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September 1st, 2019 Coalition Study and Report: State of Emergency; Vaping Lung Disease and Fatality Epidemic 1 Coalition Study and Report: State of Emergency; Vaping Lung Disease and Fatality Epidemic Full Report & Research Conducted by: Mailing Address: Committee on Governance 8549 Wilshire Blvd Suite 490 Chaired by Ryan Bacchas Beverly Hills, California 90211 Regional Office: 800 E Ocean Blvd. Long Beach, California 90802 Contact: P: (424) 290 - 9908 E: [email protected]

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Page 1: Coalition Study and Reportcaliforniacannabiscoalition.org/wp-content/uploads/2019/10/State-of... · additives in manufactured cannabis vape pens. ... Vitamin E supplier Honeycut,

September 1st, 2019

Coalition Study and Report: State of Emergency; Vaping Lung Disease and Fatality Epidemic

1

Coalition Study and Report: State of Emergency; Vaping Lung Disease and Fatality Epidemic

Full Report & Research Conducted by: Mailing Address:

Committee on Governance 8549 Wilshire Blvd Suite 490

Chaired by Ryan Bacchas Beverly Hills, California 90211

Regional Office:

800 E Ocean Blvd.

Long Beach, California 90802

Contact:

P: (424) 290 - 9908

E: [email protected]

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Coalition Study and Report: State of Emergency; Vaping Lung Disease and Fatality Epidemic

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Coalition Study and Report: State of Emergency; Vaping Lung Disease and Fatality Epidemic

Appendix:

Page 2: Appendix.

Page 3: Acknowledgments & Statements.

Page 4: Background.

Page 5 through 7: Cause of the Outbreak.

Page 8: Analysis.

Page 9 through 11: Findings.

Page 12 through 14: Devil in the Detail; Diluents & Chemical

Mixtures.

Page 12: Hydrogen Cyanide

Page 12 (cont.): Propylene Glycol

Page 13: Synthetic Cannabinoids – K2 a.k.a. Spice

Page 13 (cont.) to 14: Tocopherol Acetate – Vitamin E

Page 15: Research Conducted Prior to the Outbreak.

Page 16: Overview of this Crisis in Public Health & Safety.

Page 17 to 18: Nationwide Measures Being Implemented.

Page 19 to 20: Impact to the Cannabis Market.

Page 21: The Severity in Impact to Public Health & Safety.

Page 22 to 23: The Solutions.

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Coalition Study and Report: State of Emergency; Vaping Lung Disease and Fatality Epidemic

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Acknowledgements and Statements

The following is an analysis to give our Members a comprehensive and thorough background as

to the impact that the recent outbreak of Lung Disease Deaths associated with Vaping and the

implications it will have for Cannabis, the Cannabis Industry and the Cannabis Eco – System in

its entirety.

The California Cannabis Coalition has fought firmly for ten (10) years for things such as

Governmental Accountability, Efficiency and Transparency for its active participants which is

why we bring this Report to the to its viewers in order to intimately understand and propose effect

action and resolutions.

Over the past month the massive public health epidemic that is plaguing the nation is now

becoming a byproduct of what ineffective regulation and oversight brings when Government

choices not to exercise their authority to do so over specific markets such as Cannabis.

As the end of August approached, we conducted a study on the effects that misconduct and

unprofessional standards that were taking place in Licensed Testing Laboratories in the State of

California and the impact it would have on consumer safety not ensuring quality control.

Almost simultaneously the Center for Disease Control (C.D.C), had announced the first death

related to Vaporizing E – Cigarettes with an additional three hundred and fifty (350) individual

cases of what was being evaluated as Pulminary Lung Disorder.

With some of these individuals disclosing that they had also vaped pens containing Cannabis, we

decided to study where this would lead to.

In conducting this study and report, we found very conclusive and startling, with Local, State and

the Federal Government moving very quickly to tackle this issue as they have always done;

prohibition, which as all of us should be able to recognize only harms those in need of access and

the illicit market which becomes more empowered and burdensome to resources against it.

As we have concurred in prior reports it does take a village and in the words of our Founder “the

People United will Never be Divided,” therefore in stimulation of thoughts provoked by the

problem be determined to find with other solutions.

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Coalition Study and Report: State of Emergency; Vaping Lung Disease and Fatality Epidemic

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Background:

In the shift from the month of August into September, the first case of death linked to Vaping of

Electronic Cigarette Nicotine had been recorded in Illinois state.

It became the first recorded death linked in relation to vaping products after the individuals had

developed respiratory symptoms which is were then being diagnosed as a form of Pulminary Lung

Disease.

The first case of this Lung Disease surfaced early April for which the Centers for Disease Control

and Prevention (CDC) had documented one hundred and thirty – three (193) potential cases in

twenty - two (22) US states at the time, from the 28th June to the 20th August.

In only a matter of days, the illnesses turned into fatalities and almost overnight a widespread

epidemic has stricken through thirty - three (33) States calling the attention of State and Federal

Lawmakers.

