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As Demand for Hand Sanitizer Soars, FDA Warns of Makers’ Bogus Claims

MONDAY, April 27, 2020 (HealthDay News) — Some companies are selling hand sanitizers with unproven claims that they’ll protect you from the new coronavirus, the U.S. Food and Drug Administration warns.

Last week, the agency issued its first warning letter for a hand sanitizer marketed with unproven COVID-19-related claims that violated federal law.

The letter was issued to Prefense LLC for making misleading statements about its hand sanitizer, such as “Prefense … protects you from germs with just one application per day! It’s like wearing an invisible glove.”

The company’s website also wrongly claims that Prefense can “protect you from pathogens up to 24 hours or for 10 hand washes,” according to an FDA news release.

There is no evidence that hand sanitizing products can protect consumers for 24 hours or after multiple hand-washings, the FDA 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 agency urges consumers to be vigilant of products sold with misleading, unproven claims, by following our updates on our website,” FDA regulators said.

The FDA turned to manufacturers in an attempt to meet demand for alcohol-based hand sanitizer. So far, more than 1,500 additional manufacturers have registered with the FDA to produce the hand cleaners. But that’s led to safety concerns about false marketing or products that aren’t in line with the FDA’s policies.

“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 are appropriately labeled to discourage accidental or intentional ingestion,” said FDA commissioner Dr. Stephen Hahn.

“Additionally, hand sanitizers are not proven to treat COVID-19, and like other products meant for external use, are not for ingestion, inhalation, or intravenous use,” he added.

One safety precaution with alcohol-based hand sanitizer is the use of denatured alcohol. This makes the sanitizer bitter-tasting and less appealing to children.

Consuming just a small amount of hand sanitizer may be potentially deadly in a young child.

This month, the FDA received a report of a 13-year-old child drinking hand sanitizer that was packaged in a liquor bottle from a distiller. The sanitizer was not denatured and was reported to taste like normal drinking alcohol.

Hand sanitizer-related calls to the National Poison Data System last month were 79% higher than in March 2019. The majority of the calls last month were for unintentional exposures in children aged 5 years and younger, the FDA said.

— Robert Preidt

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SOURCE: U.S. Food and Drug Administration, news release, April 27, 2020

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