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As COVID-19 swept across the country in March 2020, it became abundantly clear to anyone who visited a grocery store that the United States was facing a severe shortage of essential products. Among some of the more noticeable absences from store shelves were disinfectants, personal protection equipment and hand sanitizers. Government agencies, including the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA), immediately took measures to ease some of the strict regulatory requirements governing the registration and production of disinfectants and sanitizing products in order to speed the production and delivery of these vital products to healthcare providers, essential businesses and American homes.
Sensing opportunity, or out of a moral imperative, a number of new players have entered the disinfectant and sanitizer markets and are mounting herculean efforts to ramp up the production, marketing and sales of new products. But disinfectant and sanitizer manufacturers must proceed with caution to ensure that their efforts comply with complex EPA and FDA regulatory schemes, state law, and new COVID-19 guidance. EPA and FDA have now pivoted from easing regulatory burdens to make it easier than ever before to produce disinfectants and sanitizers to bringing enforcement actions against manufacturers that fail to comply with existing regulations and modified COVID-19 guidance. Any company considering entering the disinfectant and sanitizer space should proceed with caution.