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OfflineOICU812
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Re: Making Double-Extracts [Re: Forrester]
    #18908043 - 09/29/13 05:33 PM (10 years, 4 months ago)

Quote:

Forrester said:
That's awesome man, have you looked into the licensing and other legality issues for selling tinctures?  I've been trying to do the same thing and have talked to the department of agriculture. 
In order to process any mushrooms I'm going to of course need a food processing license.  He said there might be other issues with FDA (selling them as "medicinal") or possibly issues with there being alcohol in it and being able to sell that.  I'm sure the FDA issue could be gotten around with the standard "this product is not intended...blah blah" warning, but the alcohol thing I wasn't sure about.  Have you looked into these things?




I wonder if alcohol will be an issue or not.  Go to your cupboard and look at a bottle of vanilla extract.


--------------------
--------------
"Democracy is two wolves and a lamb voting on what to have for lunch. Liberty is a well-armed lamb contesting the vote!" --Benjamin Franklin

"Those who give up liberty for security won't have, or deserve, either.". . . Benjamin Franklin
----> Read: The Fight of our Lives - Defeating the Ideological War Against the West - by Victor Davis Hanson


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Offlinenanncee
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Re: Making Double-Extracts [Re: OICU812]
    #18912016 - 09/30/13 04:39 PM (10 years, 4 months ago)

Quote:

OICU812 said:
Quote:

Forrester said:
That's awesome man, have you looked into the licensing and other legality issues for selling tinctures?  I've been trying to do the same thing and have talked to the department of agriculture. 
In order to process any mushrooms I'm going to of course need a food processing license.  He said there might be other issues with FDA (selling them as "medicinal") or possibly issues with there being alcohol in it and being able to sell that.  I'm sure the FDA issue could be gotten around with the standard "this product is not intended...blah blah" warning, but the alcohol thing I wasn't sure about.  Have you looked into these things?




I wonder if alcohol will be an issue or not.  Go to your cupboard and look at a bottle of vanilla extract.





We have been trying to research this and would love to hear what everyone knows.

What I have learned so far is that it varies by state on whether you need a license for the alcohol.


--------------------
I am a small scale farmer, come check out what we do. www.facebook.com/biocentricbros

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InvisibleAleon
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Re: Making Double-Extracts [Re: nanncee]
    #18915068 - 10/01/13 08:40 AM (10 years, 4 months ago)

I am attempting to find out all the rules and follow them. The funniest thing is its not easy to find definitive rules (obviously a loophole to make it easier to prosecute producers and keep the small businesses out).  Im not planning on making much $ or even moving alot, so i dont think i will come up on the radar anyways.  I will update after i talk to some more state officials about this.  Also we have decided we are not selling the product.  We are giving it away, but with a suggested donation.  IF some1 wants it for free i will give it to them.  I just want the, what we have termed "Vibrational essences", of these mushrooms to be out there and available.  I made this with my mind, intent, and energy.  I light fasted, meditated, prayed, and danced to the Gods during the whole process to embue them with vibrational energies.

Another thing to note is, what happened to Jesus? Or john lenin, or the dalai lama when they stood up for love in the face of evil?  They were persecuted by the very people they were trying to help; some like Jesus were even ridiculed and killed.  Being a force for good inevitably faces opposition from the mass evil within us all. I am done running, hiding; i am standing up for what is good and what is right.  Most people who do what is right and embody love get persecuted (especially by the gov.), as i already have been.  I have remained in the shadows since, and im ready for the next round.  I will lose; but ironically when you lose here you win in the afterlife.  As this land is the land of the dead. This is what the Buddha says:  We all will die, no one escapes his own death here. When we die here, we can wake up to true/eternal existence if we are attuned to it.  If not we re-collide with the infinite to have our essence be re-purposed. I am doing whats right not for any personal gain, but because im doing my best, with all my heart, to do what i beleive is right/pure.  Helping people with the tools you have been given is right. Not doing so because of persecution means that the fear of loss (of things which will die eventually anyways) has overtaken the courage needed to fill others with love in the land of the dead(which is here, the place where everything must die). With love, instead of fear, a person can be changed from a dying, stiff withering tree to a loving, living, flexible blade of grass swaying in the wind.

