FDA: Loosen Hand Sanitizer Restrictions!

Amidst critical shortages of hand sanitizer in online and brick-and-mortar stores, distillers and compounding pharmacies have stepped up to fill in a crucial gap in supply. “Not so fast!” says the FDA. The agency released two policies detailing how these entities should be producing sanitizer. These guidance documents have thwarted the efforts of distillers and compounders to produce hand sanitizer that the nation needs, highlighting once again the ineptitude, bureaucratic stubbornness, and even pettiness of the agency during the COVID-19 crisis.

Write to the FDA, with a copy to Congress, calling for more flexibility to allow distillers and compounders to make hand sanitizer during this crisis.

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Please loosen hand sanitizer restrictions

Dear [Decision Maker],

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Amidst critical shortages of hand sanitizer in online and brick-and-mortar stores, distillers and compounding pharmacies have stepped up to fill in a crucial gap in supply. Yet the FDA released guidance documents that have thwarted the efforts of distillers and compounders to produce hand sanitizer that the nation needs.

The FDA's policy stipulates that distillers use denatured alcohol in their sanitizers. According to Matt Dogali, the President and CEO of the American Distilled Spirits Alliance, introducing denatured alcohol into a distillery's production lines "renders them useless for future alcohol production barring extreme cleaning measures, because we cannot have any remnant of the denaturant in our lines, and then sell a consumable product."

According to a letter from Reps. John Yarmuth (R-KY) and Andy Barr (R-KY) to the FDA asking for flexibility,

Undenatured alcohol is food grade alcohol that is compliant with the [World Health Organization's] hand sanitizer formula and has the same effectiveness as denatured alcohol. The United States largely differentiates between the two types of alcohol for tax purposes  with undenatured alcohol incurring the distilled spirits Federal Excise Tax (FET) and paid to the federal government.

FDA rules have also restricted the ability of compounding pharmacies to make hand sanitizer. The agency's guidance stipulates the particular strength of isopropyl alcohol that that is permissible while also requiring the use of denatured alcohol. A letter from compounding pharmacists urges the FDA to grant more flexibility to compounders so they can be more helpful in this crisis. Specifically, they ask that the FDA relax its requirement for 75% isopropyl alcohol due to a shortage of this ingredient. The letter asks FDA to "consider allowing compounders further flexibility to meet the consumer need. For example, allowing pharmacists to exercise professional judgment with the use of food-grade products [such as from liquor stores] for compounding hand sanitizers."  This request is supported by a 2020 review article, which found that alcohol-based hand sanitizers which were 60-95% alcohol were effective at killing germs, given a certain amount of sanitizer was used for 25-30 seconds.

Now is not the time for red tape, but for flexibility. Please relax these restrictions to improve the ability of compounders and distiller to produce sanitizers that this nation needs.

Sincerely,
[Your Name]
[Your Address]
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[Your Email]