Comment on the DEA IFR regarding synthetic THC analogues and WIP

Hempire Building Delta 8
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National Cannabis Industry Association is putting together a response to these rules, as well as, the updated rules from USDA and answering their specific questions.

I put up a post asking people to reach out to me with comments, concerns, topics to include and cover.

I’d really like to see more interaction. I don’t want the comments just be in a silo. So please DM me. What HolyCity posts here is very true - looking at the science, explaining the impact to your businesses no matter how big or small. Its all very important. I could really use a couple of people interested in participating in a Podcast for a Call to Action on this topic.

If you are fired up about this topic - I want to hear from you. <3

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I think they post Boned the vote today

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I really hope that was an unintential typo. If not, better start upping my game with the kid’s newfangled slang words!

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Whats funny about this diagram is that we know what THCV converts into CBV(CBNV). Is interesting they put D8-THC in this diagram prominently, “aged” lol.

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It’s just a bad chart. I hate when marketers try and make this stuff.

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Synthetic means an imitation of a natural product. Ex they change the molecular structure.

Delta 8 is actually a NATURAL molecule (or an “organic” molecule to be exact).

All “synthetic” drugs are not real natural molecules, as they change the structure of the molecule.

Thus, D8 is not a synthetic molecule under any definition of the term.

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I don’t even know what you are trying to say. There are tons of synthetic organic molecules, all that means is they have carbon in them. Synthetic means that they have been synthesized: made from another molecule or molecules intentionally. You can synthesize a compound which exists in nature and it is still synthetic even though the molecules are identical (search olivetol here)

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First off, you are correct and I should of clarified further - sorry for making that confusing.

Specifically in terms of “synthetic drugs,” thats where the molecular structure is changed (they are NOT the same as the “natural molecules.”)

The term synthetic is what matters - not that its an organic molecule.

Synthesis does not necessarily make something synthetic on a 1:1 in reference to “drugs;” or even other substances for that matter, and I’ll explain why below:

You are correct that you can absolutely create synthetic molecules (without a molecular change from what is naturally occurring) solely by using chemicals (in doing so, it’s then considered chemically synthetic). The big and most important difference is where is it derived from.

If it’s derived from the same materials where it’s naturally occurring (with our without chemicals, but not solely derived from chemical), then its technically not a synthetic drug, and arguably not synthetic at all by definition - with or without synthesis.

Based on what you just called out regarding “made from another molecule or molecules intentionally,” lets look at another set of molecules for reference:

THCa and Delta 9 THC. These are two different molecules. You are synthesizing when (by way of “degradation” through applied heat, and by definition of synthesis - degradation is technically a means of synthesis) processing THCa to Delta 9 THC. Thus, if they passed any law and set any precedent to this, Delta 9 would subsequently be “synthetic” as well.

Hopefully the players pushing against this can make sound arguments along these lines. Furthermore, there are tons of examples they can pull from outside of cannabis/hemp to reference.

A precedent like this would do so much damage to industries outside of cannabis/hemp, such as food, cosmetics, etc. The DEA is playing a dangerous game going this route, and I don’t know if they even realize the implications.

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I’ve been having this conversation with people quite a bit lately. The US Code already has a definition of “synthetic” so we don’t have to wonder about what that is.

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This whole hemp process is covered by the USDA, a tiny bit by the FDA (cause they want to be out of it) and a smidgeon for more than negligent bad actors by the DEA. I feel its pretty safe to use the USDA definition of synthetic when having conversations about rules/laws/regulations from the department of Ag.

I’m trying to get the DEA to clearly define “synthetic” and “natural” also. Amazingly enough the USDA has done this already- there’s even a really cool decision tree on what is a natural vs a synthetic material. Check it out here. Because they had to start that conversation when people started worrying about things being “Organic” - and not just because they had carbon in them. :stuck_out_tongue:

The cool part about how that decision tree works is there are actually examples of the same molecule that are either a synthetic or a natural product. At the beginning of my career I did natural product synthesis - that meant making something that existed in nature but was seriously rare in a lab using materials that were significantly more available. I was making a synthetic of a naturally occurring molecule.

