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Found 23 results

  1. https://www.ttb.gov/public-guidance/ttb-pg-2020-1a TTB Public Guidance Production of Hand Sanitizer to Address the COVID-19 Pandemic March 26, 2020 TTB G 2020-1A Summary Tax-free ethanol may be used to produce hand sanitizer if it is denatured according to TTB regulations and Food and Drug Administration (FDA) guidance. Alcohol, whether or not denatured, may be delivered tax-free to state and local governments for non-beverage purposes. The same is true for hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions, if not for resale or use in the manufacture of any product for sale. TTB is temporarily waiving certain formula approvals for the manufacture of hand sanitizer using and expediting certain permit requirements. --- It goes on to clarify these items and mention this document dated March 26 supersedes other guidance and refers you to the FDA document "Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-191) Guidance for Industry" for formulation, registration, denaturing, etc. It is available here: https://www.fda.gov/media/136289/download NOTE: This document was updated on March 27, 2020 (yes after the TTB bulletin). This document lists 8 steps to produce sanitizer including registration with the FDA. You must meet all 8 steps including labeling with their specific label requirements. What you make is considered "non sterile" sanitizer which may be of limited use to hospitals or sterile environments. This product is designed and labeled for consumer and health care personnel only it seems. With the updated wording today step 1 wording changed from something like "USP Alcohol" to now giving a list of ingredients that actually allows Glycerin of USP or Food Grade Index use. Hydrogen Peroxide Concentrate USP or Hydrogen Peroxide Topical Solution USP (see footnote) which probably isn't a big deal either. Step 2 covers denaturing and states Formula 40A or 40B with or without the tert-butyl alcohol from TTB Bureau regulations in 27 CFR part 20 and 21. https://www.ttb.gov/other/regulations §21.75 Formula No. 40-A. (a) Formula. To every 100 gallons of alcohol add: One pound of sucrose octaacetate and 1⁄8 gallon of tert-butyl alcohol. (b) Authorized uses. (1) As a solvent: 111. Hair and scalp preparations. 112. Bay rum. 113. Lotions and creams (hand, face, and body). 114. Deodorants (body). 121. Perfumes and perfume tinctures. 122. Toilet waters and colognes. 141. Shampoos. 142. Soaps and bath preparations. 210. External pharmaceuticals, not U.S.P. or N.F. 410. Disinfectants, insecticides, fungicides, and other biocides. 450. Cleaning solutions (including household detergents). 470. Theater sprays, incense, and room deodorants. (2) Miscellaneous uses: 812. Product development and pilot plant uses (own use only). §21.76 Formula No. 40-B. (a) Formula. To every 100 gallons of alcohol add: One-sixteenth avoirdupois ounce of denatonium benzoate, N.F., and 1⁄8 gallon of tert-butyl alcohol. (b) Authorized uses. (1) As a solvent: 052. Inks. 111. Hair and scalp preparations. 112. Bay rum. 113. Lotions and creams (hand, face, and body). 114. Deodorants (body). 121. Perfumes and perfume tinctures. 122. Toilet waters and colognes. 141. Shampoos. 142. Soaps and bath preparations. 210. External pharmaceuticals, not U.S.P. or N.F. 410. Disinfectants, insecticides, fungicides, and other biocides. 450. Cleaning solutions (including household detergents). 470. Theater sprays, incense, and room deodorants. 485. Miscellaneous solutions. (2) Miscellaneous uses: 812. Product development and pilot plant uses (own use only). ======================== So I've highlighted/bolded things that stood out to me. We are now clearly making a non sterile product and some rules are more lax. It does not appear we need to use USP grade products to denature now due to the update they just did. I would not sell the product with further clarification as it could change your taxes/bond etc as the new bulletins aren't the clearest on this at least to me. With this new wording I would not be afraid to use "normal" products for denaturing (meaning cheaper) per TTB 40A & 40B above which the FDA is allowing for this CONSUMER product. But with the FDA taking charge of the "rules" of how the product is made, please make sure to read that bulletin and make sure to follow all 8 steps including FDA registration and labeling for sure. Wish I could be more help, but that's it for now from me. What I am curious about is how the TTB/FDA will handle people making products that are not denatured and haven't registered with the FDA since there was a brief period where this was allowed? Hopefully in good faith if product is being given away!
