According to The Washington Examiner, Department of Homeland Security secretary John Kelly said that marijuana is a gateway drug during a speech at George Washington University on Tuesday. “And let me be clear about marijuana. It is a potentially dangerous gateway drug that frequently leads to the use of harder drugs,” says Kelly. “[U.S. Customs & Border Protection] will continue to search for marijuana at sea, air and land ports of entry and when found take similar appropriate action.” The DEA recently dropped any mention of the gateway drug theory. Many argue it is a myth propagated by drug war stalwarts and even the National Institute on Drug Abuse won’t call it a gateway drug anymore.
During a crime committee meeting this morning, Attorney General Jeff Sessions mentioned a link between the illegal marijuana trade and cartel violence. “We have quite a bit of marijuana being imported by the cartels from Mexico- this is definitely a cartel-sponsored event,” says Sessions. According to The Washington Times, Sessions mentioned violence involving marijuana distribution in the nation’s capital, Washington D.C., where cannabis is legal. “So it remains a significant international criminal organization, the marijuana network,” says Sessions. This is not the first time the Attorney General has suggested a link between the plant and violence. Back in February, Sessions claimed that legal cannabis has led to an increase in violence.
The statements made this morning are the latest in a series of contradictory and uncertain messages on federal cannabis policy by the Trump administration. “DHS personnel will continue to investigate marijuana’s illegal pathways along the network into the U.S., its distribution within the homeland, and will arrest those involved in the drug trade according to federal law,” says secretary Kelly. That message, however, contradicts statements he made earlier in the week.
During a Sunday interview with NBC’s “Meet the Press,” secretary Kelly told Chuck Todd “marijuana is not a factor in the drug war.” In that interview, he went on to add that methamphetamine, heroin and cocaine are the real culprits they are after, noting the high death tolls associated with the drugs and connection to organized crime in Mexico. The Trump administration still has not issued a clear, consistent position on federal cannabis policy.
In a memo sent throughout the Department of Justice on April 5th, attorney general Jeff Sessions outlines the establishment of the Department’s Task Force on Crime Reduction and Public Safety. That task force, largely focused on violent crime, is supposed to find ways that federal prosecutors can more effectively reduce illegal immigration, violent crimes and gun violence.
The task force is made up of subcommittees, according to the memo, and one of them is focused on reviewing federal cannabis policy. “Task Force subcommittees will also undertake a review of existing policies in the areas of charging, sentencing, and marijuana to ensure consistency with the Department’s overall strategy on reducing violent crime and with Administration goals and priorities,” the memo reads. “Another subcommittee will explore our use of asset forfeiture and make recommendations on any improvements needed to legal authorities, policies, and training to most effectively attack the financial infrastructure of criminal organizations.” Those existing policies that Sessions refers to in the memo could very well be the 2013 Cole Memorandum, an Obama administration decree that essentially set up a framework for states with legal cannabis laws to avoid federal enforcement of the Controlled Substances Act.
In the past, Sessions has said he thinks the Cole Memo is valid, but remains skeptical of medical cannabis. In the last several months, comments made by Sessions and White House press secretary Sean Spicer have sparked outrage and growing fears among stakeholders in the cannabis industry, including major business players and state lawmakers. As a general feeling of uncertainty surrounding federal cannabis policy grows, many are looking for a safe haven, which could mean looking to markets outside of the U.S., like Canada, for example.
Washington State’s former Attorney General Rob McKenna, Washington State’s former Chief Deputy Attorney General Brian Moran, and Maryland’s former Chief Deputy Attorney General Kay Winfree recently went on the record identifying the BioTrack THC traceability system as fully compliant with the Cole Memo. “The key to meeting the requirements of the Cole Memorandum is ‘both the existence of a strong and effective state regulatory system, and an operation’s compliance with that system’,” says the former attorney general and chief deputy attorneys general in a press release. “As described above, Washington State has a robust, comprehensive regulatory scheme that controls the entire marijuana supply chain.