The cause of epidemic has been cited by the flavored and manufactured additives which are

associated not only with electronic cigarettes but, in addition the flavors like terpenes and other

additives in manufactured cannabis vape pens.

Due to this the CDC issued an advisory to consumers to “consider to not using them and especially

products from the street,” as the compounds within the product and mechanical hardware may

have been adulterated.

As experts in the medical field quickly began to investigate and weigh in on this “mysterious lung

disease” they directly began linking the cause to electronic cigarettes and Illicit Cannabis vape pen

products from the Illegal and Unregulated Cannabis.

In an interview with Buzzfeed with physician at the University of Utah, Dr. Sean Callahan made

references to data and research conducted going back to 2012.

He also stated that what they have seen is “a lot of otherwise healthy young people suddenly

arriving with fast-developing pneumonia in emergency rooms.”

“This is new,” as Dr. Callahan suggested however, there has been research undergone prior to this

outbreak dating back to as early as 2012.

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Coalition Study and Report: State of Emergency; Vaping Lung Disease and Fatality Epidemic

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Causes of Outbreak:

This form of pulmonary disease is correlated to all vaping “cutting agents” to dilute solutions and

other substances however, is in larger proportion to this occurring with products originating from

the illicit cannabis market.

Announcements by health departments in Indiana, California and Minnesota, following the deaths

initial deaths in Illinois and the next in that first week Oregon, were “due to a specific chemical

exposure in the respiratory system.”

In light of this FDA began testing more than one hundred (100) product samples used by patients

who developed lung diseases after vaping, in an effort to find out exactly what’s in them and what

could be causing illnesses.

They began to narrow this down to ingredients such as Propylene Glycol, Vegetable Oil and

Glycerin, Tocopheryl Acetate commonly referred to as Vitamin E.

At the end December 2018 about thirteen (13%) of seniors in high school disclosed usage in a

federal survey prompting the CDC to warn consumers against using counterfeit and “homemade”

vape pen cartridges because they main contain these type of additives and ingredients.

New York’s health commissioner, Howard Zucker, warned residents Saturday to stop using vape

products until the CDC could determine the cause of the vaping-related illnesses nationwide

including, advisory to Medicinal Cannabis patients within the States program.

The state’s health department found vitamin E acetate, in a majority of all of the cannabis samples

from victims identified according to the and after the announcement by Governor Cuomo, issued

subpoenas to three (3) of the major companies that provided this as an ingredient for products on

the illicit market.

Thursday September 5th, New York State Health Officials pointed directly to Vitamin E Acetate,

as “an unauthorized additive in Cannabis vape cartridges,” as a focus of their investigation into the

outbreak.

That following day, a spokesman for Food and Drug Administration (F.D.A), “no one substance,

including Vitamin E acetate, has been identified in all of the samples tested” with medical

authorities ruling in other additives like synthetic cannabinoids or interactions.

However, while the FDA stated at the time it does not have enough data to conclude that vitamin

E acetate is the direct cause of the injuries, “it is prudent to avoid inhaling this substance.”

The FDA did however, state that the percentage of actual Tetrahydrocannabinol (THC) and

Cannabidiol (CBD) present was roughly seventy percent (70%) with the rest of the products

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containing diluents at thirty percent (30%) suggesting a “standard in street carts” i.e. ratios of

70:30.

This caused licensed companies in the California Cannabis market even the national CBD market

like Select Brands, Jetty, Stiiizy, Rove and many others reassuring customers their products do not

carry these additives particularly Vitamin E Acetate in their Cannabis Vape pens and contain only

Cannabis and Terpenes.

While on the other hand companies such as Constance Therapeutics and WercShop issued

statements that theirs did.

Constance has a patent on “plant based” ALPHA-Tocopherol, which they deem safe for human use

“with their formulations.”

WercShop was using as it stated “trace amounts” of this same substance from the plant source to

stabilize its “Nexus 2.0” formula, which they have also have patented and is Proprietary property

of the company but, in light of this current epidemic ceased using in their product.

The company TrueTerpenes, a national whole provided of this product noted in their statement

they do not use Tocopheryl Acetate, denying anonymous claims and testing results on blogs and

forum discussions and the company; Vitamin E supplier Honeycut, based in the City of Los

Angeles based in Downtown proper, no longer has a website for wholesale.

Despite this, patients in California told their physicians they were purchasing vapes from pop-up

shops or other illicit market providers which has become the pipeline for counterfeit products

going back to early 2017.

In fact a 2017 study conducted by researchers in an independent Laboratory test in the Journal of

the American Medical Association found that specifically seventy percent (70%) of CBD products

were mislabeled with eighty four (84) products from thirty one (31) companies.

With Oil and Vape pens becoming the fastest growing segment of the industry nationwide,

counterfeit THC product producers have followed this trend and found alarming means in order to

make their booming business now fatal for the safety of Public Health.

