FDA Insight: Episode 18 – Transcript
>> Anand Shah: Welcome back to another episode of FDA Insight. I'm Dr. Anand Shah, the Deputy Commissioner for Medical and Scientific Affairs here at the FDA. Thank you so much for joining us for another great episode. Joining me today, is Elizabeth Jungman, the director of the Office of Regulatory Policy in the Center for Drug Evaluation and Research, or CDER, at FDA. Elizabeth leads much of our agency's work around the regulation of hand sanitizers. Elizabeth, welcome to FDA Insight.
>> Elizabeth Jungman: Thank you for having me.
>> Anand Shah: Well, Elizabeth, let's jump right in. In the face of the COVID-19 pandemic, public health officials have been focused on the three Ws; wear a mask, watch your distance, and wash your hands often. Today, I want to focus on the last W and good hand hygiene. What do consumers need to know?
>> Elizabeth Jungman: One of the most important steps that you can take to help prevent the spread of infection, such as COVID-19, is to thoroughly wash your hands with soap and water for at least 20 seconds, especially after going to the bathroom, before eating, after coughing, sneezing, or blowing your nose. When my kids were little, to help them scrub for long enough, we would sing the ABC song with a few made up handwashing related lyrics while they were washing their hands, to be sure we were getting to that 20 seconds. If soap and water are not available, that's what the CDC, the Center for Disease Control and Prevention, recommends using an alcohol-based hand sanitizer. You want to look for one that contains at least 60 percent ethanol, which is also called ethyl alcohol, or 70 percent isopropyl alcohol.
>> Anand Shah: Is there a difference between washing your hands with soap and water versus using hand sanitizer?
>> Elizabeth Jungman: According to the CDC, washing your hands with plain soap and water is one of the best ways to prevent the spread of infection and decrease the risk of getting sick. There are currently no drugs, including hand sanitizer, that are approved by FDA to prevent COVID-19.
>> Anand Shah: FDA continues to warn about dangerous hand sanitizer products. Can you explain to consumers what some of the key issues are and what they should be looking out for?
>> Elizabeth Jungman: I'm glad you asked. There are actually five issues that I want to talk about, things that we worry about and that we hope that consumers will watch out for.
First, hand sanitizers that are contaminated with methanol or 1-propanol. Methanol and 1-propanol are not acceptable ingredients in hand sanitizers, and they could be toxic. Methanol can cause serious side effects, including nausea, vomiting, headache, and blurred vision when it's absorbed through the skin, and it can cause blindness or death if swallowed; 1-propanol can also be toxic and life threatening when it's ingested. And, concerningly, products that are containing methanol or 1-propanol may or may not have labels that list them, so to avoid those products, you want to check the list on FDA's website and make sure you're never drinking hand sanitizer.
The second thing that we worry about, is hand sanitizers that are packaged to appear as drinks or candy or water bottles, as well as products that are marketed as drinks or cocktails. The agency has discovered that some hand sanitizers are being packaged in containers that resemble children's food pouches or water bottles, juice bottles, vodka bottles, and we found hand sanitizers that contain food flavors, such as chocolate or raspberry. Those products could confuse consumers into accidentally ingesting hand sanitizer. And children are particularly at risk with these products, because ingesting only a small amount of hand sanitizer could be deadly in a young child. Given the high concentration of alcohol in these products, it takes only about two and a half teaspoons of hand sanitizer to be potentially lethal in an 18-month-old.
The third thing that we are concerned about is hand sanitizers that don't contain a sufficient amount of alcohol. So, remember that per the CDC recommendations, you want to use an alcohol-based hand sanitizer if you can't wash your hands. If the active ingredient in your hand sanitizer is ethyl alcohol, that alcohol content should be at least 60 percent; if the active ingredient is isopropyl alcohol, it should be at least 70 percent, because subpotent hand sanitizer products may not be as effective in reducing bacteria on your skin.
Fourth, we're concerned about hand sanitizers that are sold or offered for sale with false, misleading, or unproven claims that they can prevent or spread viruses such as COVID-19, or claims that they can provide prolonged protection. So, for example, we've seen hand sanitizers with claims that they last up to 24 hours, which may lead consumers to think that they're protected when they actually are not.
And fifth and finally, consumers should be really cautious about hand sanitizers that are marketed as FDA approved, since there are no hand sanitizers that are approved by FDA. There are plenty of hand sanitizers that are legally marketed, but if you see one that's claiming to be FDA approved, that's just not true.
>> Anand Shah: That's a lot to look out for. What should consumers do if they have hand sanitizers that raise any of the issues that you mention?
>> Elizabeth Jungman: So, if you have a potentially contaminated or subpotent hand sanitizer product, you should immediately stop using it; you should dispose of it. And if it's contaminated with methanol, it should ideally be disposed of in a hazardous waste container.
>> Anand Shah: We've seen news reports of consumers who've died due to drinking hand sanitizer. How dangerous is this?
>> Elizabeth Jungman: It is extremely dangerous to drink hand sanitizers. We urge consumers not to do so under any circumstances. The dangers of drinking hand sanitizers are compounded when the product is contaminated with methanol or other toxic chemicals. Drinking methanol contaminated hand sanitizer is more life threatening than drinking a product that is not contaminated, but it's really never a good idea.
>> Anand Shah: Is hand sanitizer dangerous for children?
>> Elizabeth Jungman: It can be. For children under 6 years of age, hand sanitizer should be used with adult supervision according to the directions on the label. People don't think about this much about kids drinking hand sanitizers, but it happens, and it can be very dangerous. As I mentioned earlier, drinking only a small amount of hand sanitizer can cause alcohol poisoning in children. So, there's no need to be concerned if your kids are, you know, eating after they apply hand sanitizer or lick their hands after using hand sanitizer.
