The Food and Drug Administration sent an official warning letter to the makers of Purell hand sanitizer, ordering them to stop making unsupported claims about the goo's ability to fend off disease.
In the letter, dated January 17, FDA compliance director Nicholas F. Lyons takes aim at marketing literature which says the product helps "eliminate" MRSA, VRE and other diseases and reduces student absenteeism.
These statements, made in the context of the Frequently Asked Questions section, clearly indicate your suggestion that PURELL® Healthcare Advanced Hand Sanitizers are intended for reducing or preventing disease from the Ebola virus, norovirus, and influenza. As such, the statements are evidence of your products' intended uses. However, FDA is currently not aware of any adequate and well-controlled studies demonstrating that killing or decreasing the number of bacteria or viruses on the skin by a certain magnitude produces a corresponding clinical reduction in infection or disease caused by such bacteria or virus.
Based on the above claims, PURELL® Healthcare Advanced Hand Sanitizers are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.
Therefore, knock it off:
The violations cited in this letter are not intended to be an all-inclusive list of deficiencies regarding your products. Please be aware that you are responsible for investigating and determining the causes of these violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
A disease specialist contacted by Yahoo News says that the stuff probably works, but soap definitely works, so wash your hands.
Peter Gulick, an infectious disease specialist with the Michigan State University College of Osteopathic Medicine, tells Yahoo Lifestyle that the alcohol in hand sanitizers is toxic enough to handle enveloped viruses, but says that "the FDA wants to be really certain and really careful of how [products] word things."
Gulick says that washing your hands with soap and water is the best way to prevent yourself from getting sick. "Wash your hands as often as you can," he says. The Centers for Disease Control and Prevention says that it doesn't matter whether the water is warm or cold, and recommends scrubbing your hands for 20 seconds (the equivalent of singing the "Happy Birthday" song twice.)
