Halloween may have passed, but the suspense remains as Minnesota lawmakers begin drawing up plans and proposals for the state's upcoming 2020 legislative session. Legislators don't resume work at the capitol until February, but some important announcements have shed light on the fight to be expected next year.

Over the past few months the news has been dominated by reports of people being hospitalized with severe lung injuries from bad THC carts. The FDA and CDC are finally on the same page regarding the most common factor between the nearly 2,000 cases nationwide with an update released at the end of October. Minnesota confirmed that two more deaths were linked to the outbreak.

In an expected fashion, elected officials in the state have made announcements of their plans to take on the outbreak and address youth use of nicotine at two separate press conferences early this week.

“We’re not waiting anymore,” said Rep. Laurie Halverson, DFL-Eagan. “There’s no wait and see to see if these things are dangerous. We know they’re dangerous. People across the country and in Minnesota are dying using these products.” Halverson's comments echoed many at the capitol conflating commercially available nicotine vapes with tainted THC cartridges. 

The proposals also include a tax increase. Halverson and others believe that raising tobacco prices are "the best way to prevent youth from ever starting to smoke," in her own words. Lawmakers and media sources inaccurately stated that vapor products are tax exempt. Currently Minnesota sales taxes apply to retail vapor purchases, as well as a 95% excise tax on all nicotine that crosses state lines.

Another major point of contention is the documented rise in youth use and experimentation with vaping. Proposals to combat the rise include the taxes mentioned before, raising the minimum age to purchase to 21, and the most extreme proposal includes an overall ban on flavored vaping products. Prohibition has been the route several other states have gone already, but court decisions over the last two weeks have put bans in Michigan and Oregon on hold. Massachusetts' ban was upheld, but some changes  must be made going forward.

Smokeless's own Jesse Griffith was interviewed by Minnesota Public Radio.
"
“We have customers who definitely want their voice heard on this,” Griffith said. Policymakers, he said, are conflating legal vape materials and illicit THC products.

“The way that state and federal officials responded has been solely focused on trying to minimize the access to flavors, so I think that certainly sends the message that our industry is the problem, not the illicit drug trade,” he said.
"

Last week, DFL Gov. Tim Walz spoke on the issue during visits to several Minnesota schools. The Governor supports a tobacco 21 measure, but is much more wary of banning flavors for adults.

“Prohibition does not work,” Walz said. “You can make things more attractive by doing that.”

Minnesota's legislative session resumes on February 11th, 2020.

It's the kind of race you hope no one finishes, let alone wins.

This week, New York and Michigan became the first two states in the nation to finalize rules banning flavors in nicotine eliquid across their states.

In both cases, the bans came via an executive order in one form or another. Andrew Cuomo, Governor of New York, announced the plan last week, and was given the green light by the NY Public Health and Health Planning Council after a hearing on Wednesday. The council heard from many speakers, but ultimately voted to approve the Governor's ban with only a single dissenting vote. Vape shops in the state have a paltry 14 days to comply and sell all existing stock. The ban in New York is effective for 90 days.

In Michigan, the rule was written a little differently. The order came from Governor Gretchen Whitmer, but had to be officially written by the Department of Health. The governor doesn't have the authority to make such bans a law via direct executive order, but the MDH has the ability to write new rules that are enforced as law for a period of 6 months and can be renewed one time after that.

In both cases, the rules will need to be challenged in court or overturned by the legislature. Contact from voters is beginning to have a large impact, as talk of the effect a ban would have in the 2020 election begin to permeate the conversation.

The Floodgates Have Opened

With the President's announcement last week that the FDA is looking to finalize guidance banning flavors, it seems the prohibition fire has been lit and states have essentially been given permission to pursue their own actions against vaping. 

