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January 29, 2020 02:52 pm PST

FDA warns Purell to back off hand sanitizer germ-killing claims

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.

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Original Link: http://feeds.boingboing.net/~r/boingboing/iBag/~3/tfsm89A8hSE/fda-warns-purell-to-back-off-h.html

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