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Swetha Kaul, PhD

An Insider’s View: How Labs Conduct Cannabis Mold Testing

By Swetha Kaul, PhD
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Swetha Kaul, PhD

As both recreational and medical cannabis legalization continues to progress across the country, each state is tasked with developing regulatory requirements to ensure that customers and patients receive clean cannabis for consumption. This requires cannabis to undergo laboratory testing that analyzes the presence of microbial impurities including yeast and mold.

Some states, such as Colorado, Nevada, Maine, Illinois and Massachusetts use total yeast and mold count testing (TYMC) and set a maximum yeast and mold count threshold that cultivators must fall below. Other states, such as California, require the detection of species-specific strains of Aspergillus mold (A. fumigatus, A. flavus, A. niger and A. terreus), which requires analyzing the DNA of a cannabis sample through polymerase chain reaction testing, also known as PCR.

Differences in state regulations can lead to different microbiological techniques implemented for testing.Before diving in further, it is important to understand the scientific approach. Laboratory testing requirements for cannabis can be separated into two categories: analytical chemistry methods and microbiological methods.

Analytical chemistry is the science of qualitatively and quantitatively determining the chemical components of a substance, and usually consists of some kind of separation followed by detection. Analytical methods are used to uncover the potency of cannabis, analyze the terpene profile and to detect the presence of pesticides, chemical residues, residuals solvents, heavy metals and mycotoxins. Analytical testing methods are performed first before proceeding to microbiological methods.

Petri dish containing the fungus Aspergillus flavus
Petri dish containing the fungus Aspergillus flavus. It produces carcinogenic aflatoxins, which can contaminate certain foods and cause aspergillosis, an invasive fungal disease.
Photo courtesy of USDA ARS & Peggy Greb.

Microbiological methods dive deeper into cannabis at a cellular level to uncover microbial impurities such as yeast, mold and bacteria. The techniques utilized in microbiological methods are very different from traditional analytical chemistry methods in both the way they are performed and target of the analysis. Differences in state regulations can lead to different microbiological techniques implemented for testing. There are a variety of cell and molecular biology techniques that can be used for detecting microbial impurities, but most can be separated into two categories:

  1. Methods to determine total microbial cell numbers, which typically utilizes cell culture, which involves growing cells in favorable conditions and plating, spreading the sample evenly in a container like a petri dish. The total yeast and mold count (TYMC) test follows this method.
  2. Molecular methods intended to detect specific species of mold, such as harmful aspergillus mold strains, which typically involves testing for the presence of unique DNA sequences such as Polymerase Chain Reaction (PCR).


Among states that have legalized some form of cannabis use and put forth regulations, there appears to be a broad consensus that the laboratories should test for potency (cannabinoids concentration), pesticides (or chemical residues) and residual solvents at a minimum. On the other hand, microbial testing requirements, particularly for mold, appear to vary greatly from state to state. Oregon requires random testing for mold and mildew without any details on test type. In Colorado, Nevada, Maine, Illinois and Massachusetts, regulations explicitly state the use of TYMC for the detection of mold. In California, the recently released emergency regulations require testing for specific species of
Aspergillus mold (A. fumigatus, A. flavus, A. niger and A. terreus), which are difficult to differentiate on a plate and would require a DNA-based approach. Since there are differences in costs associated and data produced by these methods, this issue will impact product costs for cultivators, which will affect cannabis prices for consumers.

 

States in Northeast Push Legalization Bills Following Massachusetts, Maine

By Aaron G. Biros
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On Election Day in November, two major states in the Northeast legalized recreational cannabis: Maine and Massachusetts. It seems that a handful of other states in the region are looking to legalize recreational cannabis now that their neighbors have done so.

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New Hampshire Capitol Photo: Jim Bowen, Flickr

In New Hampshire, a bipartisan bill was introduced on January 4th to establish “a commission to study the legalization, regulation, and taxation of marijuana.” The commission formed by House Bill 215 aims to “study the experiences of states that have or are in the process of legalizing and regulating the recreational use of marijuana by adults, with particular attention to be given to the ways the changes in marijuana laws in Maine and Massachusetts, as well as Canada, impact our state,” the bill states. Notably, the bill provides for a representative from the Marijuana Policy Project to be a member of the committee.

