As the DEA Diversion spirals into constitutional crisis, all eyes now turn to incoming Administrator Terrance Cole. With the Supreme Court, DOJ, and Congress aligned on the illegality of the agency's ALJ system, Cole faces a clear mandate: dismantle the DEA's kangaroo court framework, remove corrupt leadership like Thomas Prevoznik, Matthew Strait and attorney Aarathi Haig, restore sound marijuana policy and return the agency to the rule of law. His next moves will determine whether the DEA Diversion can be salvaged-or whether it must be restructured from the ground up.
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NewsTranscript
00:00segment number two which is all let's uh shift things back to the u.s and an interesting story
00:04there's a press release that came out from mmj biopharma yesterday saying that the dea in a lot
00:10of ways has blocked conducting federal compliant research of theirs for over 2300 days despite fda
00:17support the reason why this got some attention is because the current attorney general pam bondy is
00:22also backing a lot of these claims as well so with that let's welcome in their ceo duane boise first
00:28time of the podcast good to meet you how are things hey doing great chad anthony nice to meet
00:33you both thanks for having me today so that was an interesting press release it grabbed a lot of
00:37people in this industry a lot of attention with the backing of attorney general pam bondy but first
00:42walk us through like uh maybe a little bit about your background what you've been working on and
00:48really a lot of the challenges that you've been facing for that's a long time which 2300 days is
00:53that five six seven years seven years seven years and we filed in december of 2018 for
01:00the dea api bulk manufacturing license which is dea speak to grow marijuana for pharmaceutical
01:08formulation right um it's it's been an interesting challenge so let me just give you the short overview
01:15yeah three companies were formed uh mmj international holdings is the clinical trial study company which
01:22has the imds with the food and drug administration uh mmj biopharma cultivation applied in 18 to the dea
01:31to grow uh specific cultivars that we use to develop our active pharmaceutical ingredient and then mmj
01:38biopharma labs which is the recipient of a dea schedule one analytical lab license which we still have
01:45um the interesting uh note here is that the same team they got the schedule one licenses labs it's
01:53the same team that's in cultivation but they didn't give us the schedule one licenses that so
01:58i mean the hypocrisy is a mile long here wow um so how how was it or how was the process getting that dea
02:07testing license um were you interfacing a lot with them were they easy to deal with was it very rigorous
02:13like how was it obtaining that license i can say that uh the lab license was um it was difficult
02:25because she had to meet all the security protocols i'm sure and had to meet the regulations to the
02:29controlled substance act um a different investigator they call it a 303 investigation both for the lab
02:38and for the cultivation came in and the personalities were so different that i mean you could tell that
02:44the lack of knowledge was significant on one of the investigators tom cook mainly um his first question
02:51he was doing the api bulk manufacturing or the grow registration he asked us if we were growing the
02:56marijuana in a 10 by 20 vaults so i mean that's where it started and he went progressively downhill
03:04pretty quickly wow yeah all the way to the point where we are now so uh you know this is the dea not
03:10training their people properly and it's just uh ignorant and bias and uh they're being stubborn in this
03:17case but i'm fighting them all the way down on the cultivation license and we'll uh we'll eventually
03:22succeed now for context the bulk the bulk uh bulk the bulk cultivation api license is that the same
03:30thing as the licenses that are currently issued from the dea with certain institution or certain
03:35uh universities in the united states where they're doing research currently on cannabinoids
03:41or it's a different license it's a different that's a researcher's license right okay that's a different
03:46registration so who currently has who currently has api bulk manufacturing for cameras in the states
03:52well that was the the great scam on behalf of the dea so they came out and all these people invested
04:00all sorts of money one of which being us uh there were six or seven registrations issued most of
04:08those registrations are defunct out of business bankrupt and nobody's grown any pharmaceutical marijuana
04:14so the the best example was royal emerald i don't think they fell for bankruptcy protection yet
04:21uh they went out and purchased a uh uh kmart facility 100 000 square feet renovated into grow rooms
04:30spent a ton of money on the renovation air conditioning lights and so forth and so on
04:34get it all done they've applied for the registration they get the registration
04:38they go to polores and take down i don't know 15 or 17 million and 15 percent the payments were 178
04:48thousand a month pick up the phone ceo calls the dea in the quota section and the gal says to him well
04:56are you doing a clinical trial and ceo says no and well do you have a doctor that needs you know 100
05:03000 square feet of marijuana no so well we can't give you quota so evidently royal emerald was unaware
05:10of what the quota requirements are and in order to meet quota you would have to have gone about it the
05:16way we did okay nds clinical trials at the food and drug administration right uh back into the amount
05:23of quantity you would need for those clinical trials and eventual approval by the fda and that would
05:29give you your quota and that's the way we approached it so anyhow the short of it is that they got quota
05:35for 20 plants and 100 000 square foot facility so what's the hold up here this has been seven years
05:40now have you gotten a clear concise answer because you know it's not normally outside of ann milgren
05:45that we have to hear names but you've named a few names which is matthew straight and thomas
05:49preb president prebosnik at the dea so what role have they played in this delay because that is a long
