FDA Announces Temporary Policy for Producing Hand Sanitizer

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Several health and safety items have become incredibly difficult to come by, hand sanitizer among them.

Our health care system is reportedly already overwhelmed. The First Responders and medical professionals tirelessly serving others—much like our industry pros—are running ominously low on sanitizer, masks and other essential equipment.

Posts about making “homemade” sanitizers using alcohol have been disseminated throughout social media, several news outlets, and popular websites. The US Food & Drug Administration (FDA) has responded by releasing their guidelines for producing and distributing of hand sanitizer intended for use by the public.

One of the concerns the FDA aims to address with these guidelines is ensuring hand sanitizers produced by manufacturers can be used on human skin safely. The last thing our medical professionals need right now is to deal with adverse reactions to homemade sanitizers—they have enough on their plates.

Unless they’ve received an exemption, a brewery or distillery is subject to FDA rules. And as we’ve reported, several distilleries—large and small—have stepped up in a big way to produce hand sanitizer for the public, medical community and First Responders.

Please read this: Webinar Replay: COVID-19 Planning: 90 Ways to Survive the Next 90 Days Confirmation

Due to the national health crisis that has gripped the United States, the FDA has said they’re not planning on intervening to prevent manufacturers (“firms,” in their parlance) from producing alcohol-based hand sanitizers:

“Specifically, FDA does not intend to take action against firms, for the duration of the public health emergency declared by the Secretary of HHS [Health and Human Services] on January 31, 2020, for violations of sections 501(a)(2)(B), 502(f)(1), 505, or 582 of the FD&C Act (21 U.S.C. §§ 351(a)(2)(B), 352(f)(1), 355, and 360eee-1).”

To clarify, that statement pertains to manufacturers that adhere to several circumstances outlined by the FDA here.

The document also reads, “At such time when the public health emergency is over, as declared by the Secretary, FDA intends to discontinue this enforcement discretion policy and withdraw this guidance.”

I’m sharing this information for a few reasons. First, it’s understandable that, due to the uncertainty of this public health emergency and empty shelves, people would consider using homemade hand sanitizer. Feeling desperate to obtain such products is normal and justifiable but people need to do their best to make rational decisions to avoid putting themselves and others at greater risk. Taking into account the FDA’s concerns about skin safety, making and/or using homemade hand sanitizer should be avoided.

Second, the rapid response by breweries and distilleries to step to plug the hand sanitizer hole is incredible. Some of you reading this are brewers, distillers, and brewpub operators, and you want to help by producing this increasingly important product.

Third, we all need help wherever we can get it to get through the coronavirus crisis. That brewers, distillers, and others in myriad hospitality industry roles are being proactive in multiple ways to support others is to be applauded.

Please read this: Sanitize Your Surfaces: How Long Can COVID-19 Survive?

So, please click here to read the FDA’s “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry,” which includes important formulation and labeling information, if you operate a facility that can safely and responsibly produce hand sanitizer.

Disclaimer: The production of hand sanitizers should be left to experienced and professional manufacturers. Bar & Restaurant Expo, Nightclub & Bar Show, and Questex do not recommend or otherwise endorse the production of homemade sanitizers or sanitizing solutions. Anyone who manufacturers such homemade products does so at their own risk.

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