The flagship component of this regulatory scheme is the WSLCB’s seed to sale inventory system, the BioTrackTHC Traceability System.” Those commendations from a former attorney general could provide some solace to business operating with the seed-to-sale traceability software.
Still though, worries in the industry are fueled by speculation and a general lack of clarity from the Trump Administration and the Department of Justice. In an email obtained by an open records request and first reported by the International Business Times, a DEA supervisor asked a Colorado prosecutor in the state attorney general’s office about a number of cannabis-related prosecutions. The DEA supervisor asked for the state docket numbers of a handful of cases, including one involving cannabis being shipped out of state, according to The Denver Post. “Some of our intel people are trying to track down info regarding some of DEA’s better marijuana investigations for the new administration,” reads the email. “Hopefully it will lead to some positive changes.” So far, only speculations have emerged pertaining to its significance or lack thereof and what this could possibly mean for the future of federal cannabis policy.
Martha’s Vineyard is renowned for its beautiful beaches, quaint whaling towns and picturesque rolling countryside. The island is well known as a popular vacation spot for the rich and famous, including the Obamas, the Clintons and Larry David. The movie Jaws was filmed there and the infamous Ted Kennedy-Chappaquiddick incident took place there in 1969. Its summer population of 115,000 drops to about 17,000 as the island slows down for the winter. It is also home to roughly 120 registered medical cannabis patients and a dispensary that will have to deal with the complexities of operating on an island.
In 2012, Massachusetts became the eighteenth state to legalize medical cannabis and in 2016, the state legalized adult use of cannabis. Geoff Rose, co-founder of Our Island Club, a local organization that offers discounts to full-time residents, saw a great need for a medical cannabis dispensary. Rose was granted a provisional license to both cultivate and dispense, as required by the state, on the island. Rose’s nonprofit that received the licenses, Patient Centric of Martha’s Vineyard, plans to operate in West Tisbury, a small town located in the center of the island.
Travel to and from the island is restricted to either boat or plane with the vast majority of traffic occurring on ferries operated by the Steamship Authority. But Rose cannot transport any cannabis on the ferries or even a smaller, non-commercial vessel because the waters are under the jurisdiction of the Coast Guard, a federal agency tasked with enforcing The Controlled Substances Act. The same goes for aircraft under FAA jurisdiction. Transporting cannabis products on the ferries, or any vessel for that matter, would be a felony.
Martha’s Vineyard is not just a physical island, but also a jurisdictional island where all cannabis growing, lab testing and dispensing must occur on the island. Currently, those 120 medical cannabis patients living on the island have no legal method of obtaining medical cannabis, unless they grow it themselves. Rose and his nonprofit, Patient Centric, hope to change that. We sat down with Geoff Rose to learn more about his mission to bring medical cannabis to the Vineyard and some of the legal implications associated with running a cannabis business on an island.
Cannabis Industry Journal: How did you get started with the idea to open a dispensary on the island?
Geoff Rose: Well I moved here almost sixteen years ago and as I have often said, when you move here you have three options: you can contribute to the community, you can hide and stay reclusive or you can leave. It is a very unique community and I chose to contribute. We started Our Island Club, which is a service program for year-round residents that helps them save on essential products and services as a means to cope with the high cost of living here. Clearly there is a need as there are 7,000 year round residents participating in that program. We have donated over a half-million dollars to 175 or more charitable organizations on the island. In addition to that, because of the membership fee, anyone who can’t afford it can still receive the membership.
I have come to launch the dispensary in the same manner. There is a need. [Legal medical cannabis] has now been law since November of 2012. Over four years later and still no dispensary on the island- I have continued to persevere because I know that there is a need.
CIJ: It is a pretty tight-knit community; did you meet any local opposition?
Geoff: Dukes County (the Vineyard) voted in favor of medical marijuana by a wide margin and 82% of West Tisbury voted in favor of medical marijuana, one of the highest in the state. Well I am currently waiting on my special permit application that I am required to apply for in West Tisbury. It has been sent to the Martha’s Vineyard Commission (MVC) for review.
