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On April 15, the Food and Drug Administration (FDA) released an updateTrusted Source to its decision to relax the rules governing the manufacture of hand sanitizer in response to the COVID-19 crisis.
On April 27, FDA officials announcedTrusted Source there were 1,500 additional manufacturers of hand sanitizer registered with the agency.
In that same announcement, agency officials said they’re trying to address safety concerns with products possibly not in line with FDA guidelines, or those being marketed with unproven claims.
“We appreciate [the] industry’s willingness to help supply alcohol-based hand sanitizer to the market to meet the increasing demand for these products, and are grateful for their efforts,” Dr. Stephen M. HahnTrusted Source, the FDA’s commissioner, said in the announcement.
“With this increased supply comes our continued mission to ensure safety of these products. It is important that hand sanitizer be manufactured in a way that makes them unpalatable to people, especially young children, and that they’re appropriately labeled to discourage accidental or intentional ingestion,” Hahn added.
So, with the flood of new products on the market, how can you be sure the hand sanitizer you’re purchasing at a store or online is meeting these standards and is safe to use?
According to the April 15 FDA directive, unlicensed entities can temporarily register facilities as over-the-counter drug manufacturers to make alcohol-based hand sanitizer during the duration of the emergency.
They also need to list products in the FDA Drug Registration and Listing System.
The FDA “does not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as healthcare personnel hand rubs for the duration of the public health emergency,” the agency wrote.
The FDA recommendsTrusted Source using “alcohol (ethanol) that is not less than 94.9 percent by volume,” or USP-grade isopropyl alcohol.
The agency also lists glycerin, hydrogen peroxide, and sterile water as necessary ingredients.
The FDA also points to Centers for Disease Control and Prevention (CDC) recommendationsTrusted Source that hand sanitizers contain at least 60 percent alcohol.
Hand sanitizer with a higher alcohol content can be more expensive, but the agency says don’t buy any product with less than 60 percent alcohol.
Despite the more lax regulations, companies are still responsible for the quality of their product.
“Anyone selling a product is still liable for any product liability harms that happen,” Shashank Upadhye, a Chicago-based attorney specializing in FDA law, told Healthline.
“For example, in typical topicals, you can have issues related to allergens, itching, rashes, chemical burns, etc. Now, if you add the bad taste aspect, what would a manufacturer add, and what product liability issue could arise? And when it comes to taste, what tastes bad to someone may not be so bad to another,” he said.
Taste is a factor because, despite the loosened regulations, the FDA still mandates companies use denatured alcohol. Denaturing means adding an unpleasant taste to the mixture to deter those who can’t read labels from mistaking hand sanitizer for something else.
“Denaturing the ethanol is critical because there have been reports of adverse events, including deaths, from unintentional ingestion of hand sanitizer, particularly in young children,” an FDA spokesperson told Healthline.
The guidelines mandate no additional ingredients be added to improve the smell or taste. The label must also include, in addition to the ingredients, a warning to keep the product from the reach of children, information on getting medical help if swallowed, and a note to supervise anyone under 6 years old using the product.
“Every year there are a number of adverse events resulting from children who intentionally, or unintentionally, drink hand sanitizer,” the FDA spokesperson said. “In an 18-month-old child, it takes only a small amount to be potentially lethal.”
On its website, the CDC notesTrusted Source that “studies show hand sanitizers work well in clinical settings like hospitals, where hands come into contact with germs but generally are not heavily soiled or greasy.”
The agency adds that studies have also shown the higher the alcohol concentration — ideally between 60 and 95 percent — the better the hand sanitizers work.
They note that if the alcohol content is less than recommended, the solution may simply reduce the growth of germs rather than kill them outright.
The CDC recommends that when using hand sanitizer, you should apply the product to the palm of one hand (read the label to learn the correct amount) and rub the product all over the surfaces of your hands until they’re dry.
Alcohol also evaporates off skin quickly, so don’t wipe it off until it dries.
Despite the safety oversight, the FDA noted in its April 27 announcement that calls related to hand sanitizer to the National Poison Data System in March rose 79 percent compared to March 2019.
One report involved a 13-year-old drinking hand sanitizer packaged in a liquor bottle from a distiller. The sanitizer wasn’t denatured and reportedly tasted like drinking alcohol.
The FDA noted on April 27 that it had sent a warning to a hand sanitizer manufacturer for marketing its product with unproven claims concerning COVID-19 prevention.
“The FDA is constantly trying to police the ads by manufacturers,” Upadhye said. “This is especially true because you can imagine that sellers advertise ‘cures coronavirus’ or ‘FDA approved.’ But sellers prey on the buyers until they get caught.”
Experts also say to avoid any product that says it’s specifically geared for COVID-19.
Diana Rodriguez-Zaba owns ServiceMaster by Zaba, a cleaning company in Chicago specializing in property disinfection and sanitization.
“There are many benefits to making your own hand sanitizer,” Rodriguez-Zaba told Healthline. “It’s usually cheaper, and you can skip all of the chemicals like synthetic fragrances and use only natural, effective ingredients. This is important if you have skin allergies or other skin issues that can be aggravated by synthetic ingredients.”
“Making your own hand sanitizer with essential oils smells really great, and essential oils have been shown to have some health benefits,” Rodriguez-Zaba said. “Since I started making my own hand sanitizers, I don’t think I’ll ever buy over the counter again.”
Rodriguez-Zaba says she mixes 5 ounces of 99 percent alcohol with 10 drops of essential oils, blending rosemary, eucalyptus, clove, cinnamon, and lemon. She mixes that with aloe vera gel at a 1:2 ratio to keep its germ-fighting power.
She also says not to use straight alcohol, as it’s harsh on human skin. All those chemicals can also pose another kind of danger.
“Being in the restoration industry, we have seen fires caused by rubbing alcohol when mixed with products that are flammable,” she said. “Be very cautious, especially if you spray alcohol on your hands before or after pumping gas. Familiarize yourself with the products you’re using.”
Vanessa Thomas is a cosmetic chemist and CEO of the health and beauty company Freelance Formulations, which markets hand sanitizers among other products.
“Another issue with making sanitizer in a place that is not approved, like your home, is that the home is not sterile, and it is not set up for safe manufacturing. Therefore, the sanitizer could become contaminated,” Thomas told Healthline.
“Sanitizer is made with alcohol, but the consistency is similar to a gel. In order to get this consistency, thickeners and emollients have to be added in the right amounts. The ingredients have to be mixed together with a lab mixer or an industrial mixer,” she explained.
For the record, the FDA recommends againstTrusted Source consumers making their own hand sanitizer, because if the product is “made incorrectly, hand sanitizer can be ineffective, and there have been reports of skin burns from homemade hand sanitizer.”
