Hand Sanitizer Guidance from the American Craft Spirits Association

On March 23, 2020, MFH listened in on a very helpful webinar presented by the American Craft Spirits Association.

ACSA will be making the presentation slides and other resources available. Please contact Kimberly Frost at kfrost@mfhliquorlaw.com if you’d like her to pass along what she receives from ACSA.

The following are the most important points that we came away with.

All distilleries who want to make hand sanitizer must read this document for FDA’s requirements that apply even though TTB has relaxed some requirements—including:

  • Mandatory registration with FDA as an over-the-counter drug.
  • Mandatory labeling requirements with drug facts.
  • Mandatory reporting of adverse events reported to you by users of your hand sanitizer.

All distilleries who want to make hand sanitizer must read the World Health Organization’s guidelines for manufacture. This is the gold standard and will offer distilleries the most protection from liability.

FDA is saying that only the WHO formulation is authorized without separate approval.

Denaturing with isopropyl alcohol is recommended. It is thought to be best tolerated on people’s skin. The amount of essential oils, glycerin, and other ingredients that people use tend to irritate skin. Also, isopropyl alcohol is what’s included in the WHO guidelines.

Though our physical offices are closing soon, we at Martin Frost & Hill will continue working remotely to serve you during this difficult time. Please call or email us if we can be of assistance.

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