Yes, EPA is authorized to take enforcement action to prevent the sale or distribution of disinfectants with false or misleading claims on their labeling. EPA is also authorized to take enforcement action to prevent the sale or distribution of unregistered disinfectants when the seller or distributor is making claims that they work against SARS-CoV-2 (the coronavirus that causes COVID-19), and to prevent the sale or distribution of registered pesticides that are not permitted to make SARS-CoV-2 claims by the terms of their registration.
Due to the ongoing pandemic, EPA is concerned with pesticide products entering the United States, or produced, manufactured or distributed in the United States, that claim to address COVID-19 impacts. The Agency will focus on ensuring compliance with requirements applicable to these products to ensure protection of public health.
The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) governs the registration, distribution, sale, and use of pesticides, which includes disinfectants, in the United States. FIFRA prohibits the sale or distribution of pesticides that are unregistered, misbranded (e.g., their labeling lacks required elements such as warnings, directions for use, an ingredient statement, or includes false or misleading claims, etc.), and the sale or distribution of registered pesticides with claims that substantially differ from those allowed under the terms of their registration. FIFRA also prohibits the sale of misbranded pesticide devices.
EPA and its state partners monitor for related activities defined as unlawful under section 12 of FIFRA. Monitoring occurs through the screening of products intended for importation into the United States, inspecting a variety of locations related to distribution and use, as well as following up on tips and complaints. EPA typically enforces FIFRA through stop-sale orders and penalty actions authorized under sections 13 and 14, respectively.
EPA recently announced that it is expediting its review of requests from registrants pursuant to the Agency’s Emerging Viral Pathogens Guidance for Antimicrobial Pesticides. This guidance provides a pathway for registrants to make claims in off-label communications that their registered disinfectants may be used against viral pathogens like human coronavirus.
Once such claims are approved, they can be made for the disinfectant in off-label materials only, such as technical literature distributed to health care facilities, physicians, nurses, or public health officials, non-label-related websites, consumer information services, and on social media sites. Nothing in this expedited review eliminates the need to comply with FIFRA.
For more information, see the recent advisory on products claiming to kill the novel coronavirus from EPA’s Office of Enforcement and Compliance Assurance.