Photo: David L, Flickr
Photo: David L, Flickr

New Hampshire Senate Minority Leader Jeff Woodburn (D) says he plans to sponsor a recreational legalization bill separate from House Bill 215. According to the New Hampshire Union Leader, Woodburn would work with lawmakers and stakeholders to set a timeline and regulatory framework.

In Connecticut, a number of lawmakers have sponsored bills this session that would legalize recreational cannabis. Senate President Martin Looney (D) filed a bill that would legalize, regulate and tax cannabis, with the tax revenue going to the state’s general fund, according to the New Haven Register. State Rep. Melissa Ziobron (R) introduced a piece of legislation that would legalize adult use over the age of 21. Lawmakers are optimistic that with Massachusetts legalizing it, perhaps the outcome will be different than previous failed attempts to push cannabis legalization.

Providence, RI Photo: David Wilson, Flickr
Providence, RI
Photo: David Wilson, Flickr

Lawmakers in Rhode Island told reporters they want to be the first state to legalize recreational cannabis via the state legislature, rather than a ballot initiative, the most common path to legalization for other states. Sen. Joshua Miller and Rep. Scott Slater of Rhode Island, both Democrats, plan to introduce a legalization bill, the seventh year in a row that such a bill has been introduced in the state. They are also hopeful that after Massachusetts’ legalized it in November, they will have more success this time around. “Our constituents think it is time for lawmakers to pass this legislation, and we should listen to them,” says Miller. “If we fail to pass the bill this year, we will lose significant ground to Massachusetts.” Their bill would tack on a 23% tax on cannabis sales.

In each state’s case, lawmakers are keeping a close eye on Massachusetts and Maine’s regulations and tracking their progress. While the bills in the state legislatures are nascent in their journey to becoming law, the important takeaway is that geographic proximity to states with legalized cannabis is a catalyst for reform in New England.

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2016 Year in Review: Why the Cannabis Industry Needs Resiliency

By Aaron G. Biros
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2016 was a tumultuous, but productive year for the cannabis industry. Larger companies began to take interest in the fledgling market, like Microsoft and Scotts Miracle-Gro. This year brought major innovations in technology like market data tools, advances in LED tech, efficient cultivation tech and patient education tools. The Supreme Court set an important precedent by shutting down a challenge to Colorado’s cannabis market.

Voters legalized cannabis in 8 states last month Photo: Nicole Klauss, Flickr
Voters legalized cannabis in 8 states on Election Day.
Photo: Nicole Klauss, Flickr

Election Day brought a renewed sense of vigor to the market with voters in eight states legalizing forms of cannabis. California, Nevada, Maine and Massachusetts passed recreational cannabis measures, making legalization’s momentum seem exponential.

But November 8th also gave Donald Trump the presidency, and his cabinet appointments, namely Sen. Jeff Sessions as Attorney General, gave many a feeling of uncertainty for the future of federal legalization. Adding insult to injury, the DEA repeatedly stood by their antiquated and ludicrous judgment for cannabis to remain a Schedule 1 narcotic.

Gage Skidmore, Flickr
Trump nominated Sen. Jeff Sessions (R) for Attorney General Photo: Gage Skidmore, Flickr

A lot of the fervor surrounding public safety could be described as overdramatic or somewhat unwarranted. 2016 was the year of misinformation. Fake news spread like wildfire with people sharing stories like this or this that turned out to be very misleading or just downright false.

States with legal cannabis came under heavy public scrutiny and addressed problems like consumer education, public safety and lab testing. Pesticides became a highly publicized and persistent issue in a number of areas, with some states regulating it heavily and addressing public health concerns. Plenty of new rules were formed surrounding labeling and testing, with Oregon, Colorado and Washington experiencing some regulatory growing pains.

Those growing pains shed light on the need for regulators to craft rules that allow for changes, adding rules where necessary and getting rid of cumbersome rules that might thwart market growth. Rules need to be able to adapt as the industry grows, much like businesses need to adapt to a changing market climate to stay afloat. This is all the more reason why cannabis businesses need to make their voices heard and work with regulators to move things forward.

