December 21, 2001 - This is our response to the FTC: We
have basically said the same thing you do, but per your request, we are
removing the information on Anthrax.
Warren Lynn, President
Enhance-It™, LLC/American Air & Water®, Inc.
FTC staff has reviewed marketing claims on your website relating to Anthrax. We remind you that the FTC Act requires that health-related claims, such as claims that an air cleaning device can kill or otherwise eliminate disease causing bacteria or viruses, including anthrax spores, must be supported by competent and reliable scientific evidence at the time the claim is made. In other words, it is against the law to make health claims without scientific support or to exaggerate deceptively the benefits of products or services you are promoting.
According to experts in the field, bacterial spores, including anthrax, are very highly resistant organisms. Research conducted with other forms of bacteria generally cannot be used as a basis for conclusions about the effect of any substance or device upon anthrax spores. In general, if your product has not been tested against anthrax spores (or a scientifically valid and government-approved surrogate), you should not be making claims, expressly or by implication, about protection against anthrax.
You should review all claims that your products may be effective in killing anthrax spores or in any way reducing the risk of anthrax infections. Please notify us in 7 days of any changes made to your website.
Some air cleaning devices generate ozone. We are aware of no scientific evidence that ozone will have any effect on bacterial spores when the ozone is within the limits set by the Food and Drug Administration (FDA) for medical devices that generate ozone (maximum output of .05 parts per million). Even if higher ozone levels, those not recommended for use in space occupied by people or animals, are generated, there does not appear to be any evidence to support such claims. In addition, higher levels of ozone may cause damage to household items such as wiring, computers, and telephone equipment.
UV Light Products
Other air cleaners may use ultra-violet (UV) light to kill organisms. The potential effect of UV light on bacteria depends upon a number of factors: the wattage of the light, the distance of the organism from the light, and the length of exposure or "dwell time" under the light. Bacterial spores would require a relatively long time under the light for the light to have a killing effect. Most household air cleaners move air too quickly to provide adequate exposure time.
Filtration devices are designed to capture particles of a given size. However, the fact that a filter might remove a high percentage of a certain-sized particle, present in air forced through the filter in a laboratory test, does not mean the filter will clean household air to the same extent. The actual effectiveness of an air filter in a home depends upon several factors, including: the amount of air the device can process, the nature of the pollutants present, and the rate at which those pollutants are introduced into the indoor environment. Heavier particles, including anthrax spores, may settle on the floor or other surfaces and not reach the filtration device.
You should be aware that you may also be subject to the jurisdiction of other federal agencies. If your air cleaning or filtration devices purport to kill, trap, inactivate, or suppress growth of microbial agents, such as bacteria, viruses, or fungi, you are subject to the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Environmental Protection Agency regulations adopted pursuant to that law. This means that your product must be registered with the EPA before any germ-killing claims can be made for it. In addition, if medical claims are made for an air cleaner or filter, the device becomes a "medical device" subject to the authority of the FDA. You should check with each of these agencies to determine whether your product claims may violate their regulations.
We strongly urge that you review all claims you are making for your product, particularly claims about protection against disease-causing bacteria or viruses, including anthrax. If your claims cannot be supported by competent and reliable scientific evidence – the kind of evidence that would be relied upon by those with adequate training and experience in the field of microbiology – they should be deleted or revised immediately.
FTC investigators have copied and preserved the pages of your online promotional materials and will be revisiting your website soon.
Please notify us via electronic mail to email@example.com within 7 days of the specific actions you have taken to address the agency's concerns.