SBOH – Board Meeting
(November 18, 2019)

The State Board of Health voted to adopt emergency rules implementing a prohibition on the sale and distribution of nicotine and cannabis vapor products containing vitamin E acetate.

Here are some observations from the Monday November 18th Washington State Board of Health (SBOH) Board Meeting hosted at The Davenport Grand Hotel in Spokane.

Cannabis Observer extends its thanks to Washington SunGrowers Industry Association (WSIA) Executive Director Crystal Oliver, who attended the board meeting in person, observed the proceedings, and shared her audio recording with us.

My top 4 takeaways:

  • The State Board of Health considered emergency rulemaking to ban vitamin E acetate from vapor products following the advice of state and federal health officials.
  • Board members first received an update on litigation challenging the SBOH’s authority to ban flavored vapor products before hearing public comments.
    • A lawsuit against the state was filed by the Vapor Technology Association (VTA) and Baron Enterprises on October 22nd challenging the SBOH’s authority to declare a new prohibition on flavored vapor products (audio – 6m).
      • Assistant Attorney General Lilia Lopez, lead counsel for SBOH in the case, told the Board that the plaintiffs were “essentially seeking a stay of the emergency rule” and had asked for a “temporary restraining order” (TRO). Lopez complained plaintiffs had “attempted to do it without notifying” the SBOH of their intent and the judge had given the SBOH three days to “file a response.”
      • Lopez said the lawsuit claimed SBOH lacked sufficient “statutory authority, that the action was arbitrary and capricious, and they also had a first amendment free speech argument.” During the initial hearing for the TRO, Lopez claimed the judge ruled in the Board’s favor on both the arbitrary and capricious and free speech claims “right away” but the statutory authority challenge elicited a request from the court for “more briefing.”
      • In the subsequent preliminary injunction hearing on November 8th—which Cannabis Observer was present for—Lopez stated that the SBOH’s argument (audio – 5m) hinged on their authority to “prevent and control infectious disease,” including “food and vector borne illness” in RCW 43.20.050(2)(f) arguing that compounds in vapor products were “external to the body, that comes into the body, and makes you sick.” Whereas the plaintiffs focused on the phrasing of ‘infectious disease’ in their interpretation of the law (audio – 6m).
      • Lopez said that the Board didn’t have a “final order yet from that ruling. Once we get that it’ll be 30 days for the petitioners to file their request for an appeal if that’s what they want to do” adding she expected “they probably will do that.”
      • Complete Audio of Preliminary Injunction Hearing – 22m (MP3)
    • During public comment, citizens were allowed five minutes to address the Board as significantly fewer people signed up to testify compared to the October 9th meeting.
      • In addition to testimony in person, the Board published written comments received from businesses and individuals before the meeting.
      • Clay Schueman, owner of a tier 2 producer/processor license in Spokane, described how the flavored vapor products ban impacted his business and suggested a modification of SBOH’s definition of “characterizing flavor” (audio – 7m).
        • Schueman said his outdoor grow saw a single annual harvest producing roughly 450 pounds of “usable material” most of which was extracted for use in cannabis edibles and THC vape products. He praised the cleanliness of his company’s CO2 extraction process, but lamented that it often damaged extracted material’s terpene profile, which in turn altered the extract’s flavor and effects. As a result, Schueman chose to add “chemically identical” terpenes to his extracts because it was economical and facilitated product consistency.
        • He advised the Board to change their emergency rule definition of “characterizing flavor” in WAC 246-80-010(3), saying he felt the Board had “made a mistake” and that the definition should include “compounds derived and identified in the cannabis sativa plant regardless of source.”
        • He also commended Uncle Ike’s OK Cannabis program which tested products from 50 brands for the presence of vitamin E acetate. Schueman said the products had “all passed” adding that the health problems were from unregulated vapor products.
        • Schueman offered a final comment on “this lung issue” suggesting it was “multiphase causality” beyond vitamin E acetate. “I think there’s a pesticide problem, and I think that there’s a heavy metal problem. If you want to affect this lung issue,” he surmised, “affect those three things.”
      • Brad Bellinger, owner of Lilac City Vapor in Spokane offered observations on the effects of the flavored vapor products ban, asking the Board to overturn it (audio – 3m).
      • Travis Gent, owner of The Vapor Lounge in Spokane implored the Board to rescind the flavored vapor products ban in light of new information suggesting vitamin E acetate was a culprit. He believed the substance was only found in THC vapor products and that it could be successfully identified and removed from the 502 market (audio – 5m).
