The market for hand sanitizers – already over $2 billion – is expected to reach $5.5 billion by 2024.
As more people use them to protect themselves from germs, the FDA wants to know if they are safe.
In April, the agency asked drug manufacturers for more data about to determine if three common ingredients in hand sanitizers are safe and effective: benzalkonium chloride, ethyl alcohol and isopropyl alcohol.
The request for more information follows at least a decade of research into the safety of ingredients used in hand sanitizers, as well as recent advances in science that enable researchers to better understand how the body absorbs chemicals. The agency in 2016 banned triclosan from hand sanitizers over potential health concerns.
Theresa M. Michele, MD, director of the FDA’s Center for Drug Evaluation and Research’s division of nonprescription drug products and new drugs office, explained why they are looking for more research on hand sanitizer ingredients and what it means for consumers.
The interview has been edited for clarity and length.
WebMD: Why did the FDA decide to study these particular chemicals -- benzalkonium chloride, ethyl alcohol, and isopropyl alcohol -- in hand sanitizers now?
Michele: This is part of a bigger effort by the FDA to review antiseptics. We have been working on these antiseptic rule-makings for about 10 years now and these three ingredients are ones that manufacturers have come to us and said that they would like to develop the data for.
WebMD: Why were these three ingredients chosen? Why were there questions about them?
Michele: We are looking for data to show how much of the ingredients is absorbed, as well as some efficacy studies. For benzalkonium chloride, we are also looking at [antimicrobial] resistance data. And then, in addition to that, we are looking at some safety toxicology studies.
WebMD: Is the request for more information related to the fact that we have more scientific tools available to understand the absorption rates of these chemicals?
Michele: That is exactly what is going on. Also, I should mention the use of these ingredients has changed dramatically over the years. This was driven largely because of the risk of hospital-acquired infections. You know, 20 years ago you never saw hand sanitizers and anti -bacterial soaps on the consumer market. That just didn’t exist. And all of a sudden, we have this huge use today. Today, it is in every hospital, every school, every airport, all of the grocery stores. You can find it everywhere. So it is a very, very different use than a number of years ago.
WebMD: What does the current research show about their safety?
Michele: Nothing in our data suggest that these ingredients are unsafe. We believe that consumers should continue to use them, while we await the necessary data. We just don’t have enough information, at this date in time, to make a definitive conclusion.
WebMD: Do these ingredients make the products more effective or are they more for vanity purposes (smell, color, etc)?
Michele: The important thing to understand is that hand sanitizers… are drugs because they are used to reduce the number of bacteria on the hands that can potentially cause disease and these are the active drug ingredients.
WebMD: So these are the ingredients that make the product effective?
Michele: Yes. These active ingredients produce the drug’s effect, in this case, the reduction of bacteria.
WebMD: How effective are they at killing germs?
Michele: That is some of the data that we have asked for and we are expecting to have those as part of the data sets that are submitted.
WebMD: Do any of these chemicals get into your blood stream or have any unsafe consequences if used often?
Michele: We are asking that exact question. Do these chemicals get into the bloodstream when they are used often and when they are used to the maximum extent that is recommended in the labeling.
WebMD: Are they safe for kids? (A recent study said hand sanitizer was more effective than hand washing at reducing sick days in day care centers.)
Michele: We can’t comment on particular studies…The important thing to understand here is the Food and Drug Administration and the Centers for Disease Control and Prevention as well as the labeling for these products recommend washing your hands with plain soap and water. If plain soap and water are not available, then use a hand sanitizer. We are not recommending using these as an alternative to washing your hands.
WebMD: Have people experienced side effects or reactions from the sanitizers? Such as dry skin and dermatitis?
Michele: Those are expected side effects from the use of hand sanitizers. We are, as part of this effort, looking at the safety database for hand sanitizers in general. The other thing that I would warn people against is drinking hand sanitizers. These are not intended for oral consumption. They are intended for use on the hands.
WebMD: Does using the sanitizers often have an effect on antibiotic resistance?
Michele: In terms of resistance, it depends on the ingredients. So for the alcohol….ethyl alcohol and isopropyl alcohol … [because of] the mechanism by which they kill bacteria is pretty immediate, we don’t believe they have any effect on resistance of bacteria. And in fact the vast majority of hand sanitizers on the market are ethyl alcohol-based. There are a few that contain benzalkonium chloride and we are asking for specific evaluation of resistance for benzalkonium chloride.
WebMD: Could hand sanitizer decrease the body’s natural defenses and thereby result in more bacteria being on people’s hands?
Michele: I don’t know that I can comment on that. We are, again, looking at safety and effectiveness of hand sanitizers and that is part of the data set that we will be evaluating.
WebMD: What would you say to people who are concerned about their safety in terms of using them?
Michele: We don’t believe these ingredients are unsafe; we just don’t have enough information to evaluate and make a definitive conclusion that they are safe and effective. So that is what we are looking at. In the meantime, I would say consumers should feel confident to use their hand sanitizer if soap and water are not available. If they feel very uncomfortable, there is always the fall back of soap and water.
WebMD: When do you expect to have a final determination on safety and effectiveness of these ingredients?
Michele: I don’t really have that date at this point and time. It really depends on how the science evolves and also it is difficult to predict how long the rule-making actually takes. That goes beyond the reaches of my crystal ball, I’m afraid.
WebMD: I have had doctors tell me that during cold season, use a hand sanitizer because that is more effective at killing a virus than a bacteria. Is that correct?
Michele: That is an interesting conclusion. The hand sanitizers actually have no indication for treatment of viral illness. That isn’t to say they are not effective, but we have no data and they are not tested for that.
WebMD: Any final comments?
Michele: The take home message is that FDA isn’t saying hand sanitizers are unsafe. We recommend you wash your hands with plain soap and water and if plain soap and water aren’t available, then use your hand sanitizer. We are continuing to work to make sure there are safe and effective products out there on the market for consumers.