Pesticide Use was a major issue of 2016 Photo: Michelle Tribe, Flickr
Pesticide use was a major issue in 2016
Photo: Michelle Tribe, Flickr

With so much uncertainty surrounding the future of legal cannabis in America, the word of the year for 2017 should be resiliency. In a social-ecological context, resiliency is “the capacity of a system to absorb or withstand perturbations and other stressors such that the system remains within the same regime, essentially maintaining its structure and functions. It describes the degree to which the system is capable of self-organization, learning and adaptation.”

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A warning label for cannabis in Oregon after the October 1st compliance deadline

Self-organization, learning and adaptation are three very important attributes of a resilient system. Without knowing what will happen when Trump’s cabinet takes the reigns of federal agencies, it is important to prepare for the unexpected. Adhering to standards like FOCUS allows cannabis businesses to prepare for unexpected events like recalls or product safety failures.

Those standards could also become the law down the road, as government officials often look to an industry’s voluntary consensus-based standards when deciding how to regulate it. In 2017, a number of state governments will embark on the heavy undertaking of writing the regulatory framework for legal cannabis.

2017 will bring opportunities and challenges to the cannabis industry. The industry’s rapid growth juxtaposed with political, economic and regulatory uncertainties create a climate that requires resilience to be built into the system at all levels. It is critical, now more than ever, that cannabis businesses build strong relationships with industry groups, advocacy groups and regulators to craft the institutional capacity and mutual trust needed to weather the uncertainty ahead.

Recount Effort Stops, Maine Cannabis Legalization Moves Forward

By Aaron G. Biros
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Update: The No on Question 1 Campaign has rescinded their recount effort, according to the Portland Press Herald. “We promised folks that if we came to a point where we could not see any chance of reversing the result, we would not drag the process out,” says Newell Augur, legal counsel for No on 1 campaign. “We are satisfied that the count and the result are accurate.”

On Election Day in Maine, voters were heavily divided on Question 1, a ballot initiative that would legalize recreational cannabis. Voters passed the initiative, but with a very narrow margin, according to a WGME article.

Maine Capitol building Photo: Mark Goebel, Flickr
Maine Capitol building
Photo: Mark Goebel, Flickr

Out of almost 760,000 ballots, Question 1 passed by a margin of only 4,073 votes, roughly 50.2% in favor and 49.8% against. Maine Secretary of State Matt Dunlap says State Police is responsible for collecting the physical ballots and bringing them to Augusta. Dunlap’s office is coordinating with volunteers to recount each vote by hand.

Dunlap is quoted saying there would have to be significant vote changes in every town to indicate any discrepancies in the polling. He says the state can recount up to 25,000 votes a day, but with the upcoming holidays, the recount will continue into 2017.

According to International Business Times, Gov. Paul LePage, who is a cannabis legalization opponent, has said he would delay the process of legalization even if the measure passed. He also said he would speak with president-elect Donald Trump regarding the enforcement of federal cannabis prohibition. Governor Lepage said if the Trump administration embraces states with legal cannabis then he too would honor the voters’ wish to legalize recreational cannabis.

Election Day Results for Cannabis: California, Nevada, Massachusetts, Maine Legalize Recreational Cannabis

By Aaron G. Biros
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Update: With 100% reporting (589 of 589 precincts), voters in Maine passed Question 1, legalizing recreational cannabis by a very narrow margin of 50.2% to 49.8% (378,288 in favor and 375,668 against is a margin of only 2,620 votes)


Voters in California, Massachusetts, Maine and Nevada passed ballot initiatives legalizing the recreational use of cannabis, creating huge new markets for the cannabis industry overnight. Voters in North Dakota, Florida, Montana and Arkansas passed ballot initiatives to legalize forms of medical cannabis. Voters by a margin of 52.2% to 47.8% rejected Arizona’s Proposition 205, which would have legalized recreational cannabis.

With 100% of the votes in for Maine’s Question 1, voters narrowly passed legalizing recreational cannabis, the polls show it won by a very slim margin, less than 3,000 votes.

newfrontier_logo_finalNew Frontier Data and Arcview Market Research released an Election Day update to their growth projections for the cannabis industry by 2020. The release projects: “The legalization of cannabis in California, Massachusetts, Nevada, Florida, Arkansas and North Dakota will result in new markets that account for $7.1 billion in sales by 2020. We project the overall U.S. cannabis market will exceed $20.9 billion by 2020.” Those numbers include overall cannabis sales and assume the markets are all fully operational by 2018.

