A cannabis regulatory expert spoke to the committee about cannabinoid regulation, including research, media reporting, federal statistics, and legislative efforts outside of Washington state.
Here are some observations from the Friday December 2nd Washington State House Commerce and Gaming Committee (WA House COG) Committee Meeting.
My top 3 takeaways:
- University of Washington (UW) Researcher Gillian Schauer, also the Executive Director of the Cannabis Regulators Association (CANNRA), had a background in tobacco and cannabis research and had been involved in Washington cannabinoid policymaking.
- Schauer gave a presentation on impairing cannabinoids for senators in November 2021.
- She last spoke before WA House COG on January 22nd to testify in support of HB 1668, Washington State Liquor and Cannabis Board (WSLCB) request legislation to expand agency authority over cannabinoid regulation which ultimately wasn’t approved by lawmakers.
- Schauer joined a June 21st WSLCB Deliberative Dialogue panel pertaining to Cannabis Impairment, and participated in a July 28th Listen and Learn Forum on Cannabinoid Regulation.
- At a September 16th UW Addictions, Drug, and Alcohol Institute (UW ADAI) symposium, Schauer presented on "Regulatory Considerations and Challenges for Cannabis Products with High THC [tetrahydrocannabinol] Concentration." During the symposium, she talked about the difference between cannabinoid potency and concentration. Schauer said the latter term was a “better marker of what we’re talking about” since, “for me, ‘potency’ means how much of a product do you need to achieve a certain effect,” compared to ‘concentration,’ which indicated “how much THC is in the product.”
- Bia Carlini, the UW ADAI Research Scientist leading the Cannabis Education and Research Program (CERP) and Program Chair for the symposium, credited Schauer among researchers who conducted a survey and response analysis for a legislative report (draft) on high-concentration THC product regulations.
- At publication time, Schauer served on the WSLCB Cannabinoid Science Work Group, though she wasn’t in attendance at their first meeting on December 1st.
- Schauer briefed the committee on “National Trends and State Updates on Regulating Intoxicating Hemp-Derived Products,” addressing research, state level policy, and federal action on the issue (audio - 14m, video, presentation).
- Following a WSLCB panel, Schauer promised to touch upon “updates to the science to adverse event reporting and really to what other states are doing.” She made clear that CANNRA was a “nonpartisan nonprofit organization that exists to convene, support, and educate cannabis regulatory agencies,” with “more than 40 States and US Territories in our membership.” The organization was “primarily funded by membership dues, and we're an affiliate of the Council of State Governments,” Schauer added. She then gave “a quick disclaimer” that she had no “industry funding to disclose and this presentation doesn't necessarily represent official opinions of CANNRA or any of the states with whom I work.”
- Stating that concerns over delta-8-tetrahydrocannabinol (delta-8-THC) had expanded to “really become an alphabet soup" including “a ton of different molecules that have come out that are being derived from hemp,” she named:
- Delta-10-tetrahydrocannabinol (Delta-10-THC)
- THC acetate ester (THC-O-acetate)
- Hexahydrocannabinol (HHC)
- Tetrahydrocannabiphorol (THCP)
- Tetrahydrocannabihexol (THCH)
- Tetrahydrocannabioctyl (THCjd)
- THCjd had been reported to be “quite a bit more potent and stronger than delta-9-THC,” said Schauer.
- Available product types had “changed a bit,” she told the committee, going from “a lot of edible and vaping products” to also have “marketing of dabs on the hemp derived product landscape.” Schauer noted a “bit of a bump…in smokeable products that look like a cigarette” but turned out to be ”hemp plant matter and then it's sprayed with…delta-8 extract.” Moreover, many items were packaged to look “very similar to the products that we see in the regulated adult use cannabis space.”
- Schauer quickly reviewed the process of extracting cannabidiol (CBD) from hemp plants: “you add acids, heat, and solvents to convert that CBD extract into other cannabinoids, some of which are found in nature, some of which are not and which we know very little to nothing about.” Mentioning the general lack of regulation around hemp derived products, she stressed there were many solvents that could be used “some of which are much more dangerous than others.” Schauer relayed that researchers were starting to “publish in the peer-reviewed academic literature some of the composition of…these hemp-derived impairing products,” highlighting several examples:
- “Novel Δ8-Tetrahydrocannabinol Vaporizers Contain Unlabeled Adulterants, Unintended Byproducts of Chemical Synthesis, and Heavy Metals”
- “They looked at 27 hemp derived delta-8 vape cartridges from ten different brands. They found that none of them had accurate delta-8 labeling, there was up to 40% variance, generally poor testing that could be indicative of falsified results. 11 of them had cutting agents” which she related to “the vaping lung injury outbreak [in 2019,] vitamin E acetate was used as a cutting agent in…mostly illicit…THC vape cartridges.” All products had residual traces of heavy metals and byproducts, including those “that have not been well characterized pharmacologically and can cause problems.”