On a final note, there may not be anyone to oversee/inspect these products soon anyways after this government "shutdown".  The FDA inspections will mostly be curtailed because of lack of funding. http://calorielab.com/labnotes/20110408/government-shutdown-fda-food-drug-inspections/


--------------------
Mushroom medicines available at:
www.swordandshieldwellness.com


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OfflineAmanita virosa
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Re: Making Double-Extracts [Re: Aleon]
    #18916168 - 10/01/13 01:10 PM (10 years, 4 months ago)

Good Manufacturing Practices stuff.  Here is the scoop. 
In a nutshell, it is a shit load of paperwork.  you must first develop a Master Manufacturing Record (MMR), which documents your product overview, recipe, equipment, etc.  Basically, what you would need if you were going to make the product.  Next, you need a form called a Batch Process Record.  This is a form which documents what you actually DID when you made a batch of product, and how it differed, if it did, from the MMR.  Note that these are not standard cookie cutter forms that you fill out.  You generate these forms yourself.  like is said its a shit load of paperwork.  if you are selling to "clients"  you do not need all this.  if you are trying to get your product into other retail stores, whole foods for example then you do.  for instance, acupuncture clinics sell all kinds of unregulated tinctures and pills to their "clients" without any regs.


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Offlinedrake89
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Re: Making Double-Extracts [Re: Amanita virosa]
    #18917745 - 10/01/13 06:51 PM (10 years, 4 months ago)

Quote:

Amanita virosa said:
Good Manufacturing Practices stuff.  Here is the scoop. 
In a nutshell, it is a shit load of paperwork.  you must first develop a Master Manufacturing Record (MMR), which documents your product overview, recipe, equipment, etc.  Basically, what you would need if you were going to make the product.  Next, you need a form called a Batch Process Record.  This is a form which documents what you actually DID when you made a batch of product, and how it differed, if it did, from the MMR.  Note that these are not standard cookie cutter forms that you fill out.  You generate these forms yourself.  like is said its a shit load of paperwork.  if you are selling to "clients"  you do not need all this.  if you are trying to get your product into other retail stores, whole foods for example then you do.  for instance, acupuncture clinics sell all kinds of unregulated tinctures and pills to their "clients" without any regs.




this is very good to know.  is this just a NC thing, or a federal thing?  :thumbup:


--------------------
Fiery Fungi (like us on faeboo)


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OfflineAmanita virosa
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Re: Making Double-Extracts [Re: drake89]
    #18917858 - 10/01/13 07:16 PM (10 years, 4 months ago)

FDA pal.


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OfflineForresterM
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Re: Making Double-Extracts [Re: Amanita virosa]
    #18918701 - 10/01/13 10:25 PM (10 years, 4 months ago)

Quote:

Amanita virosa said:
Good Manufacturing Practices stuff.  Here is the scoop. 
In a nutshell, it is a shit load of paperwork.  you must first develop a Master Manufacturing Record (MMR), which documents your product overview, recipe, equipment, etc.  Basically, what you would need if you were going to make the product.  Next, you need a form called a Batch Process Record.  This is a form which documents what you actually DID when you made a batch of product, and how it differed, if it did, from the MMR.  Note that these are not standard cookie cutter forms that you fill out.  You generate these forms yourself.  like is said its a shit load of paperwork.  if you are selling to "clients"  you do not need all this.  if you are trying to get your product into other retail stores, whole foods for example then you do.  for instance, acupuncture clinics sell all kinds of unregulated tinctures and pills to their "clients" without any regs.





Awesome info, that's a good idea about the "client" thing, I had actually wondered about that...

So, do you think giving them away w/suggested donataion, a la ALeon's idea would get around all that paper work as well?

I'm really only looking to be able to set up a table at a local farmers market, not get into Whole Foods or anything.  Do most people just go for it and hope nobody that cares notices?  I mean if I was department of agriculture compliant, I'm guessing the FDA doesn't send a whole lot of reps out to police farmer's markets...?


--------------------
Repugnant is a creature who would squander the ability to lift an eye to heaven, conscious of his fleeting time here.
-------------------

Have some medicinal mushrooms and want to get the most out of them?  Try this double extraction method.


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OfflineOICU812
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Re: Making Double-Extracts [Re: Forrester]
    #18919698 - 10/02/13 06:02 AM (10 years, 4 months ago)

Title 21: Food and Drugs
PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

§ 111.1  Who is subject to this part?


(a) Except as provided by paragraph (b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including:

(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and

(2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

(b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.

21 CFR part 111 subpart E requires that quality control personnel review and approve a justification of why meeting in-process specifications in combination with component specifications will ensure all product specifications are met for identity, purity, strength, and composition and the limits for contamination of microbiological, heavy metals, and other applicable contaminants. For example, drying a wet granulation would usually need a specification for moisture content to ensure the granulation is properly dried. A solution being adjusted to a certain pH would require a specification for pH. Specifications for weight, hardness, and thickness are typical for tablets during tablet compression. Encapsulation operations would require specifications for fill weight.

It is a requirement that you monitor in-process points, steps, or stages where control is necessary and be able to detect deviations that occur at those points.  Deviations at the in-process control points should initiate an out of specification investigation to trace back to the root cause and determine if additional control points are necessary to ensure the batch is meeting all specifications throughout the manufacturing process.



