(WCMH) — The Food and Drug Administration is warning Purell to stop advertising that its hand sanitized products can eliminate germs such as Ebola and flu.
In A January 17 warning letter, the FDA calls Purell an unapproved new drug based on claims made in advertising.
Among the claims the FDA finds problematic:
- “Kills more than 99.99% of most common germs that may cause illness in a healthcare setting, including MRSA & VRE”
- “To help prevent transmission, hand hygiene with an alcohol-based hand sanitizer is recommended along with handwashing if hands are soiled. PURELL® Advanced Gel, Foam, and Ultra-Nourishing Foam Hand Sanitizer products demonstrated effectiveness against a drug-resistant clinical strain of Candida auris in lab testing.”
- “PURELL® Products Help Eliminate MRSA & VRE . . . 100% MRSA & VRE Reduction . . . A recent outcome study shows that providing the right products, in a customized solution, along with educational resources for athletes and staff can reduce MRSA and VRE by 100%”
- “The PURELL SOLUTION™ has the products you need to help prevent the spread of infection this germ season. Visit GOJO.com for more information.”
- Claims that suggest that PURELL Healthcare Advanced Hand Sanitizers, which are formulated with ethyl alcohol, may be effective against viruses such as the Ebola virus, norovirus, and influenza.
The FDA also took issue with claims that student absenteeism is reduced by 51% when Purell products are used in conjunction with hygiene curriculum.
According to the FDA, they are not aware of any hand sanitizers that have been tested against Ebola, including Purell.
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.FOOD AND DRUG ADMINISTRATION
The FDA does note that the Centers for Disease Control and Prevention (CDC) recommends the use of alcohol-based hand sanitizer as a preventive measure during an Ebola outbreak. Purell is an alcohol-based sanitizer.
Purell’s claims, according to the FDA, amount to the advertisement of a new drug without approval. The agency wants Purell to either apply to have it recognized as a new drug or stop making the problematic claims.
Your labeling claims that PURELL® Healthcare Advanced Hand Sanitizers are effective in preventing disease or infection from pathogens such as Ebola, MRSA, VRE, norovirus, flu, and Candida auris, and in preventing the spread of infection, go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings. Furthermore, the claims on your product websites suggest that PURELL® Healthcare Advanced Hand Sanitizers are effective in reducing illness or disease-related student and teacher absenteeism also go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings. Such claims are not described in any OTC final rule, the above-referenced TFM (see 59 FR 31402, June 17,1994), or any rulemakings being considered under the OTC Drug Review. Additionally, we are unaware of any adequate and well-controlled clinical trials in the published literature that support a determination that PURELL® Healthcare Advanced Hand Sanitizers are GRASE for the above-described intended uses. Furthermore, we are not aware of a similar OTC product as formulated and labeled that was available in the United States market on or before the inception of the OTC Drug Review.FOOD AND DRUG ADMINISTRATION
The FDA asked Purell to promptly investigate and take action to correct the alleged violations.