For instance - you can get natural calcium stearate from cows… or you can make it in a lab using steric acid and calcium. One is a natural product, the other is a synthetic. They are both calcium stearate.

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Thanks for the link! Unfortunately, this just raises more questions then answers haha.

The big part in the attachment is “or by a process that chemically changes a substance…” There is in fact a chemical change in the substance by a process (Ex heat).

This is the part that’s concerning in reference to the link regarding THCa / Delta 9 example:
“Calcium oxide (quicklime)
Synthetic
Substance is produced from a natural source (mined
mineral), but undergoes chemical change caused by
heating the mineral.”

They are calling this synthetic based on heating the mineral. Thus degradation would be considered a chemical change (synthesis) from this definition.

Does that mean Delta 9 by way of this definition is actually synthetic?

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Their flowchart actually specifically calls out “heating” as a natural process, that if you used it on an extracted product in your example THCa and arrived at d9-THC then you would have arrived at a natural product, not a synthetic. I agree that their table which using an example of a mined material being heated as a synthetic process is confusing - but that’s not from a plant or from an animal (so not a “food”). And this is department of Ag, so source material should also be included here, not just the downstream processing. The example of molasses is probably appropriate - natural raw material, extracted, heated - tada you have molasses, and its a natural product. Closest example to THC production given it comes from a plant, gets extracted, undergoes distillation, and heat-based modification of the chemical structure.

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Considering the evidence you provided and your previous experience, I have a two-part question for you:

What do you think is going to happen in regards to the DEA’s overall interpretation (in terms of all hemp extracts), and specifically, do you think they will classify D8 as synthetic or non-synthetic?

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I think that the way the DEA wrote it allows for all hemp extracts - but requires clarification from both the USDA and DEA on how to handle intermediate products which go above 0.3% THC (the FDA provided some limited guidance on this, suggesting in their guide on clinical trials, to contact the DEA when transporting intermediate products). I’ve been on that train of thought - that the states are allowed to define what “negligence” means and so can the USDA. And that unless someone is intentionally being negligent and also not handling their waste products correctly - the feds should leave them alone. I mean its written that way in the AIA - so why not enforce it that way?

I think that it really depends on the process being used to get the D8. The current processes are highly synthetic in my opinion, except for chromatography to separate naturally occurring D8 (which has been found in limited quantities). But using multiple solvents to break CBD into pieces, then recombine them back to a mixture of d9 and d8 and then forcing d9 into d8 and then purification? Sounds synthetic to me. I think people know its synthetic - and I think they also know that its already been on the WHO’s list of synthetic isomers of d9-THC.

So perhaps they will be able to show its natural (how, I don’t know). Or perhaps they will be able to convince the DEA that all synthetics are supposed to be legal as long as they have a starting material that comes from hemp.

Regardless - I think that now that people have started making it AND that other people have also started using d8 to make d9 on the black market. That the potential for diversion is too great and it will be handled and regulated similar to how they are treating natural products that produce meth. Even if they handle it with Schedule 3-5 gloves, there are still quotas, controls, security, and oversight that happens. You know?

And that all goes in the same bucket as why is there prohibition to begin with? As long as we have a marketplace that can create materials that are safe (I’m not sure d8 is safe…especially impure d8) and you know, prevent children from unknown consequences - they should just leave the industry alone.

Of course they haven’t wanted to do that for almost 100 years. So I don’t expect this ship to change lightly. But I’m actively lobbying the government for this change and I assume most of us here are. Because change needs to happen to keep people safe.

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“requires clarification from both the USDA and DEA on how to handle intermediate products which go above 0.3% THC”

This is the part that concerns me the most. If they rule against having intermediate products - that makes every CBD manufacturer an “illicit drug manufacturer.” Any extracted CBD product would essentially become illegal at its initial extraction point, and one would have to break the law to make it compliant. It’s a pretty illogical approach to this… but wtf… its happening. Ha. Personally, I don’t see this becoming law - whatsoever.

I think its much more likely they go after D8 specifically, if anything.