  2. I think this site covers this really well. http://melniklegal.com/weblog/1380663946_Mobile-Apps-FDA.html Guidance Documents After a regulation is issued, the FDA may determine that it needs to provide stakeholders with more information on how the FDA intends to exert (or decline to exercise, as the case may be) its regulatory authority. The FDA does this through issuing Guidance documents. The FDA follows the procedures required by its "Good Guidance Practice" regulation to issue FDA guidance. FDA guidance describes the agency’s current thinking on a regulatory issue. Guidance documents must not set new legal standards or impose new requirements. Unlike regulations, guidance documents do not contain amendments to the Code of Federal Regulations and are not subject to the notice and comment process. Are FDA Guidance Document Law? No. As the FDA makes clear, the FDA guidance documents are not legally binding on the public or the FDA. BUT, the FDA has come to rely on guidance documents as a means of informal policy making. By telling industries when it does and does not plan to act, the FDA is giving industry stakeholders notice of its position on certain issues (e.g., how the FDA intends to treat mobile medical apps). As a result, impacted industries would be wise to take heed and pay attention to the guidance documents. So, for practical purposes, FDA guidance documents are laws. =============== So the take away is that if you follow the directions outlined in their guidance docs, they won't be coming after you. The thing to keep in mind is that this is TEMP authority to make a new product that we are not normally BONDED to make. Keep in mind this is a temporary solution with an easier way to make sanitizer than usually done as required by the FDA. =============== On another note. The Covid-19 virus and the TTB/FDA allowing DSPs to make sanitizer is going to be a great feather in the cap of DSP in the USA (and other places) if we don't screw it up. In months/years to come this could affect laws in ways that make it easier to open smaller micro distilleries or expansions of existing facilities and maybe even home distillation (like beer and wine). Where at present some city/towns and counties try hard to keep DSPs out or make it very hard, we might be seen in a different light and be more welcomed knowing that we are there if needed in times like Covid-19 or similar. Anyone trying to open or expand facilities should take advantage of this and build it into their business plans from stocking of key ingredients and distribution bottles to having partnered with other local business to help with fermentables & packaging to having a plan for distribution including city/town employees including rescue, police, fire, first responders and health care providers. This could even be a partnering with the city/town to have stock of certain items for just such an emergency that you could use to turn out a product. Showing how you would try to put community first in time of need will go along way in some areas.
  3. Update, courtesy of the Virginia Distillers Association: as always, please check with your state's regs! Some of this info looks like a repeat but there is indeed updated guidance. Also, as with @InsuranceMan 2.0's mention, please keep any potential insurance liability in mind and proceed at your own risk. I personally have been in touch with state representatives that have assured me their support in our production of this - for whatever it's worth lol! Apologies in advance for any link issues - let me know if you have a problem accessing and I'll re-work them. FDA: The FDA has issued guidance for its temporary policy for compounding of certain alcohol-based hand sanitizer products. Please CLICK HERE for the presser. The downloadable guidance document entitled " Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-191 ) Guidance for Industry" (attached to this post) provides protocol for distilleries to manufacture hand sanitizer. Items 1-6 listed in the document provide the essence of the protocol that will need to be followed. Item 6 states you will need to register with the FDA, but it appears once you register online you will receive immediate approval by FDA. TTB: Due to the Coronavirus 2019 (COVID-19) pandemic, the Acting Administrator of the Alcohol and Tobacco Tax and Trade Bureau (TTB) has found that it is necessary or desirable to waive provisions of internal revenue law with regard to distilled spirits, and therefore is providing certain exemptions and authorizations to distilled spirits permittees who wish to produce ethanol-based hand sanitizers to address the demand for such products during this emergency. Any existing DSP therefore can immediately commence production of hand sanitizer or distilled spirits (ethanol) for use in hand sanitizer, as described below, without having to obtain authorization first. These measures are generally authorized under authorities that apply in disaster situations, and as a result, are initially approved through June 30, 2020, with the possibility for extension as necessary. Permit guidance for alcohol fuel plants (AFPs) and beverage distilled spirits plants: TTB is exempting AFPs and beverage DSPs from the requirement to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer to other TTB permittees who are authorized to receive such distilled spirits. TTB is authorizing this exemption under the authority of 26 U.S.C. 5562. AFPs and beverage DSPs must continue to keep records of their operations, including any undertaken as authorized under this exemption. Tax guidance for the manufacture of hand sanitizer: Hand sanitizer products are not subject to Federal excise tax if made with denatured ethanol. However, if made with undenatured ethanol, Federal excise tax applies. For information regarding denaturants, please contact TTB’s Scientific Services Division. WHO production: https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf DistilleryTrail.com map and listings for producers: https://www.distillerytrail.com/blog/breaking-ttb-gives-distillers-green-light-to-produce-ethanol-based-hand-sanitizer/ ADI survey: https://www.surveymonkey.com/r/QMXWY32 FDA_Hand Sanitizers Immediately in Effect Guidance Other Firms FINAL_0.pdf
  4. Does anyone know anything more about the tax relief mentioned by DISCUS in this news release? News Statement by Distilled Spirits Council of the United States President Chris Swonger on House Passage of COVID-19 Relief Package Which Includes Critical Tax Waiver for Distillers’ Production of Hand Sanitizer: March 27, 2020 1:36 pm “We are grateful that Congress recognizes the significant contributions of the nation’s distillers in producing hand sanitizer to help fight COVID-19, and for waiving the federal excise tax on these much-needed products so that these distillers are not subjected to a tax bill for their goodwill. We urge the FDA to update its guidance for distillers to ensure this tax provision can be implemented. The hospitality industry is one of the hardest hit by COVID-19, and many craft distilleries are facing the very real possibility that they may not be able to open their doors again when this crisis is over. There is more to be done, and we look forward to working with Congress and the administration to ensure future success for distilleries across the United States.”
