FDA Blocking Efforts to Produce Hand Sanitizers

April 16, 2020

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.

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39 responses to “FDA Blocking Efforts to Produce Hand Sanitizers”

  1. mary frank says:

    We would appreciate your not blocking others efforts. We need all the help now. It is no time for bureaucracy to stand in the way.

  2. What’s the matter with you, FDA? Why are you so rigid? Start protecting public health during the coronavirus pandemic!!

  3. Marian Schienberg says:

    We need hand sanitizer . Can’t find it anywhere.

  4. EUGENE OBRIEN says:

    FDA–immediately allow the use of non-denatured alcohol for use in hand sanitizers. PEOPLE ARE DYING!

  5. Marcie Rivera says:

    It is uncomprehensible that during this time the FDA does not modify their rules to get much needed product out into the marketplace. Is it because the lobbyists have such hold on an organization that is supposed to be looking our for the people? Unfortunately, it seems the FDA only looks out for organizations that have deep pockets and donates to it.

  6. Charlotte Fremaux says:

    The FDA is, sadly, in the pay of Big Pharma. The fact that it approves so many medications and OTC drugs that have appalling side effects, yet resists this simple solution to a dire shortage during a crisis is further proof that it is under the control of corporations. Common sense appears to be utterly lacking in our government, and this prohibits us from being an agile and intelligent respondent in novel times. This doesn’t bode well for our future.

  7. Linda Moore says:

    FDA

    Ease up on your strict guidelines for hand sanitizers!

  8. Charlotte Fremaux says:

    The FDA is, sadly in the pay of Big Pharma. The fact that they routinely approve medications and OTC drugs the have appallingly harmful side effects, yet balk at this simple and commonsense solution to a dire shortage during a crisis is proof that they are controlled by corporate forces. I ma disgusted that my government refuses to be an intelligent and agile respondent to a crisis by eschewing common sense and logical thinking. Must be that there’s no money in it for them…

  9. Jim Mailhot says:

    What a bunch of turkeys

  10. Diana Brady says:

    Please cooperate with hand sanitizer producers. They have the safety of the public in mind. The public needs to acquire the effective 60-95% alcohol-based sanitizers that can be produced and distributed in a timely manner. Do not hold up this critically needed commodity. At a time of pandemic dangers, we need your cooperation. Thank you.

  11. Mark and Jamie Luce says:

    THIS IS COMMON SENSE ! WHICH IS NOT SO COMMON ! WE NEED HAND SANITIZER NOW !!

  12. John says:

    Why listen to or obey the FDA anyway? The agency is staffed to the hilt with pharmaceutical insiders anyway. We the people are NOT supposed to be subservient to government, government is supposed to be subservient to the people.

    Maybe this tumultuous time will encourage us to get angry enough to take back the power that’s rightfully to be ours. Dissolve the FDA, the CDC, the private Federal Reserve criminals, the IRS, and the worst terrorist organization in the world, the CIA.

  13. Mike Rick says:

    Drain the Swamp

  14. David Clark says:

    What else that is happening is States are closing liquor stores where people can get the undenatured alcohol that works just as good as the commercial hand sanitizers. The shortage is bunk.

    What exactly is wrong with liquor anyway? No problem selling it before the plandemic, now all of the sudden we close the stores that have an abundant supply of a form of hand sanitizer? What a scam !

  15. Carol Tao says:

    Please relent on your strict guidelines for hand sanitizer.

  16. Marin Quezada says:

    Stop blocking efforts to make hand sanitizers!! We are in a pandemic!!! Do your JOB and quit blocking products!!

  17. J. Dana Forbes says:

    To the FDA: Time to wake up and smell the coffee…allow an emergency production of hand sanitizers by those who are able to do the job quickly, safely and efficiently.

  18. Leslie Sutherland says:

    Unfortunately you feel your purpose is to obstruct to show your worthiness. You are a big part of the swamp. The FDA needs to be abolished immediately.

  19. LuAnn Heller says:

    There needs to be a shake down within the FDA. they are still acting on Obama rules. they are not doing their job and make it clear they don’t care about the American people. We don’t need their BS any time let alone a pandemic. They ave been the cause for the lack of tests and medical equipment etc. Congress needs to take action and over see the FDA!!

    • Karen says:

      Hey, LuAnn
      Leave Obama out of this. It was your King the so called President who dismantled the CDC and FDA amount many other agencies then put his cronies in place. Educate yourself

  20. Rossen Vassilev Jr. says:

    Stop Blocking Efforts to Produce Hand Sanitizers!!!

  21. please this country is desperate for hand sanitizer- please relent on your strict guidelines- use your science and common sense.

  22. Theodora Boura says:

    we nee sanitizers!!!!!!!!!!!!!!!!!!!!!