- A Washington State Department of Health (DOH) investigation into lung injury cases from that period found a somewhat different picture, explaining that although “national findings suggest THC-containing vapor products, particularly those from informal sources like friends, family, or in-person or online dealers, are linked to most patients with vaping-associated lung injury and play a major role in the outbreak…About 13 percent of patients nationally and about half of [27 identifed] patients in Washington report only using non-THC vapor products. It is unclear if these patients are not fully disclosing THC use, are being exposed to a substance that is also in THC products, or have lung injury unrelated to vaping. Additionally, it is possible that there may be multiple substances in multiple vapor products that cause lung injury.”
- “They looked at 27 hemp derived delta-8 vape cartridges from ten different brands. They found that none of them had accurate delta-8 labeling, there was up to 40% variance, generally poor testing that could be indicative of falsified results. 11 of them had cutting agents” which she related to “the vaping lung injury outbreak [in 2019,] vitamin E acetate was used as a cutting agent in…mostly illicit…THC vape cartridges.” All products had residual traces of heavy metals and byproducts, including those “that have not been well characterized pharmacologically and can cause problems.”
- “Vaping Cannabinoid Acetates Leads to Ketene Formation”
- Researchers had “explored a theory that, in particular, THC-O-acetate can have an acetate part of the molecule that can create poisonous ketene gas, and there's a theory that ketene gas may have been one of the ways that vitamin E acetate was implicated in the vaping lung injury outbreak. He didn't explore human effects of that, but he did confirm that delta-8 products that are THC-O-acetate can form that ketene gas.”
- Portland State University (PSU) Organic Chemistry Professor and Strongin Lab Director Robert Strongin, one of the authors of the paper, provided an informed perspective on chemical synthesis using hemp-derived cannabinoids as well as the state of cannabinoid knowledge and research to members of the Washington State Senate Labor, Commerce, and Tribal Affairs Committee (WA Senate LCTA) on May 10th.
- “Novel Δ8-Tetrahydrocannabinol Vaporizers Contain Unlabeled Adulterants, Unintended Byproducts of Chemical Synthesis, and Heavy Metals”
- Lacking better understanding around “byproducts and adulterants being used in…these delta-8 and similar products," Schauer blamed an absence of federal regulation of the products. With “adverse event reporting continu[ing],” she showed media mentions of warning and poisonings, like a “case in Virginia where a four year old allegedly consumed a large amount of Delta 8 gummies and died.”
- Schauer then shared how the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) “have recently updated National Poison Center data, they looked at data between January 1st, 2021 and February 2022. I want to mention up front, this is certainly an under-report of adverse effects” as it only counted “people that knew what they had consumed and took the time to call a poison center and report on that.” Schauer showed statistics on the “more than 2,300 exposure cases” reviewed:
- “41% involved pediatric patients less than 18 years of age
- 40% involved unintentional exposure to Delta-8 (and 82% of these
- unintentional exposures impacted pediatric patients)
- 70% of cases required health care facility evaluation, 8% of those resulted in admission to critical care (45% of patients requiring evaluation were pediatric patients)
- One pediatric case was coded with a medical outcome of death”
- Finding that federal action on the issue was muted due to the schedule 1 status of cannabis, Schauer said the response was so far “limited to issuing a few warning letters to companies with egregious violations particularly purporting medical benefit of products” although “they have a data acceleration plan to collect more data.”
- In 2019, the FDA distributed warning letters to 15 companies “for illegally selling various products containing cannabidiol.”
- By May 26th, the agency had sent four warning letters “for Illegally Selling CBD Products Intended for Use in Food-Producing Animals.”
- And on November 21st, they issued more warnings to “Companies for Illegally Selling Food and Beverage Products that Contain CBD.”
- Find out more from the dedicated FDA page on Warning Letters and Test Results for Cannabidiol-Related Products, which had warnings and results going back to 2015, along with Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol: Communication & Regulatory Resources.
- Additional perspective on the acceleration plan was offered in 2021 Food and Drug Law Institute coverage, “FDA Focuses on Safety With the New Cannabis-Derived Product Data Acceleration Plan (DAP).”
