[socioecologist]

As we know, the federal government has barred the DOJ (which includes DEA) from using their budgets to interfere with cannabis operations that abide by state law and conform with the Cole memo. Interstate sales of legal hemp products were added to the list of DEA prosecution exception in the FY2016 budget too. These are all huge wins!

It's almost as if certain forms of cannabis are close to legal nationally. Except...the FDA has stepped in and looks to shut down segments of the non-psychoactive cannabis market before it takes off.

12. Can products that contain cannabidiol be sold as dietary supplements?

A. No. Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if a substance (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was "marketed as" a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol

Welcome to the new normal. Cannabis is basically legal in certain forms, but producers / manufacturers cannot participate in the national market without risking an enforcement action from the FDA (not to mention IRS, depending on your accounting practices). Now the world's leading practitioner of reductionist science and one of the worst offenders of "revolving door" politics is in charge of cannabis rules. Out of the frying pan, into the fire.

Thoughts on this? How will this shake out in the next couple years?

From: https://www.fda.gov/NewsEvents/Public...etsuppsexclude

[dank.frank]

Yep. Saw this coming a mile away. Your can get your heroin from the doctor via a prescription but you can't grow poppies in your back yard. Did you think it would be any different??? This is pretty much what I have expected to happen on a federal level.



dank.Frank

[theJointedOne]

Interesting

[socioecologist]

I guess I was paying more attention to the "definition" of marijuana that the 9th circuit court of appeal put out in the hemp industries association decision. The only cannabinoid that is explicitly scheduled is THC. The DEA claims otherwise, but they will lose a legal battle if challenged. That means non-THC containing cannabis is full of unscheduled substances; so now we're in the position of producing chemicals that are totally legal--but can't be sold as supplements. CBD vape pens would still be legal though (and "refills" for them). WTF?

I feel a bit silly for NOT seeing it a mile away, even though it took 9 months for the FDA to figure out how they could prohibit CBD as a supplement--their previous guidance was basically "we can't do anything to stop this". Looks like Novartis / Otsuka / GW finally got them turned around...

There has to be some loophole in the FDA rules that prevents them from banning the addition of a safe, unscheduled substance to other dietary supplements...?

[G.O. Joe]

It's worse than you think! The government employees of FDA are in the back seat. Politicians are still at the wheel that the police have a hand on.

Originally Posted by socioecologist

non-THC containing cannabis is full of unscheduled substances

The entire plant is scheduled except for the seeds and stalk.

The trend in the newest MMJ laws named after an epileptic kid is to make CBD whether natural or synthetic the same as child porn, vehicular manslaughter, armed robbery, all but the highest level crime, so far. It won't stop there, because it never does, does it?

[socioecologist]

Originally Posted by G.O. Joe

The entire plant is scheduled except for the seeds and stalk.

A close reading of HIA v. DEA (2004) says otherwise. You are right that the entire marijuana plant is scheduled, as is synthetic THC and its analogues. The 9th circuit court was very clear that cannabis not containing THC is considered hemp instead of marijuana. The 2014 Farm Bill (sec. 7606) provides the formal distinction between the two (<0.3% THC = hemp, all else marijuana). A socially constructed difference? Most definitely--but it's arguably one of the most important ones in the history of cannabis legalization.

I agree that it does seem like roadblock after roadblock with this plant and these agencies...my experience has been that there are more politicians who are helping the non-monopolistic industry (i.e. big pharma) right now than trying to hurt it (with most simply agnostic and not willing to support pro-canna legislation). These agencies (FDA, DEA, NIDA, etc.) are the ones actively undermining the legislative gains we have achieved through a strange assortment of politicians. I mean, how often do we see right wing Rs (Senator McConnell) collaborating with left wing Ds (Rep. Blumenauer) to legalize large scale cannabis farming?

[St. Phatty]

Originally Posted by dank.frank

Yep. Saw this coming a mile away. Your can get your heroin from the doctor via a prescription but you can't grow poppies in your back yard. Did you think it would be any different??? This is pretty much what I have expected to happen on a federal level.
dank.Frank

Actually, you can grow poppies.

What you can't do is talk about how to refine it into the medication, which is basically a re-do of simple methods that would have been used by pharmacies and their suppliers in the US from 1776 to the mid-30s.

And if you do grow poppies, it can also invite attention. "what you doing with those pretty flowers".

[G.O. Joe]

Originally Posted by socioecologist

A close reading of HIA v. DEA (2004) says otherwise.

Unlikely, from memory. You are invited to point out where it says the court is ruling on anything other than seed and stalk products. That doesn't apply to anything because it doesn't apply to the federal law as written, and never did. The ruling against DEA is against their attempt to amend the law as written by Congress, which no judge in San Francisco can change either.

For all I know DEA decided to put a stop to trade in seeds and whatnot - despite the long-time legality of hemp products and sterilized seed - because that's how they roll, but then had to come up with some way to prevent a worse court ruling showing they acted in bad faith. So they published their silly extra line or whatever it was rule, knowing it would be shot down.

The law says it's fine if the stalk and sterilized seed are mostly THC. The rest of the plant, it doesn't matter what it is - water distilled from the leaves is scheduled.

(16) The term "marihuana" means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

[socioecologist]

Great response G.O. Joe, sincerely appreciate it. You are right that the court was striking down shoddy rule-making by the DEA; their opinion has broad implications though because of how they interpreted the existing listing of cannabis in the CSA--and their interpretation of the CSA can only be overturned by the Supreme Court or an act of congress. Your hypothetical example of THC extraction from seeds or stalks is correct too, although in that case the DEA could create new rules that prohibit such action if they contained psychoactive levels of THC. What made me type what I did was this, from the conclusion of HIA v. DEA:

Originally Posted by 9th Circuit Court of Appeal

The DEA’s Final Rules purport to regulate foodstuffs containing “natural and synthetic THC.” And so they can: in keeping with the definitions of drugs controlled under Schedule I of the CSA, the Final Rules can regulate foodstuffs containing natural THC if it is contained within marijuana, and can regulate synthetic THC of any kind. But they cannot regulate naturally-occurring THC not contained within or derived from marijuana—i.e., non-psychoactive hemp products—because non-psychoactive hemp is not included in Schedule I (my emphasis). The DEA has no authority to regulate drugs that are not scheduled, and it has not followed procedures required to schedule a substance.

The court differentiates between marijuana and hemp, with marijuana being cannabis containing psychoactive amounts of THC (this level was left undefined) and hemp not--the former is a schedule 1 drug, the latter is unscheduled. The reason hemp production in the US was up in the air until 2014 was due to lack of solid definition of what constituted "psychoactive" amounts of THC; Congress remedied that with the 0.3% THC definition in the Farm Bill last December. All other cannabinoids, terpenes, oils, etc. are not listed in the CSA and the court affirmed that they must be listed before the DEA can claim jurisdictional authority.

That's my reading of it though. Please do what you can to tear it down (seriously--a little peer-review from competent and knowledgable members of the community goes a long ways). Thanks again for your contribution here!

[G.O. Joe]

Originally Posted by socioecologist

The court differentiates between marijuana and hemp

The court is using my definition and you are using yours. Theirs: We refer to hemp stalks, fiber, oil and cake made from hemp seed, and sterilized hemp seed itself—i.e., those substances excluded from the definition of marijuana under 21 U.S.C. § 802(16)—as “non-psychoactive hemp.”