Two representatives from New York announced a bipartisan act that would, as stated:

• Ban flavored e-cigarettes and other flavored tobacco products
• Increase the federal tax on cigarettes from $1 per pack to $3 per pack
• Create a tax on e-cigarette products equivalent to $3 per pack
• Increase annual funding for the Centers for Disease Control and Prevention (CDC)’s Office on Smoking and Health from $210 million to $500 million

Rep. Tom Suozzi, a Democrat from N.Y. and Rep. Pete King, a Republican from the same state, are behind the “Quell Underage Inhaling of Toxic Substances (QUITS) Act. The legislation is awaiting an official file number at this time. It was the first federal proposal to ban flavors since the president's announcement last week.

The US Senate now has its own bill a day later. Utah Senator Mitt Romney alongside Oregon Democrat Jeff Merkley proposed the Ending New Nicotine Dependencies or ENND act on Thursday. The legislation would ban e-cigarette flavors other than tobacco, specify e-cigarette design standards, monitor the public health risks of using tobacco products, apply existing cigarette taxes to e-cigarettes and direct the Department of Health and Human Services to educate the public about health implications of using e-cigarettes.

California Governor Gavin Newsom announced on Monday of this week that his administration will also draft rules banning flavors in the state.
"Let's just dispense with any niceties. You don't have bubble gum flavor, mango-flavored tobacco products, unless you're trying to target an audience that you are losing. That's young people." Newsom stated.

The most restrictive action called to date comes from New Jersey, where Senate President Stephen Sweeney seeks to expand on a bill that stalled in previous attempts. Sweeney's proposal doesn't have a clever acronym yet, but his statements indicate that it largely mirrors the total flavor ban Trump spoke of the same day; with one important difference.
In his own words, the senator says "I’m starting to think the more and more we find out about vaping, maybe we should ban vaping altogether"
Though the language is the strictest used yet, the New Jersey ban has not been written or submitted yet. But, Sweeney said, he’s “seriously looking into" the idea.

We Vape, We Vote.

A rather large block of voters across the country vape, including significant portions in swing states. As many as 2.55 million vapers vote in 12 states the president won by a narrow margin in 2016. Pressure from residents can seriously turn the tide and stave off sensationalist reactions and overreaching bans.

STAY INFORMED

Last week, we took a dive into the still developing story of lung diseases popping up suddenly around the country. Well, it's been a very busy news week. We have quite a few updates for you. The CDC is officially on the case after several deaths, an earthquake of an announcement out of Michigan, and FDA officials identifying a common link in the nation's lung disease outbreak.

First deaths reported

Illinois released slim details last week about a person dying "after vaping," but, in the middle of the article, did mention a link to THC cartridges. The Illinois Department of Public Health did not release the person's name, age, sex or where they lived, according to CBS Chicago. Investigators at the Oregon Health Authority's Public Health Division said on Thursday that they received reports that an individual who died in July had recently used "an e-cigarette or vaping device" containing cannabis purchased from a cannabis dispensary. During the noon conference call on Friday, CDC officials noted a 3rd confirmed death, and one other under investigation.

Friday afternoon, Minnesota's Department of Health identified the 4th official death as a 65 year old with "a history of underlying lung disease and was hospitalized with a severe lung injury that progressed to include other conditions." They were hospitalized in August. Investigators said the lung injury was associated with vaping illicit THC products. MDH officials say that none of the over 25 cases in the state involved THC vapes purchased through the state's medical marijuana system.

The CDC gets involved

The Centers for Disease Control and Prevention announced that they were investigating as many 450 cases of severe pulmonary disease across 33 states and 1 US territory. Their announcement still pins the blame on e-cigarettes and vaping, though. During Friday's conference call, most speakers noted the involvement of THC vaping products but the CDC reiterated several times that they caution the public to "avoid all use of vaping and e-cigarettes" until more research is done.

Vitamin E Acetate now a focus

Mid-Thursday afternoon, The Washington Post reported that FDA and State agencies found Vitamin E acetate to be a link between patients.
"The chemical is an oil derived from vitamin E." WaPo wrote "Investigators at the U.S. Food and Drug Administration found the oil in cannabis products in samples collected from patients who fell ill across the United States."
The FDA also told state officials Thursday that its lab tests found nothing unusual in nicotine products that had been collected from sick patients.