You can read more at this website, or at the US Goveco e-CFR Data site.


Edited by OICU812 (10/02/13 08:14 PM)


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InvisibleAleon
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Re: Making Double-Extracts [Re: Amanita virosa]
    #18924926 - 10/03/13 08:20 AM (10 years, 4 months ago)

Quote:

Amanita virosa said:
FDA pal.




Thanks for all the info man :bow2:  When you say FDA, are there inspections?  DO you have to register with them?  Or do you just have these forms available for them if the decide to inspect you?

OICU is this information government regulated/mandated? The website is not a .gov  Also i cant really understand much of it; why do they do this with everything?  All political/gov documents are written like they are "beating around the bush".  I wish they would just get to the point and say it in English, but that would allow people who cannot afford legal protection/advice (small businesses) a chance to do things alongside coporate mega's.  And they wouldn't want that to happen, a small business may be able to create a superior product through devotion to what the producer does; whereas large corps. only devotion is to money not the quality of their products or their consumers reactions.

Im almost done with labels should have pics up today or tomorrow :eek:


--------------------
Mushroom medicines available at:
www.swordandshieldwellness.com


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OfflineAmanita virosa
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Re: Making Double-Extracts [Re: Aleon]
    #18924996 - 10/03/13 08:46 AM (10 years, 4 months ago)

they do inspect you.  they generally let you know when they are coming but they can call anytime and request your info.  all these regs are less than 3 years old.  prior to that it was a free for all.  you could sell a dietary suppliment in a tincture bottle with little or no regulation and you could sell it anywhere.  so, the gov. is still a bit new on these regs as well as the producers. i learned this info from a guy making whole plant tinctures of goldenseal and blood root.  He spent 80,000$ in grant money to develop his products but now he is out of money and cannot produce them.  most of his money was spent on dealing with regs and also chemical analysis of his products ( note:  you do not have to have your product chemically analyzed.


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Offlinedrake89
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Re: Making Double-Extracts [Re: Amanita virosa]
    #18925969 - 10/03/13 01:46 PM (10 years, 4 months ago)

Quote:

Amanita virosa said:
they do inspect you.  they generally let you know when they are coming but they can call anytime and request your info.  all these regs are less than 3 years old.  prior to that it was a free for all.  you could sell a dietary suppliment in a tincture bottle with little or no regulation and you could sell it anywhere.  so, the gov. is still a bit new on these regs as well as the producers. i learned this info from a guy making whole plant tinctures of goldenseal and blood root.  He spent 80,000$ in grant money to develop his products but now he is out of money and cannot produce them.  most of his money was spent on dealing with regs and also chemical analysis of his products ( note:  you do not have to have your product chemically analyzed.




$80K down the drain, WOWZA.  similar situation to a local food distributor operating out of the warehouse I'm growing in.  they've almost burned through 50K in grant money, and are not self sufficient.


--------------------
Fiery Fungi (like us on faeboo)


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OfflineOICU812
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Re: Making Double-Extracts [Re: Aleon]
    #18926254 - 10/03/13 02:56 PM (10 years, 4 months ago)

Quote:

Aleon said:
OICU is this information government regulated/mandated? The website is not a .gov  Also i cant really understand much of it; why do they do this with everything?  All political/gov documents are written like they are "beating around the bush".  I wish they would just get to the point and say it in English, but that would allow people who cannot afford legal protection/advice (small businesses) a chance to do things alongside coporate mega's.  And they wouldn't want that to happen, a small business may be able to create a superior product through devotion to what the producer does; whereas large corps. only devotion is to money not the quality of their products or their consumers reactions.

Im almost done with labels should have pics up today or tomorrow :eek:




The second link: e-CFR Data is the .gov website where the official "CFR" regs live.  Read them one at a time starting at the top.

There are online GMP course training websites like this one from dicentra.  You can take these courses at your leasure, get your certificate, register with the FDA and produce your product.

If you are at all familiar with ISO-9000 type quality systems used by general manufacturing, this one seems to be similar.  After you dig around a while, you will find and learn what you need at a reasonable cost if you are persistent.  You either need the money to pay someone else to do it for you or the time to learn and implement the system yourself.



--------------------
--------------
"Democracy is two wolves and a lamb voting on what to have for lunch. Liberty is a well-armed lamb contesting the vote!" --Benjamin Franklin

"Those who give up liberty for security won't have, or deserve, either.". . . Benjamin Franklin
----> Read: The Fight of our Lives - Defeating the Ideological War Against the West - by Victor Davis Hanson


Edited by OICU812 (10/03/13 03:10 PM)


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OfflineForresterM
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Re: Making Double-Extracts [Re: Aleon]
    #18928505 - 10/03/13 10:19 PM (10 years, 4 months ago)

Quote:

Aleon said:
Also i cant really understand much of it; why do they do this with everything?  All political/gov documents are written like they are "beating around the bush".  I wish they would just get to the point and say it in English, but that would allow people who cannot afford legal protection/advice (small businesses) a chance to do things alongside coporate mega's.  And they wouldn't want that to happen, a small business may be able to create a superior product through devotion to what the producer does; whereas large corps. only devotion is to money not the quality of their products or their consumers reactions.