- Schauer found there were “two major issues that states are facing in regulation, one is how to deal with these chemically derived impairing cannabinoids…the other is how to deal with impairing amounts of delta-9-THC that is legally allowed in products that meet the hemp definition per the farm bill because hemp is defined on a dry weight basis.” She explained, “in a plant that may not be a lot of THC. But by weight, in gummies, or a chocolate bar, or a beverage, you can pack a lot of THC into that.” Schauer pointed to a December 2021 paper from the Oregon Liquor and Cannabis Commission (OLCC) that had a chart that “really shows how much Delta 9 THC you can legally have in these products and how that compared to the Oregon market at the time that they presented these data to their legislature.” OLCC staff found “three, four times the amount of delta-9-THC in a chocolate bar, way more than that in a beverage,” she remarked.
- The subject matter could be challenging “for non-scientists,” Schauer said, and there wasn’t scientific consensus “on how to define impairing and intoxicating…what synthetic means,” how best to define cannabinoids “not found in nature,” and “what to do about full spectrum products. People that say they want a lot of cannabinoids in their products along with the CBD, those types of products can have high levels of THC and how do we classify those. And then what to do about biosynthetically derived cannabis that's coming from yeast or algae.” With Washington having “different agencies regulating hemp and cannabis,” Schauer found the emerging commercialized compounds “lack safety data and profiles so legislation that seeks to just…name the list of molecules that we’re concerned about quickly becomes outdated.”
- Schauer highlighted several state policy responses:
- “Oregon – HB 3000 (2021) Gave broad regulatory authority to OLCC to regulate impairing hemp-derived cannabinoids, set THC limit per serving in hemp (2mg/serving, 20mg/package). Recent task force to review regulations made to date.”
- Schauer also testified to the Oregon State House General Government Committee in March 2021 in support of HB 3000. Find out more opinions about the impact of the bill:
- Take a look at the task force draft report, published on November 23rd, which included recommendations “focused on consumer protections, funding and tools for law enforcement to combat the illicit market, and needed environmental and humanitarian protections.”
- “Michigan – HB 4517 (2021) Gave CRA [Michigan Cannabis Regulatory Agency] authority to set a limit of THC in products, requires licensing from CRA for sales of Delta-8 and other forms of THC.
- Nevada - SB 49 (2021) Broadly defines THC (D8,9,10, THCO) and requires a license and approval from NV CCB [Nevada Cannabis Compliance Board] to make or sell Delta-8.”
- According to Schauer, Michigan and Nevada had “somewhat similar approaches…to Oregon.”
- “Colorado – SB22-205 (2022) Created a taskforce to make recommendations to regulate intoxicating hemp and THC products. Report with recommendations due to legislature Jan 1.
- Virginia – HB 30 (2022) Task force to analyze industrial hemp extracts and other substances containing THC intended for human consumption. Draft report was delivered on Nov. 8th” and its final report on November 14th.
- State task forces were also popular approaches, she said, “in some cases those task forces were extremely diverse,” like Colorado, while Virginia “was more science-based.” In Virginia, “their draft report was unable to reach consensus on” many of the challenges she’d named, while Colorado’s group “had the same challenges…they've not been able to get much further than the legislatures did in discussion.”
- Minnesota – HB 3595 (2022) Legalized consumable hemp-derived products up to 5mg THC/serving, 50 mg/package with no purchase limits, and no required licensing.”
- “Many have called the legalization scheme in Minnesota ‘adult use hemp’,” Schauer remarked, resulting in what she termed “an unregulated adult use approach, and the types of products that you can buy on the hemp market in Minnesota are probably very similar to adult use products that you would find in many states.”
- “Oregon – HB 3000 (2021) Gave broad regulatory authority to OLCC to regulate impairing hemp-derived cannabinoids, set THC limit per serving in hemp (2mg/serving, 20mg/package). Recent task force to review regulations made to date.”
- Summing up her impressions of the varied approaches, Schauer said there were “some that I would argue are working better than others. This does continue to be a challenging area, CANNRA’s put together some resources” that “can be good primers” for those unfamiliar with the topic.
- WA House COG Chair Shelley Kloba thanked Schauer for the presentation and signaled her approval of WSLCB engagement with CANNRA (audio - 1m, video).
- Kloba appreciated knowing that Washington regulators weren’t “the only ones who are struggling with this…I like to think that Washington leads on a lot of things and I hope that we can continue to really make sure that product safety and minimizing risk is important” .