Media coverage starting to catch up

As recently as last week, the only sources putting adulterated THC carts front and center were numerous marijuana magazines and the California Department of Public Health. Most major outlets said vaping was to blame, only mentioning the THC cart link by burying the lead in the middle of their coverage, or not mentioning them at all.

In the past week, you could see headlines starting to come around, placing THC carts in the headline or at least mentioning their involvement more clearly. 
A quick search for "vape" on Gizmodo looks like this:

Notice the difference in headlines? It would appear that as the story develops, publications are either finally starting to connect the dots, or they can no longer ignore the almost obvious link between the rise in popularity of THC carts and this mysterious and sudden severe illness.

The story is also being picked up by larger publications, like this article from Rolling Stone. The media coverage appears to be coming around, at least for the time being. Rolling Stone went on to publish a guide to identifying fake carts, as well.

Even Dr. Scott Gottlieb, former FDA commissioner, noted on twitter that the vapor industry has been under tight regulation since 2017. "FDA has conducted thousands of inspections of manufacturers and vape stores, published manufacturing guidance, sought product removals etc." noted the doctor, "These tragedies point to illegal vapes and THC."

With the recent revelation about Vitamin E acetate, one would hope that the media can now report accurately on the story. But you can expect plenty of coverage that doesn't bother to distinguish between vaping nicotine eliquid and vaping THC cartridges.

Damage Report: Michigan Strikes First

The media awakening may be too little, too late. Wednesday morning, Michigan's governor announced her administration was drafting an administrative rule banning the sale of all flavored eliquids. The ban will be imposed by the Michigan Department of Health and Human Services (MDHHS) through direction from Governor Gretchen Whitmer and prohibits online and retail sales of flavored nicotine vaping products.

This is not an executive order, however. Michigan's administrative rules process allows state agencies to create regulations or policies that, once authorized, act as laws. Once filed the rule will take effect immediately, giving retailers 30 days to comply. The rule will need to be reauthorized after 6 months, and can be challenged in court, according to Michigan law.

Michigan legalized recreational marijuana at the end of 2018. 6 cases of the sudden lung disease outbreak were identified in the state. This flavor ban applies only to eliquid and vaping; including mint and menthol eliquids. This move makes the state the first to enact a statewide flavor ban. Earlier this year several cities in California instituted flavor bans of their own.

It's easy to see how banning flavors will create an underground market of Do-It-Yourselfers making and selling their home brews on the street and under the table. The same prohibition and demand is responsible for the black market THC carts causing the very outbreak that Gov. Whitmer and her colleagues in Michigan seek to rout.

CASAA has created a call to action for Michigan residents. 

This story is developing rapidly, and we will continue to track it. 

More than two dozen cases of severe lung disease have been diagnosed in Wisconsin, Illinois, and Minnesota. Media reports have taken to painting vapor products as the culprit behind the sudden hospitalizations. But this isn’t the first time the media has employed sensationalist tactics in its long-standing affront on the vapor industry, and just as in every instance before, there is much more to the story than originally reported.

The latest round of anti-vaping fervor started with a press release from the Wisconsin Department of Health Services on July 25th, warning of a lung disease cluster in the state. 

“All patients reported vaping in the weeks and months prior to hospital admission,” the memo states, written by epidemiologist Dr. Jonathan Meiman. “The names and types of products used remain unknown, and patient interviews are ongoing. Clinicians are encouraged to remain alert for potential cases among persons presenting with progressive respiratory symptoms who report a history of inhalation drug use, particularly vaping.”

Let’s examine that language. How often have you heard "inhalation drug use" used to describe vaping? Such carefully chosen wording seems to indicate that the initial press release hasn't effectively implicated vaping as a whole. Let's put a pin in that; we’ll circle back to it soon.

Fast forward to August 13th, when the Minnesota Department of Health issued an alert linking 4 teens to similar lung disease symptoms. The MDH, which historically has been combative toward the harm reduction model, capitalized on the cases to further demonize vaping categorically. The reaction isn't all that surprising, considering how often MDH seems to deliberately ignore the science. And as their press release and the subsequent media coverage of these cases leaves out, black market THC carts were reported by most of the teens affected.

