WA Hemp in Food Task Force - Meeting
(August 31, 2022)

Here are some observations from the Wednesday August 31st Washington State Hemp in Food Task Force (WA Hemp in Food Task Force) Meeting.

My top 4 takeaways:

• After a planned briefing on hemp in food policies outside of Washington state was postponed, members acknowledged how crucial that understanding would be in producing their legislatively mandated report (audio - 6m).
  • During the August 17th meeting of the task force, Joy Beckerman, Hemp Ace International Founder and Colorado Hemp Works Senior Advisor and Co-Founder, promised to present what she’d learned about policies in other states and countries. At the beginning of the meeting, WA Hemp in Food Task Force facilitator Steven Byers acknowledged that Beckerman had been unable to attend due to a “veterinary emergency.” The group chose to use their time to provide updates from the work groups which had been organized at their previous meeting (audio - 6m).
  • Jessica Tonani, Verda Bio CEO, checked to see if WSDA staff had collected any comparable information. WSDA Commodity Inspection Division Assistant Director Jessica Allenton responded that she wasn’t aware of an agency effort as she thought the task force was leading on the topic. Bonny Jo Peterson, Industrial Hemp Association of Washington (IHEMPAWA) Executive Director, recalled “conversations for quite a while around the WSDA being the one to put a lot of that information together” in an “unbiased way.” She additionally understood that the department budget included hiring a toxicologist to assist in authoring their required report to lawmakers and felt that WSDA background on what had been tried elsewhere would be “critical” (audio - 5m).
    • The department was allocated $200,000 for the Hemp in Food Task Force in SB 5693, "Making 2021-2023 fiscal biennium supplemental operating appropriations."

• The Concentration and Safety work group discussed their deliberations, outlining data points they would collect; definitions and classifications of products; and who on the task force would act to distribute them.
  • Tonani explained that the work group had met on August 30th and “identified the data that we needed,” including information on cannabidiol (CBD) “and what’s been done from clinical trial perspective, as well as state-by-state, or country-by-country.” Indicating there was also “clinical trial data on some other cannabinoids,” she remarked that members would, “to a large degree, wait for the Definitions [work] group to get back on” defining impairment or what constituted “compounds that have the probability or potential of getting people impaired.” Given those definitions, Tonani expected their next step would be using a common definition to “identify safety levels” and “product classes” which may have “different allowances of cannabinoids” (audio - 2m). 
    • Defining cannabinoids which could be impairing proved challenging for regulators at the Washington State Liquor and Cannabis Board (WSLCB). During the 2022 legislative session, agency leaders tried and failed to pass a request bill seeking additional authority to make similar standards.
  • Amber Wise, Medicine Creek Analytics Science Director, asked Byers about the process for disseminating their notes to task force members. He deferred to WSDA staff as the “official depository,” unsure if the department would make it available online or via a “task force email list” (audio - 1m).
  • Tacoma-Pierce County Health Department Food Safety Program Manager Christina Sherman, a new addition to the task force, clarified the work group title (audio - 1m). 

