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EPA Warns Against False or Misleading Antiviral Claims, Highlights Enforcement

Key Takeaways:

  • 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.

© 2020 Beveridge & Diamond PC National Law Review, Volume X, Number 154

TRENDING LEGAL ANALYSIS


About this Author

Alan J. Sachs Regulatory Attorney Beveridge & Diamond Washington, DC
Principal

Alan’s practice focuses on the wide range of regulatory issues faced by the global agriculture, food, biotechnology, and bioenergy industries.

Practicing environmental law provides him with daily opportunities to use his legal skills and training to help clients overcome often extremely technical business and regulatory challenges in order to ensure compliance with applicable environmental requirements.

He advises numerous Forbes Global 2000 companies on the legal and regulatory requirements associated with both domestic and foreign production, and the import, export, and...

202-789-6049
Kathryn E. Szmuszkovicz Litigation Attorney Beveridge & Diamond Washington, DC
Managing Principal

Kathryn E. Szmuszkovicz litigates and provides strategic regulatory counsel.

Kathy litigates on behalf of individual companies, groups of companies and trade associations in federal and state courts across the country. She also provides alternative dispute resolution (ADR), compliance, strategic planning, and commercial services focused on the regulatory aspects of her clients’ businesses. Kathy’s practice focuses on clients who manufacture, sell, and use products regulated by EPA, USDA, FDA, DOI, DOC, and analogous state agencies under the environmental, health, and safety laws that these agencies implement.

In particular, Kathy works with clients in the agricultural sector (including pesticides and seeds businesses), and food, chemicals, and consumer products industries. This includes traditional products and products produced through biotechnology or nanotechnology. Examples of her work include:

  • Bringing or defending litigation where necessary to protect clients’ products, projects, or practices.
  • Advising clients on strategies for obtaining federal approvals for new products or substances, defending products once they are on the market, and phasing out products for regulatory or commercial reasons.
  • Advising clients who manufacture, sell, license, or use these regulated products on government requirements and commercial transactions.
  • Defending companies against enforcement actions.
  • Proposing and commenting on regulatory and legislative initiatives.
  • Supporting acquisition or sale of particular products or businesses.
  • Advising on stewardship and sustainability practices.

Kathy has litigated in federal courts across the country, including the United States Supreme Court, and has represented clients in every EPA region and many states. She has advocated for clients in ADR proceedings, including ADR mandated by statute, mini-trials and other ADR designed by parties to resolve disputes privately without court intervention, and mediation.

Kathy is Beveridge & Diamond’s firmwide Managing Principal. Before assuming this role, she served for many years on B&D's Management Committee and as the chair or co-chair of the firm’s pesticides and biotechnology practices. Kathy served for six years on the Board of Directors of a privately held company that discovers, manufactures, and sells proprietary chemicals. Before her legal career, Kathy served in federal and Michigan state government.

202-789-6037
Jack B. Zietman Regulatory Environmental Attorney Beveridge & Diamond Washington, DC
Associate

Jack litigates and practices regulatory environmental law with a focus on groundwater issues and the agriculture, food, and chemical manufacturing industries.

His representative experience includes work on products liability and environmental tort litigation, as well as regulatory counsel for products regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). He is also familiar with fishery management issues, particularly pertaining to the conservation of endangered species, and the evolving U.S. regulations of...

202-789-6036