This is what states and the federal government are finding in their nationwide investigations which

at first could not directly link the devices or products linked to all cases but, concluded profuse

contamination in counterfeits and other pseudo – brands, “as many victims report buying

marijuana on the street rather than from a store.”

Before the epidemic became full blown, May an NBC4 investigation team began investigating this

through several products finding that all the brands which had almost the exact same packaging

and name as the Licensed version was in fact a counterfeit.

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Heavy Hitters and Mammoth Distribution even noted how “incredibly convincing” they were and

understood how the consumers themselves if not properly educated or informed on how to tell the

difference.

Even a spokesperson for Heavy Hitters stated the only difference was the small hologram seal

located under the box of the authentic product which as she noted, “is one small detail but, very

easy to overlook.”

Research Director of the University of California Los Angeles Cannabis Research Initiative Ziva

Cooper said her thoughts on the issue even from that of a month ago have shifted once believing

risks from vaporizing could be different to that of smoking however, given the disparities of the

situation, something that “deserves immediate attention.

As was to be determined through long term health risk that could have been associated have now

become proven and no longer theory and unfortunately the major cause which has long began

being so confirmed only within weeks.

The second week of September, Minnesota's first vaping-related death involved a 65-year-old man

with a history of lung issues, and at the time of was using an Illicit Vape Pen from the Underground

Cannabis Market.

Soon after, Indiana, Tulare County Los Angeles County also their first fatalities and that same

week in Oregon, a middle - aged man had been pronounced dead from a cannabis vape pen

purchased at a licensed Retailer.

The incident in Oregon was stated by epidemiologist at Washington University School of Medicine

in St. Louis Jacob Borodovsky, “likely that the processing of THC, rather than the compound itself,

is the cause of recent lung issues.”

He further stated, “in order to produce vape pen liquid, THC is suspended in an oil solution that

often also includes chemicals to alter the flavor or consistency of the mixture, which users then

heat and inhale; I would put it on the way in which the THC is prepared and delivered.”

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Analysis:

As of Sept. 11th, officials counted three hundred and eighty (380) confirmed cases related to vaping

illness reported by thirty six (36) states and the U.S. Virgin Islands, according to the CDC; by

September 16th, it was estimated at four hundred and fifty (450) possible cases of the lung illnesses

and within another week, surged to five hundred and thirty (530) by September 20th.

By the 27th the tally had increased fifty - two percent (52%) to eight hundred and five cases (805)

and thirteen (13) deaths across forty - six (46) states.

Unfortunately as history always does and as Legalization gets closer, cannabis is once again

correlated subject to this situation as deaths being recently recorded with over fifty percent (50%)

of illness, are being cited to be linked to illicit products being purchased by consumers not,

knowing the difference between regulated and unregulated product but, most of all the ingredients

contained in the product.

Due to the phenomena the White House has announced it will look to ban all Non – Tobacco

Flavored products.

States such as Massachusetts and Washington State have already moved to do what the White

House has proposed to do, in banning vape products of all kinds including Cannabis vape products.

In the State of California Los Angeles City announced on September 25th, the motion to ban all

vaping products including Cannabis, for a total of three hundred and sixty - five (365) days.

The rampant outbreak, has forced the State of California declare a state of emergency urging

“vapers” to put down their E-Cigs and protect themselves from possible infliction.

As it is the fastest growing sector of the Cannabis Industry and Supply Chain across the country

for the factor of convenience it brings to consumers and patients, what has come to light in this

situation is the “cut” or subsidized elements in these products that are now officially being linked

to these illnesses and deaths.

By 2022, cannabis concentrates nationwide sales, with vaping products at the top, are projected at

$8.4 billion according to Arcview, which in contrast to the sales anticipated by the illicit market to

be just the same by 2024 from the Illicit market as BDS Analytics has found, that gives us an idea

of where majority of those sales are being currently derived from.

A prime example is Colorado where they saw a seventy – eight percent (78%) increase in the

number of concentrates purchased by consumers during the periods of 2017 to 2018, according

to numbers from the Department of Tax Revenue, whereas history for them has shown the illicit

market was still in business.

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Findings:

With the most recent numbers from September 27th, the fifty two percent (52%) at thirteen (13)

deaths, and eight hundred and five (805) cases reported in forty six (46) States and one (1) territory

with more than two – thirds (2/3rd) of the reports being caused by illicit cannabis vape pen products

purchased on the Illicit Market clearly Federal prohibition is continuing to cause an issue.

Of course, this is the case overall for Cannabis as it remains Federally, across the board even for

states particularly the eleven (11) that have fully commercialized use of the product as the illicit

market has continued to find creative and now fatal ways to keep churning a profit.

With counterfeit packaging and vape cartridges that can be found on websites such Alibaba,

China’s largest online commerce company, with licensed brands packaging for Heavy Hitter

packages as cheap as $225 for one hundred (100) empty cartridges and Kingpen at $200 that from

there take the simple fill of oil being sold at $6 per gram a liter on the Illicit market, obviously it

is not hard to be done.

