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SB22-205 Task Force - Shared screen with speaker view
Danielle Henry, DOR MED
41:44
Task force member sign inhttps://docs.google.com/document/d/1tHNvGfLwfFo0MG7G1_L6GKee8kV_Okvb/edit
Allison Robinette - Colo. MED
43:48
Public Comment Sign Up: https://docs.google.com/forms/d/e/1FAIpQLSd8QR5LXkLnJe1hDuNSdFsJguXYexLhG7u6BXgNmtmOHQ1dew/viewform
Allison Robinette - Colo. MED
46:11
Link to the Meeting 1 Activity Board: https://drive.google.com/file/d/1fLVdfp1A0QFY4j5jXrnlvqafC1OoKLmb/view?usp=sharing
Allison Robinette - Colo. MED
52:41
All slides will be saved in the Public Task Force Folder and will be available on the MED Website following today's meeting, along with the meeting recording.
Shannon Gray, CO MED
53:27
The meeting recording will be posted to the 205 task force webpage by the end of this week, but likely by the end of the day tomorrow.
Wanda James
54:01
I have to step away for about 15 minutes. I will be back, so sorry.
Danielle Henry, DOR MED
57:48
Taskforce webpage: https://sbg.colorado.gov/med/205-Task-Force
Danielle Henry, DOR MED
58:34
Materials for today: https://drive.google.com/drive/folders/1Hjas43Hs_oual6vkh5Fgq3HRaRCuaI9t
Alan Lewis - Natural Grocers
01:06:34
Kyle I made this observation. Hemp ingredients are included in hemp products. We need to look at those ingredients in many of these regs and recs, rather than just finished hemp products.
Allison Robinette - Colo. MED
01:10:12
Public Task Force Folder: https://drive.google.com/drive/folders/1Hjas43Hs_oual6vkh5Fgq3HRaRCuaI9t
Danielle Henry, DOR MED
01:12:13
Discussion Document: https://drive.google.com/file/d/1GLPK450RF9mhxNu-4pOFGfvA9MfdRo8J/view?usp=sharing
Alan Lewis - Natural Grocers
01:26:55
The FDA will eventually go deep and specific. Might as well get them pointed in the right direction to support legalization in alignment with Colo guidelines.
Sasha Kalcheff-Korn
01:27:35
I agree with “includes but not limited to” I also agree with Kyle’s point on not including structural similarity to d-9
Stephen Cobb
01:28:45
Kyle - do you have any proposals on a better technical term for 'structural similarity to THC’. Perhaps we could describe ring structure and general substitution or something in that regard?
Alan Lewis - Natural Grocers
01:34:27
I think the law refers to hemp "from the plant" - not to molecules created in a lab.
Kyle Ray
01:36:51
Stephen, I would say that we should attempt to utilize substation patterns, alkyl analogues, functional group analogues etc. In a separate definition in total intoxicants. Leave THC's definition as true Tetrahydrocannabinols.
Stephen Cobb
01:37:28
Thanks Kyle
James Granger
01:37:34
Option 2 makes most sense in a public view
Kyle Ray
01:37:55
Substitution patterns*
Truman Bradley
01:39:20
The overarching goal of the task group should be to regulate total intoxicants. That said, from a labeling perspective whether it's one number or multiple numbers that are clearly identified, it needs to be clear to the consumer what they are taking (and how much).
Alan Lewis - Natural Grocers
01:40:30
Hemp products should not be intoxicating. FDA will not recognize an intoxicating product as a dietary supplement. We need to head towards a label the FDA can accept as non-intoxicating. Stating "total intoxicants" on the label is a problem. I know this jumps to labeling, but part of same problem.
James Granger
01:40:52
Agreed with Truman that it Also needs to be broken down for detailed consumer knowledge as public education continues
James Granger
01:42:33
Clarification- was commenting previously on “Total intoxicants” section
Alan Lewis - Natural Grocers
01:43:19
Remember "Zero Trans Fats" = less than .5% per serving on food labels = no the absence of trans fats. We need to work toward "nonintoxicating" based on THC per serving. Our language will matter.
