This year has highlighted the consumer demand for hand sanitizers. Hand sanitizers, as antiseptic rubs, are meant to be used for antimicrobial purposes when there is no access to soap and water. FDA has issued special temporary policies to make hand sanitizer more easily available for use in the U.S. during the SARS-CoV-2 (COVID-19) pandemic, or ‘Public Health Emergency (COVID-19)’. Sponsors and consumers should know that once these policies end, there is a need for the manufacturers of the hand sanitizers to follow the rules and regulations related to the manufacturing of pharmaceuticals, because FDA considers hand sanitizers to be non-prescription, or OTC, drugs.
Even though the sources of ethanol and isopropanol have been slightly relaxed during the COVID-19 emergency in documentation from FDA, methanol cannot be used in alcohol-based hand sanitizer products. Methanol is toxic, and there have been consumer injuries reported in 2020 that have been contaminated with methanol. FDA has posted dozens of products with from the newer ethanol (ethyl alcohol) hand sanitizer products that have tested positive for methanol contamination.
From a consumer standpoint, there are many choices of hand sanitizers for sale. The only active ingredients currently allowed in products under the U.S. OTC hand sanitizer (antiseptic rub) monograph are ethanol, isopropanol and benzalkonium chloride. Clinical studies would need to be conducted for the use of other active ingredients, and then the data presented to FDA for approval or addition to the monograph ingredients for antiseptic rubs. Inactive ingredients are also a consideration in the choice of hand sanitizers, not only because they may enhance the feel, moisturizing and smell of the product, but because some may actually lower the efficacy of the antimicrobial activity.
There are examples from this year of shipments of hand sanitizer being held at ports of entry into the U.S. because of improper labeling, certain ingredients, and lack of registrations or listings. While being good for consumers to have products checked, this is not good news for importers. This is an unnecessary setback, especially if had been easily avoidable by proper paperwork. Using an experienced regulatory consultant will provide compliance measures to successfully market a hand sanitizer in the U.S.
BRG has been assisting clients manufacturing, importing, or repackaging hand sanitizer for a decade. We have been helping many more companies since January. The need for hand sanitizers is likely to continue across the world market with the global theater of emerging viruses. Please contact us to be your pharmaceutical consultants to best position your hand sanitizer project and product development for regulatory compliance and success in the U.S. A good OTC drug consultant with experience can make all the difference for the product lifecycle of a hand sanitizer. If you need help with establishment registrations and electronic product listings for your OTC, contact us for expedited services.
The opinions and statements in this blog are those of the authors and are based on personal experience and reviews of information publicly available or identified in other database searches.