Hand Sanitizer from GNS

[SCLabGuy]

I agree wholeheartedly with dhdunbar's analysis.  Thank you for taking the time to parse it.

[DrDistillation]

From https://www.ttb.gov/public-guidance/ttb-pg-2020-1a under Guidance section it gives an overview and then lists: see See 26 U.S.C. 5214(a)

This has 13 listed reasons.  Besides withdrawing Ethanol for state and local government only #3 seems to apply "(3)free of tax for nonbeverage purposes and not for resale or use in the manufacture of any product for sale—"  This is also the same wording used in the bulletin with the added waiver.

This to me makes it clear that the product produced by the DSP is not allow to use it for any product (sanitzer) that is for sale.  This is the same way I read the TTB bulletin as well.

In my reading of "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." from ttb bulletin linked above this states the DSP can not resale or use the product in the manufacture of a product for sale.  I do not read this as the DSP is excluded and it only apply to the others listed.  My reading goes with 26 U.S.C. 5214(a) as referenced which has clearer wording.

Am I wrong? dhdunbar, what do you think when you read 26 U.S.C. 5214(a) as noted in the the guidance?

 

[Pour Decisions]

2 hours ago, DrDistillation said:

From https://www.ttb.gov/public-guidance/ttb-pg-2020-1a under Guidance section it gives an overview and then lists: see See 26 U.S.C. 5214(a)

This has 13 listed reasons.  Besides withdrawing Ethanol for state and local government only #3 seems to apply "(3)free of tax for nonbeverage purposes and not for resale or use in the manufacture of any product for sale—"  This is also the same wording used in the bulletin with the added waiver.

This to me makes it clear that the product produced by the DSP is not allow to use it for any product (sanitzer) that is for sale.  This is the same way I read the TTB bulletin as well.

In my reading of "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." from ttb bulletin linked above this states the DSP can not resale or use the product in the manufacture of a product for sale.  I do not read this as the DSP is excluded and it only apply to the others listed.  My reading goes with 26 U.S.C. 5214(a) as referenced which has clearer wording.

Am I wrong? dhdunbar, what do you think when you read 26 U.S.C. 5214(a) as noted in the the guidance?

 

 

 

@DrDistillation This is the same excerpt I posted in the other thread regarding sales. Of those 13 reasons listed, #1(c) covers it

26 U.S. Code § 5214

(a)Purposes Distilled spirits on which the internal revenue tax has not been paid or determined may, subject to such regulations as the Secretary shall prescribe, be withdrawn from the bonded premises of any distilled spirits plant in approved containers—

(1)free of tax after denaturation of such spirits in the manner prescribed by law for—

(A)

exportation;

(B)

use in the manufacture of ether, chloroform, or other definite chemical substance where such distilled spirits are changed into some other chemical substance and do not appear in the finished product; or

(C)

any other use in the arts and industries (except for uses prohibited by section 5273(b) or (d)) and for fuel, light, and power; or

[DrDistillation]

I'd not think so as "arts and industries" will usually refer to manufacture of cleaning fluids, detergents, proprietary antifreeze solutions, thinners, lacquers, and brake fluids; and for fuel, light, and power.  As in things used in industry but not medical or pharma.

[John Bassett]

I spoke to two manufacturing places today that are jumping into making sanitizer.   None of them understand proofing at all.   It may be too easy to get FDA Approval that they would allow companies that do not know the dangers of alcohol or why to denature.   I tried to provide advice to the one place on the value of getting a hydrometer, thermometer, graduated cylinder and Meerket's program.  I have no idea if they will take that advice.  His comment was "Isn't that on the provider of alcohol"?   I told him that if he is blending, the final product is on him. 

[Pour Decisions]

@John Bassett well, they are just idiots. What labeling will they use and what will it say the alcohol content is? Not expecting you to answer that BTW

[John Bassett]

1 hour ago, Madspeed said:

@John Bassett well, they are just idiots. What labeling will they use and what will it say the alcohol content is? Not expecting you to answer that BTW

That is a very good question.  FDA won't check labels on OTC products.  They can get away with it.  We're probably worrying way too much, but then we also have to answer to TTB.

