ACI Seeks Safe Remedy for Refilling Hand Sanitizer Containers

The American Cleaning Institute (ACI) wants the U.S. Food and Drug Administration (FDA) to clarify labeling and refilling practices involving bulk containers of hand sanitizer.

 In a letter sent to the agency, ACI noted that the hand sanitizer market now offers bulk hand sanitizer formats (e.g., gallon jugs, 55-gallon drums) and refillable dispensers. These new products are especially prevalent in public locations such as retail shops, schools, lobbies, and 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,” said Dr. James Kim, ACI vice president of science and 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 is asking 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.