• An overview from the Definitions work group precipitated a lengthy discussion including several comments on the need to define the impairing potential of compounds before other topics could be addressed.
  • University of Washington Center for Cannabis Research (UW CCR) Director Nephi Stella sought an update and notes from the work group and learned that they were “tied up” with Beckerman as well. Work group member Dylan Summers, Lazarus Naturals Vice President of Government Affairs, conveyed their idea of using the “Hemp Lexicon” from the American Herbal Products Association (AHPA) or “the U.S. Hemp Authority’s lexicon.” He continued, stating that they might advise copying existing definitions or “adding our own flavor,” but their meeting had generally been “foundational” without many details emerging even after they "got into the weeds" of “cannabinoids versus hemp metabolites” (audio - 3m). 
    • Learn more about the AHPA Hemp Lexicon originally published in April 2021 and updated on August 24th. The association hosted an educational webinar on the lexicon on September 1st and offered the recording for sale.
  • Stella asked whether “impairment” or “intoxication" had been contemplated. Summers acknowledged it had been but no “clear answer” had resulted. Peterson said it had been talked about from "the structure and function end of things” to potentially include use of a "tetrad test" or a "scientific panel.” One aim was to be certain their definitions were "getting any new cannabinoids…or metabolites" not already known (audio - 1m). 
  • A key question for Peterson was “how does the tetrad test start”: what entity would initiate the research and who paid “for the whole process" (audio - 3m). 
    • Brad Douglass, Spoke Sciences Chief Regulatory Officer and Vice President of Chemistry, remarked that “what I was looking at was precedent" where "the onus is on industry, the industry sponsor, to submit a dossier that has the safety data." He felt it was reasonable that the business interests advocating for a cannabinoid or hemp compound would have "the burden of proof" to show whether it was impairing, and would "submit that to the agency for review." Douglass stated that this was the way "these similar types of submissions are done on a federal level for food" rather than being a requirement of a regulator to prove a substance’s safety. Tonani shared her impression that the Concentration and Safety work group had a similar perspective.
    • Stella cautioned that "these are actually hard experiments to do" and that "it will be quite a burden on the industry" to gather the “essential data.”
  • Task force member Lukas Barfield, Quality West Cannabis (QWC) Owner, offered the opinion that getting hung up on the question of impairment was “falling into a trap.” He asserted that the U.S. Drug Enforcement Administration (DEA) “is not our friend" and they shouldn’t default to using that agency’s testing standards, or else prohibition policies were “really going to bog us down" (audio - 1m). 
  • Wyckoff Farms CEO Dave Wyckoff had begun to believe that responsibility for ingredient approval was sounding costly and “onerous for the industry to provide those.” That made him feel the approach might not be “workable” since he expected regulators would have to “review and evaluate” any information submitted anyway (audio - 6m). 
    • Tonani followed up to state that the work group had been focused on what she called “non-impairing cannabinoids” and that establishing those could serve as the parameters against which other compounds were judged, since "there could be some creative chemistry in the future" to synthesize cannabinoids.
    • Stella suggested looking through existing academic literature for “what are the levels, for example, for CBD” to guide state officials regulating those products. For “new compounds that were emphasized on the labels or on the marketing,” he said that they would need to demonstrate safety through testing but probably wouldn’t need to engage in clinical trials in order to show “impairing properties of compounds.” Summers agreed with this, feeling a generally recognized as safe (GRAS) process would be “a heavy lift” on a state level, with the exception of CBD which was in a “unique position because of the Epidiolex preclusion.” Peterson noted that while the work group had yet to discuss it, officials could adopt federal laws defining ingredient disclosure which required labeling of ingredients representing two percent or more of a food item.
  • Wyckoff echoed Summers’ comments, mentioning his interest in “broad spectrum” products with a varied profile of cannabinoids. He wondered how regulators might approach that and if it would necessitate a “new dietary ingredient study” (audio - 6m).
    • To Summers, this "depends on if you're marketing that" ingredient on a product label. He brought up the Dietary Supplement Health and Education Act of 1994 (DSHEA) and how federal authorities had “been going back and forth in whether there will be a compelled” New Dietary Ingredients (NDI) process through the U.S. Food and Drug Administration (FDA). Summers commented that they had to consider “individual compounds” which had “to do with [a] court ruling with red rice yeast,” but the industry was “strongly encouraged” to undertake the NDI process. He encouraged them to gather data showing compounds were not intoxicating by isolating and categorizing substances, resulting in a “list of exempted cannabinoids” appropriate for food items.
      • Additional commentary on CBD and the NDI process:
        • The dietary supplement industry’s drug preclusion predicament (2021)
        • The FDA’s Stance on Hemp-Derived CBD as a Dietary Supplement, Part 2 (2019)
        • Hemp and CBD: Is red yeast rice the proper legal precedent for FDA regulation? (2018)
    • Wyckoff returned to his question about “broad spectrum products” with several “minor” cannabinoids, curious whether the NDI process would be needed for each compound. Summers was candid that he lacked “a good answer for you" but they could “reframe and go away from the cannabinoid taxonomy and start looking at…hemp metabolites.” He termed it a “fundamental question” of whether they wanted to replicate policies from other jurisdictions or set “a new trail.” 
  • Wyckoff next asked about identifying molecules that were metabolites, and Summers deferred “to the scientists” (audio - 1m). 
  • Peterson sought to understand whether a molecule interacted with certain cannabinoid receptors when evaluating potential ingredients, which she felt was more important for the "made in the lab type" synthesized cannabinoids. She said the group was trying “to keep this as simple as possible without introducing a whole bunch of new lexicons” and respond to "some very specific priorities" from legislators to determine serving sizes for CBD and tetrahydrocannabinol (THC). Peterson was trying to decide how much needed to be spelled out in a draft hemp in food bill she’d been working on to allow food and dietary supplements of cannabinoids “that don’t get you high” without a lot “of hoops to jump through” like the NDI system (audio - 3m). 
  • Eric Elgar, Nextraction Vice President of Quality Operations, noted that hemp was “a broad spectrum plant” which made it hard to look at each compound in the plant when “there's all sorts of trace cannabinoids in there." To Tonani, this was why they'd been debating the impairing capacity of cannabinoids, anticipating they could find “a broad bucket of cannabinoids" without particular “safety concern[s]” as ingredients (audio - 3m). 
  • Wyckoff then asked how they’d determine which compounds weren’t impairing. Tonani observed the Concentration and Safety work group was “somewhat punting” to the Definitions group even though they knew many cannabinoids “aren’t impairing,” but the “issue is that there’s future cannabinoids coming down the market that may require additional testing.” Douglass agreed it was “pretty clear” that CBD and cannabigerol (CBG) weren’t impairing but standardized testing and dosages were needed. He noted that in 2022, Peterson’s draft of the bill attempted to limit compounds that bind with CB1 receptors and “look similar to THC, and they act similar to THC” (audio - 4m). 
  • Finding that some people were cultivating “specialized” hemp crops to generate a “full spectrum extract” for a final product with somewhat high levels of minor cannabinoids, Wise inquired whether there was a definition for full spectrum extracts before they’d been “purified” or “converted.” Stella concurred, wondering how many cannabinoids “are we talking about” beyond CBD and CBG that would end up as a food or dietary supplement. Wise elaborated that “what claimed to be” full spectrum products were already on the market and appeared “to be relatively safe,” though they weren’t consistently defined and tested (audio - 3m). 
  • Peterson felt the group was “pinned up against a corner" to define intoxicating substances, and that her draft bill had settled on establishing Class A (“what we know gets you high") while Class B was "everything else," which she thought "would cover that full spectrum aspect" (audio - 3m). 
    • David Gang, Washington State University Center for Cannabis Policy, Research, and Outreach (WSU CCPRO) Director and professor at the WSU College of Agricultural, Human, and Natural Resource Sciences supported Peterson’s view of the different classes of compounds in hemp (audio - 1m). 
  • Elgar believed that "broad spectrum" was mostly going to be CBD, but the task force should expect products like his that had “a [cannabidiolic acid] CBDA or a [Cannabigerolic acid] CBGA dominant, with CBD being just a minor [cannabinoid] in there” (audio - 1m). 

