Over the last week, there has been some coverage by the major media outlets on a document released by the United States Food and Drug Administration (FDA). The federal agency has asked for more data on the safety and efficacy of hand sanitizers. Although this may appear to sound an alarm, there is no reason for concern. After all, the FDA even says within the text of the document that, “The proposed rule does not require any consumer hand sanitizer products to be removed from the market at this time", and that this rule “does not mean these products are unsafe or ineffective.”It’s an official standard regarding a specific chemical or group of chemicals and is used to certify a product containing these chemicals – also known as active ingredients – is safe when used appropriately.
As one might expect, the process was not quick and final monographs didn’t appear until at least ten years later. But slowly the number grew and included categories such as anti-acne products, toothpaste, antiperspirants, dandruff products, antacids, sunscreens, and cough, cold and allergy remedies. Today, there is a searchable list of monographs for anyone wishing to learn more about a particular product.
Though nearly forty years have passed since the monograph endeavor was started, some are still in in the review process. One of these focuses on what officially are called topical antimicrobial drug products – most of us simply call them hand sanitizers. The journey has been long but the final document is slated to be published in the government's official rules and regulations publication, the Federal Register, in 2019. This particular monograph is the reason for last week’s announcement.
In terms of effectiveness, alcohol hand sanitizers have proven in hundreds of scientific articles to be useful in keeping people safe. All that’s required is a concentration between 62 and 70% alcohol – ethyl alcohol to be exact – and 15 seconds on contact time and the majority of pathogenic threats will be killed. This includes bacteria, viruses, and fungi. It’s why this product is considered by the United States Centers for Disease Control and Prevention (CDC) to be the best option to prevent infectious disease spread when running water and soap are not available.
As for safety, there is more than enough information to show the safety of alcohol hand sanitizers. Even the FDA agrees as the only data gap is long term daily use. Thankfully, researchers have shown continual use of alcohol hand sanitizers (30 times an hour over 12 hours) leads to the same absorption as drinking a non-alcoholic beverage like fruit juice.
In essence, the recent FDA announcement is an administrative formality heading towards the 2019 publication of the Final Monograph. Over the coming months, the information found in the scientific literature will be put forth to the regulatory body such that they can begin to fill in the gaps. Come 2019, when this monograph will be finalized, one can be sure the agency will find ethyl alcohol, to be an integral part of hygiene and hand sanitizers will be given the regulatory endorsement to complement the overwhelming public approval.
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