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DisinfectionJanuary 25, 2022
EPA Comes Down on Misleading Disinfection Device Claims
As the COVID-19 pandemic reaches the two-year mark, disinfection continues to be a top priority for both businesses and consumers. With the abundance of disinfection solutions on the market, from air purifiers to UV lights to dry fog, it’s relatively easy to order a system for your organization. But do you know how effective and reliable that disinfectant product really is?
The market for disinfection solutions and tools has grown exponentially in the past two years, and looks to continue. The global air filters market is projected to grow from $13.75 billion in 2021 to $22.15 billion in 2028 at a compound annual growth rate (CAGR) of 7.1% during the forecast period. Similarly, the global ultraviolet disinfection equipment market size is expected to reach USD $8.39 billion by 2028, registering a CAGR of 12.1%.
With new products hitting shelves and websites seemingly daily, there are more options than ever. But the question now is not if you should utilize a disinfection system—as nearly all organizations should have disinfection practices currently in place—but which one should you purchase, and how can you ensure it actually works? Companies aren’t the only ones wondering this—the U.S. Environmental Protection Agency (EPA) is looking to ensure reliability of disinfection products on the market too.
The EPA Weighs in on Disinfection Systems
During the COVID-19 pandemic, the EPA has regulated air filters and purifiers, including ones that use ultraviolet (UV) light technology, as pesticide devices under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) because of their ability to remove bacteria, viruses, and “pests,” from the air. However, the EPA has cited its concerns that consumers may be misled about the efficacy of products in mitigating COVID-19, and is looking to take action (as well as against other types of disinfection devices that make claims). In April 2021, the EPA published a notice declaring that it would scrutinize product labels and online marketing materials to ensure that devices entering U.S. commerce are not misbranded within the meaning of FIFRA Section 2(q)(1)(A).
The EPA is monitoring related activities defined as unlawful under section 12 of FIFRA. Monitoring occurs through the screening of products intended for importation into the United States, inspecting a variety of locations related to distribution and use, as well as following up on tips and complaints. The EPA typically enforces FIFRA through stop-sale orders and penalty actions.
One product that caught the attention of the EPA recently was a disinfection product by Microforce. Its owners advertised that a product used in their disinfecting service could bond to surfaces and create a layer that could kill bacteria and viruses, including SARS-CoV-2. This claim was deemed false and the Colorado Attorney General’s Office has announced a grand jury indictment against the four owners for felony theft for deceptively marketing and selling a disinfecting service with a product they knew could not mitigate COVID-19. Microforce used Monofoil X in its disinfecting services, but the EPA has never approved it as an effective disinfectant against bacteria or viruses.
The Types of Claims that the EPA is Examining
In implementing the mandate, the EPA is not limiting its review to new claims that product manufacturers have made in response to the pandemic, but it is considering the totality of all marketing claims appearing on product labels. The EPA will also reconsider longstanding statements for products that have already been on the market for some time.
While notices of refusal issued by the EPA are not always published with detailed explanations of why companies are receiving the notices, an article written by a law team in UV Solutions Magazine reveals that the EPA seems to be generally focused on the five following types of claims:
- Unqualified or generic claims. These are claims about a purifier or filter’s ability to kill, capture, or eradicate “germs,” “viruses,” “bacteria,” “mold” or “fungus” without specifying the species of microorganism on which the product has been tested.
- Germicidal light claims. These are claims that UV lights are “germicidal lights” and are “effective against most viruses, spores, and cysts,” unless the claims are qualified on labeling and supported by efficacy testing.
- Efficacy testing claims. These are claims that fail to distinguish whether efficacy testing was performed on a virus.
- Label discrepancies. These are discrepancies between labels and labeling, especially as between statements included in product containers and information on company websites.
- “More effective” claims. These are claims that a given product or device is more effective than competing brands, without specifying the brands in question.
In focusing on addressing these types of claims, the EPA is making clear that disinfection service and product providers must be able to support their claims for their products. If they cannot, they will be subject to penalties and legal action.
How to Ensure Disinfection Products Meet Regulations
In response to COVID-19, the EPA activated its Emerging Viral Pathogens Guidance, which provides a pathway for registrants to make claims in off-label communications that they registered disinfectants may be used against viral pathogens like SARS-CoV-2. Once claims are approved, they can be made for the disinfectant in off-label materials only, like technical literature, non-label-related websites, consumer information services, and on social media sites. Nothing in this review eliminates the need to comply with FIFRA.
For organizations looking to ensure their chosen disinfection solution is capable of destroying SARS-CoV-2 spores, they should look to the EPA’s List N of Registered Disinfectants Against the Coronavirus (COVID-19). Products on this list are ones that the EPA expects to kill all strains and variants of SARS-CoV-2 when used according to the label directions.
One product that appears on List N is Halosil’s HaloMist™ (EPA Reg. No. 84526-6). Halosil’s proven hydrogen peroxide disinfectant is able to kill off infectious pathogens like SARS-CoV-2, as well as MRSA, C. auris, C. diff, norovirus, and other viruses. Learn more here: https://halosil.com/products/halomist/.