  5. Personal Comments I want to say a few personal things before saying anything more on this thread. i think the observations are germane to the issues. I post here in sterile terms. This, I say, is what I think the regulations say. It seems officious. Bureaucratic. Uncaring. It is "i" dotting and "t" crossing in a time of public need and social upheaval. Where is the perspective? So, I want to offer a little personal, hopefully humane, perspective before getting back to the officious. It begins with some observations on which I will not elaborate. Bureaucracies do not exist without the people who staff them. They act only through those people. if they are composed of mean people, then they do mean things. TTB as I know it has never been composed of mean people. There are a few bastards, but by and large, TTB employees care. Before TTB issued the more detailed guidelines I've been discussing, , back when DISCUS had said that they were talking with TTB about sanitizers and that DISCUS understood that guidelines would be coming out, I got a call from a client. He said something like this, "The firemen down the street are looking for hand sanitizer. They can't get any. They are asking for help. What can I do?" I started by saying this rule says this, that rule says that, etc., and then got personal. I told him that I could not advise anyone about the risks they might want to take. That is not my business. My business is to say what I think is required, so that others can evaluate the risks of any "civil disobedience" in which their conscience might dictate they engage. I said, if it were me, I'd adopt the Nike motto and "Just do it," make a clear record of what I had done, and be prepared to suffer the consequences later. I added that I doubted that there would be any consequences unless what I did demonstrated a reckless disregard for public safety or indefensible profiteering in the face of an emergency.. I still feel that way. I live far enough to the east of the Washington State hotbed that, as of yesterday, my rural county had recorded only four known cases of Covid-19. However, I know two of those people - no recent contact - and also know, by one or two degrees of separation, at least 20 more in Western Washington who have tested positive, one of whom died. This morning's reports on the 15,000 plus cases in New York state only fuels my conviction. I "know," in the visceral sense, that this is going to get catastrophic. Fast. It is not a time for fuddy-duddy concerns. So, I would without hesitation take action, on the local level, to meet the needs, which cannot now be filled by a national supply chain. of the local health care providers and other public service agencies on which my community depends. To do so, I would assume gray areas were a go. But I would not open a store front business selling the stuff unless I knew that the gray areas where in fact white. That is what I would do. I do not advocate that you do it. But the concerns are mostly unnecessary. In most cases, the TTB guidelines provide a reasonable way for you to meet local needs. There is no need to set your own rules to get things done. If you want t to make a product that works, then it is no more difficult to do so following TTB's guidance document than it is to ignore them and do your own thing. With that, I'll return to the more officious analysis, identifying the gray areas as I find them, and trying to tell you how I would argue, if I had to, that they permit what I did, especially in times of emergency when being absolutely sure one is right can hog tie action that is need immediately. Stay safe
  6. As I said somewhere a long time ago in this now too long thread, DISCUS and its likes are better able to deal with this by playing above the rim than a pipsqueak like me is. I'm copying, below, two documents from the Distilled Spirits Council's website. https://www.distilledspirits.org/news/discus-statement-on-u-s-reps-yarmuth-barr-letter-to-fda-commissioner-urging-flexibility-for-distilleries-producing-hand-sanitizer/ One is a letter members of congress have sent to the FDA on this issue. The other is the councils statement on the letter.. It's time to let the big boys play. I'll have one more post on the matter of things other than hand sanitizers and then I'm retiring. I never want to hear the word hand sanitizer again :-). I wash my hands of it, so to say. DISCUS Statement on U.S. Reps. Yarmuth, Barr letter to FDA Commissioner Urging Flexibility for Distilleries Producing Hand Sanitizer March 29, 2020 1:05 pm Statement by Distilled Spirits Council of the United States President & CEO Chris Swonger on a letter sent by Co-chairs of the Congressional Bourbon Caucus Chairman John Yarmuth and Congressman Andy Barr and 85 members of the House of Representatives to U.S. Food and Drug Administration Commissioner Stephen Hahn urging the agency to update its guidance to recognize the use of undenatured alcohol in the production of hand sanitizer during the COVID-19 health crisis: “Distillers across the country are jumping in to produce hand sanitizer for first responders, hospitals and those in need in their communities. The recently-passed CARES Act includes an important provision to guard distillers from having to pay federal excise taxes on the alcohol used. Unfortunately, FDA must first update their guidance to permit distillers to use undenatured alcohol, which is recommended by WHO and is the type of alcohol distillers readily have on hand. We appreciate the support of Chairman Yarmuth, Congressman Barr and the 85 House members in calling on the FDA to be more flexible during this crisis so we can get hand sanitizer to those who need it most. The Distilled Spirits Council of the United States is committed to working with the FDA to explore appropriate ways to address any safety concerns.” BACKGROUND: For weeks DISCUS has been urging FDA to update its Guidance to permit distillers to use undenatured alcohol in its hand sanitizer formula as directed by the WHO Guidance. Most beverage alcohol companies exclusively make products with undenatured alcohol and may not be able to access the required denaturing materials. Denatured spirits are those that are treated with bittering agents to make them unsuitable for human beverage consumption. DISCUS has raised concerns with FDA regarding potential shortages of denaturing ingredients as well as the effect the denaturing materials may have on distilling equipment. Due to the highly concentrated nature and toxicity of the bittering agents, these components are very