EPA Increases Scrutiny of Products Making Claims Related to COVID-19

The United States Environmental Protection Agency (“EPA”) is increasing its scrutiny of sanitizers, disinfectants and other products that claim to kill viruses, bacteria, and other microbial organisms. Under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”),^[1] EPA has authority to regulate “pesticides” and “pesticide devices.” The definition of “pesticides” under FIFRA includes sanitizers, disinfectants and many cleaners and disinfectants that are intended to be applied to surfaces for cleaning.^[2] EPA is taking enforcement action against companies importing, producing and selling products associated with antimicrobial claims if they have failed to register under FIFRA and/or have made unsubstantiated claims about a product’s effectiveness against SARS-CoV-2, the virus that causes COVID-19 disease, including requesting such products be removed from third-party marketing platforms (e.g., Facebook and eBay).

FIFRA requires that any person or company manufacturing, selling, distributing and importing “pesticides” (including disinfectants, sanitizers and other antimicrobial substances or devices) within the United States register the product with the EPA. EPA grants a registration and/or license that permits the distribution, sale and importation of pesticides only after EPA has concluded that there is reasonable certainty of no harm to people or the environment from the product. If the product makes any claims on its labels or other marketing materials regarding the effectiveness of the product against, viruses, bacteria and other microbial organisms, then the seller or distributer of the product also must obtain approval from EPA prior to making such claims.^[3]

EPA’s Focus on COVID-19 Treatments

EPA has announced that it is concerned with pesticide products manufactured in, sold in, or imported into, the United States that claim to kill SARS-CoV-2. When EPA identifies a product that is not compliant with the requirements of FIFRA, EPA can issue a “Stop Sale, Use or Removal Order” if it finds that such an order is necessary to prevent an “imminent hazard.” FIFRA provides EPA with the discretion to impose civil and criminal penalties for violations.

EPA also is expediting its review of products seeking to make claims that they are effective against SARS-CoV-2. EPA’s Emerging Viral Pathogens Guidance for Antimicrobial Pesticides allows sanitizers, disinfectants and cleaning products to be approved for claims regarding their effectiveness against SARS-CoV-2 if the claims are made off-label (e.g., in technical reports, websites, consumer information services and on social media sites) rather than on the label of the product.[5] EPA also has created a list of products that have complied with the FIFRA registration requirements for use against COVID-19.^[6]

Recent Enforcement Actions

EPA has taken enforcement action against companies that manufacture and sell products intended or claimed to combat the spread of COVID-19 if the products or companies do not comply with FIFRA.

• Virus Shut Out. In March 2020, EPA announced that it had worked with the U.S. Customs and Border Patrol to prevent the importation of several shipments of Toamit Virus Shut Out, a product that Virus Shut Out failed to register as a pesticide with the EPA. Virus Shut Out made unsubstantiated claims in labeling and in online advertising materials regarding its ability to kill SARS-CoV-2.^[7] Then, on April 9, 2020, EPA and the U.S. Department of Justice announced that they had filed criminal charges against a Georgia resident that was illegally importing and selling Toamit Virus Shut Out through eBay, claiming that it would help protect individuals from SARS-CoV-2 and other viruses.^[8]
• EPA Asks Third Party Sellers to Remove Unregistered Products. On April 23, 2020, EPA requested that Facebook, eBay, Alibaba, Shopify, Qoo10, JoyBuy.com, Wish.com and banggood.com remove unregistered disinfectant products from their platforms that made claims regarding COVID-19.^[9] This is not the first time that EPA has targeted third-party sellers for allowing unregistered pesticides to be sold on their platforms. In February 2018, Amazon settled claims that it had violated FIFRA by allowing the sale of unregistered pesticides.^[10]
• Seal Shield. On April 24, 2020, EPA issued a Stop Sale, Use or Removal Order to Seal Shield, LLC in Orlando, Florida, requiring the company to immediately halt the sale and distribution of certain products because they were unregistered pesticide devices that made unsubstantiated antimicrobial claims regarding the products’ effectiveness against SARS-CoV-2 and other viruses.^[11] The products subject to the order included computer equipment, mobile devices and TV accessories. EPA issued the order because the products were being sold to hospitals and other healthcare providers with claims that the products protected against viruses and reduced microbial growth.

The heightened demand for disinfectants during the COVID-19 crisis may drive more frequent and aggressive actions to control or exclude from the United States unregistered products or products with unverified antimicrobial claims.

^[1] 7 U.S.C. §§135 et seq.
^[2] EPA regulates sanitizers, antiseptic washes and antibacterial soaps that should not be applied to human skin while the Food and Drug Administration (“FDA”) regulates sanitizers, antiseptic washes and antibacterial soaps that should be applied to human skin. See EPA, Why aren’t hand sanitizers listed on List N?, https://www.epa.gov/coronavirus/why-arent-hand-sanitizers-listed-list-n
^[3] “Misbranded” as defined by 7 U.S.C. § 136, subd. (q), meaning the product's labeling lacks required elements such as warnings, directions for use, an ingredient statement, or includes false or misleading claims, etc.
^[4] An “imminent hazard” is a substantial likelihood of serious harm during the duration of a cancellation proceeding.
^[5] EPA, Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants, https://www.epa.gov/pesticide-registration/emerging-viral-pathogen-claims-sars-cov-2-submission-information-registrants (last visited on May 6, 2020).
^[6] EPA, List N: Disinfectants for Use Against SARS-CoV-2, https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2 (last visited on May 6, 2020).
^[7] EPA, U.S. EPA Acts to Protect the Public from Unregistered “Virus Shut Out” Product Imported into Honolulu and Guam, Mar. 25, 2020, https://www.epa.gov/newsreleases/us-epa-acts-protect-public-unregistered-virus-shut-out-product-imported-honolulu-and.
^[8] U.S. Department of Justice, Georgia Resident Arrested for Selling Illegal Products Claiming to Protect Against Viruses, Apr. 9. 2020, https://www.justice.gov/opa/pr/georgia-resident-arrested-selling-illegal-products-claiming-protect-against-viruses.
^[9] EPA, U.S. EPA calls on eight technology companies to address fraudulent COVID-19 disinfectants, Apr. 23, 2020, https://www.epa.gov/newsreleases/us-epa-calls-eight-technology-companies-address-fraudulent-covid-19-disinfectants.
^[10] EPA, Amazon Services LLC FIFRA Settlement, https://www.epa.gov/enforcement/amazon-services-llc-fifra-settlement (last visited on May 6, 2020).
^[11] EPA, EPA Issues Order to Seal Shield, LLC in Orlando, Florida to Stop Selling Unregistered Pesticides and a Misbranded Pesticide Device, Apr. 24, 2020, https://www.epa.gov/newsreleases/epa-issues-order-seal-shield-llc-orlando-florida-stop-selling-unregistered-pesticides.