[Pour Decisions]

They'll just label it as whatever they think it is and sell it., I get it, but that just pisses me off, way too much false advertising and inaccurate labeling out there. I am one that tends to read labels for almost everything I purchase and expect accurate information. 

[bluestar]

9 This is consistent with the USP and FCC grade requirements for purity. Lower ethanol content alcohol falls within this policy so long as it is labeled accordingly and the finished hand sanitizer meets the ethanol volume to content concentration of 80%.

 

Can someone tell me what that footnote means? That is on the 94.9% alc by vol requirement on the ethanol for hand sanitizer. Some interpret that to say a lower proof can be used, but I can't find a corroboration of that interpretation. What is "labeled accordingly"? At first I thought it meant somewhere on the hand sanitizer, but I am suspecting they are saying if it is lower proof, but is labeled as meeting USP grade purity, it is okay, but that would mean it would not apply to distillers distilling below 94.9%, correct?

[SlickFloss]

Bluestar,

     I will copy paste an email I have with Discus attorney below. I don't think you have to use a notation on a. finished package of sanitizer. Only if your selling alcohol to someone else to make sanitizer. Convoluted and not my interpretation, but see from Discus below.

 

My message:

Subject: Re: COVID-19 Hand Sanitizer: Updated FDA Guidance Documents

Date: April 18, 2020 at 10:46:32 AM CDT 

Joe,

        We are blasting away at sanitizer, thanks for all the guidance.

 

        I do have a question about labeling when we use less than 189.8 proof alcohol.

 

I have some 180.00 proof (90%) I want to use and I don’t want to run it back through the still (energy costs)

 

According to the guidelines:

• Minimum Proof: FDA requests that the alcohol be not less than 94.9% ethanol by volume prior to denaturing, which is consistent with the USP and FCC grade requirements for purity; however, they have provided that lower ethanol content alcohol falls within this policy so long as it is labeled accordingly and the finished hand sanitizer meets the ethanol volume to content concentration of 80%. 

 

So with that in mind, in order to include the lower proof booze in our product we would have to alter the label. Would you want us to ad something like this:

 

 “This product was made with ethanol less than 189.8 proof”

 

 Or something like this:

 

“This product was made with 90% Alcohol”

 

Thanks,

 

 

Here was their response

Begin forwarded message:

From: Courtney Armour <courtney.armour@distilledspirits.org>

Subject: RE: COVID-19 Hand Sanitizer: Updated FDA Guidance Documents  

Date: April 18, 2020 at 2:27:22 PM CDT

Hi Nick,

 

If this is for hand sanitizer (rather than the alcohol being sold as an API to someone else to make hand sanitizer), the label should just provide the final alcohol percentage which needs to be a minimum of 80%.  The recommended labels are provided in the appendices of the FDA temporary policy, starting on page 9.  

 

Let us know if you have any other questions.

 

Courtney 

 

Courtney Armour Chief Legal Officer and Corporate Secretary O: (240) 232-8527 😄 (202) 445-1903     #DistillersUnited4aCause

 

 

In a very convoluted way, this is directly from your own attorneys that you've never met, but will be defending you if anything goes wrong

[dhdunbar]

Here we go again.  from TTB's newsletter today::

 

EXTENSION OF HAND SANITIZER GUIDANCE

On March 26, 2020, TTB issued guidance providing certain exemptions and waivers to distilled spirits permittees to facilitate the production of alcohol-based hand sanitizers, see TTB G 2020-1A, Production of Hand Sanitizer to Address the COVID 19 Pandemic.

On March 27, 2020, the CARES Act was signed into law, providing for additional flexibility with regard to removals of distilled spirits free of tax for use in or contained in hand sanitizer that is produced and distributed in a manner consistent with Food and Drug Administration guidance related to COVID-19.

We are therefore working to update our original guidance and also provide guidance on the additional flexibilities of the CARES Act. In the interim, we are extending any exemptions, waivers, or other authorizations currently provided in TTB G 2020-1A, through December 31, 2020.

