WA Hemp in Food Task Force - Meeting
(November 16, 2022)

Here are some observations from the Wednesday November 16th Washington State Hemp in Food Task Force (WA Hemp in Food Task Force) Meeting.

My top 3 takeaways:

• WSDA Produce Safety Program Management Analyst Jill Wisehart detailed the draft of the legislative report as task force members raised initial questions.
  • Wisehart went over the revised second draft of the report which “incorporated all the feedback that I've received thus far” consisting of only “a couple questions and some suggestions for additional appendix items.” She felt the group was “in a really, really good spot at this point” though there remained “a couple of questions and considerations” that she “thought would be helpful…for the group to discuss” (audio - 1m).
    • Nextraction Vice President of Quality Operations Eric Elgar voiced concern that “some of the language might give a reader the impression that the task force results are incomplete or flawed due to the time constraints” which could then “potentially decrease the value of the report.” He saw “a lot of verbiage around the report having a very short time frame and some things couldn't be agreed to,” something he didn’t find reflective of the fact that “we did kind of hammer out a lot” (audio - 2m).
      • Kelly McLain, WSDA Policy Advisor to the Director and Legislative Liaison, believed it was possible to “strike a balance” because officials wanted to “to push back on legislative deadlines that are shorter than they should be.” She argued the task force did “an amazing amount of work…I don't want to underplay how much work happened, but…I've gotten to a place where I'm repeatedly pushing back in every report to the legislature when they give us less than, say, 12 to 18 months to get something done because they get…what the group can bear in the time that's available.” She hoped to address Elgar’s point but found it important for the report to communicate how “we didn't have as much time as we should have had.”
      • Washington State University Center for Cannabis Policy, Research, and Outreach (WSU CCPRO) Director David Gang followed up on McLain’s point, stating, “the specific time frame given here was actually pretty bad for a lot of people because it's during the harvest season.” He regarded the mandated deadline as “not the best timing in the year for something like this to happen.” McLain described having “four legislative reports going in in the next two months and all of them” would be indicating to lawmakers “that you asked us to do work when farmers…and people that work with the farming community are not available, and that makes it really, really tough for us to get it done” (audio - 2m).
  • WA Hemp in Food Task Force facilitator Steven Byers found the executive summary to be “pretty straightforward” as Wisehart remarked that it had included all the suggestions of Industrial Hemp Association of Washington (IHEMPAWA) Executive Director and task force member Bonny Jo Peterson (audio - 2m).
    • Gang called attention to administrative recommendation four: “All hemp products for consumption sold in Washington State must follow federal food and dietary supplement labeling standards.” McLain explained that hemp items “must be specifically labeled with the concentration, any other information identified by the legislature, or in a future agency program, and…warning statements” (audio - 6m).
      • Elgar wanted their report to advise “deviat[ing] as little, or none…from standard dietary supplements labeling from the FDA.” Gang and others cautioned that labeling was different for food and beverages, including less use of “warnings” while still acknowledging risks for children or the presence of potential allergens.
      • McLain noted their recommendation would require listing concentrations of “anything that's an active ingredient.”
    • Spoke Sciences Chief Regulatory Officer and Vice President of Chemistry Brad Douglass mentioned the fifth administrative recommendation: “Any packaging must be cautious of appealing to children,” made sense, but “efforts should be made to limit youth shelf access” was less clear to him. He thought it “could be read as having an age gate for all or some of these products,” and wanted “to be careful what we’ll be recommending as a task force (audio - 6m).
      • McLain shared her intention was to be broad in the language, noting that Washington State Department of Health (DOH) representatives were “pretty focused” on ensuring “the labeling isn’t appealing to children.” She felt this could be inclusive of placement on shelf space “or something else is done like an age gate,” and invited comments from members.
      • Tonani regarded age restrictions as “historically” reflective of “extremely high in impairing compounds and we may be closing that loophole.” Additionally, many products had been “unicorn colors and things like that,” so she regarded the first part of the recommendation as reasonable, but the “second half may end up being product specific, or different rules in the future.” Tonani didn’t see how age restrictions made sense on cannabidiol (CBD) only products. Elgar wondered how many states had age restrictions on CBD items as it “might not be a bad thing.”