persistent and distillers may have to develop a special cleaning method to remove them before beverage grade product can be reintroduced. Requiring denaturing could also significantly increase the amount of time it takes to produce this product and get it to those who need it now. The WHO Formula is a very high proof alcohol with hydrogen peroxide, which is less palatable than other denatured products currently on the market. Thus, further bittering should not be needed, particularly in light of the present need. ### ____________________ Friday, March 27, 2020 The Honorable Stephen Hahn Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Dear Commissioner Hahn: We write regarding the U.S. Food and Drug Administration’s (FDA) guidance to manufacturers who are producing hand sanitizer as part of the COVID-19 crisis. As you know, hundreds of distilled spirits producers across the country have immediately responded to the current health crisis by halting their regular operations and quickly turning to the production of hand sanitizer. These distillers are fulfilling a critical need in their communities and providing the hand sanitizer to health care professionals, first responders, and local and state governments. They have diligently followed the guidance released by their regulator, the Alcohol, Tobacco Tax and Trade Bureau (TTB), and are producing hand sanitizer according to the World Health Organization’s (WHO) formula. Unfortunately, the FDA’s “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19): Guidance for Industry” does not acknowledge the reality that these distillers have stepped up in a time of crisis to produce hand sanitizer using the alcohol they have readily available, which is undenatured. Undenatured alcohol is food grade alcohol that is compliant with the WHO’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. A provision was included in the recently-passed COVID-relief package that would temporarily remove the Federal Excise Tax on hand sanitizer production as long as the distiller has followed FDA guidance. Through the current guidance, the FDA is standing in the way of hundreds of thousands of gallons of hand sanitizer from being produced and given to those on the front lines battling this pandemic. We have a responsibility to provide more resources to help flatten the curve and alleviating this burden would allow distilleries the opportunity to step up and help their communities. We strongly urge the agency to update its guidance to recognize the use of undenatured alcohol in the production of hand sanitizer during the COVID-19 health crisis and work with industry on reasonable safeguards to keep hand sanitizer out of the hands of children. This will ensure distillers do not face a tax bill for filling a vital need in their communities. Sincerely, _________________________ _________________________ John Yarmuth Andy Barr Member of Congress Member of Congress
  7. If you think the world is over-reacting to COVID-19 you have not understood the problem. Comparing it to normal flu is irrelevant. You need to compare it to the 1918 Spanish Flu. The only good news so far is that the Chinese have proven that it can be beaten - using basically the same techniques that worked in 1918 and against SARS. If you are prepared to invest half an hour into understanding the process and the risks we face, have a read through this article. Our problem in the west is that we rank personal freedoms above those of the group and this makes it more difficult for us to implement the group focused solutions that have worked for the Chinese.
  8. Greetings! I'm an independent spirits bottler in Berkeley, California and am trying to do some research on the best way for craft producers to navigate the hurdles involved in in hand sanitizer production. I spoke to two bulk alcohol suppliers today who were not able to reassure me about current or continued availability of GNS, especially for new customers and at smaller quantities (~1000 liters). From the bulk supplier's point of view, the supply chain supporting large manufacturers is more efficient at distributing this needed resource. This opinion was reiterated by someone who runs a column still capable of producing GNS efficiently and also works with large volumes (tens of tanker trucks) of bulk product. A few questions for everyone: What has been your experience with sourcing GNS recently / in the last week or so? If GNS is unavailable, or at least unavailable in small enough quantities to be appropriate for craft bottling operations, how many craft distillers are able to produce 192 proof (or 185 proof per dhdunbar's analysis above) spirits and at what volume? If supply chains supporting small producers are not working, do we need to discuss an effort to organize transfer-in-bond operations (and any other legal issues?) that could facilitate a cooperative bulk order? Is this practical? I have heard of craft producers selling hand sanitizer to recoup costs and others giving it away. Is hand sanitizer a viable means to cushion the financial impact of the COVID-19 effect on a small business or an opportunity for community service? Can it be both? Thanks for your help, Nate
  9. Edit on 23March2020. The information below is out dated due to new guidance and guidelines that have recently changed. I am leaving this post up as current regulation loosening may be temporary. Best to check with the proper authorities for anyone reading this after the covid-19 outbreak passes. Went over this already. Hand sanitizer is regulated by the FDA as a OTC drug. Unless you are licensed as a drug manufacturer and reseller you are treading in dangerous territory. https://www.fda.gov/drugs/information-drug-class/topical-antiseptic-products-hand-sanitizers-and-antibacterial-soaps A few have said "we won't call it hand sanitizer." Well, you can call it whatever you want, but if the feds and/or state say it looks like a duck and quacks like a duck, they are the ones who determine (not you) if it's a duck. If anyone knows for sure otherwise, please let me know. FYI one of our suppliers for beverage alcohol is focusing their entire operation towards fulfilling orders for hand sanitizer manufacturers and all beverage alcohol is delayed 2 weeks. There's the very real chance you could lose your business and 1 day later every Home Depot has 20 pallets of the stuff. You probably spent years and your entire life's savings opening a business in a highly regulated industry, don't risk it by treading into another highly regulated industry that you aren't licensed in.