_______________________

 

 

[John Bassett]

On 4/20/2020 at 4:07 PM, dhdunbar said:

Here we go again.  from TTB's newsletter today::

 

EXTENSION OF HAND SANITIZER GUIDANCE

On March 26, 2020, TTB issued guidance providing certain exemptions and waivers to distilled spirits permittees to facilitate the production of alcohol-based hand sanitizers, see TTB G 2020-1A, Production of Hand Sanitizer to Address the COVID 19 Pandemic.

On March 27, 2020, the CARES Act was signed into law, providing for additional flexibility with regard to removals of distilled spirits free of tax for use in or contained in hand sanitizer that is produced and distributed in a manner consistent with Food and Drug Administration guidance related to COVID-19.

We are therefore working to update our original guidance and also provide guidance on the additional flexibilities of the CARES Act. In the interim, we are extending any exemptions, waivers, or other authorizations currently provided in TTB G 2020-1A, through December 31, 2020.

_______________________

 

 

WOW, I just heard this too.   

[John Bassett]

On 4/19/2020 at 12:39 PM, SlickFloss said:

Bluestar,

     I will copy paste an email I have with Discus attorney below. I don't think you have to use a notation on a. finished package of sanitizer. Only if your selling alcohol to someone else to make sanitizer. Convoluted and not my interpretation, but see from Discus below.

 

My message:

Subject: Re: COVID-19 Hand Sanitizer: Updated FDA Guidance Documents

Date: April 18, 2020 at 10:46:32 AM CDT 

Joe,

        We are blasting away at sanitizer, thanks for all the guidance.

 

        I do have a question about labeling when we use less than 189.8 proof alcohol.

 

I have some 180.00 proof (90%) I want to use and I don’t want to run it back through the still (energy costs)

 

According to the guidelines:

• Minimum Proof: FDA requests that the alcohol be not less than 94.9% ethanol by volume prior to denaturing, which is consistent with the USP and FCC grade requirements for purity; however, they have provided that lower ethanol content alcohol falls within this policy so long as it is labeled accordingly and the finished hand sanitizer meets the ethanol volume to content concentration of 80%. 

 

So with that in mind, in order to include the lower proof booze in our product we would have to alter the label. Would you want us to ad something like this:

 

 “This product was made with ethanol less than 189.8 proof”

 

 Or something like this:

 

“This product was made with 90% Alcohol”

 

Thanks,

 

 

Here was their response

Begin forwarded message:

From: Courtney Armour <courtney.armour@distilledspirits.org>

Subject: RE: COVID-19 Hand Sanitizer: Updated FDA Guidance Documents  

Date: April 18, 2020 at 2:27:22 PM CDT

Hi Nick,

 

If this is for hand sanitizer (rather than the alcohol being sold as an API to someone else to make hand sanitizer), the label should just provide the final alcohol percentage which needs to be a minimum of 80%.  The recommended labels are provided in the appendices of the FDA temporary policy, starting on page 9.  

 

Let us know if you have any other questions.

 

Courtney 

 

Courtney Armour Chief Legal Officer and Corporate Secretary O: (240) 232-8527 😄 (202) 445-1903       #DistillersUnited4aCause

 

 

In a very convoluted way, this is directly from your own attorneys that you've never met, but will be defending you if anything goes wrong

So, basically you do not have to put that statement on your labels?

[SlickFloss]

5 hours ago, John Bassett said:

So, basically you do not have to put that statement on your labels?

not basically, I was explicitly told in an email that I (so also you) can and that the labeling only applies to the finished product, and if the finished product is at 80% concentration, I do not need to list the concentrations of the alcohols combined to make it.

[CalwiseSpirits]

Don't mean to throw this thread off too much, but on the subject of proof... I've seen a few distilleries selling sanitizer at 70% strength. Their labeling looks to be on point in every other way so I imagine they know what they're doing but I'm trying to figure out if they're just ignoring the 80% rule or they know something I don't. Was there a recent recommendation from FDA or TTB allowing this? I didn't see anything but maybe I'm missing something.