      • McLain suggested changing the language on shelf access so that “any legislative action taken should include an evaluation of whether any youth access measures should be taken.” She considered it ideal to have legislative authorization to include youth access as a criteria in regulation, but that could be suggested to legislative leaders in a work session on CBD or in legislative testimony. Elgar backed restrictions like “no colorful dinosaurs on the package,” which McLain affirmed could be done in WSDA rule without additional legislative direction, similar to the department regulation of cannabis edibles. She anticipated a standard warning label, potentially reading “do not mix with alcohol not intended for consumption by pregnant or nursing women and keep out of reach of children,” wording she thought was already “on almost all the CBD products that are currently available on the market.”
    • Tonani inquired whether administrative recommendation six using the distinction of “THC-like effects,” and “non-THC-like effects” would consistently refer to cannabinoid classification of Class A and Class B, respectively (audio - 7m).
      • Peterson shared history around how classification-based naming had evolved, anticipating it was a system that “will continue to be discussed.” McLain noted that federal drug scheduling categories started with what was perceived to be the most dangerous substances, and that such classification would be familiar to legislators.
      • Regarding a potential limit of 2.5 milligrams (mg) of THC in a product, Wise noted a high ratio of CBD or other cannabinoids would be the “major active component” to exclude items with only THC. She wanted the report to say a “minimum ratio of 20:1" rather than strictly “prescribing exact ratios.”
    • Wyckoff Farms CEO Dave Wyckoff brought up previous feedback that besides a ratio of Class A and B cannabinoids there be a requirement that “non-impairing cannabinoids be CBD dominant in the ratio.” McLain asked for responses on whether this point “can be worked out in the rulemaking process” by WSDA staff looking at appropriate ratios, with the goal being an “iterative process on this, so in a year, or two years, if science dictates higher or lower thresholds having that allowance be a rule” change (audio - 11m).
      • Peterson revealed that in conversations with WSLCB staff the concern was over “products that weren't CBD dominant and…those having a lower threshold” than the “minimum 20 to one ratio piece.” She didn’t “think we need to call it out specifically,” believing the “recommendations will be flushed out when we have the bill filed.”
      • Wyckoff was in agreement with the idea that for products where CBD wasn’t the dominant cannabinoid present, “the amount of THC should be reduced” to levels backed by WSLCB staff. Peterson commented that there was “peer-reviewed stuff to show them saying ‘here, this is safe’” for certain cannabinoids besides CBD. Tonani suggested the report appendices call out “why we think certain levels will be justified today and the science behind that.”
      • Wise called for “putting something relatively straightforward” about CBD as the dominant cannabinoid, and members landed on a legislative recommendation that “Products maximum levels of Class A cannabinoids should be dictated by the primary Class B (non-impairing) cannabinoids.”
    • Contemplating synthesized cannabinoids, Douglass advocated for their recommendation stating that “no synthetic or chemically transformed cannabinoids are permitted.” McLain agreed that “legislation should exclude allowances for chemically transformed cannabinoids” (audio - 8m).
      • Tonani reasoned that the focus should be on synthesized cannabinoids because “if somebody has a plant that's producing delta-8[-tetrahydrocannabinol] at decent levels someday I don't think that should be restricted…I think synthesizing delta-8 is a different story than having a plant naturally produce a compound…at low levels.”
      • Wisehart drafted a legislative recommendation that “legislation should exclude allowances for chemically transformed cannabinoids.”
      • Peterson called for including “hemp metabolites" in this definition, but Tonani said the definition “might be [too] complicated.” To Gang, hemp metabolites could even include “terpenes,” sugars, or other “flavonoids” produced by the plant, which he wasn’t trying to restrict. Peterson remained concerned people would transform these compounds, but Gang saw no need to “call them out and raise that red flag and say we've got to worry about this when we don't” (audio - 1m).
    • Peterson, Douglass, and others debated whether delta-8-THC needed to be expressly mentioned because it could potentially be naturally derived. Peterson felt delta-8-THC was “the biggest piece of the whole conversation really” when it came to legislator concerns over cannabinoid products (audio - 4m).
      • Tonani contributed that “we're saying if the plant naturally produces this you can only have so much of these compounds,” which would both limit cannabinoid content and bar synthesized compounds. Other task force members like Douglass, Gang, and Lazarus Naturals Vice President of Government Affairs Dylan Summers agreed the recommendation language needed to center on prohibiting chemically transformed cannabinoids in products.

