IAre you staying in the hand sanitizer business long-term?

[BRoot]

I have a lead on a large government contract (100,000+ units/year, bid already submitted) for WHO formula hand sanitizer that I am going to be unable to fulfill long-term.  I told the prime contractor , who is located in Texas, I would reach out nationally to see if other distilleries are staying in the sanitizer business.  The state of Oregon is making it extremely difficult if not impossible for distilleries to continue to be in this business after September.  If you are staying in this business long-term, please get in touch.  bev.root@ewingyoungdistillery.com

[SteelB]

we will be , along with the liquid type hand sanitizer we will be making a gel version as well, currently working on FDA approval

[Pour Decisions]

@SteelB, please keep us posted as to how you make out with your FDA approvals for the gel. I'm curious as there is alot of information going around about this topic, and it is my understanding that you'd need a whole new license from the FDA and and this falls outside of current TTB regulations,.

[BRoot]

I have received several private messages on this and am finding a common theme--people haven't yet figured out what they need to do to get re-certified after their State Board of Pharmacy's temporary COVID provisions expire, and the FDA's temporary guidelines  expire at the end of the year.  It was upon digging into the Oregon regs that I could see this was not going to be feasible for our distillery. 

 

I am starting to wonder if any distilleries are going to stay in this business once they see the regs and red tape involved.  After all, pharma is the only industry more regulated than ours.  Ugh.

[SteelB]

On 6/26/2020 at 7:03 PM, BRoot said:

I have received several private messages on this and am finding a common theme--people haven't yet figured out what they need to do to get re-certified after their State Board of Pharmacy's temporary COVID provisions expire, and the FDA's temporary guidelines  expire at the end of the year.  It was upon digging into the Oregon regs that I could see this was not going to be feasible for our distillery. 

 

I am starting to wonder if any distilleries are going to stay in this business once they see the regs and red tape involved.  After all, pharma is the only industry more regulated than ours.  Ugh.

im finding that to be true, finding the necessary supplies is one thing , and you almost have to have a chemist on staff. We have a partner who is a chemist so that may help. there is certainly a boat load of money to be made if you can manage to jump through the right hoops. All the RFQs we ve had are in the millions of units. Every one. so we are trying to figure it out and throw some money at it. We are working with a company called rigistrar corp.if anyone knows of a better option we are all ears. Truth , Big Pharma is million times worse than dealing with the TTB. They usually do not like outsiders.

[daveflintstone]

9 hours ago, SteelB said:

 We are working with a company called rigistrar corp.if anyone knows of a better option we are all ears. Truth , Big Pharma is million times worse than dealing with the TTB. They usually do not like outsiders.

What are they charging for this?

[SteelB]

$995 to take care of the registration process, 995 a year to renew and keep everything up to date on the account with the FDA

 Also thy offer different packages for labels. each label is registered separately. so like one label is $695, but they have 5 and 10 bundle packs that will bring down the cost ( 5 pack = 595 a label) . my only issue with them is much like everyone else  that i have had to deal with to get this process were it is. they are  slow with response.  That being said it took up to a week while setting up the portal by myself as the ESG folks would get back to me in two days to a week.

You will have to have a third 

[SteelB]

it is several thousand dollars to get all in on it. unless you will be producing thousands of gallons it really doesnt seem worth it.

[Bier Distillery]

I could very well be wrong, but to me it looks like Registrar doesn't do anything that you couldn't otherwise easily do yourself.  Registering your facility and product (even one that doesn't match the WHO/FDA guidelines like a gel) is relatively simple (and free) once you understand some basics.

What I'm really wondering is what the process was for selling hand sanitizer before COVID.  It looks to me that any company could have registered with the FDA before COVID and started selling.  That seems incorrect to me but how?  Is this regulated by the states somehow?  Are there additional licenses to be had?  Google is failing me because all the references to hand sanitizer now are post COVID. 

I've seen several mom & pop businesses pop up in the past few months selling sanitizers with their own proprietary recipe.  Are they doing so illegally?  Did they do anything other than registering with the FDA like we've all done?

So on a related note, what must a distillery (and any other type of company) do to continue to sell sanitizer after Dec 30, 2020?  It's unclear to me.

 

[Bob Morris]

We will be and through our network of distilleries have the capacity to produce over 4,000 gallons a day bottled. We can surge much higher. In the consortium we have some 10 - 12 distilleries in multiple states.  We woudl welcome the opportunity to work with this prohject. Our lead is a SDVOSM and already Federally SAM registered. Both of these woudl be very helpful to the Prime.  Contact me any time.