  10. https://www.fda.gov/media/136118/download Because of the public health emergency posed by COVID-19, FDA does not intend to take action against compounders that prepare alcohol-based hand sanitizers for consumer use for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present: It's only 9 pages that are easy to read. I didn't even give thought to selling this when reading the thread and just thought it was for own personal/family use. Interesting they give a recipe using 80% alcohol plus Glycerol (1.45% v/v), Hydrogen peroxide (0.125% v/v), Sterile distilled water or boiled cold water.
  11. Edit on 23March2020. The information below is out dated due to new guidance and guidelines that have recently changed. I am leaving this post up as current regulation loosening may be temporary. Best to check with the proper authorities for anyone reading this after the covid-19 outbreak passes. Unless i'm reading this wrong, it does not say distillers can make hand sanitizer Disclaimer: I have not finished reading it yet.
  12. Further reading: Edit on 23March2020. The information below is out dated due to new guidance and guidelines that have recently changed. I am leaving this post up as current regulation loosening may be temporary. Best to check with the proper authorities for anyone reading this after the covid-19 outbreak passes. I am not entirely familiar with USP certification or grade. Is what we make USP grade? I'm guessing not. Ethanol, 80% vv denatured according to TTB. If you do not have the checkbox for denaturing operations, you can not legally do this. Mind "The compounder does not add other active or inactive ingredients", so a compounder (pharmacist) may not veer from the above recipe. Also keep in mind that only ethanol can be used which rules out using heads for this purpose. I'm not trying to be a downer. I fully support this and will dedicate all available resources towards this if and only if we can legally do it.
  13. The form on DISCUS may or may not help distilleries connect with vendors looking to help supply necessary ingredients https://www.distilledspirits.org/distillers-responding-to-covid-19/
  14. Edit on 23March2020. The information below is out dated due to new guidance and guidelines that have recently changed. I am leaving this post up as current regulation loosening may be temporary. Best to check with the proper authorities for anyone reading this after the covid-19 outbreak passes. Same with us. Those laws and regulations are there for a reason. You wouldn’t trust a distillery to make Baby Asprin, would you? It’s production is regulated no different. As a PROFESSIONAL distiller I am obligated to follow the rules and laws of what I can manufacture and how it’s to be manufactured. This is largely for public safety. As a healthcare professional I am obligated to “do no harm” and ensure the proper steps and procedures are being followed when it comes to patient safety. Going rogue, abandoning guidelines, and having total disregard for the law is reckless and puts consumers and employees at unnecessary risk. But hey, I’m sure it’s a great marketing opportunity during a global crisis :eye roll: That being said, if the feds give us the direction and approval to start making a sanitizing product, they have the full support of our entire production facility and all available staff. Until that happens though, we will follow the law.
  15. Updated FDA Guidence 3/24/20 This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. Download full doc below. Ethanol-for-Hand-Sanitizer-FINAL-3.24.20.pdf
  16. DISCUS has put together a resource page for distillers here: https://www.distilledspirits.org/distillers-responding-to-covid-19/ Our COVID-19 Hand Sanitizer Connection Portal is a resource for distillers looking to produce hand sanitizer – providing a list of the necessary ingredients and supplies for making sanitizer and identifying distribution methods.. The portal is available for ALL American distillers to access.
