October 19, 2021

Volume XI, Number 292

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October 18, 2021

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January 2021 FDA Issues Guidance on Consumer-Based Antiseptic Hand Sanitizer Rubs Final Rule

On Dec. 31, 2020, the Food and Drug Administration issued Guidance to answer questions about its April 12, 2019 Final Rule for consumer-based antiseptic hand sanitizer rubs (Hand Sanitizers). The Guidance addresses (1) the fate of active ingredients ethanol, isopropanol, or benzalkonium chloride and (2) the ban on all other active ingredients. Companies formulating Hand Sanitizers with ethanol, isopropanol, or benzalkonium chloride do not need to get FDA approval through its still-yet-to-be-formalized OTC Drug Review process. Stakeholders need to know, however, that this position is subject to change as FDA implements the Final Rule. 

The safety and efficacy of Hand Sanitizers has been a point of contention between industry and FDA since the 1970s. FDA last systematically evaluated scientific data regarding Hand Sanitizers in 1994. Even then, FDA recognized that there were gaps in the data regarding formulations, safety, and efficacy. Regardless, FDA determined that there were 31 active ingredients permitted to be marketed under FDA’s June 17, 1994 Tentative Final Monograph

Finding a lack of studies showing that they were “generally recognized as safe and effective,” or “GRAS/E”, the FDA’s April 12, 2019 Final Rule formally banned 28 of the 31 active ingredients in consumer-based antiseptic hand sanitizer rubs. The ban was deferred for a year. This meant that Hand Sanitizers formulated with one or more of 28 specific active ingredients had until April 13, 2020, to be removed from the market. The permitted active ingredients were ethanol, isopropanol, and benzalkonium chloride. 

Hand Sanitizers with ethanol, isopropanol, or benzalkonium chloride could remain on the market while the interested parties completed studies necessary to submit safety and effectiveness data. Originally, the FDA gave interested parties until April 13, 2020, to submit the studies before the FDA would promulgate a final rule on the three active ingredients. But no rule has come yet. 

The Dec. 31 Guidance reiterates that the banned 28 active ingredients should have been removed by April 13, 2020. Fortunately, or unfortunately, the impact was not as great as expected, since the COVID-19 health emergency left a dearth of Hand Sanitizers with those active ingredients. More importantly, it appears that FDA is extending its review period – the Guidance clarifies that FDA is still accepting safety and efficacy studies, although it is well past the original April 13, 2020, due date. Regardless, the Dec. 31 Guidance reiterates that FDA needs to see safety and efficacy studies and that the window to formulate the hand sanitizer under the 1994 Tentative Final Monograph is closing. FDA could tighten the permissible concentration limits of the active ingredients or – though unlikely – place an all-out ban on monograph Hand Sanitizers. If there are changes, FDA could defer the changes for a year so that companies can adjust. Manufacturers and other stakeholders relying on the 1994 Tentative Final Monograph should closely monitor for FDA updates, rules changes, and FDA Antiseptic Letters.   

©2021 Greenberg Traurig, LLP. All rights reserved. National Law Review, Volume XI, Number 4
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About this Author

Eleanor (Miki) A. Kolton, Greenberg Traurig Law Firm, Washington DC, Healthcare and Cybersecurity Law Attorney
Of Counsel

Eleanor (Miki) A. Kolton has wide-ranging legal, administrative and management experience in medical practice law; HIPAA, Stark, Medicare and CMS regulations; with the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC); and other civil and administrative law areas. She possesses executive corporate experience and broad clinical background in a variety of health care settings, including the ability to understand scientific and medical community cultures, business challenges and concerns.

Prior to joining the firm, Miki...

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Michael R. Goodman ASSOCIATE Intellectual Property & Technology Food, Beverage & Agribusiness
Associate

Michael R. Goodman is an attorney and registered patent agent who advises clients on FDA regulatory compliance and intellectual property needs in the food, medical device, pharmaceutical, biotechnology, dietary supplement, and consumer products industries. Michael assists companies of all sizes in navigating regulatory compliance and developing strategies to avoid delays in their operations. He also prepares, reviews, and negotiates supply and distribution, manufacturing, and advertising agreements, as well as assists with stock and asset purchase agreements.

303-572-6500
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