05:58time so we knew that we were getting blocked pretty much from the get-go because every time i called in
06:04for a status update nobody got back to me okay the inspection finally started and then through the
06:10course of the inspection we got very little guidance on what they actually wanted so i had hired two
06:17retired dea agents that were in administration so that they could guide us through the 303 investigation
06:23to get an approval okay i i'm hearing off the record that uh it's the marijuana bias because
06:32agents have gotten killed in mexico over this marijuana thing and an milligram and a couple
06:38people didn't want to let this move forward because of the death of those agents gotcha that has nothing
06:44to do with helping patients and creating a pharmaceutical drug so what do you say in that situation then
06:48i mean watch the action not to speak i always say right yeah so the action has been consistent
06:56obstruction by them to the point that we know they're obstructing it intentionally now i believe
07:02the second part of that intentional obstruction is that they know how much marijuana we need to be
07:07growing to get the essence of the fill of those gel caps right now they could fight us on quota
07:14through the clinical trials but they can't fight us once the fda approves that because i need a
07:19million square feet of grown marijuana gotcha to fill potentially billions of pills and i think that's
07:25where the rub is they don't want this to get out of the box it's so it's so right now but you're in
07:31line at the fda correct because i know one of the drugs is orphan and one of the other drugs is fast
07:35tracked uh that's correct so the orphan designation is significant and we're focusing on the
07:41huntington's trial and we're going back and forth with the fda now and really i gotta say they've
07:47been very nice to deal with and they're asking credible questions uh the agency has put a cmc hold
07:53on our clinical trial because they're asking these very tough chemistry questions and how we've gone
08:00about in the consistent reproducibility of this natural drug in the jump cap form we've responded
08:08to all the questions and now they're the question comes in where the damages are they said do you
08:14have enough extract to continue into the quasi commercialization and use in clinical trials
08:20and the answer was no i mean the dea gave us a permit to ship out of canada where we did all this work
08:26and we shipped into cattle and pharmaceutical in st petersburg florida and then we worked with them
08:32for several years on developing the soft gelatin capsule uh to the point where we have all that
08:38scientific data stability and all the other requirements that the fda asked us to do so with
08:43with with the fda is the rub right now the fact let's say let's use epidiolex as an example i know that
08:50they're using a synthetic cbd in their medication which is consistent which is which enables consistency
08:55um throughout in terms of the actual molecule so that obviously passes muster with the fda the fda
09:02is rubbed right now is the fact that you want to use natural thc and they're asking you to prove
09:07the consistency um it's consistent reproducibility of the drug right and we we have that but the
09:14problem is is that the dea not allowing us to take the thc in and grow it under the api bulk
09:19manufacturing license that's where the rubber comes in so things changed with this new administration
09:26like we're seeing reversals from the doj you have support from attorney general pam bondy we talk
09:32about am milgram in the fda that was or excuse me the da uh in the past that was the previous
09:37administration so are you seeing any kind of difference since trump has uh stepped in i know
09:43uh terry cole is still yet to be uh confirmed as the head of the dea but are you seeing any change
09:49since the trump administration has entered in i think the pam bondy was significant change because
09:56if you have to understand the agency's administrative law process and this sort of comes back to the
10:02rescheduling issue too you hire all these high-powered attorneys and they're going into a kangaroo court at
10:09the dea so if you think about it the administrative law judge is appointed by ann milligram right you got
10:16the attorneys in the dea that work for the doj but they're still dea attorneys yeah and so you know
10:22the cards are stacked against you so that that judge that's doing that hearing in our case and in the
10:28rescheduling case could come out and agree with both of us and then it goes right back to the
10:34administrator the administrator says i don't like doing i don't like rescheduling no no and that's the end
10:40of the story okay so now all that data that they've stacked against you and slanted it negatively against
10:50you is now of the record so if you appeal it you're fighting an uphill battle so good call go finish your
10:57thought in our case we stopped that kangaroo court process i sued him as a violation of our constitutional
11:04rights and and i used the supreme court axiom decision and chersky's decision which basically
11:12they one was in the fcc and one was i think the faa and the agencies are similar on how they operate
11:19these kangaroo courts and the court came out and said that it was denying the parties their right to
11:25a trial by jury but as per as per the the quote and as per the letter that you had sent me yesterday
11:33correct me if i'm wrong but didn't ag bondi or the solicitor general say that while the laws
11:39while the stringent laws around the removal of an alj are unconstitutional they agree there but
11:47they're still not willing to remove the alj due to the due to the fact that the alj has not caused harm
11:54um to yourself being the plaintiff which you admitted um in the case as well um as per that letter am i not
12:01correct yes you're correct and that's what the judge in rhode island said so what happened is is
12:05that they're teaming up against us they file a motion for the judge to dismiss what the judge in
12:11rhode island should have done we hope that he would have done was dismiss the case because of
12:15pam bondi's letter yeah and then issued an injunction against the dea from proceeding
12:21got the unconstitutional hearing he didn't do that and he based his decision on the fact that we