There have been concerns, including from the local school. But state law requires that a dispensary be located beyond 500 feet from a school. The current location that I am asking for approval is over seven times that distance. There is a perceived concern about that. The first round of applications in 2013 included a score-based application process and while there were four competitors, none of us met the minimum score. In the second round, it moved to a compliance-based application process, and I was the only one who kept the effort alive and was awarded the license.
CIJ: There is a bit of an opioid problem on the vineyard, and multiple scientific studies have suggested a causal relationship between cannabis legalization and a reduction in opioid overdose-related deaths; do you see this as part of the solution?
Geoff: I have seen studies, particularly one by Johns Hopkins that does show a correlation between medical cannabis and the reduction of the use of opioids. I think it is a byproduct of opening the dispensary, so yes. I shared these findings with the Superintendent of Schools. I think education is the key to really develop awareness. The state has mandated that schools are required to develop a drug education program, it’s part of the school curriculum, and I see that as a critical component in our outreach effort to the community. We have a responsibility to the community in many ways, whether it’s law enforcement or education.
I recently announced that we would allocate a percentage of our net profits for grant money to programs involved in drug education. Community outreach and education are very important. There also needs to be some positive education. There is a clear understanding that children need to be educated about the misuse of cannabis, which is true. But they also need to be educated about the medical value of cannabis. For example, many in the medical community will acknowledge the benefits of cannabis as it relates to cancer patients, whether it is helping nausea, appetite, pain management or being used as a sleep aid. This is an important message that needs to be disseminated to children. How does it help your family member, friend or neighbor who is suffering from the effects of cancer? That is one of the messages that would be helpful for children to receive. We can address the impact of all drugs including cannabis on the developing brain; I understand and agree, and publicly support that in an educational context. I want to be part of the solution.
CIJ: What problems do you run into trying to open a cannabis business on the island?
Geoff: I received my provisional cultivation license in September of last year. Part of the issue is the fact that cultivation has to occur on the island. The Coast Guard regulates everything surrounding the island including all the ferries, or any watercraft.
As part of my provisional license, I am required to have an independent cannabis-testing laboratory on the island that will perform the requisite testing mandated by the state. I am currently in conversations with Ph.D. chemists consulting for the laboratory. I have had numerous conversations with lab directors in other parts of the state, including Proverde Labs and MCR Labs. The Coast Guard has stated that cannabis is a Schedule One substance and therefore any transport is illegal. Unfortunately the law is very specific and not exactly written with Martha’s Vineyard in mind.
Editor’s Note: If you have further questions relating to Patient Centric of Martha’s Vineyard, you can reach Geoff Rose at firstname.lastname@example.org
According to National Cannabis Industry Association (NCIA) executive director Aaron Smith, seven measures were introduced today at the Capitol, covering a variety of issues that, if signed into law, would ease many of the legal implications on the federal level affecting cannabis businesses in legal states currently.
In a very important development, Rep. Carlos Curbelo (R-FL), a member of the House Ways and Means Committee, joined Rep. Earl Blumenauer as a lead sponsor of the 280E tax reform bill. According to an NCIA press release, that bill is The Small Business Tax Equity Act of 2017 and was introduced in the Senate by Sen. Ron Wyden (D-OR), Sen. Rand Paul (R-KY) and Sen. Michael Bennet (D-CO).
That bill gives cannabis businesses in legal states the opportunity to take business deductions like any other legal business. Right now cannabis businesses cannot deduct any expenses related to sales, given its Schedule I status. “Cannabis businesses aren’t asking for tax breaks or special treatment,” says Smith. “They are just asking to be taxed like any other legitimate business.”
Rep. Jared Polis (D-CO) introduced the Regulate Marijuana Like Alcohol Act in the House, which would put cannabis in the section of code that regulates intoxicating liquors, essentially giving the ATF oversight authority. “The flurry of bills on the Hill today are a reflection of the growing support for cannabis policy reform nationally,” says Smith. “State-legal cannabis businesses have added tens of thousands of jobs, supplanted criminal markets, and generated tens of millions in new tax revenue. States are clearly realizing the benefits of regulating marijuana and we are glad to see a growing number of federal policy makers are taking notice.”
