The U.S. Food and Drug Administration (FDA) recently issued a stern warning letter to Purell, the household name of hand sanitizers which claims to be effective at "killing 99.99% of the most common germs."
Generally speaking, the FDA seemed less than impressed with Purell's heavy-handed marketing language, citing numerous violations and reclassifying the hand sanitizer giant as an "unapproved drug" (as opposed to the over-the-counter product it has been).
"We are not aware of evidence demonstrating that the Purell Healthcare Advanced Hand Sanitizer products as formulated and labeled are generally recognized by qualified experts as safe and effective for use under the conditions suggested, recommended, or prescribed in their labeling," stated the FDA in their letter.
Purell has been known for using strong claims in support of the efficacy and usefulness of its hand-sanitizing products for a while now, but that time may be coming to a close soon as Purell works to address the FDA's regulations.
"It is our responsibility to ensure that we comply with all requirements of FDA regulations and federal law, and we take that responsibility very seriously," Purell stated on their website. "To that end, we have begun updating relevant website and other digital content as directed by the FDA and are taking steps to prevent a recurrence."
One of the specific pieces of language in question even relates to Ebola. In fact, one of Purell's claims states, "Purell Healthcare Advanced Hand Sanitizers, which are formulated with ethyl alcohol, may be effective against viruses such as the Ebola virus, norovirus, and influenza."
However, according to the FDA, no hand sanitizers have been tested against Ebola.
The warning letter, sent late last month, is hitting Purell amid mounting concerns over COVID19, otherwise known as the Wuhan coronavirus. The world has seen false information going viral about how to prevent infection, escalating incidences and fatality figures (over 82,000 cases and 2,800 deaths), and growing negative impacts on the global economy.
That said, the FDA has been investigating active ingredients in a variety of sanitizers and antiseptics since at least 2016, including ethyl alcohol, isopropyl alcohol, and benzalkonium chloride. The active ingredient in Purell is ethyl alcohol.
First produced in 1988, Purell is manufactured by the privately-held GOJO Industries of Ohio. Back in 2004, Pfizer (NYSE: PFE) had actually acquired the rights to Purell, and later in 2006, Johnson & Johnson (NYSE: JNJ) acquired Purell. GOJO Industries reacquired the Purell brand from Johnson & Johnson in 2010.
Other well-known hand sanitizer brands include products like Germ-X and Wet Ones. Germ-X is produced by the private Vi-Jon Laboratories, and Wet Ones is owned by Edgewell (NYSE: EPC), which is also responsible for personal care brands Playtex and Schick.