Cannabinoid Safety and Regulation Act - US Senate Bill Introduced

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Hello all.

In case you did not see - the senate has introduced a bill to make all cannabinoids equal throughout the country regardless of where they come from. The first combined hemp/marijuana bill to come out of the federal government in recent times.

Wyden Introduces Legislation to Clean Up Hemp Market, Keep Products Out of Kids’ Hands | U.S. Senator Ron Wyden of Oregon.

You can read the bill here.

You can read the one pager here.

You can read a section by section review here.

This is the opposite of everything else happening across the country. We’re working hard to make sure there is consumer focused option on the board that keeps access while leveling the playing field between states.

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I like everything in this bill except their definition of THC as I feel like it limits access. It is preposterous that they clarified semi synthetics shall be available but wouldn’t allow for real THCa products…

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Could you elaborate? Perhaps how you would change it? <3

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I feel like including THCa, Delta 8, etc under the definition of THC will put many products off store shelves. It’s weird to me they clarify semi synthetics are alright but then put THCa specifically under under .3%. What real use cases would remain for THCa? No flower, hash, useless in edibles. And I think THCa has such a more studied history than other hemp products they will be allowing. Honestly I’m fine with trading semi synthetics for THCa access, but realistically in an ideal world I would just take the THCa out of the definition of THC and keep everything else the same…

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Ah. I think this is perhaps a misunderstanding of the bill.

This is for descheduling / legalization of ALL CANNABINOIDS. Not just hemp.

So as long as you had a registered store front and met all the other requirements for safe consumer products you could have products that are not hemp or hemp products or combination products etc.

Its a new category for cannabinoids completely - treating the plant and all the things that come from the plant whether naturally occurring or synthetic equally.

So I think there would be lots of stuff with THCa in it on store shelves. Shipping around the country. And maybe internationally as well - there are provisions for international trade written in as well.

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Oh, that’s great then! Thanks for all your work. Amazing job if you had something to do with this.

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Let me look a bit further into this. The last draft I have before this was published was treating all cannabinoids as equals regardless of where they come from.

Letting the states regulate things if they want but establishing a framework to keep the FDA at bay from foods and dietary supplements that contain cannabis.

I feel like there’s a big change to “hemp” which is that it is the non-consumable stuff. While cannabinoid products are everything else.

But I might also be misunderstanding. So I reached out to the staffers and Senators and lobbyists for clarification. I shall let you know what they have to say about it. <3

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That is what I saw too and wanted you to clarify, you beat my to it. Let me know that you hear.

Technically, is not for g human consumption on hemp any different from it not being FDA approved now?

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The difference here is that they are pulling “cannabinoid products” out of “hemp”. So hemp would be like… fiber, concrete, fuel, etc. And cannabinoid products would be other than that.

But yeah - we shall see what comes back from the legislators. :smiley:

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A lot to unpack here

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Basically just rewriting the entire FDA code to include all drugs and Cannabinoids, as if cannabinoids are not included in the “set of all drugs.”.
We will have a new office of Cannabinoids in parallel with FDA. We know Wyden himself is not behind this.
“ it bears or contains, or has been manufactured, prepared, or processed from, artificially or synthetically derived cannabinoids of any kind.”
This is in opposition to naturally occurring or “semi-synthetic”: “A drug that is formed through the chemical reaction of a naturally occurring drug to form a new product.” But of course according to their logic…decarboxylation is NOT a semi-synthetic product.

So now we can add “Wyden’s Non-semi-synthetic “ neutral cannabinoids to the list of Oregon’s “non-aliphatic Ethanol”….we are so glad they are here to help us out.

“It has been manufactured, prepared, processed, packed, or held in insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health”

Get ready to convert your production facility to a pharmaceutical grade standard GMP…both production and packaging.