[DrDistillation]

I have the sneaky feeling they are doing this by incorrectly reading this section:

Look at page 5 of https://www.fda.gov/media/136289/download  Footnote 18 & 19

18 Consistent with the 1994 TFM, alcohol should be used in a final product concentration between 60-95% (v/v) in an aqueous solution denatured in accordance with this guidance (see also FDA guidance for industry Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19); isopropyl alcohol should be used in a concentration between 70-91.3% (v/v). This guidance is consistent with WHO’s recommended formulation specifications of 80% alcohol and 75% isopropyl alcohol.

19 One benefit of FDA’s policy relying on use of the WHO formula is that minor errors in production are still likely to result in a finished hand sanitizer product that exceeds 60% alcohol content (see FDA’s 1994 TFM and the CDC Statement for Healthcare Personnel on Hand Hygiene during the Response to the International Emergence of COVID-19). 20 Although WH

---------------------

But the formula step #1 on page 3 states:

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product a. (Select one of two options) (1) Alcohol (ethanol) that is not less than 94.9% ethanol by volume8 ; OR (2) United States Pharmacopeia (USP grade) Isopropyl Alcohol9

Footnote 8

8 This is consistent with the USP and FCC grade requirements for purity. Lower ethanol content alcohol falls within this policy so long as it is labeled accordingly, and the finished hand sanitizer meets the ethanol concentration of 80%.

-----------------------------

So while 70% meets the 1994 TFM as footnote 18 on page 5 mentions, it does not meet the actual formula on page 3 step 1 and footnote 8 which requires the final product to have a concentration of 80% (using Ethanol).  So the way I read it this 70% product if produced under the waiver is NOT CORRECT.

Now keep in mind if a commercial product not made to the WHO/FDA spec then it could certainly have a lower ABV as it also uses other/additional ingredients and has been tested/certified.  For example a bottle of "Assured Hand Sanitizer" I have on my desk is only 62% but it's not a WHO formula.

 

Others agree/disagree?

[bluestar]

On 4/19/2020 at 11:39 AM, SlickFloss said:

Bluestar,

     I will copy paste an email I have with Discus attorney below. I don't think you have to use a notation on a. finished package of sanitizer. Only if your selling alcohol to someone else to make sanitizer. Convoluted and not my interpretation, but see from Discus below.

 

My message:

Subject: Re: COVID-19 Hand Sanitizer: Updated FDA Guidance Documents

Date: April 18, 2020 at 10:46:32 AM CDT 

Joe,

        We are blasting away at sanitizer, thanks for all the guidance.

 

        I do have a question about labeling when we use less than 189.8 proof alcohol.

 

I have some 180.00 proof (90%) I want to use and I don’t want to run it back through the still (energy costs)

 

According to the guidelines:

• Minimum Proof: FDA requests that the alcohol be not less than 94.9% ethanol by volume prior to denaturing, which is consistent with the USP and FCC grade requirements for purity; however, they have provided that lower ethanol content alcohol falls within this policy so long as it is labeled accordingly and the finished hand sanitizer meets the ethanol volume to content concentration of 80%. 

 

So with that in mind, in order to include the lower proof booze in our product we would have to alter the label. Would you want us to ad something like this:

 

 “This product was made with ethanol less than 189.8 proof”

 

 Or something like this:

 

“This product was made with 90% Alcohol”

 

Thanks,

 

 

Here was their response

Begin forwarded message:

From: Courtney Armour <courtney.armour@distilledspirits.org>

Subject: RE: COVID-19 Hand Sanitizer: Updated FDA Guidance Documents  

Date: April 18, 2020 at 2:27:22 PM CDT

Hi Nick,

 

If this is for hand sanitizer (rather than the alcohol being sold as an API to someone else to make hand sanitizer), the label should just provide the final alcohol percentage which needs to be a minimum of 80%.  The recommended labels are provided in the appendices of the FDA temporary policy, starting on page 9.  

 

Let us know if you have any other questions.

