WA House COG - Committee Meeting
(April 1, 2019) - CBD Work Session

THC versus CBD - Dynamic Therapeutic Index
[ Event Details ]

Industry, academic, and agency representatives brought lawmakers up to speed on CBD product research and policy development in Washington state.

Here are some observations from the Monday April 1st, 2019 Washington State House Commerce and Gaming Committee (WA House COG) work session titled “Examining the Regulation and Science of Cannabidiol (CBD) and CBD Products.”

My top 3 takeaways:

  • Industry representatives from the Cannabis Alliance and the Washington CannaBusiness Association (WACA) presented their perspectives first.
    • It’s Cannabis Observer’s understanding that the request by legislators for perspectives on CBD from within the regulated community arrived late - and only on demand from Alliance leadership.
    • Mitzi Vaughn, General Counsel for the Cannabis Alliance, provided perspective on the current state of law and trade in cannabidiol products (audio - 8m, video).
      • Vaughn explained her background in “hemp and cannabis law since 2015” with clients that “imported and exported CBD extract.” She had written on the topic with “industry organizations outside Washington.”
      • Vaughn indicated U.S. companies use “pilot program hemp” and imported CBD extract from countries such as Canada, Germany, England, and Switzerland. All European extraction operations Vaughn was aware of “that export to us are food grade and subject to regulation.”
      • Vaughn mentioned “a lot of talk about ‘dirty, Chinese CBD’ but the CBD that comes from there is often tested for pesticides and heavy metals, although that is not a requirement when it is imported into the United States.” She said a report on tetrahydrocannabinol (THC), CBD, and adulterants used in the extraction process was expected.
      • Vaughn hailed CBD extracted within the Initiative 502 (I-502) market as “more reliably safe” due to state regulation, but highlighted the challenge that these products could not “leave the regulated market, even if it’s in isolate form.” Removing that barrier, argued Vaughn, “would be a great boon” as there wasn’t enough global supply for the domestic market and “major organizations” were “stockpiling CBD oil” to inflate prices.
      • Vaughn mentioned California’s ban on hemp-derived CBD in food products except in the cannabis market and claimed “California is still one of the largest markets for CBD, in part that’s because 65%...of all sales of CBD are online” adding that it was “very difficult...to deal with online sales.”
      • Vaughn claimed hemp oil products could be sold without rigorous testing in jurisdictions banning CBD products. She suggested consumers might fail drug tests for trace amounts of THC from “full spectrum oil” extracts but highlighted “there is science that suggests that the CBD is more effective when it works with THC, even those trace amounts.”
      • Vaughn emphasized public concern about CBD product labeling and testing. She mentioned Federal Food, Drug, and Cosmetics Act (FD&C) rules and said concerns about adulterated CBD products were “on par with what’s happening right now with the nutraceuticals system.” She cited a 2018 study published in the Journal of the American Medical Association (JAMA) which found 776 undeclared pharmaceuticals in diet supplements over a 10 year period.
      • Vaughn said this “parallel market model” put CBD challenges “into perspective, when a lot of the discussion seems to center around this hysteria” from news media getting “really excited about reporting these things as opposed to comparable science.” Fearing “years” would pass before federal guidance was established, she concluded regulation of CBD was up to Washington state policymakers.
    • Brooke Davies, WACA Deputy Director and Associate Lobbyist, described “how CBD is showing up in our regulated 502 market” and potential outcomes (audio - 5m, video).
      • Noting increased sales of products including CBD in the state’s regulated cannabis market, Davies reminded lawmakers that statute bars retailers from selling CBD-only items. 502 CBD products have “varying ratios of CBD to THC” and Davies claimed products with higher CBD were less psychoactive, regardless of the type of product. She said some cultivars had more CBD content and stores reserved them for buyers wanting to avoid feeling “stereotypically high.” She felt the elevated profile of CBD products disproved assumptions that customers only cared about getting “the highest THC they possibly can.”
      • Testifying that CBD-only products were widely available statewide in “gray areas,” she lobbied for changes to enable retailers to capture this market.
  • Academic researchers from the University of Washington (UW) described contemporary scientific perspectives on the medical potential of CBD and challenges before policymakers.