Giadha DeCarcer, (photo credit: CNN Money)
Giadha DeCarcer, founder and CEO of New Frontier (photo credit: Frontierfinancials.com)

According to Giadha DeCarcer, founder and chief executive officer of New Frontier, there is overwhelming support for medical cannabis and a majority of Americans are in favor of legalizing recreational cannabis as well. “The ten initiatives on the ballot reflect the accelerating public debate on legal cannabis access,” says DeCarcer. “The passage of California’s adult use measure and Florida’s medical initiative expand legal access into two of the country’s most populous states.” The market potential is notably enormous in California, it currently being the 6th largest economy in the world. “Additionally, the passage of the measure in Massachusetts opens the first adult use market in the Northeast extending the reach of legal adult use access from coast to coast,” says DeCarcer. “The passage of the measures in Arkansas and North Dakota shows that public support on this issue is not solely confined to urban, liberal markets but extends into conservative rural states as well.”

According to the release, by 2020 California could reach a total market size of $7.6B and Massachusetts could grow to $1.1B. Massachusetts being the first mover in the Northeast to legalize recreational cannabis will be watched very closely by a number of surrounding states that appeared bullish on cannabis legalization previously.

Leslie Bocskor, president and founder of Electrum Partners
Leslie Bocskor, president and founder of Electrum Partners

Leslie Bocskor, president and founder of Electrum Partners, believes the Election Day results will bring an influx of investing opportunities to the industry. “We are going to see a diverse approach from the irrationally exuberant to the sophisticated and experienced investor and entrepreneur getting involved, creating businesses and investing in the industry that will create innovation, jobs, wealth and tax revenue far beyond the consensus expectations,” says Bocksor. “The cannabis industry is more than one industry; it is an entire ecosystem, impacting so many verticals, such as agriculture, industrial chemicals from hemp, pharmaceuticals, nutraceuticals and more. We see the funding of innovation that might have been absent without the velocity and heft that has come from this phenomenon,” adds Bocksor. As these newly legalized markets begin to launch, it will require a considerable amount of time to see the industry flesh out in each new state.

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Tom Lohdan, Flickr

Donald Trump winning the presidential election and the GOP retaining control over the House and Senate could mean a lot of uncertainties for the future of the cannabis industry on a national scale. President-elect Trump has previously flip-flopped on the issue of cannabis legalization, but has said in the past he favors leaving the issue of medical use up to the states, advocating for access to medical cannabis, while recently saying he opposes regulating cannabis for adult use, according to the Marijuana Policy Project. The MPP gave him a C+ grade for his views toward cannabis.

On The O’Reilly Factor in February 2016, Trump told the conservative political commentator that he supports medical cannabis while opposing the recreational use. “I’m in favor of it [access to medical cannabis] a hundred percent. But what you are talking about [recreational use], perhaps not. It’s causing a lot of problems out there [in Colorado],” says Trump. It is still unclear at this time exactly what Trump’s policy will be for the now 28 states that have some form of legal cannabis.

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Aaron Smith, executive director of NCIA

Aaron Smith, executive director of the National Cannabis Industry Association (NCIA), appeared optimistic regarding the outcomes of Election Day. “More than 16 million voters, including in two of the three most populated states in the nation, chose legal, regulated cannabis programs that promote safety, boost the economy, help sick patients and address social injustices,” says Smith. In the press release, the NCIA spelled out their priorities for congressional action on cannabis policy: Opening up bank access for state-compliant cannabis businesses, ending the effects of federal tax code Section 280E on cannabis businesses and removing cannabis from the Controlled Substances Act via descheduling. “Last night’s results send a simple message – the tipping point has come,” says Smith.

Exploring Opportunities in Emerging Markets

By Aaron G. Biros
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This November 8th, voters in five states will head to the polls to decide on legalizing recreational cannabis and another three states have ballot initiatives that would legalize medical cannabis. If any of those five states pass a measure for recreational legalization, including Massachusetts, Maine, Nevada, Arizona and California, (which are all leading in the polls) they could potentially create massive new market opportunities for cannabis brands that have their eye on expansion.

Nancy Whiteman, co-owner of Wana Brands and chair of the Cannabis Business Alliance Infused Product Committee, sees great potential in capitalizing on those markets early. Whiteman has been working with Wana Brands since 2010 in Colorado, starting out in the young medical market there.

