A consumer advisory issued on June 1, 2020 by the United States Environmental Protection Agency (EPA) clarifies which hard-surface disinfectant products may legally make claims regarding expected efficacy against the COVID-19 virus. The advisory, titled “What You Need to Know Regarding Products Making Claims to Kill the Coronavirus Causing COVID-19,” also warns retailers of potential enforcement actions if they sell non-compliant products. 

Background 

EPA regulates hard-surface disinfectants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (human contact disinfectants, like hand sanitizers, fall under the authority of the Food and Drug Administration). On January 29, 2020, in response to the COVID-19 outbreak, EPA invoked for the first time its “Emerging Viral Pathogen Guidance” for disinfectant registration under FIFRA. This guidance sets forth an expedited process, permitting companies to submit their disinfectant products to EPA for inclusion on what is known as EPA’s “List N.”

Products identified on List N have (1) demonstrated efficacy against a harder-to-kill virus or (2) demonstrated efficacy against another type of human coronavirus similar to COVID-19. It is important to note that even those products listed on List N have not been specifically tested against COVID-19; rather, they have shown efficacy against similar viruses.

EPA’s Consumer Advisory 

The novelty of COVID-19 and EPA’s List N registration process has generated significant confusion among consumers and manufacturers alike.

EPA’s June 1, 2020 consumer advisory aims to eliminate some of that confusion. Specifically, the advisory emphasizes that:

• No surface disinfectant may make claims regarding expected COVID-19 efficacy until EPA determines that the product (1) does not pose an unreasonable risk, (2) will be effective when used according to the label directions, and (3) has demonstrated efficacy against another type of human coronavirus or a harder-to-kill virus. EPA will list all such products on List N.

• Only products on EPA’s List N meet EPA’s criteria for products expected to be effective against COVID-19. No other hard-surface disinfectant products may legally make COVID-19 efficacy claims, even if, for example, the product states that it kills “99.5% of viruses.”

• No pesticidal devices (e.g., ozone generators, UV lights, or similar products) are included on EPA’s List N. Pesticidal devices are subject to different registration requirements that do not include EPA review of any safety or efficacy data and therefore, they do not qualify for List N. These devices are, however, subject to similar penalties under FIFRA for making false or misleading claims. Thus, any device making a claim about efficacy without having been tested against COVID-19, or a harder-to-kill virus, may violate FIFRA.

• Unregistered disinfectants have not been reviewed by EPA for potential hazards to human health and therefore may pose a higher risk of harm. Additionally, using an EPA-registered product contrary to its EPA-approved labeling and directions may similarly increase potential health hazards.

Mitigating Potential Liability

EPA concludes its advisory by noting that it is receiving a “steady stream” of tips and complaints about products that may make false or misleading claims about COVID-19. EPA has been working with leading retailers, particularly those in the e-commerce industry, to protect consumers from these products.

EPA’s advisory reiterates that it will prioritize FIFRA enforcement actions against companies selling products making false or misleading claims about COVID-19. Significantly, any company in the supply chain could be held liable for violations of FIFRA and—if a product causes personal injury or property damage—could face state law tort claims brought by private plaintiffs.

To reduce the risk of potential liability, companies selling or distributing hard-surface disinfectants making COVID-19 efficacy claims should (1) ensure that every such product appears on List N, (2) confirm the product’s label does not make claims beyond those allowed by EPA, and (3) refrain from making any statements about the product’s expected efficacy against COVID-19 beyond those disclosed by the manufacturer on the product’s label.

EPA’s full advisory may be found here.

EPA’s List N database may be found here.