    • Nephi Stella, a UW pharmacology professor, offered a “scientific overview” of CBD (audio - 16m, video, presentation):
      • Stella advocated for “an evidence-based approach.” He called for “understanding the plant” and differentiating between hemp and cannabis.
      • Stella described the Center for Cannabis Research (UW CCR) as a group of researchers who had created a multimodal platform to promote innovative cannabis research. UW CCR research priorities included plant biology; occupational and environmental health; health impacts for medical use and public health; and prevention needs for parents and substance abuse professionals.
      • Stella described THC as a psychoactive molecule that enhanced sensory awareness with analgesic and appetite stimulation medical benefits. Side effects mentioned included impacts on brain development and a mental “high.”
      • CBD was described as offering no “high.” Its medical properties were anti-epileptic and anti-inflammatory. Stella remarked that CBD was “looking pretty promising that it’s a safe molecule but we haven’t really studied it in detail.”
      • Stella said the drugs behaved differently at the molecular level and the interactions of CBD with the endocannabinoid system were less well understood. A key difference was CBD appeared to reduce “neuronal activity,” potentially explaining its anti-seizure potential. Both molecules mimicked endogenous chemicals, supplementing “what our body is normally doing.” 
      • Stella encouraged lawmakers to think of a “continuum” of impacts from “beneficial” to “potential harm.” He advocated for a “dynamic therapeutic index” for THC and CBD as the science around CBD was still in flux. Stella claimed THC had clear “toxicity and harms” for young brains but the threat of damage “gets better as we age.” Risks also depended on how the product was administered, and how frequently. All of this, he insisted, “needs to be better understood.”
      • Stella mentioned potential public health benefits of CBD in helping combat the opioid epidemic and treat epilepsy.
      • Stella’s top three takeaways for the committee:
        • Develop evidence-based knowledge of the potential harm – harm reduction – potential benefit of THC and CBD.
        • Use this knowledge to guide policy and regulations.
        • Foster innovative research on CBD production and CBD-based products.
    • Dr. Beatriz H. Carlini, a UW public health professor, thanked Representative Shelley Kloba for her support and continued the presentation with a focus on CBD products already available (audio - 14m, video).
      • The three types of CBD products in the state were:
      • Carlini shared data on clinical trials with CBD. Potential medical applications cited included alcohol use disorders, post-traumatic stress disorder (PTSD), early psychosis, anxiety disorders, reducing chronic inflammatory back pain, symptoms of Parkinsons’ disease, multiple myeloma, glioblastoma, GI malignancies, infantile spasms, and recovery from brain injuries.
      • Calling quality assurance (QA) and testing procedures “a work in progress,” Carlini supported HB 2052 and said the bill “can really address many of the challenges, I would point it out as challenges that need to be tackled.”
      • Saying any of the CBD products in the state could impact public health, Carlini highlighted areas to watch:
        • Uncertainty around effectiveness for specific conditions or illnesses
        • Inaccurate labeling of CBD concentration or effects from THC content being attributed to CBD
        • Lingering concerns around quality control of pesticides, contaminants, or residues
        • How all of this impacts vulnerable populations like those with financial or health burdens, or youth
      • Carlini also highlighted the disparity in oversight between CBD products available at highly-taxed I-502 stores and unregulated CBD products widely available around the state. “Down the line,” she cautioned, “the potential negative, or neutral effect” of unregulated CBD products could discourage consumers from using safe and contaminant free products once they were available.
      • UW and the CCR aimed to continue leading research into cannabis and CBD by:
        • Developing science-based public education
        • Assessing the public perception of CBD to guide policy and regulations
        • Fostering research on CBD’s medical potential and possible impact of widely available unregulated CBD products
        • At publication time, the CCR website was inactive. The group was listed on a contact page for the Stella Lab which researched cannabinoid pharmacology and neuro-oncology. The primary cannabis research at UW was being undertaken by the Cannabis Research and Education program at the Addictions, Drug, and Alcohol Institute (UW ADAI).
    • Committee members had questions for the panel.