Nancy Whiteman holding a batch of cannabis gummies
Nancy Whiteman holding a batch of cannabis gummies

After expanding to the recreational market, Wana Brands saw its sales skyrocket. From January to August 2016, Wana had the best-selling candy brand in Colorado with 21% dollar share, according to BDS Analytics. Wana Brands has already expanded to Oregon and will launch in Nevada on November 15th, with agreements signed to expand in other states as well. “The model we are pursuing is a licensing agreement where we partner with existing or new license holders in their state,” says Whiteman. “In many ways they are doing the heavy lifting, but we are providing an enormous lift by licensing our intellectual property to them.” That model for growth is becoming increasingly common in some of the more established brands, like Steep Hill Laboratories, GFarma Labs, Dixie and others. Whiteman says that Wana Brands also has a partner in Illinois, Massachusetts and a number of other states they hope to reach.

Mark Slaugh, CEO of iComply
Mark Slaugh, CEO of iComply

According to Mark Slaugh, executive director of the Cannabis Business Alliance and chief executive officer of iComply, a compliance services provider, brands from Colorado expanding to other states need to ask themselves if their reputation is on the line with these new operators. “If you are licensing to companies that are not compliant, the penalties could be huge and they vary state to state- that could potentially hurt the overall brand image nationally,” says Slaugh. “People doing the licensing that are operating with full compliance really need to look at controlling that risk and mitigating that as much as possible.” With brand trust on the line, there are substantial risks that come with expansion. “We help clients ensure quality is consistent so, for example, an edible product would taste the same in Colorado as it would in Nevada or Arizona. They need to follow the intellectual property consistently but more importantly follow those specific regulations in that state to stay afloat.” Managing ongoing compliance in different states requires monitoring regulatory updates across multiple markets, which can get incredibly complex.

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Processing SOPs vary widely stae to state

“Six years ago, it was much easier to get into the market in Colorado,” says Whiteman. “There were no capital requirements, no limits on the number of licenses, but there was still a lengthy application and vetting process- as long as you met those minimum requirements you could get a license.” Other new states put stringent limits on the number of licenses granted and some have extraordinarily cost-prohibitive capital requirements, up to a million dollars, as is the case for New York. “Anyone who becomes a license holder in Massachusetts has to be prepared to embark on three separate business models, which is a massive undertaking,” says Whiteman. Massachusetts requires license holders to cultivate, process and dispense in a vertically integrated model.

In other states, Wana Brands is working with exclusive partners who will have the capabilities to manufacture and distribute throughout the entire state, but in Massachusetts that won’t be the case. “To cover the state, we need several partnerships; the partner we are working with is a little south of Boston,” says Whiteman. But all that could change if voters in Massachusetts legalize it recreationally, opening a much larger market than the current medical program. “With no legislation drafted yet, the regulatory environment is still up in the air in Massachusetts so there is no way of telling what the recreational market will look like.” In terms of ongoing regulatory compliance, Whiteman believes that Colorado still has some of the most stringent rules. The universal symbol printed on every individual edible product serving is one example. “Every state has different lab testing and licensing requirements, but Colorado looks like the most stringent currently,” says Whiteman. “Colorado requires a full gamut of lab testing including homogeneity, potency, residual solvents, contaminants and soon pesticides too.” According to Mark Slaugh, Nevada’s lab testing regulations are fundamentally different from Colorado’s with regard to sampling procedures, but the broader inconsistencies in lab standards need to be addressed. “The lack of laboratory standardization state to state with regard to methods creates a big challenge to get consistent, proficient lab testing across the board,” says Slaugh.

Wana's edibles come stamped with the universal symbol (THC!)
Wana’s edibles come stamped with the universal symbol (THC!) in Colorado, as required by law.

A big differentiator between Colorado and other states is that it was a first mover. “When Colorado came online there were not any established brands to speak of anywhere in the country- we were all pioneers,” says Whiteman. “Because it is so difficult to get a license in another state, either the organization or investor groups are looking to partner with established brands.” The advantages to this business model are many. Expediting your entry to market gets you the advantage of being a first mover. Working with an established brand also minimizes risks and the learning curve. “Bigger players understand that building a brand from scratch is time consuming and expensive so I think we will see a lot of these partnerships.”

