As the world faces the unprecedented spread of the COVID-19 virus, essential resources such as hand sanitizer, face masks, medical gowns, and ventilators are suddenly in short supply. In response to the dwindling availability of critical protective gear, manufacturers have a unique opportunity to serve by supplying the sudden demand for critical products.

However, manufacturers considering whether to convert their facilities so they can produce this vital equipment to help fight the virus should be aware that many of the needed products involve critical safety issues and are regulated in the United States by a variety of federal and state statutes and regulations. The regulations can be complex, and more than one agency may regulate a given product, including the Food and Drug Administration (FDA), Alcohol and Tobacco Tax and Trade Bureau (TTB), U.S. Department of Labor (DOL), Occupational Safety and Health Administration (OSHA), Environmental Protection Agency (EPA), the Centers for Disease Control (CDC), and numerous state agencies.

Fortunately, in response to the critical need for COVID-19 related products, federal agencies in the U.S. are issuing guidance that temporarily alters the rules for the design, production, and approval of essential resources. Manufacturers need to be aware of the federal regulations and administrative rules that ordinarily govern certain products as well as the temporary guidelines and enforcement policies being issued on an almost daily basis. Here are some examples:

• Hand Sanitizer: The FDA and TTB have issued a series of documents that relax enforcement standards for entities that want to convert their facilities to produce hand sanitizers or the necessary ingredients to make hand sanitizers. Guidance from the TTB additionally allows alcohol to be delivered tax-free to certain approved locations for non-beverage purposes.
• Masks: The FDA, DOL, and OSHA have issued emergency use authorizations and temporary enforcement guidelines that expand upon which personal protective equipment can be used when no FDA-cleared masks are available. The Families First Coronavirus Response Act (FFCRA) also limits liability arising from the use of masks in connection to COVID-19 in certain circumstances.
• Ventilators: The FDA and DOL have relaxed ventilator guidelines to permit the use of ventilators with hardware, software, and materials modifications that would otherwise not be approved.
• Gowns, Gloves, and Apparel: The FDA has issued a temporary enforcement policy that broadens the definition of acceptable gowns, gloves, and healthcare apparel.
• Disinfectants: The EPA has issued guidance to expediate the review of certain surface disinfectants.

If your business is contemplating the manufacture of these vital products during this time of unprecedented need, be sure to contact our Consumer Product Safety, Risk Prevention & Regulatory Compliance team for guidance through the potential pitfalls you may face along the way.