ALCOHOL-BASED HAND SANITIZERS

Due to COVID-19 pandemic, the FDA released an announcement on April 27, 2020 about the availability of alcohol-based hand sanitizer. The FDA wants to address safety concerns related to products being sold that are not in line with the FDA’s policy and others being marketed with unproven claims. Due to the increased supply of alcohol-based sanitizer, the safety of these products need to be ensured in a way that is not palatable to people, especially young children. They must be appropriately labeled to discourage accidental or intentional ingestion. Hand sanitizers are not proven to treat COVID-19, and like other products, are meant for external use. They are not for ingestion, inhalation, or intravenous use.

Following the FDA’s guidance to try and increase availability of alcohol-based sanitizers, feedback has been given about using denatured alcohol for these products. Adding the denaturant to the alcohol renders the product more bitter and less appealing to ingest, especially for young children. This approach aligns with the FDA’s policies prior to the COVID-19 pandemic. The FDA cannot express this enough now as more and more consumers rely on alcohol-based sanitizer as a tool against this deadly virus.

According to data provided by the CDC and American Association of Poison Control Centers, calls to the National Poison Data System last month related to hand sanitizer increased by 79% compared to March 2019. The majority of these calls were for exposure in young children aged 5 and younger. Ingestion of only a small amount of hand sanitizer may be potentially lethal to a young child.

This is due to an 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. The FDA found that the product ingested was not consistent with the labeling component of the agency’s temporary policy:

• the importance that a Drug Facts Label be included on these products
• warnings to keep the product out of reach of children
• information to get medical help or call a poison control center immediately if swallowed
• to supervise the use in children under 6 years of age to prevent accidental swallowing

This policy applies regardless of where the product is intended to be used, as it can easily be distributed beyond the original intended setting.

The FDA recently issued its first warning letter for a hand sanitizer that product marked with unproven COVID-19 related claims, in violation of federal law. The agency is not aware of any evidence to support hand sanitizer can protect consumers for 24 hours or after multiple hand washings. These false claims may put consumers at risk by leading a false sense of security and resulting in frequent hand washing or hand sanitizing.

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 as well as continuing to take appropriate actions against manufactures making unproven claims.

mdi is presently working with many companies on getting their hand sanitizer to market.

We can also assist you with reviewing your product labelling to ensure compliance with the latest FDA guidelines. Consumers, manufacturers or distributors who have questions for the FDA regarding hand sanitizers should email COVID-19-Hand-Sanitizers@fda.hhs.gov. Any other specific questions related to this update, please feel free to reach out to mdi for assistance via email at info@mdiconsultants.com RE: Alcohol-Based Hand Sanitizer.