As those new states come online, similarities in their regulations might appear in the form of standard operating procedures (SOPs) or good manufacturing practices (GMPs). “We might start to see a standardization from state to state that models FDA GMPs or USDA GAPs, [good agricultural practices] moving toward a framework that is more consistent with the possibility of federal regulation,” says Slaugh. Another commonality among a number of states is the implementation of a statewide tracking system. According to Slaugh, California has no such mandated system in place yet. “They will probably have one eventually but the market is so localized there- we will see if California will be ready with a statewide compliance system for tracking by 2018,” says Slaugh. “With such a weird patchwork of local governments allowing or not allowing certain operations to exist, it is a tough business to be in and it’s getting tougher every day.”

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Election Day is a Decisive Moment for the Cannabis Industry

By Aaron G. Biros
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In less than two weeks on November 8th, voters in five states will head to the polls to decide if they want to legalize recreational cannabis. California, Nevada, Arizona, Massachusetts and Maine all have initiatives on the ballot that could legalize recreational cannabis for adult use. Polls in each state show a majority of voters support the initiatives.

This New York Times article suggests that November 8th could be a major turning point in the movement to legalize cannabis in the United States. Even if the initiatives fail in most of those states, California’s initiative, which is expected to pass, could be the linchpin for federal legalization. California’s giant economy, coupled with its ability to drive national policy on social issues, sets the stage for rapid industry growth.

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Matt Karnes, founder of GreenWave Advisors

According to Matt Karnes, founder of GreenWave Advisors, the significance of California’s measure also lies in the merging of medical and recreational regulatory schemes. His firm sees a trend where “initially bifurcated marijuana markets will merge under a shared regulatory system into substantially larger enterprises.” Karnes believes the California market will conservatively reach $2.6B in 2016 and grow to $6.7B by 2021, which represents a 5-year compound annual growth rate of roughly 21%. “Should California vote to legalize recreational use this November, we expect implementation of a combined regulated market as soon as 2018,” says Karnes. “A combined California market is significant, not only because of its sheer size (~55% of the U.S. market), but it would also mark the first state to implement regulations for a fully legal market without initial oversight of medical use purchases.”

The presidential election is equally as important for the future of the legal cannabis industry. According to Hillary Clinton’s campaign, if she is elected into office then she will “reschedule marijuana from a Schedule I to a Schedule II substance.” This would have a dramatic impact on the growth of the industry, most notably by easing banking and financing restrictions. Whether she will actually follow through with her plans, if elected, to reschedule cannabis is yet to be known. Regardless, this is the first time in history that a candidate with a majority of the country’s support is introducing this concept. That represents a serious shift in mainstream attitude toward cannabis. That represents the normalization of cannabis.

Jane West, CEO of lifestyle brand Jane West and co-founder of Women Grow
Jane West, CEO of lifestyle brand Jane West and co-founder of Women Grow

Jane West, chief executive officer of the lifestyle brand Jane West and co-founder of Women Grow, believes this represents the country finally taking cannabis legalization seriously. “Given the poll results that have been publicly available, it seems likely that three or more of the initiatives will pass,” says West. “By November, about 20% of Americans will be living in states where it is legal to consume cannabis. This will accelerate the process of bringing marijuana out of the shadows, and more adults will be comfortable using this enjoyable, relatively benign substance socially and openly.” Normalizing cannabis can look like a lot of things, but mainly it takes away the counterculture stigma and puts it in a light where its regular use is not frowned upon, which could be instrumental in gaining public support.

Leah Heise, CEO of Women Grow
Leah Heise, CEO of Women Grow

Leah Heise, chief executive officer of Women Grow, agrees with West’s prediction that at least three of those states will vote to legalize recreational cannabis, citing Maine, Massachusetts and California as favorites. “Additionally, with the likelihood that more than half the states in the United States support some type of cannabis program within their boundaries, a clear message is being sent to the federal government regarding legalization on a federal level,” says Heise. “I don’t think the federal government will be able to continue to enact its cannabis policy through executive orders and funding bills. Real legislative attention will have to be given to the issue.” That legislative attention could come in the form of the CARERS Act, which would reschedule cannabis.

If you are in favor of legalizing cannabis and want to see some change within your lifetime, what can you do to help? Vote. There has never been a more important election year for legal cannabis.