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.

Disinfectants and Pesticide Devices

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulates the manufacture, labeling, marketing and sales of products intended to kill viruses, including SARS-CoV-2, the virus that causes COVID-19. FIFRA regulates both chemical pesticides and nonchemical pesticide devices (including UV lights, ozone generators and other devices making pesticide claims). In particular, FIFRA regulations focus on advertising and labeling claims regarding the effectiveness of pesticides and pesticide devices.

FIFRA requires companies to register any new production facility prior to manufacturing pesticides and pesticide devices. For antiviral pesticides, FIFRA lays out a rigorous product registration process, including submission of scientific evidence to EPA, which ensures that the product is safe for its intended use and any claims that a product is effective in killing viruses are supported. Companies producing chemical pesticides must obtain registrations for each product manufactured and labeled as a pesticide. In some instances, new manufacturers of pesticides can obtain licensing rights that allow them to rely on the scientific studies supporting other product registrations. But for new products, or products making new claims regarding their effectiveness, EPA has typically required new scientific testing and analysis – which is a potentially long and expensive process.

After the COVID-19 pandemic hit the United States, EPA agreed to relax many of FIFRA’s regulatory requirements for manufacturers of disinfectants in order to help speed the delivery of these products to market. Among these developments, EPA streamlined its process for registering new pesticide and pesticide device manufacturers and approving disinfectants that could be used against COVID-19 on the List N.[1] “While surface disinfectant products on List N have not been tested specifically against coronavirus, EPA expects them to kill the virus because they demonstrate efficacy against a harder-to-kill virus or another human coronavirus similar to the one causing COVID-19.”[2] In late March 2020, EPA agreed to provide disinfectant manufacturers more supply-chain flexibility with substitution of certain active commodity ingredients, inert ingredients and registered sources of chemicals following notification to EPA. The temporary guidance was extended in April and again in May 2020.[3]

Sanitizers

Like the EPA, after the COVID-19 pandemic began, the FDA relaxed its provisions in order to speed up the production of hand sanitizers. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), producers of hand sanitizers are considered to be “over-the-counter drug manufacturers” and must register their facilities with the FDA. But given the importance of hand hygiene, and a shortage of hand sanitizer at the beginning of the pandemic, the FDA issued a Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).[4] The FDA’s temporary policy provided guidance to entities that were not currently FDA-registered drug manufacturers on how to produce hand sanitizer. Among other requirements, the FDA required that manufacturers working under this policy produce hand sanitizer that (1) includes ethanol (or isopropyl alcohol), glycerin, hydrogen peroxide and sterile water; (2) does not include any ingredients to improve its taste or smell; and (3) is an aqueous solution and not a gel, foam or aerosol spray.

It is important to note that firms that produce hand sanitizer under the FDA’s temporary policy are still required to register their facilities and list their products under the FDA’s Drug Registration and Listing System. The FDA has stated that it does not intend to initiate enforcement actions against companies that produce hand sanitizer during the pendency of the pandemic if those companies closely follow the FDA’s guidance. This includes following the FDA’s requirements for labeling hand sanitizers; and to ease the burden, the FDA provided sample labels as an appendix to the guidance.[5] The FDA also released temporary policies for compounding alcohol-based hand sanitizers[6] and for producing alcohol for use in hand sanitizers.[7] Products that are registered as hand sanitizers by the FDA may not be used or registered as a surface disinfectant by EPA.[8]

Increased Enforcement

In late May 2020, EPA issued a compliance advisory to “address concerns related to products being used to disinfect surfaces which include claims to kill and/or be effective against SARS-CoV-2, the coronavirus causing the disease COVID-19.”[9] After restating its pesticide guidance under FIFRA, EPA advised, “It is unlawful for any person to distribute or sell a pesticide in the United States making claims that it will kill a particular pathogen, unless that pesticide is registered with EPA and that particular claim has been deemed acceptable by the agency.” In particular, EPA stated that it is focused on “potentially false or misleading claims, including efficacy claims,” and is “ working with e-commerce platforms to remove/prohibit these fraudulent and/or otherwise inefficacious products from the marketplace.” On June 11, 2020, EPA announced a stop sales order against dozens of “unregistered, misbranded, or restricted-use pesticides, and pesticide devices that make false or misleading claims,” found on two prominent e-commerce platforms.[10]

The FDA has also issued warning letters to companies that have claimed that their hand sanitizers “are intended to mitigate, prevent, treat, diagnose, or cure COVID-19.”[11] The FDA has taken the position that sanitizers that make these claims are “new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.”[12] Firms that have been found to be violation of the FDA’s regulations have been given 48 hours to complete corrective action for the violations listed in the FDA’s warning letter and are added to an FDA list of companies “marketing products with fraudulent COVID-19 prevention and treatment claims.”[13]

In addition to FIFRA and FDA requirements, companies entering the disinfectant or sanitizer markets should evaluate whether state law, international law and export/import requirements, or other federal laws (including the Toxic Substances Control Act), may apply to their new products.

[1] https://www.epa.gov/pesticide-registration/expedited-review-pesticide-registration-improvement-act-pria-submissions.
[2] https://www.epa.gov/sites/production/files/2020-05/documents/cornavirus-compliance-advisory.pdf.
[3] https://www.epa.gov/sites/production/files/2020-05/documents/98-10-temporary-amendment-2020-05-11-signed.pdf.
[4] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during.
[5] Id.
[6] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-temporary-compounding-certain-alcohol-based-hand-sanitizer-products-during-public-health.
[7] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-manufacture-alcohol-incorporation-alcohol-based-hand-sanitizer-products-during.
[8] https://www.epa.gov/coronavirus/why-arent-hand-sanitizers-listed-list-n.
[9] https://www.epa.gov/sites/production/files/2020-05/documents/cornavirus-compliance-advisory.pdf.
[10] https://www.epa.gov/newsreleases/epa-orders-amazon-and-ebay-stop-sale-certain-pesticide-products-0.
[11] https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sanit-technologies-llc-dba-durisan-606050-05072020.
[12] https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prefense-llc-605488-04232020#_ftnref2.
[13] https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products.