and Environmental Protection Agency (EPA) have published new guidance for the importation and distribution of hand sanitizer products to meet meet rising demand during the ongoing COVID-19 pandemic.
Hand sanitizers are considered over-the-counter drug products and are regulated by the FDA. Hand sanitizers (and other drugs) imported into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act and the pertinent regulations found in Title 21 of the Code of Federal Regulations (21 CFR). As such, entries of hand sanitizers are required to be filed with the FDA upon importation. Some hand sanitizer/disinfectant products are considered pesticides and require registration with the EPA before they can be imported and sold in the U.S.
Below are links to the FDA & EPA guidance on hand sanitizer products. If you have questions about how your products might be affected, please do not hesitate to contact your OTS Sales Representative.
FDA Hand Sanitizer Guidance for Industry
EPA FAQ: Registration of Disinfectant Products
FDA Filing Entries for Hand Sanitizers