Stephen Matthew Shumaker counted on in-home, in-person demonstrations to drive his water filtration business, which serves the Atlanta area. So when covid-19 hit and no one was inviting people indoors, he turned to the air-cleaning part of his operation.
He sent cards in the mail advertising air purifiers using ActivePure technology to new homeowners: 鈥淜ILL COVID-19, CORONAVIRUS IN YOUR HOME!!鈥
One card landed on the desk of a postal inspector, who called it false and misleading in a court record. Shumaker then told an undercover agent on the phone on April 24, 2020, that the air purifier 鈥渒ills the Coronavirus Virus on the spot,鈥 according to a .
Weeks later, as Shumaker was heading out the door to his daughter鈥檚 tennis tournament, eight law enforcement officers detained him. In August, he to distributing 鈥渁 pesticide device that was misbranded in that the product label was missing an EPA establishment number.鈥 In other words, he failed to follow the letter of a little-known law.
Shumaker told KHN he was just a salesperson and the devices were being shipped straight from the manufacturer. 鈥淪o I don’t know 鈥 what am I supposed to do?鈥 he asked. 鈥淗ow do I know if there’s a sticker on there or not? I don’t have a clue.鈥
The company that makes the devices, ActivePure Technologies, said Shumaker was not an authorized or known salesperson of its products.
The sting is a rare example of enforcement in an arena where money is gushing like a geyser but oversight is nearly nonexistent. Electronic air cleaners, heavily marketed to gyms, doctors鈥 offices and hospitals, companies and schools awash in federal covid relief funds, tend to use high-voltage charges to alter molecules in the air. The companies selling the devices say they can destroy pathogens and clean the air.
But academic air quality experts say the technology can be ineffective or potentially create harmful byproducts. Companies that make the devices are subject to virtually no standardized testing or evaluation of their marketing claims. A KHN investigation this spring found that over 2,000 schools across the country have bought such technology.
鈥淭hat’s one of the reasons these companies thrive, is that there’s nobody, nobody checking every aspect of what they do,鈥 said , a Colorado State University associate professor who specializes in atmospheric and indoor chemistry.
Regulatory Patchwork
An alphabet soup of federal agencies have truth-in-advertising or product medical device oversight powers but have done little about air cleaners or left broad loopholes. That has left a handful of states to take the most decisive action on the industry.
The Centers for Disease Control and Prevention does not regulate the devices but, like academic air quality experts, time-tested portable HEPA filters to clean the air in rooms. In comparison, ionizing and dry hydrogen peroxide air purifiers have a 鈥渓ess-documented track record鈥 in air cleaning, the CDC says.
The CDC also urges consumers to research the technology and 鈥渞equest testing data.鈥 Those reports, though, can be difficult to parse. They include arcane terms like 鈥渘atural decay鈥 and test conditions that only an expert could spot as different from those that prevail in real life.
The Food and Drug Administration regulates medical devices. But only air purifiers for a direct medical use or that make a medical claim, like relieving allergies, qualify. The FDA doesn鈥檛 consider ads saying a device can kill a microorganism a 鈥渕edical claim,鈥 spokesperson Shirley Simson said in an email.
Instead, the air purifiers fall under the Environmental Protection Agency鈥檚 authority as marketed to destroy 鈥減ests,鈥 which include bacteria or viruses. But 鈥渦nlike chemical pesticides, the EPA does not register devices and, therefore, does not routinely review their safety or efficacy,鈥 said.
Trying to fill the gaps, California bans the sale of air purifiers than a certain level of the toxic ozone gas. The New York State Education Department is 鈥溾 that schools buy air purifiers it describes as 鈥渋on generators鈥 or 鈥渃orona discharge technology.鈥
, a University of Toronto civil engineering professor who studies indoor air quality, said more meaningful national regulation might clarify for consumers how the devices would work in an actual room.
鈥淚f you get any serious government oversight, a big chunk of this industry will go away,鈥 said Siegel.
鈥業 Was Alone鈥
While 鈥減esticide鈥 might evoke the idea of a roach killer, the EPA applies the term more broadly: A pesticide is any substance that claims to kill or mitigate pests. Technologies that claim to do the same through physical means 鈥 including air purifiers that inactivate bacteria and viruses 鈥 are considered .
And while the agency requires proof that pesticides in its premarket review, it has no such requirement for so-called pesticide devices 鈥 such as electronic air cleaners that deploy ions or 鈥渞eactive oxygen鈥 to purify the air.
Instead, manufacturers need to obtain what鈥檚 known as an indicating where the device is made, and then they and their sellers must label their products with it. That鈥檚 the step Shumaker pleaded guilty to skipping.
鈥淭here is no review associated with that,鈥 said , a lawyer who specializes in chemical regulation law at Keller and Heckman in Washington, D.C. 鈥淭hat is automatic. It鈥檚 like trying to get license plates for your car.鈥
So Shumaker told KHN he was baffled as to why he was targeted instead of the corporate level, which in this case would be the company, Aerus, which Technologies. Dr. Deborah Birx, former adviser to President Donald Trump, joined ActivePure in March as chief medical and science adviser.
鈥淚 was alone,鈥 Shumaker said in an interview about facing charges. 鈥淣obody backed me up.鈥
Joe Urso, CEO of ActivePure Technologies, told KHN that its studies showing its devices inactivate the virus that causes covid were not completed until the fall, long after the postcards were sent. Urso said in a statement that his company鈥檚 devices do have establishment numbers, and that he supports the ruling against Shumaker.
