U.S. Food and Drug Administration (FDA) proposed rule for consumer antiseptic leave-on products
On June 29, 2016, the FDA issued its proposed rule for consumer hand sanitizers and asked manufacturers to provide the latest science for the active ingredients used in these products. This call for new data relates to the FDA’s standard protocol as it revisits this consumer product category for the first time in over 20 years.
In its press release, the agency stated this proposed rule “does not mean the FDA believes these products to be ineffective or unsafe.” The FDA also reminded the public that the Centers for Disease Control and Prevention (CDC) recommend the use of an alcohol-based hand sanitizer with at least 60% alcohol when soap and water are not available.
This is consistent with the FDA Proposed Rule for Healthcare published in April 2015, when the agency recommended that healthcare workers follow CDC and World Health Organization hand hygiene guidelines stating alcohol-based hand sanitizers are the standard of care for infection prevention.
GOJO is dedicated to developing the safest, most effective hygiene products and is working with the FDA to advance and share the latest science on these active ingredients. The FDA has indicated in the proposed rule that it already has sufficient data for ethyl alcohol, which is the active ingredient in PURELL® Advanced Instant Hand Sanitizer, as it relates to reproductive toxicity, bacterial resistance and hormonal effects in addition to others. The only area the FDA wants to see more ethyl alcohol data is for long-term daily use.
GOJO has an abundance of safety and effectiveness data, and we will work with the FDA. For example, GOJO has shared with the FDA a study from scientists at the University of Cincinnati, which found that even with frequent use of an alcohol-based hand sanitizer in the range of 30 times an hour, the absorption of alcohol was miniscule and similar to that of either drinking a glass of orange juice or eating a ripe banana.
We applaud the FDA for taking this evidence-based approach to ensure all products in our category meet the high standards for safety and effectiveness that our PURELL Hand Sanitizers do.
 Maier A., Ovesen JL, Allen CL, York RG, Gadagbui BK, Kirman CR, et Al. Safety assessment for ethanol-based topical antiseptic use by healthcare workers: evaluation of developmental toxicity potential. Regul Toxicol Pharmacol 2015 (73): 248-64. (http://www.sciencedirect.com/science/article/pii/S0273230015300258)