Once again, the agency refuses to change its mindset in the midst of the pandemic. Action Alert!
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.
The FDA’s policy stipulates that distillers use denatured alcohol in their sanitizers. Denatured alcohol is ethanol or grain alcohol that contains denaturants, or additional chemicals that make it unfit for human consumption. 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.”
Distillers, of course, do have ready supplies of undenatured alcohol they are ready and willing to put to use for the production of hand sanitizer. 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.
The senselessness of the FDA’s position hardly needs to be stated.
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 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.
The FDA’s conduct throughout this health crisis has been shocking. We saw how the agency’s baffling commitment to bureaucratic red tape knee-capped our ability to deploy timely, widespread testing that could have saved lives. This hand sanitizer debacle underlines the point: the FDA cannot be trusted to protect public health.
Action Alert! Write to the FDA, with a copy to Congress, telling the agency to relent on its strict guidelines for hand sanitizer. Please send your message immediately.