SBOH - Board Meeting
(October 9, 2019)

Wednesday October 9, 2019 9:15 AM - 3:55 PM Observed
Washington State Board of Health (SBOH) Logo

The SBOH Board Meetings provide a public forum for engagement with the State public health system.

https://sboh.wa.gov/Meetings/MeetingInformation

Observations

A NEW “PROHIBITION” on “flavored vapor products” was adopted by the State Board of Health in compliance with Governor Jay Inslee’s mandate creating unknowable economic and public health impacts.

Here are some observations from the Wednesday October 9th Washington State Board of Health (SBOH) Board Meeting.

My top 4 takeaways:

  • The State Board of Health met to consider emergency rulemaking to ban flavored vapor products following direction from Washington Governor Jay Inslee.
  • The SBOH heard dozens of public comments polarized in opposition and support of a new prohibition on flavored vapor products.
    • Chair Gellner explained that the SBOH had received “well over two thousand” public comments via email, including some form letters, prior to the Board’s meeting (audio - 7m, video).
    • More than 50 people signed up to testify during an extended two hour comment period. Gellner announced people would have between 90 seconds and two minutes to speak.
    • A pair of state lawmakers came out in a show of support for the SBOH’s efforts:
      • Representative Gerry Pollet, sponsor of HB 1932, legislation prohibiting flavored vapor products which was considered but not passed by the legislature earlier in the year, cited the health impact review (HIR) compiled before vaping “fatal illnesses” became a widespread concern. He lauded the prospective “health outcomes” of reduced youth vaping use, claiming vaping as a method of tobacco cessation lowered a person’s odds of quitting by over 25% (audio - 3m, video).
      • Representative Paul Harris said after meeting with vape business owners he’d found "for years they have not wanted to be regulated. No one really knows what they’re vaping." He felt there were too many kids vaping in his district, and asked the vape sector to help him ensure "that 18 year olds and less” weren’t using their products. He called the actions the state was currently taking the “tough way to go” but didn’t see a better option before the legislative session the following January (audio - 2m, video).
    • Several members of the cannabis community shared testimony:
      • Caitlein Ryan, President of The Cannabis Alliance, said that “as an industry, we are in strong support” of Governor Inslee’s directive. She claimed that a lack of nicotine vapor regulation led youth to the products in “staggering numbers.” Ryan reminded the Board that what remained of the state’s illicit cannabis market included vapor products with no regulations or accountability. She offered the 502 market’s experience with “transparent, tested, and traceable products.” She posited that the cannabis flavor itself was “generally not attractive to youth” and that Washington’s cannabis stores achieved a 95% compliance rate in restricting sales to minors (audio - 2m, video).
      • David Heldreth, Chief Science Officer at True Terpenes, explained that his company used “botanical terpenes from other plants” and that cannabis flavoring had not been linked to reported vaping injuries. He encouraged regulating additives and separating cannabis from nicotine  vaping regulations (audio - 2m, video).
      • Kyle Capizzi, Executive Director of the newly announced Craft Cannabis Coalition and Chair of the Cannabis Alliance Science and Standards Committee, said the prospective ban didn’t go far enough in regulating the nicotine vape industry while 502 producers and processors were “threatened” by the ban. He encouraged the SBOH to separate out cannabis and nicotine vapor product rulemaking (audio - 2m, video).
      • Sean O'Sullivan, representing Top Shelf Cannabis, attributed the vapor market problems to unregulated products and advised the Board to see that all products were tested (audio - 1m, video).
      • Gregory Foster, Founder and Citizen Observer at Cannabis Observer, said he “[did] not envy the Board’s position” but noted “prohibition as a policy-making tool should be a last resort.” He suggested that a flavor ban was contentious as evidenced by the legislature’s decision not to pass HB 1932 out of committee and should be decided by the legislature. He hoped SBOH would respond when any causes of the recent vaping injuries were clearly identified (audio - 2m, video).
      • Tracy Bailiff, employed by Floyd’s Cannabis in Sedro-Woolley, pointed out how “over-regulated” legal cannabis production was, saying she was “so tired” of keeping up with rules and testing. She encouraged the Board to treat cannabis and nicotine vapes separately, claiming her business stood to lose 40% of sales (audio - 2m, video)
    • Public health and prevention community advocates testified in support of a flavored vapor products ban:
    • Vapor community members testified in unanimous opposition of a ban:
