Man rubbing his hands

The American Cleaning Institute (ACI) is pressing the U.S. Food and Drug Administration (FDA) to clarify policies on labeling and refilling practices involving hand sanitizers.

In a letter sent to the agency, ACI expressed concerns related to the “new, increasingly widespread practice of providing hand sanitizers to consumers in public settings … that are often sold in bulk and used to fill existing dispensers, which can create a serious risk to public health and safety.”

ACI, which for decades has represented hand sanitizer product and ingredient manufacturers, asked the FDA to:

- Clarify requirements for hand sanitizer labeling and refilling practices.

- Take enforcement action against certain products that are in violation of legal requirements and raise public health and safety concerns.

- Issue safety communications to manufacturers and the public about these unsafe and unlawful practices.

ACI noted that a there are a large number of new entrants into the hand sanitizer market offering bulk hand sanitizer formats (e.g., gallon jugs, 55-gallon drums) and open refillable dispensers. These drug delivery systems are especially prevalent in public locations and are intended to encourage the public to get out and “safely” reopen our communities (e.g., retail shopping, schools, lobbies, community outdoor settings).

“It is our understanding that in most cases, these bulk systems are either not labeled at all or not labeled in accordance with FDA drug labeling requirements, and these hand sanitizers and their containers have not been validated for compatibility or stability in those bulk systems,” said Dr. James Kim, ACI Vice President of Science & Regulatory Affairs. “In addition, some businesses that provide hand sanitizer to their employees, patrons, or the general public are purchasing bulk hand sanitizer for use in refilling existing containers, including some dispensers, jugs and bottles that were not intended to be refilled.”

ACI said that these practices pose “several serious risks to health and safety” related to misbranding, product integrity, product stability and traceability.

“In addition to raising these issues for your awareness, ACI and its members stand ready to assist the FDA as a knowledgeable, helpful resource in addressing these risks,” added Kim.

Additionally, ACI and its members continue to be concerned about hand sanitizer products on the market from manufacturers that do not comply with applicable regulatory requirements. These products are potentially misleading to consumers and harmful to the industry’s reputation. ACI is hopeful that FDA will take appropriate enforcement action to prevent noncompliant companies from further disseminating false and misleading claims.