The FDA has challenged GOJO Industries Inc, makers of Purell Hand Sanitizer, for its marketing claims. Statements the company made on its websites, advertisements and labels stated that it can “reduce student absenteeism by 51%,” provide “100% MRSA and VRE reduction,” that it “kills 99.99% of most common germs that may cause illness in a healthcare setting,” that it is effective against the norovirus, influenza, and Ebola, and recommends use of Purell to fight the transmission of a dangerous fungus claiming it “demonstrated effectiveness against a drug resistant clinical strain of Candida auras."
GOJO Industries Inc. made these claims based on the presence in its products of ethyl alcohol, intended by the company for use as both a consumer and health care antiseptic rub.
But the FDA has not issued final rules on the safety or effectiveness of the use of ethyl alcohol for these indications.
The FDA found, therefore, that the company’s statements are not merely unproven marketing exaggerations that go beyond describing intended uses of a topical antiseptic. The FDA says these claims by GOJO Industries are evidence against the company of intended uses for their products that amount to a new category of unapproved new drugs.
New drugs cannot be sold through interstate commerce without the prior approval of the FDA.
To put an even finer point on its warning to GOJO and all other makers of hand sanitizers, the FDA noted it is unaware of any “adequate and well controlled clinical trials in the published literature” that support these uses, and that no product intended for these purposes is being considered under its OTC (over the counter) Drug Review.
The FDA told GOJO Industries Inc., “we are not aware of evidence demonstrating” Purell’s claims.
Purell issued a statement that it is cooperating, and a formal response is expected in a few days.
"New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA.”