Makers of air purifiers and other home health devices will face stiff financial penalties from the EPA if they make inflated or misleading marketing claims that their products can fend off the coronavirus, attorneys say.
In recent weeks, the Environmental Protection Agency has announced a number of enforcement actions targeting both companies and individuals accused of selling illegal products claiming to protect against viruses, including Covid-19.
Antimicrobial devices such air purifiers, ozone generators and UV irradiation units aren’t required to go through the same EPA registration process as conventional pesticides. But they’re still bound by the same rules governing false or misleading claims under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which the EPA has continued to enforce in full even as it’s relaxed regulations in other areas during the pandemic.
“Companies making claims that their device can mitigate coronavirus better be well prepared to back up those claims with data,” said Andrew Stewart, a compliance and enforcement attorney with Sidley Austin LLP.
Not doing so could cost a company millions, Stewart said. In 2013, EPA reached a $2.6 million settlement with the EMD Millipore Corporation for violating federal pesticide law.
Given that EPA has independent authority to make judgments and levy fines, Stewart said he would advise clients to proceed with caution.
“It can be very tempting to slap that claim on the product to sell units, but we’re operating in an environment of intense scrutiny,” Stewart said. “So if you’re a device maker, and you face a standard of making no false or misleading statements, you better be prepared with a strong data packet to back up those claims.”
Along with disinfectant products, the EPA said it plans to hold pesticidal devices, including air purifiers, to the same standard of proof when it comes to marketing their products as a defense against coronavirus.
“It is EPA’s intention to pursue enforcement for those products making false and misleading claims regarding SARS-CoV-2,” a spokeswoman said in an April 21 statement.
She said the agency is also working the Justice Department and e-commerce platforms to remove and prohibit any fraudulent or ineffective products from the marketplace.
Unlike surface disinfectants, EPA hasn’t provided a way for pesticidal devices to win approval to make claims of effectiveness against Covid-19. Compliance attorneys said It’s created a regulatory gray area that makes it particularly risky for companies to market their products to customers looking for added protection against coronavirus.
“Making health protection claims can get you in a lot of trouble, and they can often be difficult to prove in a way that regulators are satisfied with,” said James Votaw, a partner at Keller and Heckman LLP with a focus on environmental and health and safety regulation.
Further complicating the issue, Votaw said, is that a company can still be held accountable for making misleading statements even if it can produce data showing its product is effective at killing Covid-19, if it doesn’t do it in a way that provides public health protection.
“If they’re making claims that the device treats the ambient air around us, but the virus isn’t expected to be there, it doesn’t actually protect anyone,” said Sheryl Dolan, a senior regulatory consultant at Bergeson and Campbell PC.
“So, the claims these companies are making could be true, but that’s not how you get the virus,” she said.
New York State Attorney General Letitia James (D) made that argument last month when she sent cease-and-desist letters to Aller Air Inc., Airpura Industries, and Sylvane Inc., accusing them of making false claims that their air purifiers are effective against coronavirus.
“These companies have been misrepresenting that Covid-19 is primarily an airborne disease & that their $1,500 air purifiers can effectively prevent people from contracting the virus by removing the virus particles from the air,” James said in a tweet.
On its website, Aller Air says it supports many “hospitals and medical clinics with air purifiers to help control and reduce the spread of COVID-19 virus.”
Likewise, James accused Airpura of misleading consumer by citing World Health Organization statements that air purifiers are an effective anti-viral tool, without stating that WHO recommends purifiers only for use in medical environments.
Stacy Singh, Airpura’s sales and marketing director, told Bloomberg Law that it was the attorney general who is “endangering the lives of millions of Americans.”
She cited a study from the New England Journal of Medicine to bolster the claim that the coronavirus is spread through the air.
“This exact same study we brought to the NY AG’s attention was then cited by Dr. Fauci a few days later on April 2, 2020 during a live White House briefing,” Singh said in an email, referring to Anthony Fauci, the the director of the National Institute of Allergy and Infectious Diseases.
“The fact that states are recommending that people wear face masks is also an indication that this is an airborne threat,” Singh said.
The CDC’s position, along with many other health agencies, is that the coronavirus is largely spread through person-to-person contact, or contact with virus-laden droplets expelled through coughing and sneezing.
While coughing and sneezing imply some airborne element, the CDC notes that most of these droplets travel about six feet before dropping out of the air and settling on surfaces. That is why the EPA recommends hand washing, and surface disinfectants from its List N, which have been tested and proven to be effective against Covid-19.