The Common Denominator, Ignored

Early reporting of the MN cases, and plenty of the reports for the others, do mention eventually that the teens had been using normal vapes and THC cartridges. THC cartridges, also referred to as "carts", are easy-to-use disposable tanks that fit on most standard vape setups. In legal states, the cartridges are available from licensed and regulated dispensaries. They're subject to strict quality control and lab testing. They're also incredibly popular. 

The same day the cases in Wisconsin were upgraded to alert status, news broke of a man in Burlington, WI who was hospitalized specifically after using one of these black market carts. The man's brother told local reporters that the THC cart was purchased off the street. Wisconsin has not legalized marijuana in any form.

Unfortunately the reporting on this case, where they knew exactly what caused the man's condition, was still rife with conflations that vaping of any kind is the culprit. This article, from a different news outlet, handles the story with much more accurate information.

THC cartridges, an emerging black market.

The rise in popularity of legal and lab-tested carts has also given way to a rise in knockoffs. A quick google search reveals the notorious name of "Dank Vapes", a seemingly real company that may never have actually existed. The closest anyone has come to confirming a legitimate company is a twitter interview with an account that has since been deleted. There are no listings for any company by that name in California, where the Twitter account claims to have operated out of. The US patent office has a patent on file from a company named Dank Vapes, but that's where the trail goes cold.

Indeed there's a large, easily accessible market for empty cartridges. You can buy five hundred legitimate looking boxes on Amazon for under $200. As we mentioned before, legal states have strict regulation and testing requirements. There is no way to regulate what someone fills an empty cart with; be it a poorly made batch of THC distillate, or something much worse.

Myron Ronay, the CEO of BelCosta Labs, a cannabis testing lab in California, told Inverse's Emma Betuel in an interview that they "often see black-market products that contain unsafe levels of myclobutanil — a fungicide." Myclobutanil, when heated, releases toxic fumes, including hydrogen cyanide. "Small amounts of HCN are released when smoking cigarettes, but larger doses are lethal." Black market cartridges go untested for chemicals like these and employ little to no oversight with regard to the extraction and purification processes used in their production.

Development

As this article was being researched and written, California declared 7 cases of Acute Respiratory Distress. The difference in reporting is stark.  The Kings County Public Health press release specifically names unregulated THC carts as the cause. The Vapor Technology Association, who filed suit against the FDA last week, issued another release demanding that state health officials in the Midwest cease broad description of the cause as "vaping" until more information was found and made public.

Remember that pin we asked you to hold on to until later? Let's pull that out. Please take note of how different the coverage is from a state in which recreational THC has been legalized. (Illinois has legalized, but it doesn't take effect until 2020.) The vague wording and broad definitions seem intentional at worst, irresponsible at best. And it's not far fetched to see how a sudden influx of honestly scary medical conditions can cause panic. Politicians blame video games for increased gun violence despite overwhelming evidence to the contrary.

Panic is to be expected during health scares. Most will snap to attention and grasp at the first unknown thing to blame. It's easy to place responsibility on something we don't understand or even fear. The harder task is waiting until there is more concrete evidence of what's happening before jumping to the conclusion that products that have been at market for years with virtually no reported case of inhalation related injury are suddenly to blame for a recent outbreak of acute lung disease.

This story is ongoing, and we will keep following it. Hopefully more clear links and explanations will arise in the days to come. Until then the best advice would be to avoid street drugs and only buy your vapes, whatever they may be made of, from reputable and trusted retailers.

The Vapor Technology Association, alongside Vapor Stockroom, LLC have filed suit against the FDA. Coming in at 51 pages long, over 137 paragraphs, and charging two very direct counts of wrongdoing, it could have major implications for the nation's vapor industry.

The lawsuit comes in the wake of the FDA's announcement back in June that vapor manufacturers have until May of 2020 to file their PMTA applications. Premarket Tobacco Authorization applications are required of all manufacturers so they can market and sell vapor products in the United States. The process is expected to be incredibly expensive and so far comes with almost no specific instruction, even though the FDA has revised and re released guidance five different times since 2016.