Garrett Graff
01:45:00
To Alan's point around labeling, we also need to be mindful of how all intoxicating cannabinoids would be required to be labeled -- how would someone label 5 mg "total THC" and be able to communicate how much of that is D9 versus D8 versus D10.
Alan Lewis - Natural Grocers
01:45:13
Yes regs must assume new novel molecules.
Erik Paulson - Infinite CAL
01:45:46
I would agree with you Mike, but one complicating factor is that delta 9 can also be synthesized pretty cleanly from cbd
Erik Paulson - Infinite CAL
01:46:32
So we have it as both synthetic and natural cannabinoid
Truman Bradley
01:47:15
Ultimately if the group can't agree on a definition of "intoxicating" the a fallback would be to include Total THC (no matter what kind).
Mike Hennesy
01:50:15
I agree with Kyle. The dose makes the intoxication. I don't think total intoxicants is a good way to define this.
Sasha Kalcheff-Korn
01:50:34
Likewise to what Alan stated and Kyle just reiterated - focusing on serving size is important here
Sasha Kalcheff-Korn
01:51:09
And using “serving size” versus “dose” for FDA acceptance
Alan Lewis - Natural Grocers
01:55:01
Don't scream, but we should probably use "potentially intoxicating" based on potency and serving size. This could help take the stigma away.
Jared Stanley
01:56:15
Agree with Alan. Intoxicating should stay in the delta's and potentially intoxicating should be based on scientific literature on dosing levels
Sasha Kalcheff-Korn
01:57:59
Agree with you Jared - should be based on scientific literature/confirmed through research
Alan Lewis - Natural Grocers
02:00:00
Stephen, yes. FDA will use Option 1 but will base it on the work described in Option 3.
Alan Lewis - Natural Grocers
02:00:43
And FDA will review new substances every 1-3 years to add to the Option 1 list.
Mike Hennesy
02:03:39
Binding affinity does not necessarily denote intoxication. Look at THCV or Rimonabant
Mike Hennesy
02:04:16
Antagonists and Neutral Antagonists have CB1 binding affinity but inactivate the receptor
Kyle Ray
02:05:29
I like what John said, black and white definitions for these cannabinoids will create confusion, we should treat the cannabinoids as a spectrum for potential intoxication.
Kyle Ray
02:06:59
If we want the state to handle these types of studies, we could potentially increase the license fees for companies interested in producing "potentially intoxicating cannabinoids" and use that additional fee to run receptor binding assays for novel cannabinoids.
Truman Bradley
02:08:49
Suggest not going down naturally vs otherwise wormhole. What's most important is that we regulate anything that is intoxicating, regardless of the origin
John Harloe
02:09:21
Good idea Kyle, could take it a step further and move to also conduct clinical dose-response curves for the purpose of advising on limits/caps
Alan Lewis - Natural Grocers
02:11:28
FDA endorses equivalency between ingredients from GMO crops vs conventional crops vs synbio/ferment. We need to address the reality of these three different methods of production. You know where this goes!
Alan Lewis - Natural Grocers
02:12:39
Is Bt pesticide created by a GMO plant a natural ingredient? Definition 1 would say yes.
Alan Lewis - Natural Grocers
02:13:26
Is a cannabinoid produced by a gene edited ecoli
Truman Bradley
02:13:34
Erik that would be awesome but it's outside the scope of the work group.
Alan Lewis - Natural Grocers
02:13:35
natural?
