CLEVELAND, Ohio (WOIO) - While the FDA said they appreciate industry’s willingness to step up and make alcohol-based hand sanitizer to help meet the demand during the COVID-19 pandemic, they are asking manufacturers to make it taste worse.
According to the FDA, more than 1,500 additional manufacturers have registered with the U.S. Food and Drug Administration to produce hand sanitizer during the pandemic.
Simultaneously, the FDA said they are addressing safety concerns related to products being sold that do not comply with FDA policy, as well as others being marketed with unproven claims.
The FDA said adding denaturants to the alcohol used in the hand sanitizer is needed to make the product more bitter, and therefore less appealing to ingest, especially for young children.
While the FDA said it understands the business and economic reasons for skipping this step in the manufacturing process, not doing so undermines the agency’s policy put in place prior to the pandemic and the safety of FDA-regulated products for consumer use.
“We appreciate 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,” said FDA Commissioner Stephen M. Hahn, M.D. “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. 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.”
The FDA emphasized the importance of using denatured alcohol by stating hand sanitizer related calls to the National Poison Data System last month increased by 79% compared to March 2019.
According to the FDA, a small child ingesting just a small amount of hand sanitizer may be potentially lethal.
The FDA provided this example of a recent case of hand sanitizer ingestion to emphasize the importance if adding denaturants:
"This month, the agency received an adverse event report of a 13-year-old child drinking hand sanitizer packaged in a liquor bottle from a distiller. The sanitizer was not denatured and was reported to taste like normal drinking alcohol. To protect consumers, especially children, it is important to make hand sanitizer unpalatable.
The FDA also found that the product ingested by the 13-year-old child was not consistent with the labeling component of the agency’s temporary policy— underscoring the importance that these products include a Drug Facts Label, warnings to keep the product out of reach of children, information to get medical help or call a poison control center right away if swallowed and to supervise use in children under 6 years of age to prevent accidental swallowing. These safety measures apply regardless of where the product is intended to be used, as it can easily be distributed beyond the original intended setting."
The FDA also provided this example of a company selling hand sanitizer under false advertising:
“The FDA is also concerned about hand sanitizer products being sold by some manufacturers during the COVID-19 pandemic with unproven claims. Last week, the agency issued its first warning letter for a hand sanitizer product marketed with unproven COVID-19-related claims, in violation of federal law. The letter was issued to Prefense LLC for selling their product with misleading claims, for example, “Prefense…protects you from germs with just one application per day! It’s like wearing an invisible glove.” The company’s webpage also states that Prefense can, “protect you from pathogens up to 24 hours or for 10 hand washes.” The FDA is not aware of any evidence that hand sanitizer products can protect consumers for 24 hours or after multiple hand-washings. 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.”