What do the FDA and EPA think?

Most consumers are rightly concerned about the safety of ultraviolet light. Everyone knows that visible "UVA" and "UVB" rays in sunlight can cause sunburn and skin cancer. Lamps that emit invisible "UVC" rays have long been used to sterilize air, water, and surfaces, but they can cause damage to skin and the eyes as well. (That's why crime-scene investigators wear protective glasses and gloves when they use ultraviolet flashlights to "light up" bloodstains.) So the U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) publish regulations and guidelines for the safe uses of ultraviolet light. Both are studying the new research demonstrating safety and efficacy of shortwave "far-UVC" light. But they have yet to publish new guidance. In the meantime, here are current rules and regulations:


Although the FDA regulates UVC sterilizers...

The FDA regulates medical products and requires makers of UVC germicidal lighting solutions designed for medical or therapeutic use to register for FDA approval. So we need to make one thing clear from the start:

...the ShortWaveAir™ Purifier is NOT a medical product...

The ShortWaveAir™ Purifier is not a medical product. It is not meant for clinical use, for use in hospitals or other medical settings, or to cure disease. It's meant only for use in the home, or at work, or for other business and consumer applications—and not in hospitals or medical centers. At least not yet.

At some point in the future, we may register the ShortWaveAir™ Purifier with the FDA for appropriate uses in medical settings. But that process takes a while. And in the meantime, we will not market it or recommend it for any medical or therapeutic use. (Click here for the FDA's question-and-answer page regarding the safety and medical uses of ultraviolet medical devices.)

...but the ShortWaveAir™ Purifier IS regulated by the EPA

Like the FDA, the Environmental Protection Agency regulates products that use ultraviolet light to neutralize airborne viruses. And because our ShortWaveAir™ Purifier attacks and deactivates airborne viruses and other pathogens, the EPA classifies it as a germicidal "pesticide device." Such devices don't have to be registered with the EPA or any other regulatory agency. But manufacturers do have to provide honest information about what the products can and cannot do.

Which means that we, the product manufacturer, must make it clear to you, the consumer, that we will back up any claims we make for the performance and safety of the ShortWaveAir™ Purifier. Here's how the EPA puts it:

"All claims in connection with the sale or distribution of a device must be true and not misleading," including "false or misleading statements concerning product effectiveness (known as efficacy), claims about product safety, false or misleading comparisons with other pesticides or devices, or any statement directly or indirectly implying that the device is recommended or endorsed by any agency of the Federal Government." 

Please read our page on far-UVC safety and effectiveness. You will see how careful we are to cite the recent scientific studies and data demonstrating that the kind of far-UVC light that our ShortWaveAir™ purifier emits can neutralize airborne pathogens with less potential harm to humans than longer-wavelength UVC light. Rather than making such claims ourselves, we let the researchers from Columbia University and other institutions do the talking for us.

And remember that no solution is a miracle cure-all. We won't make claims for our product that current scientific research data cannot support. You may see advertised on Amazon many "UV sterilizing wands" and other products that make such claims. All we can say about them is, "caveat emptor"—buyer beware. All of which brings us to our answer to a final question: 

Should I throw my mask away? 

Our answer is an emphatic NO. A good personal air purifier like ours can help reduce the viral load in your personal airspace by deactivating coronavirus and other pathogens. That's why we call it a first line of defense against the virus. But does it eliminate all potential viral threats? Does it mean you can throw away your face mask? Absolutely not.

The Centers for Disease Control (CDC) and World Health Organization (WHO) strongly recommend multiple ongoing interventions to prevent the spread of Covid-19 and other airborne diseases. Even with effective vaccines, it will take many months, and perhaps more than a year, before anyone should let their guard down. So even when you use our ShortWaveAir™ Purifier to help protect your personal airspace, you should also wear a mask, wash your hands frequently, and continue to follow social distancing guidelines.