  17. TTB Public Guidance Production of Hand Sanitizer to Address the COVID-19 Pandemic March 26, 2020 TTB G 2020-1A Summary Tax-free ethanol may be used to produce hand sanitizer if it is denatured according to TTB regulations and Food and Drug Administration (FDA) guidance. Alcohol, whether or not denatured, may be delivered tax-free to state and local governments for non-beverage purposes. The same is true for hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions, if not for resale or use in the manufacture of any product for sale. TTB is temporarily waiving certain formula approvals for the manufacture of hand sanitizer using and expediting certain permit requirements. Purpose On March 18, 2020, to facilitate the production of hand sanitizer, TTB temporarily relieved distilled spirits permittees of certain requirements related to the use of alcohol for this nonbeverage purpose (see TTB G 2020-1 “Production of Hand Sanitizer to Address the COVID-19 Pandemic”). TTB exempted permittees from obtaining formula approval from TTB before producing hand sanitizer if using a formula consistent with World Health Organization (WHO) guidance. Ethanol is one of the approved reagents in the WHO guidance. TTB’s March 18 authorization referred to both denatured and undenatured ethanol. However, on March 23, 2020, the FDA issued guidance which specifies the use of denaturants when compounding ethanol-based hand sanitizers. See Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). TTB is therefore providing this guidance to (1) supersede its prior guidance with regard to the authorized formula to be consistent with FDA guidance; (2) exempt distilled spirits plants (DSPs) from the requirements to request approval from TTB to receive denatured or undenatured distilled spirits in bond from another DSP and to obtain additional bond coverage, through June 30, 2020; (3) provide guidance and certain exemptions from requirements for state and local governments wishing to obtain tax-free alcohol, and (4) offer hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions the same streamlined application process. This guidance also restates the provisions of TTB G 2020-1 that remain unchanged. Guidance Due to the Coronavirus 2019 (COVID-19) pandemic, the Acting Administrator of the Alcohol and Tobacco Tax and Trade Bureau (TTB) has found it desirable to waive provisions of internal revenue law with regard to distilled spirits, and therefore is providing certain exemptions and authorizations to distilled spirits permittees who wish to produce ethanol-based hand sanitizers to address the demand for such products during this emergency. Any existing DSP therefore can immediately commence production of hand sanitizer or distilled spirits (ethanol) for use in hand sanitizer, as described below, without having to first obtain authorization. Any existing DSP also may remove undenatured or denatured ethanol from bonded premises free of tax for use by any state or local government to produce hand sanitizer. In addition, any existing DSP may remove undenatured or denatured ethanol from bonded premises free of tax for use by hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions seeking to use it to manufacture hand sanitizer, and not for resale or use in the manufacture of any product for sale. See 26 U.S.C. 5214(a)(3). These measures are generally authorized under authorities that apply in disaster situations, and as a result, are initially approved through June 30, 2020, with the possibility for extension as necessary. Although TTB is exempting industry members from certain tax requirements through this guidance, industry members must continue to comply with other federal and state law, and industry members should contact relevant federal or state agencies with questions about guidance issued by those agencies. Permit guidance for alcohol fuel plants (AFPs) and beverage DSPs: TTB is exempting AFPs and beverage DSPs from the requirement to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer to other TTB permittees who are authorized to receive such distilled spirits. TTB is authorizing this exemption under 26 U.S.C. 5562. AFPs and beverage DSPs must continue to keep records of their operations, including any undertaken as authorized under this exemption. Tax guidance for the manufacture of hand sanitizer: Nonbeverage products made with ethanol, including hand sanitizer, are not subject to federal excise tax. Please note that the FDA guidance referenced above specifies the use of denaturants when compounding hand sanitizer. For information regarding denaturants, please contact FDA. Formula guidance for the manufacture of hand sanitizer: TTB is authorizing the manufacture of hand sanitizer products by DSPs using a formulation in the FDA guidance cited above without first obtaining formula approval from TTB. Guidance for industrial alcohol users: Industrial alcohol user permittees may also use denatured ethanol to manufacture hand sanitizer using a formulation in the FDA guidance cited above without first obtaining formula approval from TTB. During the period covered by this guidance, TTB is also exempting industrial alcohol user permittees from the requirement to request approval from TTB to increase the quantities of denatured ethanol that they may procure. See 27 CFR 20.42(a)(3), 20.56. TTB is authorizing these exemptions under its authority in 27 CFR 20.22(b) to approve emergency variations from regulatory requirements. Guidance regarding transfers in bond. Under current TTB regulations, when DSPs want to receive either denatured or undenatured ethanol from another domestic DSP, the receiving DSP must submit an application to TTB for authorization prior to the first transfer and ensure appropriate bond coverage. See 27 CFR 19.403, 404. During the period covered by this guidance, for transfers of either denatured or undenatured distilled spirits between domestic DSPs, TTB is exempting DSPs from the requirements to request approval from TTB to receive denatured or undenatured distilled spirits from another DSP and to obtain additional bond coverage. Rather than submit such requests to TTB for approval using TTB F 5100.16, DSPs must maintain records of such receipts, which would include records of the information currently required on TTB F 5100.16. TTB is authorizing these exemptions under its authority in 27 CFR 19.28 to approve emergency variations from regulatory requirements. Guidance for state and local governments. Both denatured and undenatured alcohol may be removed free of tax for the use of a state, any political subdivision of a state, or the District of Columbia, for nonbeverage purposes, including making hand sanitizer. See 26 U.S.C. 5214(a)(2). An alcohol user permit is required to obtain alcohol from a distilled spirts plant. See 26 U.S.C. 5271(a); 27 CFR part 22. TTB provides state and local governments with a streamlined application, as authorized under 27 CFR 22.42 and 22.43(a)(1). TTB has dedicated personnel to process such applications seven days a week given the COVID-19 emergency. Please note that the recent FDA guidance cited above specifies using denaturants when compounding hand sanitizer. During the period of this guidance, TTB is authorizing state and local government permittees to make hand sanitizer for use anywhere, as needed to address the COVID-19 national emergency. See 27 CFR 22.22(b). Guidance for hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions. Hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions may obtain alcohol free of tax for their own nonbeverage purpose use and not for resale or use in the manufacture of any product for sale, as described in 26 U.S.C. 5214(a)(3). Manufacturing hand sanitizer is one such nonbeverage use. As with state and local governments, such alcohol must be obtained from a distilled spirits plant and may only be obtained by those holding an alcohol user permit from TTB. See 26 U.S.C. 5271(a); 27 CFR part 22. TTB will offer these organizations the same streamlined application, as authorized under 27 CFR 22.42 and 22.43(a)(2). Again, please note that recent FDA guidance specifies using denaturants when making hand sanitizer. Further Information If you have questions regarding obtaining a TTB permit, please contact the National Revenue Center at 877-882-3277 / 877-TTB-FAQS (toll free) or online. For all other inquiries, please contact the Regulations and Rulings Division at 202-453-2265 or online. Please visit the homepage of TTB.gov for the most recent TTB news on COVID-19 related issues.
