EPA Warns Against False or Misleading Antiviral Claims, Highlights Enforcement
- What Happened: In a new Compliance Advisory, EPA emphasized that pesticides and pesticide devices may not make false or misleading claims to be effective against the novel coronavirus, and warned of enforcement against unregistered and other unlawfully distributed products.
- Who’s Impacted: Manufacturers and distributors of disinfectant products that are potentially effective against the novel coronavirus.
- What Should They Consider Doing in Response: Monitor their products or products sold or distributed through their platforms for anti-coronavirus claims without EPA registrations and take steps to prevent such products from being sold.
- By When Should They Act: As soon as possible.
As part of its ongoing response to the global COVID-19 pandemic, the U.S. Environmental Protection Agency (EPA) on June 1 released a Compliance Advisory to address ongoing concerns related to products that make unapproved or potentially false or misleading claims to kill SARS-CoV-2, the novel coronavirus that causes COVID-19. EPA has received numerous reports of such products and warns that they may present risks to consumers because the Agency has not reviewed or accepted those anti-coronavirus claims. EPA states that it is investigating these reports and coordinating with retailers to remove these pesticide products from the market, and with the U.S. Department of Justice (DOJ) to bring enforcement cases against their distributors.
Compliance Requirements for Anti-Coronavirus Claims
EPA’s new Compliance Advisory reiterates fundamental requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in light of the COVID-19 pandemic. Its release follows a series of recent efforts taken by EPA over the last several months to help disinfectant manufacturers quickly source and obtain the ingredients necessary to produce products approved by the Agency on its List N of disinfectants effective against the coronavirus. The new advisory also follows earlier guidance issued by EPA on April 29, which included recommendations to the American public to use certain unregistered commodity substances for disinfection when EPA-approved products are not available.
FIFRA prohibits the distribution or sale of any pesticide that is not registered with EPA, including many products that make or imply anti-viral or -bacterial claims. Surface disinfectants, wipes, and other products that are intended for use to kill, reduce, or mitigate coronavirus on objects, surfaces, or in the air or water will generally be regulated under FIFRA and require registration as pesticide products. EPA will not approve and register any public health pesticide without data showing the product to be safe and effective for all claimed uses. EPA must also approve all labeling claims and regulates pesticide production, packaging, import, and advertising. Under this framework, EPA’s advisory states that the Agency “will not register a product claiming to be effective against coronavirus until it has determined that the product will not pose an unreasonable risk and it will be effective when used according to the label directions.”
FIFRA also regulates “devices,” many of which are also intended to act against microbial pests, but work by physical means and do not incorporate an antimicrobial substance. Pesticide devices can include UV lights, ozone generators, water treatment units, and air purifiers. Devices do not require product registration under FIFRA but are subject to important production, import, and labeling requirements and, like pesticides, must not be marketed with any false or misleading claims. Accordingly, and although devices do not require pre-market approval under FIFRA, EPA warns that distributors “may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.”
Heightened Enforcement Activity
EPA states in the Compliance Advisory that it is “actively review[ing]” tips and complaints about pesticide products making potentially false or misleading anti-coronavirus claims and “intends to pursue enforcement” against products distributed in violation of FIFRA. EPA also notes that it is coordinating with e-commerce platforms to remove and prohibit fraudulent or inefficacious products from the market, and with DOJ to bring further appropriate enforcement measures against distributors of such products. On May 29, DOJ separately announced a guilty plea in a case related to the sale of unregistered pesticides making anti-coronavirus claims on eBay.
Visit Beveridge & Diamond’s COVID-19 EH&S Resource Center for more information on navigating the global pandemic. B&D’s Pesticides practice has worked for forty years with U.S. and international clients who research, develop, obtain government approvals for, manufacture, promote, and use pesticidal products and devices. We help clients identify business objectives and implement the most effective regulatory, commercial, litigation, and legislative strategies to achieve or exceed those objectives. If you have any questions, please contact the authors.