The U.S. Food and Drug Administration (FDA) and Alcohol and Tobacco Tax and Trade Bureau (TTB) have issued new and updated guidance documents in addition to those previously published in order to address the decreased market supply of hand sanitizer products resulting from the rapid spread of the COVID-19 pandemic.
The new guidance document from FDA outlines the circumstances under which FDA will not take action against alcohol producing firms that manufacture alcohol (i.e. ethanol or ethyl alcohol) for use as the Active Pharmaceutical Ingredient in alcohol-based hand sanitizers. The guidance also outlines labeling for undenatured and denatured alcohol for use in hand sanitizers, as well as formulas that can be used to denature alcohol. Additionally, FDA has updated its guidance for manufacturing firms that produce alcohol-based hand sanitizers for consumers and healthcare workers.
The TTB has issued updated guidance on hand sanitizer production. In this guidance, TTB:
- Updates the formulas authorized for hand sanitizer formulas to be consistent with FDA guidance;
- Exempts distilled spirit companies from the requirements to obtain TTB approval to receive denatured or undenatured distilled spirits in bond from another DSP and to obtain additional bond coverage, through June 30, 2020;
- Provides guidance and certain exemptions for state and local governments that are seeking to acquire tax-free alcohol; and
- Provides hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions a streamlined application process to obtain tax-free alcohol for non-beverage purposes.
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) also includes a provision that provides a waiver of the federal excise tax on alcohol produced by distilled spirits companies that is used to produce hand sanitizer. There are also helpful provisions for small businesses in the alcohol beverage industry. A summary of the small business provisions of the CARES Act can be found on the Husch Blackwell COVID-19 Toolkit.
Husch Blackwell is experienced navigating the regulatory requirements of FDA and TTB. Our FDA and Alcohol and Beverage lawyers are available to discuss these developments and how companies comply with the FDA requirements to produce and sell hand sanitizer. Contact Seth Mailhot, Emily Lyons, or your Husch Blackwell attorney.