Can you recall pre-quarantine times, when hand-washing was a non-discussed topic and the C-word, corona, made you think about enjoying a beach somewhere? The pace of change in 2020 is evident in the optics of new standards and procedures, from social distancing to how, where, and when we can go out. As we adapt to the ever-changing world around us, can we be confident in guidelines being issued? In particular, can we trust our health and well-being to a hand sanitizer?
On January 17, 2020, before COVID-19 was an issue in the United States, GOJO Industries, the manufacturer of Purell, received a warning letter from the U.S. Food & Drug Administration regarding PURELL Healthcare Advanced Hand Sanitizers. Case #599132 is a look into the marketing language and claims of the manufacturer. The FDA expresses to GOJO Industries, “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.”
The warning letter can be interpreted as a hand slap against suggested claims in labeling and on Purell’s website, including:
- “Kills more than 99.99% of most common germs that may cause illness in a healthcare setting, including MRSA & VRE.”
- “The PURELL SOLUTION™ has the products you need to help prevent the spread of infection this germ season.”
- “PURELL® Healthcare Advanced Hand Sanitizers, which are formulated with ethyl alcohol, may be effective against viruses such as the Ebola virus, norovirus, and influenza.”
This is not the first time hand sanitizers and their makers have been in hot water over ingredients or claims. In 1994, the first hand sanitizers were approved. Their approval was not for use in the general public, but rather for the use of “healthcare professionals in a hospital setting or other health care situations outside the hospital.”
It wasn’t until the late 1990s that hand sanitizer started appearing on store shelves, and the product was not truly adopted by consumers until the early 2000s. This is the same year the CDC first revised its hand hygiene guidelines (2002) to recommend alcohol-based hand sanitizer as a possible alternative for both health care personnel and the average person looking to eliminate germs when soap and warm water are not available, or as a time-saving solution. With the new guideline, hospitals across the globe adopted the widespread practice of hand sanitizing stations throughout medical facilities.
Fast-forward to 2009, the outbreak of the H1N1 swine flu, which infected more than 60 million people just in the U.S., killing an estimated 151,700 to 575,400 people around the world. Fears of the virus spiked sales of hand sanitizer. This was also the year the World Health Organization incorporated new guidelines, promoting the use of alcohol-based hand sanitizer among health care professionals, especially those in resource-poor countries with limited access to clean water.
The “magic” of hand sanitizer was widely adopted by 2009-2010 and carried in the purses or diaper bags of moms everywhere. Take a minute and think back to watching someone you know change a diaper and use sanitizer to clean their hands. Today, hand sanitizers are more than a $2 billion industry, but not without some background noise of concern.
December 20, 2017, the FDA issued a ruling banning 24 ingredients including triclosan, which at the time was commonly found in hand sanitizers you or I could buy directly from our local supermarkets. The FDA commissioner of that time, Scott Gottlieb, M.D., stated in a news release, "Ensuring the safety and effectiveness of OTC health care antiseptics has been a priority for the FDA, not only because these products are an important component of infection control strategies in health care settings, but also because of the role these products may play in contributing to antimicrobial resistance if they're not manufactured or used appropriately."
Triclosan and the 23 other active ingredients aren't generally recognized as safe and effective (GRASE) for use in OTC health care antiseptic products. Manufacturers such as GOJO Industries had some work to do. They were given one year to comply with this final rule by reformulating these products or removing them from the market.
But in the same ruling, The FDA deferred final rulemaking for one year, subject to renewal, on these six active ingredients that are the most commonly used in currently marketed OTC health care antiseptic products: alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX).
The deferral of a ruling on these ingredients shows that they may not be deemed GRASE. Is alcohol safe for the skin? For years, we have been taught that bugs are bad. And some are. Bugs live in our microbiome, which actually makes up four to five pounds of your body weight. The human microbiome is the trillions of microscopic organisms that live in us and on us, both good and bad bugs. The good protect us against the bad. Our bodies are designed to protect on many levels, but the first line of defense is the skin. Our skin has approximately over two thousand antimicrobial peptides working on our behalf when there is an attack on our skin, whether it be UV radiation, germs, wind, etc.
What is happening when we use alcohol to strip the bugs? Could it potentially be causing more exterior damage or penetrating the skin and getting into the bloodstream? Furthermore, on its safety, the CDC has a webpage dedicated to fire safety of alcohol-based hand sanitizers, as “they contain ethyl alcohol, which readily evaporates at room temperature into an ignitable vapor, and is considered a flammable liquid.”
The FDA deferred a ruling on the alcohol ingredients, not claiming safety or effectiveness, and in May 2020 (yes, during this pandemic), a federal judge came down hard on the FDA for allowing Purell to make claims or falsely advertise that its hand sanitizer can prevent diseases such as Ebola and the flu. This crackdown came when a Purell competitor, Innovative BioDefense, was ordered to stop making sanitizer until it addressed the FDA’s concerns over disease-specific claims about its product. The judge in the case, David O. Carter, blasted the FDA for a “total lack of enforcement” against bigger companies in the hand sanitizer market that “are arguably causing more harm to consumers.”
Could the hand sanitizer market be out of control? The FDA in its warning letter to GOJO Industries states, “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.” In fact, to be considered a hand sanitizer by the FDA, you don’t even have to demonstrate the product kill viruses.
This ruling was written only a few short weeks before the U.S. coronavirus shutdown. Yet weeks later, the WHO and the CDC were recommending the use of alcohol-based hand sanitizer as a preventive measure during this outbreak.
And now, hand sanitizer is one of the most sought-after products on the market. The CDC states on its website, “If soap and water are not readily available, use an alcohol-based hand sanitizer that contains at least 60% alcohol, and wash with soap and water as soon as you can.” Even with the warning letter from the FDA, the FDA made it easier for companies that don’t typically manufacture hand sanitizer to start making it – think alcohol distillers and pharmacies. Consumer Reports reported, “While the FDA has praised the industry for responding so enthusiastically to the problem, last week the agency also issued cautions about some of the products companies are now producing that don’t adhere to manufacturing standards. Not all manufacturers are using the required denatured alcohol, which tastes terrible compared with regular alcohol. As a result, some people are drinking distillery-produced sanitizer, whether intentionally or by accident.”
So where do we stand? Are hand sanitizers, in fact, safe for us to use? At this point, the CDC and the WHO are recommending a product whose safety and effectiveness the FDA has concerns over, as stated in the FDA’s January letter to Purell about claims of effectiveness against killing or stopping the spread of viruses. There appears to be a contradiction between the agencies.
Germs live on our skin, and especially our hands, as they touch a million things a day. Hand hygiene is important, as on average we touch our faces 23 times an hour. It is when viruses or bacteria enter our bodies that we can become sick. Think of the nose, mouth, and eyes as a virus highway, the fast track to infection. If we are killing the good bacteria that fight the bad bacteria by using alcohol-based rubs, are we doing more harm than good to our immune systems?
When will the deferred FDA ruling over alcohol (ethanol) and isopropyl alcohol be addressed? Obviously, with warning letters and court cases, the FDA has red-flagged hand sanitizer, yet created an approved recipe for distillers and pharmacies to produce the product. It appear there is a disconnect between our government agencies’ statements and guidelines.
In this ever-changing “new” normal, is it time for a change how we treat viruses, infection, and bacteria, and does hand sanitizer really live up to its marketing hype?