12:27didn't show harm well i mean that justifies logic i mean we've been harmed seven years waiting now
12:34we're dealing with having to go to other logistical sources to get the extract for the fda to continue
12:41so it's just a game a big gameplay right so now the attorneys are drafting number one to get an
12:48injunction and get the judge recused from the hearing and then file another federal lawsuit in
12:53rhode island uh district uh for the judge to issue a permanent injunction and to demonstrate how
13:00they've harmed us got it i mean what is harm i mean we've been waiting seven years that's not enough
13:06harm yeah so what's the end what is the end game here is the end game it's yours the registry okay
13:13well and in the meantime i'm hoping to gut the dea's unconstitutional practice of the way they do
13:20business and this is why they're all fighting for their jobs right because provoznik's gone yeah
13:25the attorneys are gone judges gone okay so do you think if there is a shift and i'm not trying to
13:33string things together but do you think that if there is a shift when terry cole gets into the
13:38administrator seat and he reschedules cannabis as a whole from schedule one to schedule three do you
13:45think that that frees up the administration to effectively grant your api bulk license um no
13:53are those two events again we follow the law to a t okay we followed it under the schedule one
14:00protocol so whether they reschedule it or not it has no bearing on us right right but they're still
14:06not doing the right thing under the schedule one why would we ever think they would do it under
14:09schedule three i mean the schedule three thing is no big win uh i mean i think that you know we're
14:15one of the very few left standing and you know quite honestly they're not going to stop us because
14:20what do you mean by news what do you mean by schedule three is no big win can you elaborate on that a little
14:25more well it's still under the controlled substance act so it actually could be a derogatory effect on these
14:31state operators right i as i as i watch the action here shad it doesn't look good for the state
14:38operators trump just removed the protection of the states by funding the legal mechanism to go after
14:45it right that's hasn't been ruled on yet but that's where it's going if it is now the dea is open to go
14:53into the states on potential money laundering issues uh potential cartel issues of shipping potential
15:03shipping of say a florida grower into georgia that's all in violation of a schedule one substance
15:09and a schedule three substance so this isn't looking good for the state-to-state businesses
15:15um and those state businesses but i mean that that's obviously a big hypothetical i mean those
15:21those state businesses at least to my knowledge there's no florida businesses shipping product into
15:26georgia um if there are and that is a that is a complete violation of the mmtc program that they're
15:32being governed under in the state of florida then there is enforcement that is due in that scenario
15:38um if there are what i'm saying don't take me out of context i'm an advocate but i'm telling you i'm
15:44watching the speak and i'm watching the actions and it doesn't i agree with you i agree with you
15:48completely but also at the same time adding some nuance to it if there are operators under these state
15:54operator frameworks that are acting that are bad actors then they deserve to get enforced upon
16:00um by the federal government um blanket blanketly coming after them would be one other thing which
16:07is an implication of what you're saying which you can read between the lines and yes reneging those
16:14protections does open that up but it's to be determined if they are going to do that um correct
16:20as a whole so where does pam bondy play in this role because getting her support you know it was
16:26crucial what's the backstory involved in that because um i'm kind of getting conflicting directions
16:32here that you have in a support from an attorney general but yet it's not looking good on the states
16:38level for a lot of these companies like is rescheduling what we think it could be and you know wiping
16:44out 280e and providing growth for the industry like how do you look at it and what's this mean as i said
16:50before what her role is in a lot of this right now well as far as we're concerned she said that she
16:55wasn't going to defend any constitutional challenges for the drug enforcement administration in our case
17:00i consider that as a win now we have to go back and prove the harm and uh which i we're in the process
17:07of doing that right now and i believe we'll get the the administrative law judge recused uh we did the
17:13first one so i have no doubt that the second one will happen also so this is is going to play out
17:17but i would take that action as very positive as it relates to anything else i have no idea what
17:26terence cole is going to do when he takes over his administrator it's negative from his prior stance
17:31uh and in that hearing i watched it very attentively they were picking out the uh situation in oklahoma
17:39with the indian tribe and that they were taking from the tribal property crossing over into the state
17:44lines of oklahoma and then elsewhere uh and this is just what the dea wants to enforce so you know
17:53you got to watch watch the action not to speak and as as much as i do believe the thc should be
17:59completely free of any of this nonsense if that is happening that is by definition the dea's job
18:07function to enforce to enforce the law around that just like if there are legal companies in california
18:14or if there are legal companies in oklahoma that are backdooring cannabis crossing state lines
18:19unfortunately right now in this country that is illegal and i'm not against the dea enforcing that
18:26if it cleans up the rest of the rest of the industry and allows for mainstreaming cannabis as as a long
18:32run goal yeah well it's you're absolutely right and it's frustrating for us because we've taken the
18:38federal route we never i mean you took the most stringent route um i took the most stringent route
18:44yeah and and we we've adhered to it now the dea by their inaction and bias is forcing us offshore
18:51to get our api so that we can continue with the fda clinical trials
18:56gotcha
18:56gotcha