- The FDA is asking hand sanitizer producers to make it taste bitter so people don’t swallow it.
- More than 1,500 companies have stepped up to produce hand sanitizer during the pandemic.
- Calls to the National Poison Data System last month related to hand sanitizer increased by 79% compared to March 2019.
Last month, the Food and Drug Administration received a report that a 13-year-old consumed hand sanitizer packaged in a liquor bottle by a distiller.
The alcohol wasn’t denatured, so it tasted like regular drinking liquor, according to the FDA.
Now the agency is asking companies to make sure that their sanitizers taste disgusting.
“It is important that hand sanitizer be manufactured in a way that makes them unpalatable to people, especially young children, and that they are appropriately labeled to discourage accidental or intentional ingestion,” FDA Commissioner Stephen M. Hahn said in a statement.
Companies around the country, many of them distilleries, have switched gears to meet a demand for hand sanitizer during the coronavirus pandemic. More than 1,500 new companies have registered with the FDA to produce the cleanser in the past few months.
In response to the more flexible temporary FDA rules that are aimed at meeting the demand for sanitizers, industry leaders and congressional members have reached out to the FDA over the need for companies to use denatured alcohol for their sanitizers.
Hand sanitizer helps fight the coronavirus, but young children have been ingesting it
The number of calls made last month to the National Poison Data System last related to hand sanitizer increased by 79% compared to March 2019, the statement said. Most of the calls involved unintentional exposures in children 5-years-old and younger.
Ingesting even a small amount of hand sanitizer can be fatal for young children, according to the FDA.
“Adding denaturants to the alcohol renders the product more bitter and less appealing to ingest, particularly for young children,” the FDA said in a statement. “While the agency understands the economic and business reasons behind foregoing this step in the manufacturing process, such an approach undermines the agency’s mission of helping to ensure the safety of FDA-regulated products for consumer use, which is the FDA’s top priority.”
In addition to how the sanitizer is made, the agency is also reminding businesses to make sure their bottles are in compliance with regulations.
The labeling on the sanitizer consumed by the 13-year-old, for example, didn’t include a Drug Facts Label. The label includes warnings to keep the product out of reach from children and to supervise its use by children under the age of 6, as well information to get medical help or call a poison control center right away if the sanitizer is swallowed.
The agency has also found some companies making false claims about what the cleanser can do.
It sent a warning letter to Prefense LLC for selling its product with claims it could protect users from germs “with just one application per day.”
The company’s webpage also states that Prefense can, “protect you from pathogens up to 24 hours or for 10 hand washes,” according to the FDA.
“The FDA is not aware of any evidence that hand sanitizer products can protect consumers for 24 hours or after multiple hand-washings,” the statement said. “These types of claims may put consumers at risk by leading to a false sense of security and resulting in infrequent hand washing or hand sanitizing.”
The FDA isn’t the only government entity cracking down on companies seeking a financial gain using false claims involving COVID-19 benefits.
The Securities and Exchange Commission has taken action against at least 23 companies accused of doing so.
The SEC can stop a stock from trading for up to 10 days if it believes information posted by a company is inaccurate.