FDA Warns 1,500 New Sanitizer Makers: Follow the Rules

The FDA recently provided an update on efforts to ensure the availability of alcohol-based sanitizer to help meet demand during the COVID-19 pandemic.

Thanks to the agency’s easing of restrictions, more than 1,500 additional manufacturers have registered to produce hand sanitizer. However, there are serious safety concerns related to the products being sold that are not in line with the FDA’s policy, and others being marketed with unproven claims. 

“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.

He added, “With this increased supply comes our continued mission to ensure safety of these products. It is important that hand sanitizers 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.”

See related: U.S. FDA Hand Sanitizer Solutions Explained

Denaturing Alcohol

Following the FDA’s guidance to increase the availability of alcohol-based hand sanitizers, the agency has received feedback and questions in recent weeks from industry and Congressional members, particularly regarding the need to use denatured alcohol for these products. Adding denaturants to alcohol renders the product more bitter and less appealing to ingest, particularly for young children.

While the agency understands 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. This approach is consistent with the FDA’s policies prior to the COVID-19 pandemic for including denatured alcohol in hand sanitizer, and it is even more important now as more consumers rely on its use as a tool to fight against the deadly virus.

It is important that hand sanitizers be manufactured in a way that makes them unpalatable to people, especially
young children.

To illustrate the importance of using denatured alcohol, consider the following. According to an FDA analysis of data provided by the U.S. Centers for Disease Control and Prevention, and the American Association of Poison Control Centers surveillance team, calls to the National Poison Data System in March 2020 related to hand sanitizer increased by 79%, compared with March 2019. The majority of these calls were for unintentional exposures in children five years of age and younger.

Every year, there are hundreds of calls to poison control centers regarding exposure to hand sanitizer, many of which result in adverse events, including death. Unfortunately, ingestion of only a small amount of hand sanitizer may be potentially lethal in a young child.

In April 2020, 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.

Calls to the National Poison Data System in March 2020 related to hand sanitizer increased by 79%, compared with March 2019.

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 six 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.

See related: How NOT to Formulate Hand Sanitizers

Fraudulent Claims

The FDA also is concerned about hand sanitizer products being sold with unproven claims. In mid-April, 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 a 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 web page 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 the FDA website.

The FDA remains committed to working with manufacturers, compounders, state boards of pharmacy and the public to increase the safe supply of alcohol-based hand sanitizer available to Americans, as well as continuing to take appropriate action against manufacturers making unproven claims.

For more information, see the FDA website.