      • Shawn DaSilva, owner of vapor stores in Oregon and Washington, placed the blame for the presence of vitamin E acetate squarely on the illicit THC vape market (audio – 6m).
      • Bellinger, Gent, and DaSilva all testified against the flavor ban during the October 9th meeting.
  • The Department of Health and the Washington State Liquor and Cannabis Board presented on the status of vapor product investigations and the implementation of emergency rules banning flavored vapor products (audio – 1m).
    • The agencies outlined their efforts for the SBOH during the prior month’s meeting.
    • DOH State Health Officer and Chief Science Officer Kathy Lofy presented her latest information on vaping associated lung injuries (VALI) and perspective on the vitamin E acetate findings (audio – 14m).
      • Lofy reported there were “2,172 VALI cases reported nationally, including 42 deaths as of November 13, 2019.” In Washington state, there were 15 confirmed cases.
        • Washington state has identified 0.69% of cases confirmed nationally, yet is home to 2.29% of the nation’s people according to 2019 estimates, indicating geographic variance in distribution of cases.
      • Lofy explained “direct evidence of vitamin E acetate at the primary site of injury was found in 29 of 29 lung samples from patients in 10 states” and further testing of “lung samples for other compounds of interest were all below the level of detection.” Nonetheless, Lofy stressed a singular cause of VALI had not been identified as more research and animal studies were needed: “Findings do not really rule out that other compounds or ingredients may be contributing to these injuries.”
      • Lofy optimistically noted that the “number of new cases has been declining in recent weeks.”
    • Next, WSLCB Public Health Education Liaison Sara Cooley Broschart presented on compliance and enforcement of vapor product emergency rules (audio – 7m).
      • Broschart said that the THC and nicotine vapor product industries were “overwhelmingly in compliance” with the SBOH directive and WSLCB’s ensuing emergency rules. She claimed WSLCB aimed towards “maximizing compliance in order to maximize the public health benefit.” Broschart called outreach to licensees “paramount” in implementing the policy, and said meetings between Enforcement staff and impacted businesses had been extensive and were ongoing with a goal of reaching all 4,136 licensees by Thanksgiving (483 cannabis retailers and 3,653 vapor). “We’re well on track,” she assured the Board.
      • As of November 14th, the agency had visited 269 cannabis retailers, finding 98% were complying with the ban. Of the 2,435 nicotine vapor licensees visited during that same period, 93.4% had been in compliance. Broschart said Enforcement visits to ensure that processors had ceased producing flavored THC vapor products would begin in December.
      • Broschart described WSLCB efforts as multifaceted: mandatory signage, visits by Enforcement, and an ingredient disclosure form required of all cannabis processors.
        • Broschart claimed the agency expected to receive upwards of 11,000 ingredient disclosure forms from cannabis processors by December 1st. That deadline was not stipulated in the emergency rule CR-103E or issue paper, and was first declared to processors later the same day. When the new disclosure requirement was first being discussed in mid-October, the WSLCB had not planned to ask processors to send the forms to the agency as there were no available resources to digitize the information.
      • Broschart indicated the agency had been forced to reassign liquor Enforcement officers to perform vapor retail site visits and explain to businesses and the public exactly what items were prohibited. She noted some vapor businesses had been giving away flavored vapor products, acts prohibited under SBOH rule. Broschart said that rechecks of vapor retailers not in compliance would begin the following week with notices to those businesses and other enforcement actions possible. 
  • The Board deliberated and voted to ban vitamin E acetate in vapor products.
    • Montaño asked the Board to review materials including a memo from Wiesman and draft emergency rule language (audio – 1m).
      • Citing the compound’s presence in a majority of nicotine and tetrahydrocannabinol (THC) vapor products tested by federal investigators, the proposed emergency rule claimed that as “the outbreak of lung disease continues to grow, adoption of a rule prohibiting the sale of vapor products containing vitamin E acetate is necessary for the preservation of the public health, safety, and general welfare.”
      • The proposed rule would outlaw selling, offering to sell, or intending to sell vapor items containing vitamin E acetate for all individuals, explicitly including those “licensed under chapter 69.50 or 70.345 RCW.” The prohibition applied “at any location or by any means in this state including, but not limited to, by means of a telephonic or other method of voice transmission, the mail or any other delivery service, or the internet or other online service.”