  23. Wayne Isaac says:

    Corrupt communists , evil to the cre. Thanks for the alert

  24. Elise Phillips Margulis says:

    Please relax your requirement for 75% isopropyl alcohol due to a shortage of this ingredient. Please consider allowing compounders further flexibility to meet 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.”

  25. June Tullman says:

    We need sanitizers now!

  26. Joan says:

    The FDA has to stop sabotaging the health of Americans by your insistence that hand sanitizer be made only from denatured alcohol! We need more hand sanitizer right now, not next month or next year! There are plenty of distilleries ready to make 60-95% alcohol hand sanitizer Americans desperately need now. The FDA is playing politics with human lives. No doubt you all have plenty of hand sanitizer for your personal use.

  27. Robin Bergstrom says:

    In an attempt to save lives, you should have flexibility regarding this alcohol issue. If you do not,
    it just reinforces the opinion that many citizens have of your organization already. The “red tape” that you employ wastes time and possibly costs lives. Your efforts over the years to thwart citizens such as myself to take responsibility for my own health has been keenly noted especially in your efforts
    to limit my access to bioidentical hormones. There is NO evidence that bioidenticals contribute to
    cancer; quite the opposite. I am an extremely health (and savvy) 73 year old that is on NO prescription drugs because I have had access to supplements for YEARS. Because of this I am not a “drain” on the Medicare health system. You should keep that in mind when you attempt to
    limit my access to proven alternative care and treatments.
    If your adversarial position continues, you will loose the faith of the American people completely.

  28. Certainly U can be more helpful than stalling
    needed supplies of hand sanitizer.

  29. Lauren Johnson says:

    Why are you enforcing this unnecessary regulation at a time of dire national need? You can’t be bothered to enforce critical existing regulations like regular meat plant inspection, yet you put this nonsensical obstacle in the way of urgently needed national supplies. Stop being ridiculous!

  30. Terry Nelson says:

    It figures. The FDA need to be defunded and disbanded. Big Government red tape: more of the SWAMP needs to be drained.

  31. Karen Wishon says:

    The FDA and the USDA are in the pockets of whomever pays them the most, namely BIG PHARMA!! They’re supposed to be looking out for us, the American people, but nope it’s all about THE ALMIGHTY DOLLAR for the branches of government that SHOULD be on our team but definitely aren’t!!

    FDA just clean up your act and let us be helped NOW!!

  32. Leslie Sheridan says:

    ALLOW HAND SANITIZER PRODUCTION

  33. Kelle Schultz says:

    Trump & those Greedy Old Pricks SUCK.

  34. Paula Morgan says:

    Government doesn’t help. All is only political. People have the right to help themselves. Taking away our access to health food stores, taking away homeopathic, taking away vitamins and minierial suppliments only harms more. In America this is not the usual practice. I like freedom and that is now being restricted by the present administration in order to control our access thus forcing us to seek Big Pharma for expensive and harmful drugs.

    I’m an American and I want Freedom of Choice.

  35. Paula Morgan says:

    Hand Sanitizer is a must in today’s world.

  36. Barking Watchdog says:

    It is time to sue the FDA and put its agents in prison.
    We have a declared world pandemic, and the FDA’s agents are blocking or slowing down the approval of testing, and now of hand sanitizer. What is next ? This is criminal, and any reasonable, rational, law-abiding court should uphold the withholding of hand sanitizer and testing during a world pandemic, as a violent strike felony.
    Folks, let’s gather together, class action, and sue them in the pocketbook, where they will actually listen and learn! There seems to be no other way.
    They may be waiting for us to rise up in disorderly conduct. We the People have class, and have been absolutely peaceful even while suffering shortages of bath tissue during this world pandemic. There is absolutely NO excuse for Any of this, and it is time for violent thugs to be ousted from office and punished in a legal, orderly, peaceful and rightful way….a court of law. Further, it is time to expose the individuals by name, using journalism as our tool, and ousting them from public office. They need to be mandated by a court of law, to seek professional help, after being imprisoned and/or ordered to pay out billions in damages to those they have harmed, no sugar-coating any truth.

  37. Mona says:

    So sad, all because of greed, please help this world instead of being selfish

  38. Andy Gates says:

    I see this article as totally false, there are over 600 small Distillers across the US making hand sanitizer filling the pipeline. It is becoming plentiful in many areas. These small Distillers are getting the ethanol from corn ethanol plants that have plenty of supply, then they blend the product into sanitizer, so they don’t even use their own stilling equipment. The local distillery on my area has seen demand drop over 50% after just 4 weeks of production, so the pipeline is already filling up. Plenty of places are shipping nationwide. The FDA acted very quickly to allow these Distillers to go into production immediately, on about March 20th.

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