  18. Read the DISCUS attachments before jumping in. Then wait until TTB puts out the rules. TTB needs to waive some things and I'm not sure that they can do it, since they can't grant any waivers that would be contrary to law. §19.29 gives them broad authority, "Whenever TTB finds it is necessary to meet the requirements of national defense or necessary or desirable by reason of disaster, TTB may temporarily exempt the proprietor from any provisions of the internal revenue laws and the provisions of this part relating to distilled spirits, except those requiring the payment of tax." The phrase "those relating to the payment of tax" might be read broadly, but TTB's rules, when issued, will give you a safe haven. In the meantime, use soap. From what I read, it works a lot better. And, from someone who knows, by either one or two degrees of separation, over 20 people who have tested positive for covid-19, I've got to add "Stay safe." Only one of them has died - age 43 by the way - but a few more have felt like they were going to and all were at a minimum inconvenienced by being isolated in their own home. One, who did not know she had it, met with eight others. Five of them tested negative; three positive. That's a damned high transmission rate, but its anecdotal.
  19. Just to make sure this is clear distillers in the USA must follow TTB rules and labeling exactly as written and pay tax if the alcohol was not prepared to United States Pharmacopoeia (USP) grade or wasn't denatured. WHO and FDA set guidelines. TTB sets rules and waivers that DSP & AFP must follow for Covid-19 production of sanitizer. If in the USA start with the TTB guidance listed here and make sure you comply. https://www.ttb.gov/public-guidance/other-public-guidance-documents
  20. Special Edition - COVID-19 Production of Hand Sanitizer by Distilled Spirits Permittees Greetings! This special edition contains guidance for DSPs and Industrial Alcohol User permittees on producing ethanol-based hand sanitizers. Due to the Coronavirus 2019 (COVID-19) pandemic, the Acting Administrator of the Alcohol and Tobacco Tax and Trade Bureau (TTB) has found that it is necessary or desirable to waive provisions of internal revenue law with regard to distilled spirits, and therefore is providing certain exemptions and authorizations to distilled spirits permittees who wish to produce ethanol-based hand sanitizers to address the demand for such products during this emergency. Any existing DSP therefore can immediately commence production of hand sanitizer or distilled spirits (ethanol) for use in hand sanitizer, as described below, without having to obtain authorization first. These measures are generally authorized under authorities that apply in disaster situations, and as a result, are initially approved through June 30, 2020, with the possibility for extension as necessary. Permit guidance for alcohol fuel plants (AFPs) and beverage distilled spirits plants: TTB is exempting AFPs and beverage DSPs from the requirement to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer to other TTB permittees who are authorized to receive such distilled spirits. TTB is authorizing this exemption under the authority of 26 U.S.C. 5562. AFPs and beverage DSPs must continue to keep records of their operations, including any undertaken as authorized under this exemption. Tax guidance for the manufacture of hand sanitizer: Hand sanitizer products are not subject to Federal excise tax if made with denatured ethanol. However, if made with undenatured ethanol, Federal excise tax applies. For information regarding denaturants, please contact TTB’s Scientific Services Division. Formula guidance for the manufacture of hand sanitizer: TTB is authorizing the manufacture of hand sanitizer products consistent with World Health Organization (WHO) guidance. All TTB-permitted DSPs (including AFPs and beverage DSPs) may manufacture hand sanitizer products that are comprised of denatured or undenatured ethanol, glycerol (not less than 1.45% of the finished hand sanitizer product on a volume basis), and hydrogen peroxide (not less than 0.125% of the finished hand sanitizer product on a volume basis), without first obtaining formula approval from TTB. Guidance for industrial alcohol users: Industrial alcohol user permittees may also use denatured ethanol to manufacture hand sanitizer consistent with World Health Organization (WHO) guidance without first obtaining formula approval. During the period of this guidance, TTB is also exempting industrial alcohol user permittees from the requirement to request approval from TTB to increase the quantities of denatured ethanol that they may procure (see 27 CFR 20.42(a)(3) and 20.56). TTB is authorizing these exemptions under its authority in 27 CFR 20.22(b) to approve emergency variations from regulatory requirements. This information is available on our Public Guidance page.