    • Kutz, returning to the images of lung damage shared in Lofy’s presentation, asked whether “anybody admitted that those symptoms that did not vape in any shape or form?” Lofy answered that everyone diagnosed with VALI had “a history of vaping,” doctors had ruled out other infections, and attending physicians didn’t believe symptoms were caused by anything else. She termed it a “diagnosis of exclusion” (audio – 2m).
    • Kutz also asked about VALI patients under the age of 18, wondering how many victims “shouldn’t have had access to that stuff in the first place.” Lofy responded that nationally about 14% of patients were under 18. At the state level “we usually do it by decades” which made determining an exact percentage difficult (audio – 2m).
    • Kutz inquired what percentage of lung samples also showed the presence of “TCH”[sic] or nicotine. Lofy answered that investigators had primarily been looking for “other diluents” present in lung samples (audio – <1m).
    • Kutz concluded with an observation that “tobacco manufacturers at some point in time were prohibited from artificially enhancing the level of nicotine in their cigarettes.” Pendergrass cited a 1994 settlement agreement between the U.S. government and several top tobacco companies as restricting the cigarette industry’s ability to add nicotine to their products. However, he noted this had applied to “combustible products” rather than vaporizable ones. Kutz tried to ascertain if the state was comparing THC and nicotine levels to any limits for them in law. Lofy clarified that federal institutions were doing the lung sample and vape product testing, and she didn’t know if they were testing for concentrations of THC or nicotine (audio – 3m).
    • Pendergrass reminded the Board that only 29 patients out of over 2,100 VALI cases had received testing of lung fluid samples and vapor “inhalation is a very different process than putting it on your skin or putting it in your gut.” (audio – 6m)
      • Saying some VALI patients had reported burning of their lungs and throat, Pendergrass suggested damage may have been caused by heating levels in the vaping unit. He wanted to know more about “high temperature and vitamin E acetate and what are the compounds being generated.”
      • Pendergrass emphasized the atmosphere of uncertainty under which SBOH was making decisions which impacted multiple industries. He said there were two issues at play: preventing underage persons from initiating vaping use and targeting items which “appear” to be connected to VALI.
      • Pendergrass believed there were “a number of things that we need to do to recommend to our legislators” about “what needs to be in their approach.” He called for stricter controls on vapor packaging, advertising, and nicotine content similar to tobacco and mentioned a New York Times (NYT) editorial which raised similar points. Lutz said the NYT article dealt with “purlization” of superheated materials with different “break down properties” which may produce chemicals such as phosgene, a known poison.
    • Referring to the CDC lung fluid tests, Lutz commented about the “weakness of convenience samples” and “how the [29] samples were derived from 10 states.” Lofy noted sampling was likely “from the sickest patients” and felt the announcement’s veracity was helped by the fact that they had come from 10 states. Lutz was still concerned that health officials didn’t “know what else could be causing the problems.” He urged a “broad brush approach” that didn’t assume the problem was solved with a vitamin E acetate ban but instead should “augment” the existing flavor ban (audio – 1m).
      • Pendergrass agreed and said other compounds used for “dissolvability” may be a concern because they were “metabolically active” (audio – 1m).
    • Wiesman said that officials had hoped to find a single, definitive culprit for VALI, and that vitamin E acetate appeared to be “part of” the problem. However, lingering uncertainty over whether the illnesses were restricted to THC products or were caused by nicotine items without vitamin E acetate left Wiesman concerned that they’d identified “something sort of happening in the background” and that other illnesses from vaporization were only now being identified. He asked Lofy if that description was a “fair concern at this point” who responded that “everything you said was pretty much right on. I do think that the illicit THC products are driving this outbreak that we’re seeing.” She agreed that “there is a background of lung injury that maybe we haven’t been recognizing.” Lofy cited “case reports” from before VALI had been a prominent concern which went “back several years” (audio – 4m).
    • Hilt agreed with other comments that 29 was an insufficient sample size from which to draw conclusions. He asked Lofy for a “timeframe” to move from “diagnosis by exclusion” to a more conclusive diagnostic practice and whether such a timeline would take “years.” Lofy predicted a shorter time to better understand if vitamin E acetate was responsible for illnesses. The next stage involved “animal studies” which she expected would happen quickly. Lofy felt broader questions about other sources of “background lung injury” would take much longer (audio – 3m).
    • If the SBOH passed the emergency rule, Hilt wanted to know what the Board expected would be the next step: legislative action, an emergency rule extended by the Board, or a permanent rule? Grellner’s view was that a 120-day emergency ban permitted “time for the additional research to happen” to determine if vitamin E acetate was indeed at fault. If it was, then either the legislature or SBOH could move to make the rule permanent. Lofy agreed the state would have “a better picture” of the problem in 120 days. Grellner was reminded by Davis that Governor Inslee’s office was drafting request legislation around vaping and SBOH was engaged in the process (audio – 3m).