Sen. Wyden and Rep. Blumenauer introduced The Responsibly Addressing the Marijuana Policy Gap (RAMP) Act, which addresses banking and tax fairness for businesses, civil forfeiture, and drug testing for federal employees. Both Blumenauer and Wyden represent Oregonians, who could benefit tremendously if it becomes legislation. Rep. Blumenauer also introduced The Marijuana Tax Revenue Act, which would put a federal excise tax of initially 10% on cannabis sales, then rising to 25% after five years, according to the NCIA press release.
At the Department of Justice on Monday, Attorney General Jeff Sessions told reporters he believes cannabis use is unhealthy and leads to more violence, according to Politico. “I don’t think America is going to be a better place when people of all ages, and particularly young people, are smoking pot,” Sessions told reporters. “I believe it’s an unhealthy practice and current levels of THC in marijuana are very high compared to what they were a few years ago.” Those comments come a week after press secretary Sean Spicer suggested that the opioid crisis is tied to recreational cannabis use and seemed to hint that President Trump is okay with legal medical cannabis, but that the administration might not approve of recreational cannabis.
During a press conference last week, White House press secretary Sean Spicer told reporters “I do believe you will see greater enforcement of it,” referring to the enforcement of the Controlled Substances Act on recreational cannabis. He went on to make the distinction between medical and recreational use clear, while deferring to the Department of Justice, saying they will be looking further into the matter.
Much like press secretary Spicer incorrectly tied legal cannabis to the opioid crisis, Attorney General Sessions incorrectly tied legal cannabis to an increase in violence. “We’re seeing real violence around that,” says Sessions. “Experts are telling me there’s more violence around marijuana than one would think and there’s big money involved.” He did not discuss who those experts were or how he came to that conclusion. There are a number of studies refuting his claims, suggesting no causal link between legal cannabis and violence, with one study even suggesting a reduction in violent crimes after legalizing cannabis.
Sessions has not mentioned any specific policy actions that he would take on the enforcement of federal law. “We’re going to look at it. … And try to adopt responsible policies,” says Sessions. Jeff Sessions making these comments should come as no surprise as he expressed his disdain for cannabis a number of times and has been known to be a Drug War stalwart. President Trump promised during his campaign that he supports medical cannabis and the matter should be left up to the states. These recent comments by his newly appointed press secretary and attorney general suggest the administration may not honor that campaign promise.
Politicians in states that have legalized cannabis were quick to condemn the comments and uphold this as an issue of states’ rights. Colorado Governor John Hickenlooper told reporters legal cannabis is in their state’s constitution and he intends to uphold the will of the voters. Oregon State Rep. Knute Buehler (R-Bend) said in a press release, “I hope the new President and Attorney General keep their hands off Oregon’s marijuana law.” Regulators in Nevada have also said they plan to move forward with implementing legal recreational cannabis regulations, despite any federal actions or comments. Bob Ferguson, Washington State attorney general told the Associated Press, “We will resist any efforts to thwart the will of the voters in Washington,” and has requested a meeting with Sessions to discuss his policies. California Lt. Governor Gavin Newsom wrote a letter to President Trump telling him not to follow through on those threats of greater enforcement. “The government must not strip the legal and publicly supported industry of its business and hand it back to drug cartels and criminals,” Newsom wrote to Trump. “Dealers don’t card kids. I urge you and your administration to work in partnership with California and the other eight states that have legalized recreational marijuana for adult use in a way that will let us enforce our state laws that protect the public and our children, while targeting the bad actors.”
At this time, it remains unclear exactly how the Trump administration will address federal cannabis policy, but these vague and ominous statements from top federal officials continue to raise eyebrows in the cannabis industry. Until President Trump comes out with a clear stance on legal cannabis, those in the cannabis industry fear a federal crackdown on legal recreational cannabis is looming.