Access to fake packaging and ready-to-fill vape cartridges is widespread in Mega – Regions such

as the County and City of Los Angeles where the Illicit Cannabis market has already shown its

dominating presence to that of licensed operators.

These cases are not just for instances in which the product is coming from the illegal market for

THC vaporizer cartridges either; CBD products are now being found to be just as harmful due to

lack of regulation and ability for consumers to differentiate between what is USDA and not.

Earlier in the month Senator from Illinois Richard J. Durbin accused the FDA’s acting chief of

“sitting on his hands and calling for immediate resignation if he did not “take action” as some of

these case have involved proportions of vape usage involving CBD for which they Administration

has been slow moving on in regard to regulating.

In 2018 the Associated Press conducted a private investigation and found that some operators were

substituting illegal synthetic cannabis in vapes marketed as natural CBD, a chemical in cannabis

that doesn’t cause a high and promises mainly unproved health claims.

This private investigation came after a CNBC story on a man by the name of Jay Jenkins who’s

experience with a given to him by a friend CBD vape pen by the name of YOLO, causing him to

fall into a coma,

Mr. Jenkins initially hesitated when his friend had suggested they vape CBD and claimed “it would

relax them;” Jenkins before long would be awaking out of a coma.

Come to find there was not any CBD, the cartridge was spiked with the synthetic version of

Cannabis known as K - 2 Spice.

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That May of 2018 his friend had bought a cartridge of blueberry flavored CBD vape oil called

YOLO, acronym of “you only live once” from the 7 to 11 Market, an austere, Lexington, South

Carolina.

Jenkins suffered acute respiratory failure and drifted into a coma and stated that the nerves in his

mouth “felt like they were multiplied by ten (10), vivid images including a circle engulfed by

darkness and filled with colorful triangles filled his mind before he drifted out of consciousness”

and he realized he was immobilized.

The Laboratory testing commissioned by the Associated Press that summer found the same type

of synthetic cannabis correlated to eleven (11) deaths in Europe.

The results of laboratory testing on these products used by Mr. Jenkins in addition to twenty nine

(29) in other states and thirty three (33) in Utah being sold as CBD around the country, found ten

(10) of the thirty (30) contained this K2 compound while others had contained no trace of CBD at

all.

At least one hundred and twenty - eight (128) samples out of more than three hundred and fifty

(350) tested by government labs in nine (9) states, nearly all in the South, had synthetic cannabis

in products marketed as CBD following this investigation.

Consumable forms such as “Edibles” accounted for thirty - six (36) of the one hundred and twenty

- eight (128), while the vast majority of the others being vape products.

In analysis by authorities in Mississippi, they found fentanyl, an opioid, involved in about thirty

thousand (30,000) overdose deaths last year however, never correlated it being in illicit products.

Researchers in an independent lab to test eighty - four (84) products from thirty – one (31)

companies for a 2017 study in the Journal of the American Medical Association (A.M.A) found

seventy (70%) of CBD products were mislabeled.

The American Association of Poison Control Centers considers CBD an “emerging hazard” due

to the potential for mislabeling and contamination.

Another significant case last year involved an eight (8) boy from Washington who was hospitalized

after taking CBD oil ordered on the internet by his parent whom had hoped it would treat his

seizures.

According to a case study in the journal Clinical Toxicology published in May synthetic cannabis

were the cause of symptoms including delirium and a rapid heart rate.

In real – time the latest incidence correlated to synthetic Cannabis came as of September 27th, a

California teenager was put into a coma from a Vape Pen which contained hydrogen cyanide.

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NBC News interviewed nineteen (19) Fabian Castillo, who suffers from anxiety and by

suggestion of his uncle tried a THC vape pen.

Unfortunately, his is one of many in which the CDC is now narrowing down the cause to vape

pens containing THC coming from fraudulent and counterfeits of these products coming from

the Licensed market.

He soon after fell into a nine - day coma with x-rays showing extensive damage to his lungs,

caused by what the teen now believes was a bootleg vape pen contaminated with dangerous

chemicals, including hydrogen cyanide causing him to remain in a coma for nine (9) days.

From the incident causing Mr. Castillo to fall into a coma, NBC News worked with Cannabis

licensed testing sites concluding that all were originating from illicit market in comparison to

brands from the licensed market including Select and Tikun vapor cartridges.

Thirteen (13) out of fifteen (15) products bought from illicit operators, mostly illicit delivery

services had diluents such as Tocopheryl acetate commonly known as Vitamin E, Hydrogen

Cyanide and some synthetic compounds of THC.

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Devil in the Detail; Diluents and Chemical Mixtures:

As experts in the medical community as well as the Center for Disease Control are finding, there

is no one root cause for what exactly is causing these irreversible damages in Lungs however, they

have begun to narrow down the reasons to that of four (4) common ingredients being used as

additives and cutting agents.