      • Kloba, noting research funding imagined by I-502 supporters “never really materialized,” pursued Vaughn’s claim that unlabeled THC content could impact consumers and asked about progress testing active THC impairment compared to prior use. Carlini claimed there was “a lot of uncertainty how to determine better testing for cannabis” particularly exposures “not happening at work.” Based on her conversations at the North American Cannabis Summit, Carlini said some other states considered workplace testing “discriminatory” because of potential detection of prior cannabis use outside the workplace. Carlini highlighted apps being used to identify active impairment, but felt they needed a credible “baseline.” Stella added that cannabis impairment testing methods were often based on determining alcohol impairment in driving, but “these are completely different drugs” and “mimicking” alcohol testing “is not in our favor.” He urged tailoring of “measures of impairment according to what the cannabis drug does” (audio - 6m, video).
      • Vice Chair Kristine Reeves asked how UW CCR is funded. Stella said his past research was typically funded by the National Institute on Drug Abuse (NIDA) with cannabis procured through the NIH Drug Supply Program. He added that the University of Mississippi Cannabis Research Farm could no longer keep up with research material demand. Reeves inquired whether research---due to most funding coming from federal sources---had been “about preventing the utilization of cannabis as a whole.” Stella responded that his lab was “probably an exception” as they’d studied the medical potential of THC “early on” but acknowledged there was truth to Reeves’ assumption. Still, he maintained NIH “has actually changed their vision” to include harm reduction. Carlini said there was a “tendency to look at the harms” first as, under federal law, cannabis “cannot possibly cause any good” (audio - 2m, video).
      • Reeves then claimed alcohol, tobacco, and opiates traditionally took the majority of research dollars and cannabis research funding “wasn’t a priority” without federal de-scheduling or rescheduling. Because Washington state couldn’t wait, in-state researchers had taken the lead, notably on impacts of advertising to children (audio - 3m, video).
      • Assistant Ranking Member Kelly Chambers asked Stella about the “dynamic therapeutic index” and what impacts looked like when broken down by age brackets. He replied there was data on THC impacts, but “very little, if anything” for CBD (audio - 1m, video).
      • Kloba inquired about documentation on UW CCR funding and unfunded projects. Stella said most of the money had gone through the Alcohol and Drug Abuse Institute (ADAI) for an informational website as well as providing “small grants for research.” He was optimistic that grants would eventually be run through UW CCR directly. Carlini added that ADAI worked with UW CCR and received $247K annually, which included paying staff, leaving little funding for grants at about $30K apiece. She described these projects as “teasers” for topics they hoped to eventually understand (audio - 5m, video).
        • The UW Alcohol and Drug Abuse Institute was renamed the UW Addictions, Drug, and Alcohol Institute in 2021.
  • Regulators from the Washington State Department of Agriculture (WSDA), the Washington State Department of Health (DOH), and the Washington State Liquor and Cannabis Board (WSLCB) outlined oversight of CBD products in the regulated and unregulated CBD marketplaces.
    • Kelly McLain, WSDA Policy Advisor to the Director, offered an overview of the federal 2018 Farm Bill which removed hemp and CBD from the federal Controlled Substances Act. Key changes included “interstate commerce of hemp and hemp products,” processing hemp grown elsewhere, and maintaining FDA authority over hemp as a food or drug. Regarding Washington’s pending hemp legislation, McLain said, “Assuming the legislature passes [SB 5276] this session, CBD processing will be regulated as a food in Washington regardless of the potential issues with the current federal designation.” Provisions enabling Washington hemp to be harvested for CBD signaled a “significant shift” from previous research-focused state law (audio - 3m, video).
    • Steve Fuller, Assistant Director of Food Safety and Consumer Services, elaborated on food safety responsibilities at WSDA (audio - 5m, video).
      • Fuller said the department provided education, “inspection, sampling, lab analysis, and enforcement.”
      • He asserted that the FDA had a “prescription formulation” for CBD which raised questions at the department as pharmaceutical oversight was outside their expertise.
      • Fuller said more research was needed around the efficacy of CBD for benefits claimed, possible drug interactions, and impacts to the liver. He noted regulations could vary from a “buyer beware” label to a complex series of regulations or oversight. Potential issues for CBD included establishing a maximum potency, accurate testing, solvents or additives used, efficacy of dosing based on condition, prohibiting child appeal or accessibility, and other unforeseen challenges.
      • Fuller hoped laws passed requiring CBD regulation included “direction as to the scope of the regulatory approach envisioned” by legislators as comprehensive rules were expected to be “time consuming and expensive.” While the FDA was moving to offer guidance, he agreed with the attitude that Washington couldn’t afford to wait. As FDA had authority over most of Washington food production, the addition of CBD could leave Washington “in violation of federal law,” he commented. While food processing for cannabis retail wouldn’t face FDA inspection, other facilities could be inspected or even shut down.