    • After the close of public comment as the majority of those in attendance left the room, several exchanges between vapor advocates and the two state representatives became quite heated.
  • The Department of Health and Washington State Liquor and Cannabis Board gave presentations to the SBOH covering the status of current vapor product investigations, regulatory efforts, and statistics about vaping-related illnesses and youth vaping trends.
    • As the Board moved on to hear presentations from state officials, Chair Grellner “pleaded” for the public’s cooperation to allow the SBOH to run an orderly meeting. He went so far as to remind those watching the proceedings that SBOH staff had “authority to clear the room.”
    • Secretary Wiesman addressed the executive order’s purpose as it pertained to the SBOH and introduced Lofy, Broschart, Herendeen, Lang-Perez, and Montaño. The panel had prepared background on the outbreak of vaping-related illnesses; information the agencies had on vaping and health; and a Health Impact Review (HIR) that DOH completed on request regarding vapor product legislation from earlier in the year (audio - 1m, video).
    • Lofy walked the Board through a presentation on vapor product safety, asserting from the outset that the “diverse group of products” were "not safe and do harm an individual's health" (audio - 19m, video).
      • Lofy led with information from the National Academies of Sciences, Engineering, and Medicine (NAS) which found vapor product contents included: 
        • “Nicotine, marijuana, other drugs
        • Propylene glycol, glycerol, other carrier agents
        • Flavoring chemicals
        • Other chemicals: ultrafine particles, volatile organic chemicals, heavy metals (nickel, tin, and lead), formaldehyde, ???”
      • Lofy indicated that although propylene glycol and glycerol had been deemed safe for “ingestion” the state “really [doesn’t] yet understand their impacts when these substances are inhaled.” Furthermore, she asserted that the flavoring chemicals were targeted to youth as they included “grape, bubblegum, and cotton candy” though she acknowledged adults also enjoyed those same flavors. As vapor products were “unregulated,” Lofy believed it was likely there were “other chemicals that we have not yet recognized” in the products as well. She then claimed that tetrahydrocannabinol (THC) vapor products typically included “cutting agents” to “dilute” concentrates with the presumed goal of increasing profits.
      • Lofy said that “over the summer” health officials discovered a “new illness associated with vaping” which they termed Vaping Associated Lung Injury (VALI). She described the illness:
        • “Common symptoms include cough, shortness of breath, chest pain, nausea, vomiting and/or fever
          • Progress over days or weeks
        • Can lead to respiratory failure
        • Abnormal findings on chest x-ray or [chest] CT scan
        • Suspected cause is a chemical exposure”
      • Despite all officials had learned, Lofy cautioned that the “pathophysiology of this particular condition” wasn’t yet well understood. She reported that as of October 1st, 1080 cases had been associated with VALI from “48 states and one U.S. territory” and that 18 deaths had been attributed to the condition in 15 states. Lofy pointed out that the first reported cases were traced to “early July” and claimed that a recent decline in cases was “most likely due to a lag in reporting" to the U.S. Centers for Disease Control and Prevention (CDC). Lofy speculated it was possible that there were “multiple substances in multiple vapor products that cause injury” and “to date, the specific chemical or chemicals” causing VALI remained “unknown.”
      • While nationwide the majority of patients reported having used both THC and nicotine vapor products, two of the three Washington state cases involving only nicotine vaping found no evidence of THC use in urinalysis tests. The two Washington patients who reported vaping only THC products said they purchased them from licensed state retailers. Lofy added that “no common product has been identified among our Washington cases either.”
      • Lofy explained that DOH was cooperating with the Food and Drug Administration (FDA) and reviewed the department’s case analysis procedures. She elaborated that DOH was alerting healthcare providers and asking them to report suspected cases as well as looking at “real-time hospital data for young people with severe lung injury.” Identified cases lead DOH to review records and talk with both patients and providers to ascertain the patient’s vaping use. DOH was sending vape samples to the FDA for testing but “have not received any results yet.” Lofy noted that DOH was also “communicating with the public” to convey vaping’s risks. 
      • "Now I'm going to switch gears and talk about our youth vaping epidemic," Lofy began. She offered statistics from the Washington State Healthy Youth Survey showing that a decline in youth cigarette use from 2012 to 2018 had been surpassed by an increase in youth vaping. She inferred that many youth who “probably never would have started” smoking cigarettes became vapor users as most youth using vapor products in Washington had never smoked “even one cigarette.”