- She then endorsed the “time that our LCB folks spend engaging with CANNRA. I think that's an important investment.”
- The following week, WSLCB Board Member Jim Vollendroff, Director Rick Garza, Director of Policy and External Affairs Justin Nordhorn, Policy and Rules Manager Kathy Hoffman, and four other staffers traveled to Florida for a CANNRA event. Vollendroff and several attending officials gave their first impressions of the event during the December 6th board caucus, noting the second panel discussion focused on “hemp cannabinoids.”
- At time of publication, Cannabis Observer had not identified any public-facing information about the event, similar to when WSLCB hosted CANNRA members and selected industry guests for a two day event in June.
- CANNRA representatives were also reported to be participating in an ASTM International and U.S. Pharmacopeia (USP) virtual global workshop on cannabis quality on December 7th.
Information Set
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Announcement - v1 (Oct 26, 2022) [ Info ]
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Agenda - v1 (Nov 23, 2022) [ Info ]
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Presentation - WSLCB - v1 (Dec 1, 2022) [ Info ]
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Presentation - Gillian Schauer - v1 (Dec 1, 2022) [ Info ]
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Presentation - UW ADAI - v1 (Dec 1, 2022) [ Info ]
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Complete Audio - TVW
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Audio - TVW - 00 - Complete (1h 38m 3s; Dec 2, 2022) [ Info ]
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Audio - TVW - 01 - Welcome - Shelley Kloba (2m 47s; Dec 2, 2022) [ Info ]
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Audio - TVW - 02 - Introductions (1m 48s; Dec 2, 2022) [ Info ]
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Audio - TVW - 03 - Update - WSLCB - Introduction - Shelley Kloba (57s; Dec 2, 2022) [ Info ]
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Audio - TVW - 04 - Update - WSLCB - Introduction - Justin Nordhorn (1m 31s; Dec 2, 2022) [ Info ]
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Audio - TVW - 05 - Update - WSLCB - Overview of Authority - Justin Nordhorn (1m 51s; Dec 2, 2022) [ Info ]
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Audio - TVW - 06 - Update - WSLCB - Synthesized THC - Chandra Wax (2m 10s; Dec 2, 2022) [ Info ]
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Audio - TVW - 07 - Update - WSLCB - Synthesized THC Investigation - Joshua Bolender (3m 49s; Dec 2, 2022) [ Info ]
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Audio - TVW - 08 - Update - WSLCB - Policy Outreach and Rule Development - Kathy Hoffman (5m 45s; Dec 2, 2022) [ Info ]
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Audio - TVW - 09 - Update - WSLCB - Request Legislation - Justin Nordhorn (8m 46s; Dec 2, 2022) [ Info ]
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Audio - TVW - 10 - Update - WSLCB - Comment - Shelley Kloba (30s; Dec 2, 2022) [ Info ]
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Audio - TVW - 11 - Update - WSLCB - Question - Economics of Synthesis - Kelly Chambers (1m 5s; Dec 2, 2022) [ Info ]
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Audio - TVW - 12 - Update - WSLCB - Question - Risk - Sharon Wylie (2m 16s; Dec 2, 2022) [ Info ]
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Audio - TVW - 13 - Update - WSLCB - National Trends and State Updates - Gillian Schauer (13m 43s; Dec 2, 2022) [ Info ]
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Audio - TVW - 15 - Update - UW ADAI - Introduction - Shelley Kloba (38s; Dec 2, 2022) [ Info ]
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Audio - TVW - 16 - Update - UW ADAI - High-THC Products - Bia Carlini (1m 37s; Dec 2, 2022) [ Info ]
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Audio - TVW - 17 - Update - UW ADAI - Health Risks - Bia Carlini (2m 48s; Dec 2, 2022) [ Info ]
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Audio - TVW - 18 - Update - UW ADAI - Health Risks - Question - Titration - Shelley Kloba (1m 24s; Dec 2, 2022) [ Info ]
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Audio - TVW - 19 - Update - UW ADAI - Health Risks - Question - Titration - Chris Stearns (1m 20s; Dec 2, 2022) [ Info ]
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Audio - TVW - 20 - Update - UW ADAI - Health Risks - Bia Carlini (2m 33s; Dec 2, 2022) [ Info ]
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Audio - TVW - 21 - Update - UW ADAI - Stakeholder Surveys - Bia Carlini (5m 57s; Dec 2, 2022) [ Info ]
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Audio - TVW - 22 - Update - UW ADAI - Survey Results - Bia Carlini (7m 55s; Dec 2, 2022) [ Info ]
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Audio - TVW - 23 - Update - UW ADAI - Recommendations - Bia Carlini (2m 58s; Dec 2, 2022) [ Info ]
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Audio - TVW - 24 - Update - UW ADAI - Question - Potency Tax Study - Shelley Kloba (2m 41s; Dec 2, 2022) [ Info ]
