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OfflineShiro
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Necessary licensing for a medicinal mushroom supplement company
    #27504480 - 10/14/21 07:35 PM (3 months, 2 days ago)

So I’m now producing lions mane at a rate that I feel I may not be able to sell all of my fresh produce. I’m not looking for how to offload my fresh product ex (grocery store wholesale licensing). For I feel that branding a supplement company will produce much greater profits.

I want to be able to market my product online, to anyone, let’s say inside the US to start. After that I can look into licensing for world wide sales. But for now I’m just looking for necessary licensing and guidelines to legally sell my Medicinal lions mane in a supplement form, while complying with the FDA and any other big brother agencies.

Currently I am lost in the sauce of where to start. If anyone knows of any leads in the direction to take or forms necessary to fill out, I would be much appreciated. I know most with this knowledge are probably already marketing their product, selling online, and would see me as a competitor. Though if anyone could see out of the kindness of their heart to point a fella in the right direction. Know you would be helping a small business really get off the ground...

I will be powdering my dried lions mane and capsulating. I’d also like to create tinctures. And as far as legality of claims go, I’d like to label my product and as a neuro protectant, energy booster, and cognitive enhancer.

What special manufacturing licensing is necessary?


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Invisibleliamtheloser
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: Shiro]
    #27504994 - 10/15/21 03:35 AM (3 months, 2 days ago)

Would be considered a supplement, not a medicine.  Supplements are not a regulated industry in the US.  As long as you don't make any medical claims you can sell and market them as supplements.  To sell them WITH medical claims, you'll need to register with the FDA, do the entire trial process and seek FDA approval as a medicine or treatment.  To even register with the FDA as a producer it costs 10,000 yearly.  The approval process, successful or not, can cost millions.

So long story short, market them as supplements, clearly state that any health claims have not been evaluated by the FDA, and then sell away


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OfflineForresterM
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: liamtheloser]
    #27505679 - 10/15/21 06:35 PM (3 months, 1 day ago)

Quote:

liamtheloser said:
So long story short, market them as supplements, clearly state that any health claims have not been evaluated by the FDA, and then sell away




:whathesaid:

Just look up mushroom tinctures on etsy.  None of those people have any licensing.


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OfflineStromriderM
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: Forrester]
    #27505713 - 10/15/21 06:54 PM (3 months, 1 day ago)

Some avenues of sale will require product liability insurance. Mainly larger distributors. I ran into this recently trying to work with an online food hub and had to get a policy. It's not expensive. I think around $20 a month and it's a million dollar policy. It's only for fresh mushrooms. May would cost more with a value added product or unregulated supplement. Not sure


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Offlineseagu

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Re: Necessary licensing for a medicinal mushroom supplement company [Re: Stromrider]
    #27506250 - 10/16/21 07:08 AM (3 months, 20 hours ago)

If you don't mind me asking which Insurance company was willing to sell this? I have ran into problems of insurance companies not knowing anything about insuring mushrooms, which years back I know was a common problem for Gourmet growers.


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OfflineForresterM
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: Stromrider]
    #27506408 - 10/16/21 11:03 AM (3 months, 16 hours ago)

Quote:

Stromrider said:
It's not expensive. I think around $20 a month and it's a million dollar policy. It's only for fresh mushrooms. May would cost more with a value added product or unregulated supplement. Not sure




Fresh mushrooms are, obviously, considered a food, so I don't think this would apply to something categorized as a supplement.  (could be wrong)

But I'm pretty sure that's where the big hangup with the "supplement" industry is, that it's almost entirely unregulated.


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OfflineStromriderM
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: seagu]
    #27506490 - 10/16/21 12:17 PM (3 months, 15 hours ago)

Quote:

seagu said:
If you don't mind me asking which Insurance company was willing to sell this? I have ran into problems of insurance companies not knowing anything about insuring mushrooms, which years back I know was a common problem for Gourmet growers.




Farm bureau. I have close family and friends that work there and my great uncle actually wrote the policy. Said he'd never written one for mushrooms but he didn't question it. Idk if it was this easy because of family or because it's a big farm insurer


Quote:

Forrester said:
Quote:

Stromrider said:
It's not expensive. I think around $20 a month and it's a million dollar policy. It's only for fresh mushrooms. May would cost more with a value added product or unregulated supplement. Not sure




Fresh mushrooms are, obviously, considered a food, so I don't think this would apply to something categorized as a supplement.  (could be wrong)

But I'm pretty sure that's where the big hangup with the "supplement" industry is, that it's almost entirely unregulated.





My uncle knew I made the tincture and asked if I wanted that as a product listed on the policy. I told him no because I'm not selling it through that distributor that requires the insurance. He did offer tho so I suppose it can be done. I doubt most do


Edited by Stromrider (10/16/21 12:20 PM)


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OfflineShiro
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: Stromrider]
    #27506740 - 10/16/21 03:58 PM (3 months, 11 hours ago)

What constitutes a medical claim? So if I was to label my supplement as a cognitive enhancer, Neuro protectant, immune regulator, and energy booster. And make the statement “these statements have not been evaluated by the FDA yadda yadda.” Would I be good to roll selling as a supplement?