      • Fuller concluded that companies occasionally put the wrong additive in food items, leading to recalls. He said this would be inevitable once CBD was allowed in food, causing concerns of “cross contamination or mislabeling of the products.” He asked for “the time and resources” needed to regulate CBD.
    • Shelly Rowden, DOH Medical Marijuana Program Manager, testified that current law required DOH staff to focus on three areas: administering and maintaining the medical cannabis patient database; approving medical cannabis consultant credentialing; and overseeing compliant product regulations (audio - 5m, video). 
      • Rowden explained how DOH worked with WSLCB on voluntary standards for “higher-quality products beneficial for medical use.” She said this recognized that products were “beneficial based on the user’s intent” and formulated based on patient needs.
      • Rowden then told members that compliant products could be classified as “General Use,” “High THC,” or “High CBD.” General use products could be purchased by anyone, but high THC/CBD classifications were restricted to registered patients. Compliant products were produced according to DOH regulations, and did not include hemp-derived CBD products.
      • Reeves wanted to know if there were other state-regulated products that divided regulatory authority similar to how it handled medical cannabis. “Not that I’m aware of,” Rowden said, promising to look into it further (audio - 1m, video).
    • Joe Graham, DOH Food Safety Program Manager, said his program provided “safe practices in retail food settings” as well as “technical support to local health jurisdictions.” Without FDA guidelines on CBD in food, DOH and local health jurisdictions relied on WSDA. Acknowledging the growing popularity of CBD food items, Graham said local inspectors, absent a regulatory framework, may halt processing if encountered. Beyond food safety, DOH staff shared concerns over mixing CBD with other drugs, allowable dosages, and potential contaminants (audio - 2m, video).
      • Reeves asked whether there had been sufficient research to ameliorate fears and create a “safe, integrated food safety program.” Graham said it was an “unknown” (audio - 1m, video).
      • Representative Bill Jenkin was curious about outreach to stakeholders on the concerns that had been raised. Graham replied DOH staff had not engaged stakeholders because of federal regulations, but if state law changed “absolutely, there’d be a stakeholder process” (audio - 1m, vidoe)
    • WSLCB Director of Legislative Relations Chris Thompson introduced Cannabis Examiner Manager Kendra Hodgson (audio - 12m, video, presentation).
      • Hodgson said her team “looks at the data” around cannabis production and the market. Praising earlier testimony, she reviewed the prepared agency materials on the topic. 
        • She stated the agency mission and noted their regulatory powers didn’t include hemp or CBD explicitly. Their role and scope of authority was originally defined by I-502. In 2015, the legislature added the medical gray-market through the Cannabis Patient Protection Act, giving the agency “overall enforcement responsibility.”
        • Hodgson noted that CBD could be derived from either hemp or cannabis as the plants had “similar properties” but she believed “they truly have different chemical properties” and observed that much early policymaking emphasized THC. WSLCB could only regulate CBD created through the I-502 system, she indicated.
        • Hodgson called out HB 2334 (“Regulating the use of cannabinoid additives in marijuana products”), a 2018 law allowing the addition of CBD imported from outside the I-502 market to cannabis products, provided it was tested against state standards.
        • Explaining what kinds of CBD products were allowed to be sold in cannabis retail stores compared to outside them, she called the ratios of CBD to THC “pretty dynamic” and noted the agency only had a “line of authority” for licensee products. Complaints about CBD products sold outside the regulated market would need to go to local authorities, the manufacturer, or retailer of the product. The only exception Hodgson foresaw was “CBD vapor products” which did fall under WSLCB jurisdiction. She closed by reminding members of RCW 69.50.575 covering cannabis in health and beauty aids (CHABA) not intended for ingestion.
      • Jenkin asked for clarification on terminology about CBD being “derived from sativa plants” and whether it could be found in cannabis indica plants. Hodgson said CBD could be found in indica plants, but claimed hemp “in and of itself is sativa only, not indica” (audio - 2m, video).
    • WA House COG Chair Derek Stanford closed the meeting by saying it had been “in-depth and thought provoking.”

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