The Plaintiffs

The lawsuit has been filed on behalf of two parties. The first, the Vapor Technology Association, is a large coalition of manufacturers and small businesses seeking responsible legislation and regulation of vapor products. The other, Vapor Stockroom LLC, is a Kentucky-based vapor products manufacturer and distributor, one of the many locally owned small businesses affected by the FDA's sudden 10-month timetable for submissions. The official filing goes into much more detail, but the main facts the VTA points out are:

1. "A Wide Variety of Innovative Vapor Products Provide an Alternative to Combustible Cigarettes for Existing Smokers and Hold Great Potential to Benefit the Public Health as a Harm Reduction Tool. "

Which, science aside, if you take previous FDA commissioner Scott Gotlieb's own word for it, "E-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products and onto nicotine delivery products that may not have the same level of risks associated with them."
It's just hard to dispute that.

2. "Vapor Products, Which Do Not Contain Tobacco, Are Disadvantaged Under the Tobacco Control Act Compared to More Harmful Combustible Cigarettes Because Pre-Market Tobacco Applications Must be Filed for Vapor Products Already On the Market. "

Doesn't it seem strange that a product that contains no tobacco is regulated like it does? To quote the lawsuit "In the three years since the Deeming Rule took effect, all Newly Deemed Products, including vapor products, have been heavily regulated by FDA." And from label requirements to advertising and bottle restrictions, they're right.

3. "FDA Repeatedly Promised, But Has Failed to Deliver, Foundational Rules or Clear Guidance Setting Forth the “Rules of the Road” Upon Which Vapor Manufacturers Could Rely for the Mandatory Pre-Market Tobacco Application Process."

And thus,

4. "[Vape manufacturers] Delayed Working on Their PMTAs in Reasonable and Detrimental Reliance on FDA’s Oft-Repeated Promises That Further Guidance and a Foundational Rule Setting the “Rules of the Road” for PMTAs Would be Forthcoming and FDA’s Public Statements and Guidance Stating that Stakeholders Would Have Until August 2022 to File Their PMTAs. "

And it's true. The lawsuit alleges the "rules of the road" have yet to be established. By their own press releases, the FDA said it would provide such. It hasn't. How are manufacturers supposed to commit so much time and money if they don't have the rules laid out?

5. "FDA Materially Changed its Recommendations Regarding Harmful and Potentially Harmful Constituent Testing Between the Draft ENDS PMTA Guidance Published in 2016 and the Final ENDS PMTA Guidance Published on June 11, 2019. "

This creates a special challenge for manufacturers and small businesses. Uncertainty is always tough when running a business, but not reaching PMTA compliance has far and away more ramifications than following market trends or keeping your shelves stocked.

6. "FDA Engaged in Unlawful “Regulation by Litigation” By Superfluously Suggesting a Grossly Accelerated Ten-Month Deadline for the Submission of PMTAs Without Any Advance Notice or Opportunity for Comment by VTA or Industry Stakeholders."

This one may be the biggest shock in the FDA/vaping timeline. After so much delay, a federal ruling pushed the FDA into a 10-month deadline for accepting PMTA applications. The FDA so far has opted not to appeal the decision, a peculiar choice given how much work that will make for acting FDA director Ned Sharpless and his staff.

7. "FDA’s Arbitrary and Capricious Suggestion of a Ten-Month Deadline Presents Vapor Manufacturers ... with a Hobson’s Choice of Either Spending Millions of Dollars on PMTAs that They Know Will Be Incomplete by May 11, 2020, or Waiting for Additional Regulations from FDA and Running the Risk that Their Products Will Face Enforcement Action After May 11, 2020."

We really might not have been able to put it better ourselves.

The lawsuit alleges that the FDA violated the Administrative Procedure Act and the Due Process clause of the Fifth Amendment. As of this posting, no file number or judge has been assigned.

This case is one of a few that have come down since the June deadline shrink, but it's easily the most comprehensive and detailed suit to date.