• The group also went over information in various appendices to the report, including suggestions to document federal inaction on CBD regulations, though consensus on a THC limit remained elusive.
  • Appendix B. Investigational New Drug (IND) Preclusion (audio - 2m)
    • Douglass posed the first question around appendices, asking about adding “an appendix item that summarizes the non-safety related reasons why FDA [U.S. Food and Drug Administration] has repeatedly refused to sanction the use of CBD and CBD enriched extracts.” He reported emailing additional references on the matter and said “it's a topic that's been addressed by other states” when developing “CBD rules and regulations for food.” 
    • Verda Bio CEO Jessica Tonani was supportive, feeling “the legislature probably wants to know why isn't this allowed by the FDA, and…it's not necessarily because it's not safe to consume in small amounts. It’s because of this IND issue.”Medicine Creek AnalyticsScience Director Amber Wise also agreed with the need to include the issue in an appendix.
      • On November 21st, FDA officials issued warnings to companies including CBD in food citing the cannabinoid as not being generally recognized as safe (GRAS) and covered under a “drug preclusion” clause due to the IND status of Epidiolex. 
    • “I like the idea of an appendix item that summarizes that information,” said McLain, wondering if Douglass had ideas for a statement to add to the executive summary that “better illustrates the reasoning behind a Washington approach versus waiting on” federal action. His impression was that “context behind why GRAS and new dietary ingredient notifications haven't been accepted…could benefit but it is a little bit wonky.” McLain explained that “we don't have to go deep into it in the introduction and background information, but I can work with [Wisehart] and we can absolutely add a statement there that…better lays out” why there was no federal action to normalize CBD in food since “a lot of legislators may only read the executive summary and the introduction.” Douglass noted he was already drafting the appendix for consideration by the rest of the members (audio - 2m).
    • McLain followed up to ensure Douglass could get this appendix submitted in time to be added to the final report, adding that because this was “a report from the task force and not from the agency, I pushed back on timelines…so we have a little bit of extra time” to submit their final version to the Washington State Office of Financial Management (WA OFM, audio - 1m).
  • Wisehart indicated that Peterson had called for an appendix of “all the studies that were reviewed that helped to support and inform” task force recommendations. Peterson expected that if a legislator “read down to the appendix” (adding, “I know a couple that will”) then citing all the utilized studies “would be important” (audio - 4m).
    • Peterson pointed to a study discussed in the "last couple of days," that could help bolster the appendix, but wasn’t sure how much “data that's out there to justify the safety of consuming cannabinoids, and at what levels those can safely be consumed.”
  • Appendix C. Review of CBD Safety and Allowances (audio - 3m)
    • Tonani encouraged additions and editing to her draft of this section, stating the intent was to show the “extent of the data that we pulled.” She confirmed that their research showed “CBD in food has a maximum level of 300 milligrams per package; the dietary supplement has six thousand” milligrams “per package.”
  • Appendix E. RelevantCodes of Federal Regulations (CFRs, audio - 2m)
    • Wisehart reviewed the listed CFRs, narrowing the list to:
      • 21 CFR 101 - Food Labeling
        • 21 CFR 101.36 - Nutrition labeling of dietary supplements 
      • 21 CFR 111 - Dietary Supplements 
      • 21 CFR 117 - Food for Humans 
  • Appendix F. Meeting Notes (audio - 8m)
    • Peterson said they’d already agreed to have “notes from the subgroups” as an appendix, and encouraged including Cannabis Observer meeting links as well. Task force members talked about how to ensure all the subgroup notes were compiled and included.
  • As comments began to wrap up, Tonani made clear that “there is still some discussion around what the allowances per serving of an impairing compound should be” which would become Appendix D. Wise didn’t anticipate their final recommendation would be substantively different from their initial ones, but acknowledged “there's a little bit of pushback.” Tonani called the appendix “a work in progress.” She believed the best science on safe THC levels had come “from Canada and the EU [European Union]” and supported their input in favor of 2.5 mg servings with other Class B cannabinoids (audio - 5m).

• Looking ahead to what was left for the group to accomplish, WSDA Policy Advisor to the Director and Legislative Liaison Kelly McLain suggested an additional meeting on Wednesday December 14th (audio - 2m).
  • McLain promised an updated draft would be sent out, and raised the possibility of convening a meeting “a month out” to “check in post report delivery” so they could talk “about the legislative component.” The group agreed to meet and look at the final version of the task force report on December 14th.
    • As detailed in the initial WSDA announcement, the task force began “on June 20, 2022, and will end on June 30, 2023.”
    • The final report by the Washington State Hemp Commission Task Force was also submitted to the legislature on December 1st.