• Hydrogen Cyanide

• Propylene Glycol

• Synthetic Cannabis

• Tocophyrl Acetate (Vitamin E Acetate)

Each of these having had prior research conducted would seem as if those studies and predictions

assessed within them were anything but, far from true and while not the sole causes individually,

certainly compound to make for the worst of this situation.

Hydrogen Cyanide

By definition Hydro Cyanide is a chemical which typically used for commercial purposes

such as fumigation, electroplating, mining and pesticides among other things, is a chemical

warfare agent.

When inhaled it directly interferes with the body’s regular usage and intake of oxygen in

multiple and more often than not all organs in the body acting as a systemic chemical

asphyxiant and can have particularly grave effects to the central nervous system in those

suffering already from forms of acute respiratory failures.

If directly inhaled this chemical warfare agent over capacitates the individual most times

inducing a coma due to the brain and other cardiovascular failures compromising the

oxygen – blood flow.

Propylene Gylcol

In a published study on the subject by the New England Journal of Medicine from January

22nd, 2015, a majority of liquids used in electronic cigarettes contained both Propylene

Glycol and Glycerol.

Through their study they were able to observe a particular chemical change in the structure

of additives such as this during the heating and degradation process that occurs during

vaporization of the cartridges contents.

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The Propylene Glycol and Glycerol present turned into Formaldehyde which is a known,

byproduct of its degradation during the heating process.

By estimates of the study, more than two percent (2%) of the solvent molecules present

converted the agents carrying and releasing formaldehyde which only happens when heated

and oxygen present becomes a temperature equivalent to that which is considered “High

Voltage” or static shock to the tenth (10th) decimal power.

This is also attributed to the voltage and heating temperature given off by the batteries

themselves which are used to heat the cartridge and the aerosol particles within the heating

mechanisms.

This is why Formaldehyde releasing agents are designated a Group 1 carcinogen on the

International Agency for Research on Cancer and gaseous inhalation of it such as

vaporization has more than five (5) times of a chance as developing cancer to that of

smoking traditional cigarettes.

The reason is cited as being in a gaseous state it is easier for the releasing agents to make

depository into the respiratory tract and infecting it as plasma.

Synthetic Cannabinoids – K2 a.k.a Spice

The man - made version of Kush hence the name K2 when the Americans had in the late

1920’s toured the East Himalayas to study Cannabis and the effects it had anthropologically

on other cultures outside of the States.

The form of Hashish that they saw created, when smoked or even naturally vaporized

created a mind - altering effect similar to when the Rapid Eye Movement (R.E.M) state of

sleep takes place in between Delta and Theta states of consciousness.

In creation of the chemical now known as K2 or Spice, yes as they land of India is known

for, became an experiment of abominations as scientist instead of attempting to mimic that

chemical structure of Cannabinoids naturally occurring in the cannabis plants and

derivatives thereof, they rearranged the complete isotropic and chemical structure to create

what could be approved by the FDA.

Today synthetic cannabinoids have become associated with states of disillusion, delirium

and even fatality by those reported to have been admitted to Emergency Rooms after

consuming it.

In a statement last year by Congress and the FDA they deemed the synthetic compound to

be proven safer than that of its natural counterpart.

Tocopherol Acetate - Vitamin E

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While companies such as Constance Therapeutics have a patent, Patent number: 10238745

for Cannabinoid composition and products, which asserts it is a plant - based substitute and

safe for human consumption, those whom of which have studied this issue long and hard

know otherwise.

In fact, as experts have cited Vitamin E is typically only found in products for external use

such as topicals, creams or lotion but, never have they been proven to be safe for direct

human ingestion unlike what Constance Therapeutics patent might suggest.

Even WercShop has patent they named, Nexus 2, that is for Terpene based compositions,

processes methodologies specifically for vaporization and inhalation.

Unfortunately, even as the company has discontinued specific usage of this in their

products as many are realizing it to be unsafe no matter what the patent and research might

suggest.

Particularly now that Terpenes have come into question, many have called to question if

producers of products should be using something that is as the Patent suggest “synthetic

creations of which appear to mimic or ‘improve’ upon natural phenomena,” and “non –

obviously distinct from the same.”

Those in the medical community expert to this situation Vitamin E have concluded that

Vitamin E itself as an oil, turns back into oil, coats airways, inflammatory reaction to lung

damage when inhaled directly even vaporized into airways.

In an August 1st Study entitled the Two Faces of Vitamin E in the Lung, studies and clinical

journals from the U.S National Library of Medicine National Institutes of Health suggest

that since 1950, diets consisting of Vitamin E intake in the body is a direct cause to asthma

as well as other respiratory problems which appear the highest in countries such as the

United States.

An even older, journal from the Institute in March 2006 found that when inhaled, Vitamin

E becomes “an oxygen superoxide scavenger” which in turns begins to combust within

airways as it is inhaled causing burns within oxygen ways.