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This seems like the part that will take a lot of the current players out of the game…

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“To Protect Public Health, Federal Government Should Provide Guidance to States that Have Legalized Marijuana, Close Hemp Regulatory Loopholes, Create Public Health Campaign”- https://www.nationalacademies.org/news/2024/09/to-protect-public-health-federal-government-should-provide-guidance-to-states-that-have-legalized-marijuana-close-hemp-regulatory-loopholes-create-public-health-campaign

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We have gotten both cGMP and Iso 9001 and it is overly expensive and time consuming. The paperwork alone and the need for additional full time position as QC really hurts being a cbd extract company. Be prepared to fill out a capa every time you fart. Endless paperwork

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That was my thought indeed. It seems like a plan to destroy what is left of individual small players.

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I’ve been worried about this, yet @Cassin tells me not to worry.

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I’d argue a plan isn’t needed to destroy small players, but that market consolidation is inevitable due to debt slavery, but that’s another topic.

I truly feel 2 ways about this all, sitting from a consumer standpoint.
On one hand, some small producers have make some amazing quality products that are clean and safe that cannot be beat at scale.

On the other hand, pictures like this (among a laundry list of other complaints about safety and purity) make me wish cGMP was the requirement
89807437-13862913-image-a-7_1726635389528 (1)

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Is it not clear that these GMPs are based on the type of production? Food, dietary supplements, and cosmetics. Drug products are not included in this bill - although existing approved drugs that also happen to cannabinoids (there are only two) are now also allowed to be in Food, dietary supplements, and cosmetics.

Right now the FDA says that you cannot have CBD in food or dietary supplements because CBD is a DRUG as approved by them. Therefore, even though it is safe for consumption and there are millions of people using it as a food or dietary supplement under the farm bill and local state programs - the FDA continues to say it is an adulterant.

This bill would change that. You’d still have to be registered (just like all other food, dietary supplement, and cosmetics producers) but you are not having to file IND, NDA, or ANDA for your product, because its “not a drug”. Unless you want it to be a drug, in which case - you could always have been following the drug rules to begin with.

This is just to say that the FDA does not require ANY PHARMA or FOOD COMPANY to get ISO 9001. Indeed, the FDA doesn’t require any fucking certifications at all. They ask that you register. They may (not often I might add) come to your facility to look at things.

If you are doing this - your deviation and CAPA program is severely broken and probably not functional. <3

I mean when I commented on prior drafts of this - I had a similar thought. So I asked for specific things to be built in to make more sense for smaller players. People like me who want to be able to export around the world while also making products for my local community.

The goal is that anyone who is doing this now can continue doing so, if they have given any consideration at all to general sanitation and contamination control. Including (as far as I can tell) on-going cottage food programs and getting to utilize the same SBA stuff that limits impact to smaller businesses by reducing burdens until you are over so many millions in revenue or so many employees.

The thing that always frustrated me about all of this - is that these requirements for food, dietary supplements, and cosmetics (and drugs…) have always existed. Because there is no real mechanism for enforcement AND everyone thinks there are no rules because REASONS, some people do whatever the fuck they want.

I’ve been to some really fucking terrible places that were producing a fuckton of products. I’ve been to some really excellent places that were also producing a fuckton of products.

I’m not sure that the people fucking up all the things will see enforcement (usually that kind of thing takes years, honestly, and a consumer getting harmed…)

But I do know - that changing the categorization of cannabinoids so that they are GRAS for use in food, dietary supplements, and cosmetics in this country. And so that they can be imported and exported. And so that its clear that it doesn’t matter where the cannabinoid comes from (plant, precision fermentation, synthesis) that its still allowed.

I think those things are important. People have been asking for that clarity.

All that being said - I’d love more specific feedback. How is this thing broken? How would you break it if you could? What parts are too heavy handed that are freaking you out?

And please consider the alternative - complete removal of cannabinoids (including CBD honestly…unless THC-free chromatography like back in 2019…) from the marketplace.

Because that’s what the House has presented. This is what the Senate has presented. And I’m still trying to figure out how to get parts of this in the Farm Bill so it happens sooner (this is probably YEARS out still).

As right now - the Farm Bill proposals are still shutting down all businesses big and small.

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I feel this to my core.

If the FDA is involved, this is exactly what people can expect.

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Are you interpreting this forthcoming legislation to place cannabinoids in some section of 21 CFR?

If so, is there any clear path for 110, 111, 210, or 211?

Lots of range of possibilities depending on what category it’s placed in

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