The arrival of the coronavirus pandemic in early 2020, and the associated spike in demand for sanitizing and antibacterial products, prompted many companies to dive into the production of such products. Unfortunately, many of these businesses are not familiar with the regulatory scheme governing the production and sale of such products in the United States, and are thus likely to find themselves exposed to a number of litigation and enforcement risks, both in the short and long term. Because many new sanitizer producers are venturing into this area for the first time, many are already running afoul of federal and state pesticide registration requirements, primarily those under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. § 136 et seq. FIFRA requires the registration of all pesticide products distributed, sold, or used in the United States—which includes sanitizing and disinfecting products—and the U.S. Environment Protection Agency (EPA) is already pursuing enforcement actions and stop-sale orders against producers and distributors of illegal sanitizing products. In the short term, EPA is anticipated to continue to take action against illegal (i.e., non-registered) pesticide products that are being imported or sold in the United States market. In the long term, businesses may find themselves facing consumer fraud litigation with respect to claims that products kill over 99 percent of viruses and bacteria—claims that are very common, and also very difficult to prove. Further, businesses may face products liability claims against purportedly “ineffective” sanitizing products, as well as lawsuits related to adverse health effects associated with the application and use of sanitizing products.
FIFRA regulates all pesticides that are sold, distributed, or used in the United States, including surface sanitizers that make antibacterial, anti-viral, or other antimicrobial claims. Given the increased demand for sanitizer products during the COVID-19 pandemic, the EPA issued various advisories and guidance documents in 2020, and, most recently, an updated compliance advisory in January 2021 describing its authority to prevent the sale of unregistered sanitizing products that claim efficacy against the SARS-CoV-2 virus. EPA has also made clear that it can take enforcement actions under FIFRA sections 13 and 14 (often through stop-sale orders and/or penalty actions) against products imported into the United States. EPA has already issued some stop-sale orders to some major distributors, ordering them to cease all sales of unregistered pesticide products, including a number of products claiming efficacy against the SARS-CoV-2 virus. The United States has also engaged in criminal enforcement of FIFRA, for crimes such as selling or distributing unregistered pesticides, or smuggling them into the United States.
Sanitizing products are subject to jurisdiction by either EPA or the U.S. Food and Drug Administration (FDA). Generally speaking, antimicrobial products that are applied to surfaces are regulated by the EPA under FIFRA, while hand sanitizing products are regulated by the FDA as drugs. Throughout the COVID-19 pandemic, both the FDA and EPA have modified their regulations and enforcement guidelines related to sanitizing products. The FDA has already issued various consumer recall notices and advisories regarding methanol and other chemicals in hand sanitizers, and EPA has pursued enforcement actions and stop-sale orders for improperly labeled pesticide products. Increased litigation and agency action are also expected, particularly regarding sanitizing products imported from abroad, including China and Mexico (two of the most prolific producers of these products). Businesses should be aware of the applicable regulatory scheme associated with manufacturing and distributing sanitizing products, as both agencies have jurisdiction over these products. Businesses should also ensure they are up to date on the latest regulatory moves by both agencies, as the regulatory landscape is changing at a rapid pace.
Adding to the potential confusion for manufacturers and distributors, not every surface cleaning product is subject to EPA or FDA regulation. For example, products that are only labeled and marketed with generalized household cleaning claims are exempt from those regulations — an exemption that many companies are now attempting to claim. Under 40 CFR § 152.10, “[d]eodorizers, bleaches, and cleaning agents . . . are not considered to be pesticides unless a pesticidal claim (e.g., antimicrobial, antibacterial, or “virus killing” claims) is made on their labeling or in connection with their sale and distribution.” FIFRA defines a pesticide as “any substance or mixture of substances [is] intended for preventing, destroying, repelling, or mitigating any pest.” 7 U.S.C. § 136. FIFRA further defines pests as “any insect, rodent, nematode, fungus, weed, or [] any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals).” Id. Therefore, products intended and marketed for general household cleaning do not need to apply for registration as a pesticide under FIFRA — provided they do not make any antimicrobial or sanitizing claims. Here too, however, a producer may find themselves unwittingly subject to an enforcement claim. EPA has clarified that terms that simply imply antimicrobial properties may nonetheless be considered pesticide claims, including use of the word “sanitary.” EPA evaluates “sanitary” product claims on a case-by-case basis. It is therefore unsurprising that EPA has recently refused admission into the United States of one company’s cleaning wipes products, which the company was attempting to import and sell as general cleaning product, deeming the product a pesticide that required registration. Additional agency action and related litigation is expected with respect to products claiming general household cleaning uses but which may unwittingly use a term (such as “sanitary”) that could be viewed by EPA as suggesting antimicrobial properties, or, such as in the Zuru case, include active ingredients present in other FIFRA-registered products.
Further, within the FDA product category for over-the-counter (OTC) drugs, which includes hand sanitizers, the FDA and the Federal Trade Commission (FTC) also have dual jurisdiction. This means that the FTC could take action against companies making advertising claims that are false or misleading and that are not substantiated. Actions by either of these agencies, such as consumer redress by the FTC, or a product recall by the FDA, could also spur private party litigation.
While the short-term risks associated with sanitizer products are primarily related to enforcement actions by government agencies, the long-term risks are primarily related to the potential for consumer-filed litigation, including class action lawsuits. For example, businesses should be aware that, while many sanitizer products claim to kill over 99 percent of viruses and bacteria, these claims are very difficult to prove, despite being commonly made in the industry. As such, products making these claims are particularly susceptible to consumer lawsuits. One major hand sanitizer company has already been the subject of a few such class-action lawsuits, and at least one law firm has already begun soliciting clients who have been exposed to methanol in certain hand sanitizer products. For example, one retailer has already been sued in one putative class action lawsuit against its hand sanitizer for its claims that the product “kills 99.99% of germs.” Another company, which manufactures a different, popular hand sanitizer product, has also been sued on similar allegations in multiple lawsuits.
Producers and distributors of sanitizing products may also face products liability lawsuits filed by consumers who may allege that products are not effective against the SARS-CoV-2 virus, as claimed. One hand sanitizer company has already been sued for allegedly falsely claiming that its product can kill the virus, and similar lawsuits involving surface sanitizer products can also be expected.
Companies may also face lawsuits related to alleged adverse health effects stemming from the application of surface sanitizer products, particularly with respect to spray-application products. For example, one company has already been sued after a hospital worker alleged adverse impacts to her health caused by the cleaning product she was exposed to in the hospital where she worked before the COVID-19 pandemic. Given the increased usage of such products in the wake of the COVID-19 pandemic, it is possible that other similar lawsuits will follow.
These private party actions are not limited to surface-application antimicrobials. To date, at least one wrongful death lawsuit has been filed against both a hand sanitizer producer and retailer because a consumer died, allegedly because they ingested a hand sanitizer product. In addition, an increasing number of class action lawsuits have been filed against a hand sanitizer company because manufacturers, distributors and retailers of hand and surface sanitizers and alleging false claims on antimicrobial efficacy and personal injury and property damages attributable to hazardous and undisclosed constituents present in sanitizing products.
In order to protect themselves from potential enforcement actions or consumer litigation, businesses should take steps to understand the regulatory requirements for their products and ensure that all products are properly registered with the applicable agency or otherwise in compliance with agency rules and regulations. Businesses should also take care to avoid misleading, unsupported, or otherwise unauthorized claims, and clearly identify the directions for safe use on all of their products.