Scientist were able to use Aerosolized technology in test using sheep to determine the

effects of such elements during and post – inhalation to study short term and long - term

effects; of course their findings were quite immediate and the impacts overtly long term.

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Research Conducted Prior to the Outbreak:

In regard to this situation in its totality, it is very hard to say that no one could have foreseen what

was to come with a newly emerging industry that has remained fully unregulated and even make

health claims asserting that it is safer than smoking.

While it may be safer than smoking to some degrees depending on the ingredients it is as experts

say “still not proven fully safe or not in general.”

Studies on the ingredients date back to as early as 2006, 2008 and 2010 before the turn of the

decade extensively detailing research and effects that have proven to be a massive pre curser in

what has manifested into something unseen in history.

From the International Journal of Environmental Research and Public Health to the U.S National

Library of Medicine National Institutes of Health, it is apparent that additives have become the

latest problem and existential threat to public health and safety of the nation and possible others.

This however begs the questions, one, that if these have been proven facts and truth in regard to

the current epidemic, why did Congress and the FDA not take appropriate pre – caution and two,

why did these companies not feel the need to do right by their consumers and patient base?

In this regard it is truly every individual in this predicaments failure in not maintaining a

concurrently educated consumer and patient base but, now perhaps the ignorance of the past

coming to haunt particularly the Cannabis Industry that has left behind its community in the pursuit

of Profit not patients.

Whatever the case, it is time to take up this stain in the history of our Eco -System and do what is

right by all of them and the masses that believe in what Cannabis is capable of and trust the science.

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Overview of this Crisis in Public Health & Safety:

In the drafting of this report with, September has seen a total of again thirteen (13) deaths

nationally and eight hundred and five (805) individual cases reported across the nation forty – six

(46) states and the U.S Virgin Islands.

Cases of the fatality have been recorded in the states of California (2), Florida (1), Georgia (1),

Illinois (1), Indiana (1), Kansas (2), Oregon (1), Michigan (1), Mississippi (1), Minnesota (1) and

the thirteenth in North Carolina (1).

Of the five hundred and fourteen (514) patients studied, which is two – thirds (2/3rd) of in the eight

hundred and five (805) cases reported, seventy six point nine percent (76.9%) used products

containing cannabis originating from the illicit market and were vastly misinformed on what they

were buying or being given from those close to them whom of which had.

Just as of September 16th, the Los Angeles Times reported that counterfeit vaping packaging and

hardware are being sold all throughout the Downtown Los Angeles mega – region even as close

as two blocks away from Los Angeles Police Department.

Products reportedly bought were counterfeits of the original product from Licensed brands mainly

companies like Heavy Hitters and Kingpen.

Health officials themselves have now stated they are focusing on contaminants and counterfeit

product as a the most likely cause, narrowing the possible culprits to adulterants in vaping products

purported to have THC, although they have not ruled out adulterants in nicotine vaping products.

The death of a sixty – five year old at the end of August because of lung injuries related vaping

illicit THC products, which stirred the more direct investigation to the exact causes of the other

deaths and illnesses.

As of September 19th in Tulare County, California the seventh death associated with vaping from

an illicit market product with more than an additional eighty – four (84) percent of patients telling

their physicians they used a cannabis vape pen confirming it did not come from Licensed operators.

All reporting usage reported using fourteen (14) different brands of cannabis products; the most

common one was marketed under the Dank Vape label, which is being deemed purely a creation

of the illicit market sold on the internet, social media, and even on display at unlicensed storefronts

with an apparel line.

An August article entitled “Dank Vapes Is the "Biggest Conspiracy" in Pot That Can Put

You in a Coma: A thriving shadow economy is run on unsuspecting buyers and predatory

sellers,” went into explicit detail on how this has become in some ways a Silk Road of its own and

Darker Side that the Cannabis world had never seen until now.

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Nationwide Measures Being Implemented:

One epidemic full – blown in the case for legal cannabis; the unwillingness of Congress to Regulate

Cannabis has produced this proliferation of illegal products which now has been linked to a

widespread issue across our country predominately and almost solely.

States like Minnesota where they have experienced their first fatality related to vaping of an illicit

Cannabis product have sent police to seize seventy six thousand nine hundred and seventy – two

(76,972) cartridges containing THC in a raid of Coon Rapids in Anoka County.

The product was estimated to be worth $3.8 to $4 Million with theory that these products have

come from outside of the state; the individual suspected to be selling the carts via snapchat has

been arrested and facing charges.

In Wisconsin, authorities uncovered a ten (10) man operation that manufactured thousands of

counterfeit vaping cartridges every day for almost two (2) years.

Massachusetts has already moved to ban vaporizer - based products nicotine and cannabinoid

based.

The state of California in particular is looking for ways to uphold Public Health and Safety

including pledging $20 Million towards public outreach and education of the dangers of using

products from the illicit market.