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Audio - TVW - 25 - Update - UW ADAI - Question - Advertising - Shelley Kloba (2m 45s; Dec 2, 2022) [ Info ]
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Audio - TVW - 27 - Update - UW ADAI - Question - Psychotic Disorders - Kelly Chambers (2m 18s; Dec 2, 2022) [ Info ]
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Audio - TVW - 28 - Update - UW ADAI - Question - Causation - Shelley Kloba (2m 25s; Dec 2, 2022) [ Info ]
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Audio - TVW - 29 - Update - UW ADAI - Question - Adverse Childhood Experiences - Christine Reeves (4m 15s; Dec 2, 2022) [ Info ]
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Audio - TVW - 30 - Update - UW ADAI - Question - Industry Innovation and Consumer Demand - Clyde Shavers (3m 20s; Dec 2, 2022) [ Info ]
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Audio - TVW - 31 - Update - UW ADAI - Question - Consultation with Tribes - Chris Stearns (2m 5s; Dec 2, 2022) [ Info ]
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Audio - TVW - 32 - Wrapping Up - Shelley Kloba (20s; Dec 2, 2022) [ Info ]
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Complete Audio - Cannabis Observer
[ InfoSet ]
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Audio - Cannabis Observer - 00 - Complete (1h 38m 14s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 01 - Welcome - Shelley Kloba (2m 48s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 02 - Introductions (1m 49s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 03 - Update - WSLCB - Introduction - Shelley Kloba (57s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 04 - Update - WSLCB - Introduction - Justin Nordhorn (1m 31s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 05 - Update - WSLCB - Overview of Authority - Justin Nordhorn (1m 51s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 06 - Update - WSLCB - Synthesized THC - Chandra Wax (2m 10s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 07 - Update - WSLCB - Synthesized THC Investigation - Joshua Bolender (3m 50s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 08 - Update - WSLCB - Policy Outreach and Rule Development - Kathy Hoffman (5m 46s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 09 - Update - WSLCB - Request Legislation - Justin Nordhorn (8m 49s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 10 - Update - WSLCB - Comment - Shelley Kloba (30s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 11 - Update - WSLCB - Question - Economics of Synthesis - Kelly Chambers (1m 5s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 12 - Update - WSLCB - Question - Risk - Sharon Wylie (2m 16s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 13 - Update - WSLCB - National Trends and State Updates - Gillian Schauer (13m 44s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 15 - Update - UW ADAI - Introduction - Shelley Kloba (38s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 16 - Update - UW ADAI - High-THC Products - Bia Carlini (1m 37s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 17 - Update - UW ADAI - Health Risks - Bia Carlini (2m 48s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 18 - Update - UW ADAI - Health Risks - Question - Titration - Shelley Kloba (1m 24s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 19 - Update - UW ADAI - Health Risks - Question - Titration - Chris Stearns (1m 20s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 20 - Update - UW ADAI - Health Risks - Bia Carlini (2m 33s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 21 - Update - UW ADAI - Stakeholder Surveys - Bia Carlini (5m 57s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 22 - Update - UW ADAI - Survey Results - Bia Carlini (7m 55s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 23 - Update - UW ADAI - Recommendations - Bia Carlini (2m 58s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 24 - Update - UW ADAI - Question - Potency Tax Study - Shelley Kloba (2m 41s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 25 - Update - UW ADAI - Question - Advertising - Shelley Kloba (2m 45s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 27 - Update - UW ADAI - Question - Psychotic Disorders - Kelly Chambers (2m 18s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 28 - Update - UW ADAI - Question - Causation - Shelley Kloba (2m 25s; Dec 2, 2022) [ Info ]
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Audio - Cannabis Observer - 32 - Wrapping Up - Shelley Kloba (19s; Dec 2, 2022) [ Info ]
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WA House COG - Committee Meeting - General Information
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WA Legislature - 2022 - General Information
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Accessing the Legislature Remotely (Dec 28, 2021) [ Info ]
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WA Legislature - 2022 - General Information
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