 

Courtney 

 

Courtney Armour Chief Legal Officer and Corporate Secretary O: (240) 232-8527 😄 (202) 445-1903       #DistillersUnited4aCause

 

 

In a very convoluted way, this is directly from your own attorneys that you've never met, but will be defending you if anything goes wrong

Okay, my problem is the excerpt on minimum proof in your text could be read differently then the excerpt I provided verbatim from the FDA footnote. The difference in punctuation could be meaningful. I find the Discus reply frustrating, because it doesn't really relay any justification or explanation for the use of lower proof alcohol, just says you only have to label with the final proof, which I already assumed. That is because from the punctuation of the footnote, I don't think the labeling mentioned for less than 189.8% refers to the final product, but to something else, and that is what my question is: what is being labeled at lower proof?

[abe]

On 3/27/2020 at 4:34 PM, Thatch said:

Sure, we're all trying to save humanity. 

These new chems are not inexpensive.  We got the last of what they had a one place.  It seems that they are also somewhat controlled according to my distiller.  When purchasing you have to fill out a form and they may or may not ship to you.  It was $68.40 for the Tert-Butyl Alcohol,  2000 ml of Tert-Butyl Alcohol enough for 400 gallons of sanitizer.   50grams of  DENATONIUM BENZOATE enough for 282 gallons was $108

Hi Thatch,

I would greatly appreciate if you can please provide me with the info where I can buy USP Grade Tert-Butyl Alcohol and Denatonium Benzoate.

Thank you.

[abe]

Hi all,

I am interested in making Alcohol Based Hand Sanitizer, I would greatly appreciate if someone can assist me sourcing the ingredients needed for the Formula NO. 40-B. 

I have 192 proof GNS and I want to buy the remaining ingredients needed for Formula NO. 40-B.

Does anyone have or know where I can purchase Denatonium Benzoate, Tert-Butyl Alcohol, Hydrogen Peroxide, and Glycerine ?

I would greatly appreciate a reply!

My email address is abe@bigstillliquors.com

Thank you so much!

Abe.

 

[Naked Spirits Distillery]

26 minutes ago, abe said:

Hi all,

I am interested in making Alcohol Based Hand Sanitizer, I would greatly appreciate if someone can assist me sourcing the ingredients needed for the Formula NO. 40-B. 

I have 192 proof GNS and I want to buy the remaining ingredients needed for Formula NO. 40-B.

Does anyone have or know where I can purchase Denatonium Benzoate, Tert-Butyl Alcohol, Hydrogen Peroxide, and Glycerine ?

I would greatly appreciate a reply!

My email address is abe@bigstillliquors.com

Thank you so much!

Abe.

 

If you have any other distilleries around you I would suggest calling them before ordering to see if they are stuck with inventory. Many distilleries have excess on hand and are willing to let it go at their cost just to get rid of it. It works for both distilleries. 

[Thatch]

Sorry, we did not go that direction.  We used the WHO formula approved by the FDA which consists of:

We are registered with the FDA for our product.  If you need any, let me know.  $25/gallon FOB 44212

[abe]

17 hours ago, Thatch said:

Sorry, we did not go that direction.  We used the WHO formula approved by the FDA which consists of:

We are registered with the FDA for our product.  If you need any, let me know.  $25/gallon FOB 44212

Thanks Thatch,

I would also be interested in going this direction but doesn't the Alcohol have to be denatured? 

[Thatch]

You can go either direction based on the various threads and papers on this forum.  If it is denatured you do not have to pay federal tax.  If it is not, you do.

[abe]

 

3 minutes ago, Thatch said:

You can go either direction based on the various threads and papers on this forum.  If it is denatured you do not have to pay federal tax.  If it is not, you do.

Can you please provide me with any recent document with proof to this, Because I recently spoke to the ttb and they told me that if I am manufacturing hand sanitizer then it must be denatured regardless if we pay Tax or not as the FDA requires.

[Thatch]

That might be old news.  We are out of the business but this used to be allowed.

adiforums.com/topic/11684-ttb-public-guidance-march-26-2020/?tab=comments#comment-67180