Last week, state regulators raided two unlicensed shops selling illicit cannabis vape products in

Southern California, seizing nearly $3 Million in products and again in the last week against a

smoke shop selling behind the counter THC products of the alike kind.

September 25th, the City of Los Angeles itself announced a motion of a three hundred and sixty

five (365) day blackout ban on all nicotine and cannabis vaping products and a $1.5 Million

campaign against teenage vaping.

It is estimated that spending in the state’s unregulated market roughly averages $3 to that of every

$1 in the regulated one tremendously in part to the significant gap in consumer engagement as to

what makes a compliant and authentic product and what does not particularly from the companies

themselves.

Correlations between counterfeit vape products and the stores that sell them was illustrated August

28th when authorities raided an illicit retailer in Los Angeles which had wide display case

predominately displaying Kingpen vapes.

The company disclosed it has no affiliation with the illicit operation and further asserted that the

below market price suggest even more so it was in authentic product that did not originate from

them.

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The company has taking matters into its own hands, to sue the Chinese companies that produce

the counterfeit packaging, sending numerous cease-and-desist letters to businesses selling them.

Filing complaints with the state and other authorities even investing millions in order to redesign

its packaging and product security knowing that their cease and desist to Chinese Manufacturers

may not be honored and impossible.

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Impact to the Cannabis Market:

In the totality of the situation, this month alone due to the outbreak, there has been a somewhat

drastic drop in the market share of vape pens made by Licensed Manufacturers.

U.S News has reported, despite being the fastest growing sector of the legal industry, revenue has

seen a fifteen (15%) decrease nationwide with States seeing decreases averaging sixty (60%).

Specifically, in Portland, Oregon Licensed retailers such as Bridge City Collective have seen sales

for THC Vaporizers and Products by thirty – one percent (31%) in two (2) weeks alone.

This coming after the second recorded death linked to THC vaporizers and originating from a

licensed retailer.

Oregon, among the earliest of the eleven (11) states that legalized recreational marijuana, has seen

a sixty two percent (62%) drop in market share for vapes.

In roughly two years, they grew from a small fraction of overall sales to about one-third (1/3rd),

with $9.6 Billion in sales between 2017 and 2019, according to New Frontier Data, an economic

analysis firm that tracks the industry.

About one fifth (1/5th) of U.S. cannabis consumers reported usage of these products.

As the outbreak has spread, New Frontier Data found a fifteen (15%) decline in the market share

for vape sales nationwide during the first week of September and saw no rebound in data collected

through September 18th.

At the state level, New Mexico, Massachusetts, Nevada and Montana all saw drops of one-third

or more, while California fell by six percent (6%).

In Colorado, the company Medicine Man as of September 26th, has begun to remove Cannabis

vape pens containing Propylene Glycol, Vitamin E Acetate and other cuts that are being clinically

tested by the Food & Drug Administration (FDA) and the Center for Drug Evaluation and

Research (CDER) to truly understand and find conclusive evidence towards the cause of the

disease outbreak.

The owner of Medicine Man declared, “removing these cannabis products with the chemical

additives under scrutiny from the market is in the best interest of consumers and all of us as

operators."

In states such as, Illinois they have taken this to consumers and medical marijuana patients banning

the sharing of information related “home recipes for vape pens.”

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As sales for this sector have fallen, some retailers report sales of other cannabis products going up

specifically in Oregon where they had two fatalities one from a vape pen purchased from a state

licensed retailer.

Bridge City Collective, for example, saw what they usually describe as lackluster edible sales

increase about forty percent (40%) the same week vaping sales plummeted with consumers

showing more interest in the dried manicured flower.

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The Severity in Impact to Public Health & Safety:

In the concurrence of this report and the last day of September, TIME Magazine published an

article entitled, “CDC Says for First Time that THC could be Behind Vaping Deaths and

Illnesses.”

If that could not encapsulate the emotions and practical stances on the current situation as it has

unraveled even the summarization of this report boiled down in the most misleading headline, it

does certainly state the facts.

Cannabis and the psycho active element as well as, the newly popular non – psychoactive ones of

it as a plant has always had a demand and that will never go away and didn’t despite even current

prohibition.

In the Month of September as this outbreak began to spread, out of five hundred (500) patients,

seventy – seven percent (77%) reported using vaping products with Cannabis and on a regular

basis with sixteen percent (16%) of them reporting to have used only electronic cigarettes with

Nicotine versus thirty six percent (36%) reporting only cannabis usage.

According to the CDC, in Illinois and Wisconsin pointed to the most common cartridge being

found, Dank Vapes for which Wisconsin sent law enforcement to raid an illicit operation with

seventy six thousand nine hundred and seventy – two (76,972) cartridges through finding out the

individual was using Snapchat to advertise this specific brand and has been reported in other states

and individuals as well.

Other brands included TKO, Off White, Moon Rocks, Cookies, Chronics, Mario Carts, Kingpen,

California Confidential, Cereal Carts and Supreme G.

