FDA Releases Proposed Rule for Consumer Leave-On Antiseptic Products
New Approach to Collecting the Latest Science on Hand Sanitizing 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.
This is the beginning of a multi-phase process that could be completed as early as April 2019. The next phase of the process is for public health experts, industry leaders and others to provide feedback, new data and information to the FDA.
GOJO Supports FDA’s Approach
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.
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.
Decades of Science Demonstrating the Effectiveness of PURELL™ Products
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 FDA has only requested data on long-term daily use for ethyl alcohol.
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.
Hand Hygiene Helps Save Lives
The need to practice good hand hygiene is even more important given the rise of infectious diseases the last decade. With emerging infectious diseases on the rise, our highly mobile society and the increase in global international travel, practicing good hand hygiene is an essential healthy habit. Using hand hygiene solutions, like PURELL™ products, is an important step in protecting the health of individuals, families and our communities.
 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://sciencedirect.com/science/article/pii/S0273230015300258)