      • In 2017, 2.8% of U.S. adults and 4.2% of WA adults used e-cigarettes “some days or every day.” In 2018, 4.3% of WA adults had vaped cannabis products “in the past 30 days.” Lofy said that “JUUL became very popular in 2017” and may have caused a “spike” in vaping use in 2018.
      • Regarding nicotine vaping as a form of tobacco cessation, Lofy reported that "a really large body of literature on cessation” had shown “very mixed" results "in part, because devices have changed over time."
      • DOH’s presentation cited a 2018 report from NAS on the Public Health Consequences of E-Cigarettes which found “Insufficient evidence from randomized controlled trials on effectiveness of e-cigarettes as cessation aids compared with no treatment or FDA-approved aids.”
      • The presentation also cited a New England Journal of Medicine article, “A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy,” which found that about 80% of cigarette smokers who switched to e-cigarettes were still using the products after a year, compared with just under 10% of those who used nicotine replacement therapy (NRT).
      • Lofy indicated no vaping product had been designated as a smoking cessation aid by the FDA. "Chemicals in e-cigarettes are different from chemicals in cigarettes,” Lofy warned, and deemed the product’s potential for cessation “inconclusive” as not enough was “known long-term” about their efficacy.
      • Lofy concluded that in addition to the proposed ban on flavored products, the governor’s executive order directed DOH to work alongside WSLCB to ban the cause of the outbreak, issue consumer warnings, pursue ingredient disclosure and provider reporting, produce an education campaign, and advise on potential legislation around the vaping market.
    • Sara Cooley Broschart spoke to the WSLCB’s efforts to implement the governor’s order (audio - 5m, video).
      • Broschart said the agency had developed signage for retailers which had become “required posting” and would have a similar posting for non-THC vapor retailers soon. She said WSLCB had followed up on ingredient disclosure with processors and that the agency had been working with the industry for the last three weeks “to maximize compliance.” If specific chemicals were identified, Broschart told the SBOH that the agency would use collected ingredient lists to pull products from the market. She expected WSLCB’s Board to adopt emergency rulemaking regarding product disclosure on October 16th 
      • Broschart clarified that WSLCB’s cannabis and vapor “authorities are different” but that the agency had ample authority for “the marijuana side.” For non-THC products, she claimed the agency had more “limited authority” but after consulting with the other agencies involved in enacting the governor’s order she was confident WSLCB “had the capabilities to move forward.” Broschart also mentioned “educational outreach visits” to vapor retailers which would take place over the coming “weeks and months.”
    • Herendeen introduced fellow DOH analyst Lang-Perez before presenting the findings of a recent health impact review of HB 1932 which focused on “provisions that would prohibit the sale of flavored vapor products” specifically in relation to youth vapor use (audio - 9m, video)
      • HIRs are a process by which the SBOH weighs the evidentiary strength of available information and the impacts on “health outcomes” should a bill or policy become law.
      • Flavored vape products were defined as any item with a “characterizing flavor” aside from tobacco. The HIR defined characterizing flavor as “a distinguishable taste or aroma, or both, other than the taste or aroma of tobacco, imparted by a vapor product.”
      • Herendeen highlighted the HIR’s “strength of evidence” model for nicotine vaping products, which she noted was different than the available evidence for THC vape products.
      • The HIR found “strong evidence” that “prohibiting the sale of flavored vapor products will likely decrease initiation and use of vapor products among adolescents and young adults” due to reduced appeal and limited accessibility. Furthermore, the review found “very strong evidence that decreasing use of vapor products for adolescents and young adults will likely improve health outcomes” for these groups.
      • Herendeen noted evidence suggesting solvents and flavoring agents in vape products “cause harm at the cellular level and are cytotoxic.” This was in addition to risks such as poisoning or injuries from vapor device explosions. The HIR found adverse vaping effects included “airway and lung obstruction” and usage “independently and significantly associated with an increased risk of heart attack.”
      • According to Herendeen, the HIR found “exempting certain flavors” from the product ban “reduced overall effectiveness.” The findings also noted that “due to targeted tobacco marketing to communities of color, LGBTQIA communities, and low-income communities, prohibiting the sale of flavors in vapor products alone may exacerbate existing inequities in tobacco product initiation and use.”