Kyle Ray
02:17:33
option 1
Priyanka Sharma
02:17:53
Option 2 for “Naturally occurring/sourced cannabinoid”
Jeremy Epley - DDPHE
02:18:01
Option 1
John Harloe
02:18:04
1
Mike Hennesy
02:18:26
Option 2 for Naturally Occurring/Sourced Cannabinoid
John Harloe
02:18:50
To echo last meeting, I suspect everyone here would still agree that we need more time/more meetings
James Granger
02:19:10
Option 2 for naturally/sourced
Stephen Cobb
02:19:42
I agree with John Harloe’s point that the intent is crucial. In general if the focus for this definition is on public safety then the route of how something is manufactured should be the focus. (Definition 2)
Jared Stanley
02:19:56
Neither option 1, 2 or 3 defined naturally occurring or naturally sourced cannabinoid. Plant, extraction, dilution, product is the only naturally occurring cannabinoid with out adulteration or manipulation.
Priyanka Sharma
02:19:58
An in-person meeting would be quite beneficial.
Mike Hennesy
02:20:20
Agree with Priyanka
John Harloe
02:20:21
agree
Kyle Ray
02:20:28
agree
Danielle Henry, DOR MED
02:20:40
Public comment sign up: https://docs.google.com/forms/d/e/1FAIpQLSd8QR5LXkLnJe1hDuNSdFsJguXYexLhG7u6BXgNmtmOHQ1dew/viewform
Erik Paulson - Infinite CAL
02:21:04
The SB 22-205 text authorizes the CDPHE to regulate synthetically derived compounds, so I do believe the discussion of natural vs synthetic is pertinent.
Stephen Cobb
02:23:05
Thanks Erik
Mike Hennesy
02:24:04
Artificial means to be man-made. And I agree with Joshua who just spoke that all cannabinoids manipulated by humans are classified as artificial.
Jared Stanley
02:24:33
Spot on Iasaac
Mike Hennesy
02:24:36
All artificial cannabinioids need to go through FDA approval process. Period.
Mike Hennesy
02:24:52
Yes, nailed it Issac
Alan Lewis - Natural Grocers
02:28:03
FDA does not approve. Novel ingredients need to have a GRAS monograph presented to FDA for comment.
Mike Hennesy
02:30:24
Exactly. There is no safety data on artificial cannabinoids. The cannabis plant is known to be non-toxic, but artificial cannabinoids do not have that safety data.
Mike Hennesy
02:30:56
With the goal of public safety we need to separate natural cannabinoids from artificial cannabinoids.
Alan Lewis - Natural Grocers
02:30:57
Hence full spectrum
Christian Sederberg
02:34:36
One quick thing about the use of the term "intoxicating" - that term is used in this context to refer to "intoxication" and "intoxication" in the criminal law in Colorado and other states is defined as “a disturbance of mental or physical capacities resulting from the introduction of any substance into the body.” It is frustrating that "intoxicating" may lead to the conclusion is "toxic" when something is not, but it is what it is.
Stephen Cobb
02:34:53
Good point Christian
Priyanka Sharma
02:34:57
I would be open to an entire day meeting with small sub groups to work through consensus on these definitions.
John Harloe
02:35:05
same
Mike Hennesy
02:35:10
Agree
Allison Robinette - Colo. MED
02:35:22
If you have not already, please fill out the meeting forum survey: https://docs.google.com/forms/d/e/1FAIpQLSeCVcQ87HYTt8GyO2b2jjzhWbLniGdf1mFpg4pHnOg_m1H-AQ/viewform?usp=sf_link
Kyle Ray
02:35:25
Agree with Priyanka
Jared Stanley
02:35:33
agree Priyanka
Allison Robinette - Colo. MED
02:35:43
We added a couple questions as well, so if you already filled it out, you should be able to edit your response or submit another response. Thank you
Stephen Cobb
02:35:48
I think Erin Spies made a good point in her comment about staying nimble and getting whats important done - protecting the public in Colorado from unregulated THC and other unregulated intoxicating cannabinoids.
Truman Bradley
02:35:52
Happy to meet more. Would like to not due breakout groups due to the interrelation of these terms/issues
Truman Bradley
02:36:08
Agree with Erin Spies and Stephen
Kyle Ray
02:38:15
longer/more meetings will be required to accomplish anything of substance as a task force.