No amount of enforcement or bans will eliminate this problem in fact it will only drive the Illicit

market which has found this market profitable as it already has and is currently leading the cause

of this mess.

As the headline and we the California Cannabis Coalition agree, the massive amounts of

Regulations, Taxes and lack of Capital to enter and compete in a Compliance Industry in States

like California, and Federal Prohibition, as history has already demonstrated, is guaranteed to drive

and proliferate the activity and tremendous profit estimates of the Illicit Market.

It is not merely Cannabis or its Compounds but, the problem we face should we not call on more

pressure Cannabis, products and compounded derivatives thereof to be De - scheduled, Regulated

and provide for a legitimate Medicinal and Commercial framework for all scales and economies.

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The Solution:

While the FDA has attempted several times and tried reinforcing is companies to stop making

health claims particularly CBD, due Cannabis’ federal status being Schedule One cannot regulate

the psychoactive compound of cannabis or cannabis vaping products.

With very little to nearly no oversight in regards to products entering the market companies are

taking clear advantage to cash in for which the illicit and gray space has tremendously grown to

that of proportionate comparison of the regulated markets.

In the case of the vaping crisis as possibly one of the more tragic in modern history, the concern

has raised Health Officials to urge citizens to “go with a plant product with known quality insured

vaporizing devices,” as they determine the root cause to these cases which has become more than

apparent.

California state regulators are mandating that operators be on track and trace with the next fiscal

quarter in order to guarantee the cannabis sold to consumers is coming from licensed sourced and

now looking to tighten regulations and restrictions on vaping products and the additives in them

which of course will become another testing requirement needed to pass pre – market screening.

States like Massachusetts are moving to mandate additives testing and developing additional

standards, methods and other criteria necessary for the screening processes as well as labeling

distinctly listing all of the ingredients and additives present while, also banning all vape products

with others such as again Washington State just on the last day of September following suit.

As we all should realize and remain aware of course is bans will only repeat the historic cycle that

has become known as the War on Drugs.

The FDA through their NIH and NIDA certification and approval track is funding research on the

long - term health effects of aerosolized vape oil ingredients, terpenes, and vape trace metals, and

other testing analytics methods which will also be led in teamwork of University Researchers of

these issues.

The problem still remains that Cannabis is Federally Illegal and therefore without Regulation we

cannot effectively solve the problem despite the amount of research formally conducted.

One solution which plays into the interim goal at hand here is this crisis pushes FDA to now act

and most importantly move more quickly to prepare what will become a regulatory scheme and

framework to not only Deschedule Cannabis but, effectively regulate it through Federal

Legislation.

The next answer is education and shaping new regulatory standards with efficacy practices that

will bring about a modern solution in order to attack this problem from all angles.

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In regards to this education, consumers make purchases through decisions made on branding for

which if companies were truly focused on intimately informing their customer base on how to

identify what is a licensed product from and what is not and the details to look for there.

Brands have actually in this case failed their market and consumer base and if they do not reinforce

educating them due to these recent situations, they will surely lose trust and accountability in them

amongst others particularly in the regulatory community.

This is why the burden is on the Licensed and Regulated Market in order to build this awareness

and be the centerpiece of engagement to warn their consumer base against these decisions and give

them the guidance and knowledge in order to do so.

The third is something that will not certainly be overnight but, we can at least begin the dialogue

and introduce this conversation through consensus of the industry to show how real we want to get

in tackling this issue particularly in the name of Medicinal Cannabis.

The California Cannabis Coalition at the beginning of 2019 drafted Legislative language for

introduction as a stand - alone which would actually predicate the regulations and restrictions of

specific products such as what is contained within these cartridges and now given the situation at

hand will look to introduce this measure now within the next year cycle.

In the Controlled Substance Act, it is defined as a substance for which for man – made or processed

into a by – product into concentrated form and the chemical structure is no longer naturally

occurring to that from which the compound was derived from thereof; or simply the “adulterant”

or what pharmaceuticals are known to be as “compounded derivatives.”

Cold water and pressed forms of Hash Oils, Kief and other forms that can be concentrated from

the Cannabis – Sativa plant, would not categorized under this as it is considered a homeopathic

remedy in natural form; almost as if one were put wheatgrass or ginger in a juicer and turn it from

plant matter to liquid matter.

Something such as distillates and isolates are and they by technical definition of the Controlled

Substance Act are a Schedule 3, 4 & 5 which at that schedule can be researched and ran through

the FDA for approval to various uses even Medicinal uses to be used by the generally public

whether commercial or over the counter.

For which this is the case and can be done on the State and even National movement to not only

regulate as oppose to ban these products, it will also provide the opportunity for Operators of the

products to adapt and in addition create what has not been created as of yet through Legalization

of Cannabis for “commercial” purposes; create the Framework and the Infrastructure of the

Medical market in order to begin conducting conclusive research on cannabis and its various forms

to finally De - schedule it.

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