      • Regarding cannabis vapor items, HIR found there wasn’t sufficient research, with some products using “naturally derived terpenes” for flavoring and others using artificial terpenes and additives. The flavoring products were generally characterized as “not well regulated” with potential health risks.
    • Montaño, a policy advisor for SBOH, contextualized the emergency rulemaking before the SBOH members (audio - 6m, video).
      • She provided a quick overview of the Board’s rulemaking process which was beginning with a CR-103E - “typically the end of the rulemaking process.” An emergency rulemaking could become effective as soon as the SBOH submitted it to the Office of the Code Reviser and stayed in effect for 120 days. SBOH could reevaluate the rulemaking and choose to extend the emergency rule “at that time if necessary” .
      • Montaño called attention to the most recent version of the Board’s proposed emergency rulemaking, saying that it differed from the draft shared the Friday before. The emergency rule would create several new sections within DOH’s WAC 246:
        • WAC 246-80-001 - Purpose and Necessity 
        • WAC 246-80-010 - Definitions
        • WAC 246-80-020 - Prohibition
        • WAC 246-80-030 - Reporting
        • WAC 246-80-040 - Enforcement
      • Montaño suggested edits to the final draft, specifically around expanding the window requiring submission of VALI case reports by medical providers from one day to three. She advised further changes in rule language to have local health authorities submit their case reports within seven days of the report's completion, unless the report in question took longer than 21 days to complete. In that case authorities would share all the information they’d gathered to that point. Montaño said SBOH’s authority for these changes “primarily” came from RCW 43.20.050. 
    • Vice Chair Pendergrass asked the panel about “diluting” and “dissolving vehicles” in vapor products and their relation with VALI cases, wanting to know if the rulemaking could address those compounds. Herendeen said the SBOH should look to the “public health folks” involved, with Wiesman suggesting that such an effort was premature until cause(s) of the illnesses were confirmed (audio - 3m, video)
    • Pendergrass said that “something that really didn’t come up” from the comments the Board heard was “the vaporizing unit.” He suggested that because the vapor devices were “variable temperature possible” that a vape cartridge could become hot enough to “cause some burn[ing] to lungs or trachea.” Pendergrass cited researchers at the Mayo Clinic who suggested VALI was caused by “toxic chemical fumes.” Pendergrass then asked how the state could regulate vape units themselves, and whether WSLCB did so already. Broschart answered that her agency “did not approve devices or look at them closely.” (audio - 2m, video)
    • Next, Pendergrass wanted more information about vape cartridges from “non-licensed sources” and whether the proposed rule could be enforced against online vape distributors. Herendeen replied that online sales would be prohibited in section 246-80-020 of the drafted rule. Pendergrass acknowledged that but remained concerned about the state’s authority to enforce it. Herendeen said it was the same “broad authority” allowing SBOH to “prevent and control infectious and noninfectious disease.” (audio - 2m, video)
    • Pendergrass concluded by commenting that “we’ve heard a lot from folks about how important their vaping system is to them.” He said most of the rule was concerned with “short-term effects” and that even long-term vape consumers hadn’t “necessarily vaped with all of the things that are currently available.” Pendergrass argued that the SBOH couldn’t ignore the “acute change” observed in vaping’s effects on health. (audio - 1m, video)
    • Board Member Lutz commended how DOH had worked with local health officials to investigate the outbreak and the work of the panel. He argued there was “overwhelming evidence” of flavored vapor products appeal to youth and that the Board was at a “crossroads” between youth initiation of vape use and the risks of VALI. Lutz said he was among those who believed it was “only a matter of time” before health problems from the products became clear to local health authorities (audio - 4m, video).
    • Board Member Kutz asked for information on vaping frequency and nicotine levels, saying he’d seen people who vaped as regularly as cigarette smokers had smoked. He suspected they were equally addicted to nicotine via a different delivery system (audio - 2m, video).
    • Board Member Wood asked when the HIR had been performed by SBOH. Herendeen answered that the agency’s work began in August (audio - 1m, video).
    • Grellner asked if the HIR revealed where underage vape users were sourcing their products. Montaño said it was a question asked in the state’s Healthy Youth Survey, which found 65% of the state’s teens who use vapor or tobacco items obtained them from “social sources” including older friends or relatives (audio - 2m, video).