But if they drink it, even in small amounts, you should call poison control. Every month, there are hundreds of calls to poison control for unintentional ingestion of hand sanitizer. Last March, early in the COVID-19 pandemic, calls to poison control related to hand sanitizer increased 79 percent compared to March of 2019, and the majority of those calls were for unintentional exposures to children 5 and younger. In addition to avoiding ingestion, you also want to keep hand sanitizers out of the eye. So, it's really important to store hand sanitizers out of the reach and sight of children and to supervise young children when they're using it.
>> Anand Shah: What should consumers do if they have a reaction to hand sanitizer, if a hand sanitizer's ingested, or if they've been exposed to hand sanitizer containing methanol?
>> Elizabeth Jungman: Consumers should call their doctor if they experience a serious reaction to hand sanitizer. In the case of ingestion of hand sanitizers, you should call 911 if the person is unconscious or has trouble breathing, or call poison control or poison help at 1-800-222-1222 to connect to your local poison control center. If the person has been exposed to methanol-contaminated hand sanitizer and is experiencing symptoms, so that's nausea, vomiting, headaches, blurred vision, consumers should seek immediate medical treatment for the potential reversal of the toxic effects of methanol poisoning. We encourage consumers and healthcare professionals to report adverse events with the use of hand sanitizer to FDA's MedWatch Adverse Event Reporting Program. Information about how to do that can be found on our website.
>> Anand Shah: Elizabeth, many consumers likely remember that like toilet paper and cleaning products, hand sanitizers were not easy to find in stores over the past few months. What are some of the steps that FDA has taken to increase the hand sanitizer supply?
>> Elizabeth Jungman: [laughs] Toilet paper and hand sanitizers were, for a while, the rarest of commodities, and we don't have much of a role in paper products, but FDA was able to help increase the availability of hand sanitizer. In some cases, there were companies, like distilleries, that already had access to the raw material, alcohol, and they have facilities to manufacture hand sanitizer, even though they may not have been in the business of manufacturing those products prior to the COVID-19 pandemic. So, FDA was able to allow flexibility to allow those firms that don't typically manufacture hand sanitizers, like those distilleries, to make them if they're following the appropriate manufacturing parameters.
>> Anand Shah: So, speaking of manufacturing, if consumers can't find hand sanitizers in the store, can they make their own hand sanitizer?
>> Elizabeth Jungman: It's really not a good idea. We recommend that consumers do not make their own hand sanitizer, because if made incorrectly, hand sanitizer can be ineffective at decreasing bacteria on your hands. And there have also been reports of skin burns from homemade hand sanitizer. FDA's not able to verify the information on the methods being used to prepare hand sanitizer at home and whether they're safe for use on human skin.
So, instead, many retail stores and pharmacies sell hand sanitizers, and that's the better way to go. And I know that we discussed a lot of issues with marketed hand sanitizers, and consumers should be cautious when purchasing them to avoid those issues. So, before you buy hand sanitizers or use sanitizer that you have at home, we do recommend that consumers check our Do-Not-Use List, and that's at https://www.fda.gov/handsanitizerlist, all one word. So, that's https://www.fda.gov/handsanitizerlist. We update that list regularly with new information, so your best bet is to check the list and purchase an alcohol-based hand sanitizer, not to try to make it at home.
>> Anand Shah: That's really great information. Many surface cleaners and disinfectants say that they can be used against SARS-CoV-2 for COVID-19. What does this mean? Can consumers use these products on their hands or body to prevent or treat the virus?
>> Elizabeth Jungman: That's a great question and the answer is no, consumers should not be using disinfectant sprays or wipes that are intended for surfaces on their skin because those products can cause skin and eye irritation. Disinfectant sprays or wipes are not intended for use on humans or on animals. Instead, disinfectant sprays or wipes are intended for use on hard, non-porous surfaces. So, you want to always follow instructions on household cleaners; they're really not intended for your hands or body.
>> Anand Shah: Lately, when I've been looking at hand sanitizers in the store, I've noticed that there's a flammability warning on these hand sanitizers. What should consumers know about this?
>> Elizabeth Jungman: Well, alcohol-based hand sanitizer is flammable, and it should be applied and stored away from heat or flame. And when you use it, you want to take that hand sanitizer and rub it into your hands until they feel completely dry before you start continuing any activities that may involve a heat or spark, static electricity, or open flame.
>> Anand Shah: Speaking of storage, where should hand sanitizer be stored?
>> Elizabeth Jungman: Hand sanitizer should be stored out of reach and sight of children, and it should not be stored at above 105 degrees Fahrenheit. So, for example, you don't want to store it in your car in the summertime.
>> Anand Shah: Before we go, what else should folks know about hand sanitizer?
>> Elizabeth Jungman: Well, as with other over-the-counter drugs, consumers should always read and follow the warnings and precautions on the label of hand sanitizer. The label will also list any ingredients in the products. And finally, just remember that child safety is an important issue when using hand sanitizer. As I stated earlier, it's very important to store hand sanitizer out of the reach and sight of children, and to monitor to them when they're using hand sanitizer.
>> Anand Shah: With that, let's wrap up this episode of FDA Insight. Elizabeth, thank you for taking the time to discuss this very important safety issue. And thanks for all that you do at FDA.
>> Elizabeth Jungman: Thank you for inviting me.
>> Anand Shah: And we look forward to seeing our audience again for the next episode. As always, we'll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow. We hope you enjoyed this episode of FDA Insight. Please subscribe on your favorite podcast app, such as Apple Podcasts, Google Podcasts, Spotify, and Pandora. Thanks for listening.
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