    • Kutz recalled that many of the products with vitamin E acetate came from unregulated sources. Lofy said that was reported in research from Illinois published by the CDC (audio – 2m).
    • Kutz then asked if there was any information about people getting ill from vapor products they’d modified themselves. Lofy replied that she was “almost positive” that investigators were asking about that possibility but she hadn’t seen any national-level information on the practice (audio – 1m).
    • Grellner wanted to know if other states had acted on vitamin E acetate since the CDC’s announcement. Broschart said that Colorado’s Marijuana Enforcement Division (MED) had banned vitamin E acetate along with Polyethylene glycol (PEG) and Medium Chain Triglycerides (MCT Oil) under rules revised in October. She added that several states were “looking at a similar action.” Glasoe noted that Ohio had also banned the compound from that state’s medical cannabis industry (audio – 2m).
      • The same day as SBOH’s meeting, Colorado regulators issued industry-wide bulletin 19-07 on “New Health and Safety Rules Specific to Vaporizers & Request to Immediately Cease the Manufacture and Sale of Vaporizers Containing Vitamin E Acetate.”
    • Kutz asked if WSLCB had identified any licensees using vitamin E acetate in the state. Broschart noted that the current disclosure rules only applied to cannabis licensees and, of the 250 forms received by the agency so far, none had reported using vitamin E acetate (audio – 3m).
    • Wiesman made a motion for the Board to adopt the emergency rule banning vitamin E acetate and that staff file the CR-103E with the Office of the Code Reviser (OCR). Wiesman advised the rule stay in effect for the full 120-day period allowed by law (audio – 1m) and offered several thoughts on his position (audio – 6m):
      • Wiesman was complimentary of the vapor industry’s compliance with “something that many did not want to do” and WSLCB’s “reallocation” of enforcement staff to manage compliance with the flavor ban.
      • Wiesman also thanked “public health and the healthcare community” for understanding the problem and caring for patients. While more conclusive research was warranted, he was confident that vitamin E acetate was at least partly responsible and that the SBOH emergency rule was needed to protect public health.
      • Wiesman said he was opposed to removing the flavored vapor products ban for the time being because there were “potentially more causes out there.” He admitted being “less certain that flavors don’t maybe play a role” following information from a Health Impact Review (HIR) on flavored vapor products released by SBOH in September.
      • Wiesman acknowledged he was less confident of a “single cause” being found to explain all the illnesses, saying as investigations continued that was “less likely.” 
    • Hilt offered his perspective that he’d be likely support a vitamin E acetate ban given more information. If he saw “a little more evidence” he’d probably back the measure as he was was “almost persuaded.” But overall, Hilt said he was inclined to vote against further action (audio – 1m).
    • Grellner told the Board he shared Hilt’s fears about the “lack of science” on which to base a conclusion that vitamin E acetate was to blame for the illnesses. He planned to defer to other board members having “far more medical expertise than I do” (audio – 1m).
    • Jeffords spoke up to say that “public health science moves incrementally, oftentimes in fits and starts.” He asserted belief in the “cautionary principle” such that “if we do not know that something is safe, I’d rather be cautious.” He didn’t believe the evidence against vitamin E acetate was a “smoking gun” but it was “strongly associated” enough with harm to merit the ban before the Board (audio – 1m). 
    • The emergency rule was passed by voice vote, with Pendergrass opposed and Hilt abstaining (audio – <1m).
    • After the vote, Wiesman said the SBOH’s key position in defining health policy for Washington meant that the Board would “need to be prepared to be involved as we continue to learn more and give some thought to” extra meetings to address further developments. Pendergrass predicted the vapor discussion would become another facet of a broader dialogue around preventing addiction (audio – 3m).
    • After the meeting:
      • SBOH posted an announcement that the Board “voted to adopt an additional section to the Vapor Products and Flavors emergency rule, chapter 246-080 WAC, which prohibits the sale and distribution of vapor products that contain vitamin E acetate at its public meeting Monday, Nov. 18. in Spokane… The amended rule will become effective immediately upon filing with the Washington State Code Reviser’s Office.” 
      • WSLCB sent out a notice informing cannabis licensees of the new ban, indicating an expectation that the CR-103E would be filed on Wednesday November 20th.
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