    • Weisman asked staff to confirm that the Board couldn’t raise the purchase age for vapor products to 21 any faster than January 1st, 2020, the date mandated by HB 1074. Staff concurred that state statute listed an exact date and changing it “was not something the Board can wade into.” (audio - 1m, video).
    • Wiesman also asked about SBOH’s authority to “rescind” their emergency rule ahead of it’s 120 day limit. Herendeen said that process was actually a “suspension” of the emergency rule which would require the Board convene and vote to suspend it (audio - 1m, video).
    • Kutz praised the comments offered at the meeting saying they “brought up a lot of issues” he hadn’t considered. He suggested “longer term discussions” about things like nicotine concentration should move forward after the emergency rule the Board had before them (audio - 1m, video).
    • Grellner brought up whether or not JUUL offered “tons of flavors” from their website. Lofy said JUUL had “pulled its flavors from shelves” but claimed that the company reserved the right to put their flavored products back in stores (audio - 1m, video).
    • Grellner also noted a “strong divide” between the strictly regulated 502 market and the “non-regulated” vapor sector. He asked WSLCB to explain whether there were differences in those systems. Broschart answered that the two marketplaces were regulated “quite differently” with their authority over non-THC products significantly more limited. Despite the authority WSLCB had for cannabis products, she noted that regulators didn’t have “comprehensive testing” for those items yet, leading to “gaps in information” (audio - 2m, video).
    • Gellner mentioned the “United Kingdom model” for vaping had been held up as an ideal system and then asked if that nation’s laws were producing “safer known, standardized, tested products.” Lofy replied that the U.K.’s system was “much different,” limiting nicotine concentration to lower levels than the U.S., restricting marketing toward youth, and other differences. She then confirmed that the country wasn’t “seeing the explosion of youth vaping” evident in the U.S. (audio - 3m, video).
    • Lutz asked if the proposed rule should consistently refer to “disease” or “illness” as regards the vaping condition it sought to address. Staff responded that the terms “worked together” (audio - 1m, video).
  • The Board deliberated before voting to ban flavored vapor products in compliance with the governor’s executive order.
    • Wiesman offered the motion that the Board adopt the emergency rule. Several board members offered final comments prior to the vote (audio - 1m, video).
      • Wiesman thanked officials investigating the VALI cases around the state and those who commented saying he related to the struggles of familial tobacco addiction. He felt that while the emergency rule wouldn’t permanently eliminate flavored products for everyone, it would help the state combat “losing another generation” of youth to the harms of nicotine addiction (audio - 8m, video).
      • Pendergrass called the issue before the SBOH “difficult” and “complicated” but agreed he didn’t want kids “to smoke anything” (audio - 2m, video).
      • Wood was similarly grateful to participants but felt the “science that we have at our fingertips” in addition to the data from the state suggested they had the opportunity to “protect public health” (audio - 1m, video).
      • Lutz acknowledged the “challenges that people have” with the idea of a flavor ban. Nonetheless, he said the rule was about being “as proactive as possible” in preventing health risks (audio - 1m, video).
    • Gellner’s comments drew interruptions and condemnation from several in the audience who took issue with his concerns over youth tobacco use initiation through vaping. He promised that the Board was taking temporary action and would be prepared to reverse any action given sufficient new information. Gellner urged those with concerns or outrage over the impending vote to “get support from your legislators” and held up the cannabis industry as a model for how to do so (audio - 6m, video).
    • The Board voted unanimously to enact the emergency rule, with the exception of Vice Chair Thomas Pendergrass who quietly abstained from voting (audio - 1m, video).
    • Following the emergency rule’s passage:
      • WSLCB sent notice to all cannabis licensees confirming that sales of flavored vapor products were prohibited with immediate effect. 
      • Governor Inslee released a statement, saying “I am pleased the State Board of Health agrees we cannot wait to act on this very important public health issue. It comes down to protecting the health of Washingtonians, especially young people. These emergency rules will help protect public health and save lives."
      • On October 10th at 12:27pm PT, the SBOH filed the CR-103E to implement the new prohibition effective immediately.

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