Federal Trade Commission officials have written warning letters companies during the pandemic. The commission requires claims about a product鈥檚 safety and efficacy to be supported with 鈥渃ompetent and reliable scientific evidence.鈥
One of the last high-profile actions the FTC took against an air purifier company was in 1997, when the Justice Department on its behalf against Alpine Industries, which made ozone-generating air purifiers. In 2001, a judge fined Alpine $1.49 million for failing to stop making unsubstantiated claims about its devices, which it had said relieved allergies and removed indoor pollutants.
Alpine is a related company to , according to the FTC. And a majority of EcoQuest International assets were bought in 2009 , according to its 2021 press kit. ActivePure makes the device Shumaker got into trouble for selling.
Siegel, of the University of Toronto, consulted with U.S. government agencies targeting the misleading marketing claims of some air-cleaner companies about 10 years ago. He finds the company-by-company approach to be a game of 鈥渨hack-a-mole.鈥
鈥淎 company goes away because they have regulatory scrutiny and reinvent themselves a few months later,鈥 he said. 鈥淭he only solution I see to this problem is a government agency really takes ownership of this 鈥 the information dissemination to consumers and the claims by manufacturers. I see no other path forward.鈥
鈥業t鈥檚 Just Buyer Beware鈥
The Federal Insecticide, Fungicide, and Rodenticide Act, which regulates pesticide devices, was written decades ago and applied to things such as flypaper, long before anyone anticipated machines that would blast ions to clean the air.
鈥淲e’re just pushing EPA to try and get updated,鈥 said Patrick Jones, president of the . 鈥淚t鈥檚 just buyer beware.鈥
Even before the covid pandemic, Jones鈥 group was ringing the alarm over the increasing public health claims around pesticide devices. The pesticide control association wrote in a 2019 to the EPA of its concern about the growing use in health care facilities of 鈥渘on-government evaluated pesticide devices that make unsubstantiated human health claims 鈥 with no scientific data being submitted to EPA to prove their effectiveness.鈥
EPA spokesperson Tim Carroll said in an email that the agency is developing more outreach materials for schools on air purifiers.
But as few independent authorities assess the effectiveness of the devices, school officials have been snapping them up.
Last summer, the private St. Thomas More School in Kansas City, Missouri, bought ionizing air purifiers to fight covid. Scott Dulle, the director of building and grounds, said he went with technology he saw health leaders buying.
鈥淲e followed the doctors and the hospitals and the government,鈥 he said. 鈥淭hey would not put their patients and staff in harm鈥檚 way.鈥
AAPCO鈥檚 Jones said changes to federal oversight are needed to better deal with the flood of devices. His solution: If a pesticide device makes a public health claim, it should be evaluated with the same rigor used for pesticides like ant spray.
But to alter the law fundamentally would take congressional action, EPA鈥檚 Carroll said.
The EPA pesticide device companies and sellers if a product makes misleading or false claims 鈥 and fines can reach into the millions, according to Brandon Neuschafer, a lawyer who specializes in agricultural regulations at the St. Louis-based firm Bryan Cave Leighton Paisner. He noted companies are often turned in by their competitors.
Last fiscal year, Carroll said, the agency issued 19 import refusal notices and sent six advisory letters for covid-related air-purifying products 鈥 a small fraction of its 2020 pesticide actions. Carroll said such investigations are ongoing and a high priority.
But EPA鈥檚 resources were not the same as they were many years ago, Neuschafer said, as the agency is working with smaller staffing and budgets.
鈥榃orse Indoor Air Quality鈥
Almost a decade before covid emerged, New York鈥檚 education department asked state health officials an AtmosAir bipolar ionization unit to see if it would improve the air quality.
During a test in an empty classroom, they found that levels of harmful ozone gas and 鈥渦ltrafine particles鈥 that can cause were elevated, indicating “worse indoor air quality when the AtmosAir Bipolar ionization unit is operating,鈥 the 2013 state Bureau of Toxic Substance Assessment .
New York State Department of Health officials released the study in response to a KHN public records request about the education department鈥檚 covid-era guidance, which urges schools .
AtmosAir spokesperson Sarah Berman said the device studied in 2013 is discontinued and 鈥渁ll current products have no affiliation to鈥 it. She also said in an email that tests by third-party labs found that 鈥渙ur bipolar ionization products do not contribute to unacceptable levels鈥 of volatile organic compounds, which are potentially harmful substances.
The California Department of Public Health advised in September 鈥渁ir cleaning devices that generate harmful pollutants (i.e., ionization devices or ozone generators)鈥 on the third page of a single-spaced, 44-page document. That guidance was widely overlooked. Districts from to to bought ionization systems.
But the state does have a one-of-a-kind law: It bans air purifiers that emit anything above a certain level of ozone.
New Jersey doesn鈥檛 have the same kind of regulation: that a public school district there bought of ozone-emitting Odorox devices on the California Air Resources Board鈥檚 list of 鈥溾 air purifiers. Since then, the New Jersey health department warning schools about the air purifiers 鈥渢hat may harm health,鈥 listing the specific hazards of ozone to children鈥檚 health.
Back in Georgia, Shumaker more than $9,000 and is on two years鈥 probation.
And the postcards that got him into trouble? Those led to only a handful of sales.
鈥淪o it was just like setting money on fire,鈥 he said.
