Hand Sanitizer from GNS

[StonesRyan]

2 minutes ago, Classick said:

We offered to give our first batch  to our local city fire marshal for free, and they're insisting on paying fair market value for it... something about it needing to be like that for their books.

*Shrugs*

It appears I misunderstood.

It's been a dizzying whirlwind trying to keep up with the ever-changing rules.

[Classick]

1 minute ago, StonesRyan said:

It appears I misunderstood.

It's been a dizzying whirlwind trying to keep up with the ever-changing rules.

No kidding.. 

I've been reading things over 3 times, trying to make sure WHAT im reading is the most current.. .then asking questions here just to get 2nd eyes on it... I think as long as we're all respectful, and appreciative of the considerable time folks are donating to clarifying things... we'll get through this

Thanks to all who have contributed guidance so far. Its helpful and maddening at the a same time haha. i guess this is the new normal

[RevolutionSpirits]

34 minutes ago, Thatch said:

  50grams of  DENATONIUM BENZOATE enough for 282 gallons was $108

Is your math wrong or is mine?

Preferred formula for 100 gallons is 1/16 avoirdupois ounce (28.35 grams) denatonium benzoate. 

28.35/16=1.77 grams per 100 gallons

So 50 grams should be enough for 2820 gallons, not 282.

 

Also I straight up cannot find a USP grade source for denatonium benzoate. Only source I've found is "for research use only" and specifically not FDA certified. Any leads?

[twowheels]

1 hour ago, DrDistillation said:

That bulletin has been superseded and is no longer valid because people were having trouble understanding it.

 

 

My understanding is that TTB G 2020-1A superseded TTB G 2020-1.  I haven’t been able to find a newer release.  Is this available somewhere?

[Thatch]

2 hours ago, StonesRyan said:

But it's ok to skip the denaturing as long as we give it away and absorb the costs to produce?

You can't skip the denaturing.  The TTB has deferred to the FDA and the FDA mandates denaturing.

[Thatch]

1 hour ago, RevolutionSpirits said:

Is your math wrong or is mine?

My math is wrong, we're going to have way to much.  Thanks for checking my math.

[Classick]

6 minutes ago, Thatch said:

My math is wrong, we're going to have way to much.  Thanks for checking my math.

Were you able to find USP grade? 

This is what i've found so far.. pretty pricy.

 

[Thatch]

1 hour ago, DrDistillation said:

Were these USP grade as required?

Don't know, trying to get in touch with our distiller

 

[RevolutionSpirits]

4 minutes ago, Thatch said:

Don't know, trying to get in touch with our distiller

 

If it is I'll buy some from you

[Classick]

ditto

[daveflintstone]

Oh I'll be skipping the denaturing that's for sure.  Just like every distillery that's been producing it up until now.  Come and get us FDA!  GTFO

[adamOVD]

5 hours ago, DrDistillation said:

And you need to make sure to purchase USP grade ingredients for denaturing as well.

Where does it say this? Im looking for it but cant find it.

[DrDistillation]

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!

 

[Classick]

thanks once again for clear, concise and useful analysis.

[Thatch]

Thanks Dr D, 

Well said.

For @RevolutionSpirits  and @Classick, he mis-typed, we have a line on 5 grams, not 50 and it is not USP.  

Going back to plan A.

[Roger]

It says "may be used , not "must be used".

[Thatch]

First, I'm not a lawyer.  This is the newest FDA doc

https://www.fda.gov/media/136118/download

You will note that at the top of many of the pages there is text that says

"Contains Nonbinding Recommendations"

When you search on that text, you come up with several legal opinions,  one of the opinions was written by the Attorney General of the United States.  The question is, do you have to follow FDA guidance that includes this text.  The answer is, it is not law.   https://www.achesongroup.com/post/fda-guidance-do-i-have-to-comply  

 

[DrDistillation]

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.

 

[bluestar]

1 hour ago, Thatch said:

https://www.fda.gov/media/136118/download

 

For me the most IMPORTANT take away from this update, is the ADDITION of Formula 3C (adding 5% isopropanol) to Formulas 40A and 40B in the updated guidance. This means those already using Formula 3C can continue to do so. This also adds to the guidance the denaturing  method I previously suspected would be most appropriate.

[DrDistillation]

§21.37   Formula No. 3-C.

(a) Formula. To every 100 gallons of alcohol add:

Five gallons of isopropyl alcohol.

 

Only downside to this is the amount needed 20:1 ratio which is a lot higher then the other 2 methods.  If you can source it locally it's probably the easiest and cheapest way otherwise shipping can be a killer compared to other ingredients.  The good side is you have 105 gallons vs 100.x gallons.

@Bluestar what strength isopropyl alcohol are you using?

[DrDistillation]

Just curious, but what size batches are you guys making that are donating to the public?

What size containers are you distributing in?

[Huffy2k]

We're expecting to get around 140 gallons off the still this week.  The local hospital will take whatever size containers we give them.  We're thinking maybe a drum and some 5 gallon buckets or 1 gallon jugs. 

[Classick]

Our idea is to offer 5 gallon closed head jugs with dispensing pumps... then maybe 10-20 8oz bottles that they can then refill.. cuts down on the bottle usage we have to deliver to each location.

 

assuming we can find anymore of those things at all. sigh

anyone had luck signing up on DISCUS's form to be linked with vendors?

[Thatch]

We were lucky to get 200 2 gallon jugs donated by a local packaging supplier.  We asked and they were happy to help out.

[dhdunbar]

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.”