I do agree the process in creating D8 could easily be classified as “synthetic.” I just wonder how it could possibly be enforced from a legal standpoint, because its a natural molecule found in a currently legal plant/process. Thus if someone got pulled over with a liter of D8 - it would be very difficult and/or expensive to prove its synthetic… and even then… a good legal team could easily install reasonable doubt.

When the DEA first released their “interpretation,” I thought it was simply a tactic to get the States and licensed cannabis agencies to look at it… because they can pass “amendments,” or “rule changes” much faster than the federal government could pass a law.

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I don’t know about this. The degradants and other isomers that are present from making D8 (at least almost all of the D8 I have seen…) are pretty indicative of a synthetic process. The residual solvents left behind would also be indicative of a synthetic process. But really - just as the WHO has decreed in their documentation on illicit isomers of d9-THC, it would probably be the stereoisomers that are present - which do not occur naturally that would catch people up. They just don’t exist in nature, and they exist in various levels even in highly purified d8-THC.

Seems to me that it would be a better play to convince the FDA that CBD can be allowed in food, nutraceuticals, etc. instead of trying to convince the DEA that a potentially psychoactive substance isn’t synthetic. I’m under the impression its an overabundance of CBD which is causing people to look for other options. Unless they are looking for a means of “easily” transporting d8 and then converting it to d9 when it gets to its destination.

Bad actors have been doing this kind of thing for decades with other illicit substances. But really - if we could just get rid of the prohibition on THC in general, then we would be having the real conversation. And that conversation is about consumer safety, the purity of the highly purified natural or synthetic compound, and records telling us if people are having adverse reactions to these highly purified compounds.

That’s what the DEA is getting in the way of - and they have for decades. Science performed outside of the guise of preventing “drug abuse”. Science to for efficacy. Science for side effects.

How long have they been saying that “science” says that THC is as addictive or more than heroin? How long have they been saying that it hurts babies? How long have they been saying it stunts brain development?

And all of this being said - with limited research because of the prohibition and the selective approval of research being performed by labs that want to maintain prohibition. :frowning:

What happened to @SidViscous - he was in this conversation and now it just feels like the two of us.

What do other people think about this topic?

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Ooooo

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Yep I’ll be honest I checked out on the conversation a bit because I’m licensed for THC so it’s not really as much of a deal breaker for me whether the isomers are legal.

One thing you mentioned which I’m not sure I’m clear on yet is the naturally occurring stereoisomers; I’ve heard some people say their occurrence is racemic and others say it’s not. I’ll be honest in that I haven’t dug that much but I am curious

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The DEA makes up its collective minds and issues negative opinions concerning what is synthetic and what isn’t synthetic. Needless to say, trying to convince them otherwise is an uphill battle. 1973, Nixon declares “war on drugs”. Almost 50 years later, the Federal stance on the psycho-activity of Marijuana and has not changed one click. Until MJ is removed from Schedule 1 classification, the struggle continues. Getting rid of the prohibition of THC? We’ll land humans on Mars before that happens. They’ve been growing MJ on Federal property for 50 years at the University of Mississippi. They dole out MJ that has been frozen for 10+years or has been stored improperly at the least. They are not growing what is being consumed. How on earth can the FDA get an accurate picture of the benefits of Cannabinoids when they have yet to use any other MJ for research than what is in frozen storage in Mississippi. The FDA announced a few years(2015-2016) back that they would be expanding the number of manufacturers and growers, but has yet to name any. They only grow so much in UM, then store it in deep freeze or otherwise. That is the Federal stockpile for performing Scientific studies. If you applied for a grant or permission to do a Scientific study, the MJ you would be supplied with could have been harvested a decade ago. If they really wanted to they could expand and put wheels on the program with a stroke of the pen. No, they want to argue the wording of the Farm Bill of 2018. They can’t even come to some common understanding of CBD. Then throw Delta 8 into the mix.

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The following is recent as of 10/01/2020. It’s an excellent write up on the FDA & Cannabis $ Research:FDA and Cannabis: Research and Drug Approval Process | FDA.pdf (313.4 KB)

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Hmm I doubt this is done
And eventhou it is a possibility written in the WHO report I would love for someone to
Give a sop for it s how to
Since gooing to high D8 is easy it would be nice to then take it to high D9
Any refrance ??