• Facilitator Steven Byers brought the meeting to a close as members planned to collect data, better coordinate outside of their meetings, and learn about other jurisdictions' policies (audio - 7m). 
  • Tonani advocated for having notes from each work group circulated among task force members. Finding that the Concentration and Safety group had “a pretty large data lift that we needed,” she hoped there would be clarity on whether they had to gather this information or “it will be done by a consultant.”
  • Allenton remarked that she’d be speaking with Kelly McLain, Policy Advisor to the Director and Legislative Liaison, as well as WSDA information technology (IT) staff about a “data reserve” for the task force. She further pledged to find out more about WSDA hiring a toxicologist and other states’ policies. 
  • Wise requested clarity at the next meeting over “whoever’s compiling this final report” and the timeframe for when a draft would be due to elected officials. Byers expected McLain could speak to that timeline and assured her that he would add the matter to their agenda while encouraging Wise to offer her own concept for their schedule. Wise agreed, but admitted to being unfamiliar with the “time constraints” of the regulatory entities involved (audio - 3m).
  • Byers pointed out that they could schedule a full task force meeting for Wednesday September 7th in the hopes of hearing Beckerman’s “imperative” presentation. He asked members to think about “what the next cycle, or series, of meetings will be” for the task force.
    • At publication time, the September 7th meeting of the task force had been cancelled. However, on September 5th Byers indicated that the September 7th meeting may go forward without his facilitation.