  21. Special Edition - COVID-19 Production of Hand Sanitizer by Distilled Spirits Permittees Greetings! This special edition contains guidance for DSPs and Industrial Alcohol User permittees on producing ethanol-based hand sanitizers. Due to the Coronavirus 2019 (COVID-19) pandemic, the Acting Administrator of the Alcohol and Tobacco Tax and Trade Bureau (TTB) has found that it is necessary or desirable to waive provisions of internal revenue law with regard to distilled spirits, and therefore is providing certain exemptions and authorizations to distilled spirits permittees who wish to produce ethanol-based hand sanitizers to address the demand for such products during this emergency. Any existing DSP therefore can immediately commence production of hand sanitizer or distilled spirits (ethanol) for use in hand sanitizer, as described below, without having to obtain authorization first. These measures are generally authorized under authorities that apply in disaster situations, and as a result, are initially approved through June 30, 2020, with the possibility for extension as necessary. Permit guidance for alcohol fuel plants (AFPs) and beverage distilled spirits plants: TTB is exempting AFPs and beverage DSPs from the requirement to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer to other TTB permittees who are authorized to receive such distilled spirits. TTB is authorizing this exemption under the authority of 26 U.S.C. 5562. AFPs and beverage DSPs must continue to keep records of their operations, including any undertaken as authorized under this exemption. Tax guidance for the manufacture of hand sanitizer: Hand sanitizer products are not subject to Federal excise tax if made with denatured ethanol. However, if made with undenatured ethanol, Federal excise tax applies. For information regarding denaturants, please contact TTB’s Scientific Services Division. Formula guidance for the manufacture of hand sanitizer: TTB is authorizing the manufacture of hand sanitizer products consistent with World Health Organization (WHO) guidance. All TTB-permitted DSPs (including AFPs and beverage DSPs) may manufacture hand sanitizer products that are comprised of denatured or undenatured ethanol, glycerol (not less than 1.45% of the finished hand sanitizer product on a volume basis), and hydrogen peroxide (not less than 0.125% of the finished hand sanitizer product on a volume basis), without first obtaining formula approval from TTB. Guidance for industrial alcohol users: Industrial alcohol user permittees may also use denatured ethanol to manufacture hand sanitizer consistent with World Health Organization (WHO) guidance without first obtaining formula approval. During the period of this guidance, TTB is also exempting industrial alcohol user permittees from the requirement to request approval from TTB to increase the quantities of denatured ethanol that they may procure (see 27 CFR 20.42(a)(3) and 20.56). TTB is authorizing these exemptions under its authority in 27 CFR 20.22(b) to approve emergency variations from regulatory requirements. This information is available on our Public Guidance page.
  22. FDA guidance relevant to hand sanitizer production at DSPs (all documents found here: 3/14/20 FDA-2020-D-1106 Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency 3/19/20 FDA-2020-D-1106 Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) 3/24/20 FDA-2020-D-1106 Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry TTB guidance relevant to hand sanitizer production at DSPs: 3/26/20 TTB G 2020-1A Production of Hand Sanitizer to Address the COVID-19 Pandemic (supersedes prior guidance). Note: The TTB guidance above (TTB G 2020-1A) has a reference to a March 23 FDA guidance document but the hypertext link appears to download a copy of the 3/19/20 FDA-2020-D-1106 version linked above. It's difficult to tell which is which when you're clicking around (I haven't seen any document revision tracking system beyond stating the month of publication). Also linked above is the 3/24/20 version of FDA-2020-D-1106, which has direct instructions about denaturing ethanol: ."..FDA does not intend to take action against alcohol production firms that manufacture alcohol [for use in] alcohol-based hand sanitizers ... provided the following circumstances are present: ... 3.The alcohol is denatured ... using the formulas in Appendix C of this document. ... Beyond alcohol, water, and denaturants (if added at the point of production), the alcohol production firm does not add other ingredients. Different or additional ingredients in the API may impact the quality and potency of the finished hand sanitizer product. ...
  23. TTB G 2020-1A Production of Hand Sanitizer to Address the COVID-19 Pandemic This guidance appears to promote two paths to getting ethanol products from DSPs to consumers. One path allows ethanol (denatured or undenatured) to be removed tax-free for non-beverage use at government or health facilities. Correct me if I'm wrong, but this path does not seem to require ~95% neutral spirit. Another path allows tax-free production of hand sanitizer products per FDA interpretation of WHO rules. This either requires denaturing in house or purchase of bulk denatured product. Transfer in bond applications are waived. With appropriate record keeping, bulk product can move around between DSPs more efficiently.
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