My thoughts exactly!  :confused:


--------------------
Repugnant is a creature who would squander the ability to lift an eye to heaven, conscious of his fleeting time here.
-------------------

Have some medicinal mushrooms and want to get the most out of them?  Try this double extraction method.


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InvisibleAleon
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Re: Making Double-Extracts [Re: Forrester]
    #18930568 - 10/04/13 10:31 AM (10 years, 4 months ago)

Thanks for the info OICU. 

Here are the pictures of the final product:



--------------------
Mushroom medicines available at:
www.swordandshieldwellness.com


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Offlinepseudotsuga
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Re: Making Double-Extracts [Re: Aleon]
    #18930818 - 10/04/13 11:38 AM (10 years, 4 months ago)

Quote:

Aleon said:
Thanks for the info OICU. 

Here are the pictures of the final product:






Very Nice Aleon!
Those labels look legit.:thumbup:


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OfflineOICU812
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Re: Making Double-Extracts [Re: Aleon]
    #18931833 - 10/04/13 03:48 PM (10 years, 4 months ago)

Quote:

Aleon said:
Thanks for the info OICU. 

Here are the pictures of the final product:






Good looking packaging.  I hope you do well.


--------------------
--------------
"Democracy is two wolves and a lamb voting on what to have for lunch. Liberty is a well-armed lamb contesting the vote!" --Benjamin Franklin

"Those who give up liberty for security won't have, or deserve, either.". . . Benjamin Franklin
----> Read: The Fight of our Lives - Defeating the Ideological War Against the West - by Victor Davis Hanson


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InvisibleAleon
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Re: Making Double-Extracts [Re: OICU812]
    #18936362 - 10/05/13 02:32 PM (10 years, 4 months ago)

Has anyone made double extracts with chaga? Just met a oyster/LM farmer and he also has wild chaga.  Thinking about getting bulk and making some extract.


--------------------
Mushroom medicines available at:
www.swordandshieldwellness.com


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OfflineForresterM
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Re: Making Double-Extracts [Re: Aleon]
    #18936798 - 10/05/13 04:36 PM (10 years, 4 months ago)

Quote:

Aleon said:
Has anyone made double extracts with chaga? Just met a oyster/LM farmer and he also has wild chaga.  Thinking about getting bulk and making some extract.




Yeah I've made them with chaga, works nicely.  I used 180g per quart jar, more than with most other mushrooms. 

Powdered chaga has such small particles it's nearly impossible to filter so I just let my extractions settle overnight, most of the particles will settle out, then just take the liquid off the top.

And watch out, it will dye the hell out of just about anything it touches.  I usually boil and strain several times, then boil all that down to get it super concentrated.  You'll still be pulling a lot of color (and I assume medicinals) out of the chaga mass even on the 3rd or 4th boil.


--------------------
Repugnant is a creature who would squander the ability to lift an eye to heaven, conscious of his fleeting time here.
-------------------

Have some medicinal mushrooms and want to get the most out of them?  Try this double extraction method.


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InvisibleAleon
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Re: Making Double-Extracts [Re: Forrester]
    #18942206 - 10/06/13 08:22 PM (10 years, 4 months ago)

Thanks forrester, i was assuming id need to change the ratio of dry weight to volume.


--------------------
Mushroom medicines available at:
www.swordandshieldwellness.com


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OfflineAmanita virosa
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Re: Making Double-Extracts [Re: Forrester]
    #18943908 - 10/07/13 09:37 AM (10 years, 4 months ago)

Quote:

Forrester said:
Quote:

Aleon said:
Has anyone made double extracts with chaga? Just met a oyster/LM farmer and he also has wild chaga.  Thinking about getting bulk and making some extract.




Yeah I've made them with chaga, works nicely.  I used 180g per quart jar, more than with most other mushrooms. 

Powdered chaga has such small particles it's nearly impossible to filter so I just let my extractions settle overnight, most of the particles will settle out, then just take the liquid off the top.

And watch out, it will dye the hell out of just about anything it touches.  I usually boil and strain several times, then boil all that down to get it super concentrated.  You'll still be pulling a lot of color (and I assume medicinals) out of the chaga mass even on the 3rd or 4th boil.




using a  brewers siphon tube made for decanting wort or wine works well.  It has a little end that sits on the bottom in the sediment and keeps it from being sucked up into the tube.


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