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OfflineNPoB
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: Shiro]
    #27506851 - 10/16/21 05:34 PM (3 months, 10 hours ago)

No license is required.
Tinctures and extracts are supposed to be prepared in an "FDA registered facility". I think this went into effect in October of 2018? You can find details on the FDA website by searching for manufacturing herbal extracts.
The change in regulations mostly mean they want to be able to inspect the site if a problem arises but it did add some labelling requirements including such things as producer contact information, amount included per serving, date of preparation and an identifying batch or lot number. A lot of people I've encountered (including buyers for grocery stores) either don't know this or they don't care about it.


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Offlinethe man
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: NPoB]
    #27507225 - 10/16/21 11:24 PM (3 months, 4 hours ago)

im sure there is a point at which it doesnt matter IE stuff prepared at farmers market are often made in home kithens..


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OfflineNPoB
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: the man]
    #27507875 - 10/17/21 02:04 PM (2 months, 30 days ago)

Farmers markets can depend. Some places it is very loose. I'm in California where this varies county to county. Our primary venues here in Mendocino County are certified markets so won't allow extracts but there is no problem selling at any of the renegade farmers markets or direct to customers or retailers.
Unless a person gets really big it is unlikely they are going to come onto anyone's radar. That said, the research I did on this suggested that even then doing the prep in a certified kitchen could enable a person to stay inside of the lines. At least two local businesses will rent access to theirs if I work at night and there is a Grange hall that will rent access during the day.


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OfflineNPoB
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: NPoB]
    #27507883 - 10/17/21 02:10 PM (2 months, 30 days ago)

In Mendocino County there is insurance available through FLIP or the Food Liability Insurance Program. It works out to about $20 a month for a million dollar policy. As of an event last year when a gust of wind picked up someone's popup while they were shutting down and sent the market's musician to the hospital with a concussion this became mandatory for all vendors.


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Offlinepatischof
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: Shiro]
    #27519118 - 10/26/21 06:28 PM (2 months, 21 days ago)

Where I can buy some good vitamins?


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OfflineQuirkmeister92
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: patischof]
    #27520501 - 10/27/21 07:29 PM (2 months, 20 days ago)

:notsureif:


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OfflineShiro
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: NPoB]
    #27524697 - 10/31/21 12:16 AM (2 months, 17 days ago)

Considering making tinctures requires glass containers, alcohol, boiling water, and a blender. And no oven, I think they should reevaluate the condition necessary for a commercial kitchen dependent upon what is being manufactured.

I purchased a Soxhlet extractor for extracts and plan to set it up in my barn in a sanitary custom built mini lab. I’ll place a little foot activated hand washing system, run a hepa in there and call it good. I could imagine most scheduled kitchen would be dirtier.

Maybe FDA can make an exception considering I need no equipment that is in most legal kitchens and those kitchen won’t have the extraction equipment I want to use, unless I may bring mine which I’m assuming is fine but kind of defeats the purpose.

I don’t mind if FDA rolls thru as I produce in a sanitary environment following sanitary procedures.


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OfflineQuirkmeister92
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: Shiro]
    #27524733 - 10/31/21 12:42 AM (2 months, 17 days ago)

Sounds pretty legit to me!


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InvisibleTechnicavolous
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: Quirkmeister92]
    #27527831 - 11/02/21 07:30 PM (2 months, 14 days ago)

https://www.fda.gov/food/food-industry/how-start-food-business

"Under federal regulations at Title 21, Code of Federal Regulations (CFR), section 1.227 (21 CFR 1.227), a private residence is not a “facility” and thus, is not required to be registered with FDA."

FDA appears to only regulate if you're selling across state lines.


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Re: Necessary licensing for a medicinal mushroom supplement company [Re: Technicavolous]
    #27529371 - 11/03/21 11:38 PM (2 months, 13 days ago)

In most states you don't need a license for producing and selling whole, unprocessed mushrooms, growing, harvesting, selling, repeat.

When you start cutting them up, drying them, cooking them, extracting things from them, is when you need a separate, licensed/inspected facility that is not your residence. I just talked to a guy from my state agriculture department about this. Miiiight be different state to state, and as far as enforcement goes could be wildly different too.

If you're trying to start a legit business, I'd...you know, do it legit. That's just me though.


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OfflineShiro
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: MrPinkFloyd]
    #27547027 - 11/17/21 02:47 PM (1 month, 30 days ago)

I agree that the licensing starts being necessary as soon as you process a raw agricultural product beyond harvest and packaging. But from what I found dietary supplements, until you make big $$$$$ are in this super grey area and provide a wide open window with little regulation, as long as you follow labeling guidelines, CGMP standards, and include the “this product has not been evaluated by the FDA and does not Intend to diagnose, treat, cure, or prevent disease.” I intent by all means to create in a sterile workspace and develops high quality standards regardless of little to no regulation.

From my research you can even sell dietary supplements across state boundaries. Please correct me if I’m wrong.

Now making jerky for instance out of mushrooms requires processing, and it’s not a dietary supplement. So any non dietary supplement needs that extra licensing and requires you to produce in a licensed kitchen.


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InvisibleShroomintune
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Re: Necessary licensing for a medicinal mushroom supplement company [Re: patischof]
    #27547361 - 11/17/21 08:21 PM (1 month, 30 days ago)

Quote:

patischof said:
Where I can buy some good vitamins?




https://www.costco.com/all-vitamins-supplements.html


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