During a press conference on Thursday, February 23rd, White House press secretary Sean Spicer made a number of comments hinting at the Trump administration’s stance on legal cannabis. He identified a clear distinction that he makes between medical and recreational cannabis laws, while mentioning President Trump’s previous statements on medical cannabis. Roby Brock, a journalist at Arkansas news website Talk Business & Politics, asked a question about the state and federal conflict in cannabis laws. “The Obama administration chose not to strictly enforce those federal marijuana laws,” says Brock. “My question to you is with Jeff Sessions over at the Department of Justice as AG, what is going to be the Trump administration’s position on marijuana legalization where it is in a state-federal conflict like this?”
Sean Spicer replied with more of the same of his previous statements regarding the Trump administration’s stance on cannabis legalization. “There are two distinct issues here: medical marijuana and recreational marijuana,” says Spicer. “I think medical marijuana- I’ve said before that the president understands the pain and suffering that many people go through, who are facing especially terminal diseases and the comfort that some of these drugs, including medical marijuana, can bring to them. And that’s one that congress, through a rider in 2011, I think put in the appropriations bill saying the Department of Justice wouldn’t be funded to go after them.” The rider in the appropriations bill he is referring to is the Rohrabacher–Farr amendment that became law in December of 2014, but must be renewed each fiscal year. That piece of legislation provides for exactly what he said- preventing the Justice Department from using funds for activity that might interfere with state’s legal medical cannabis programs. Regarding the actual conflict between federal and state laws, Spicer said “I do believe you will see greater enforcement of it,” referring to the Department of Justice enforcing the Controlled Substances Act.
Spicer went on to make some questionably ill-informed remarks, including linking recreational cannabis use to the opioid crisis. “There is a big difference between that [medical marijuana] and recreational marijuana,” says Spicer. “And I think that when you see something like the opioid addiction crisis blossoming in so many states around this country, the last thing we should be doing is encouraging people- there is still a federal law that we need to abide by… When it comes to recreational marijuana and other drugs of that nature.” Though those comments are unclear, it could suggest that Mr. Spicer believes in a possible link between recreational cannabis use and the opioid crisis, or at least grouping them in the same category. While there is not much evidence suggesting of the link he is referring to, a study published in 2014 in JAMA Internal Medicine, a peer-reviewed medical journal published by the American Medical Association, suggests a possible link between medical cannabis laws and the decrease in opioid overdoses.
Spicer continued to emphasize his distinction between medical and recreational use of cannabis. “I think there is a big difference between medical marijuana, which states where it is allowed, in accordance with the appropriations rider, have set forth a process to administer and regulate that usage versus recreational marijuana, and that is a very very different subject,” says Spicer. National Cannabis Industry Association executive director Aaron Smith issued a statement regarding Spicer’s comments.
“It would be a mistake for the Department of Justice to overthrow the will of the voters and state governments who have created carefully regulated adult-use marijuana programs,” says Smith. “It would represent a rejection of the values of economic growth, limited government, and respect for federalism that Republicans claim to embrace.” Smith says he was very disappointed when he heard press secretary Spicer relate cannabis to opioid addiction. “Science has discredited the idea that marijuana serves as any kind of gateway drug, and the addiction and death rates associated with opioids simply do not occur in any way with cannabis,” says Smith. In October 2016, NCIA published a report identifying cannabis as a possible solution to the opioid crisis.
Isaac Dietrich, chief executive officer of MassRoots, a social networking platform for medical cannabis, sees Spicer’s words having a direct impact on his business. “I have a feeling our stock is going to take a beating tomorrow, but that just creates an opportunity for investors who believe in the long-term trajectory of the cannabis market,” says Dietrich. He goes on to directly refute Spicer’s statements. “Colorado is one of the only states in the nation that is seeing a decline in opioid deaths — that’s not a coincidence,” says Dietrich. “Cannabis is a healthy alternative to pain pills and heroin, not a gateway to it.”
Press secretary Sean Spicer did not allow a reporter present at the press conference to ask a follow up question on the matter.
Members of Congress last week announced the formation of a ‘Congressional Cannabis Caucus’ in order to organize and affect cannabis policy at the federal level. Representatives Earl Blumenauer (D-OR), Dana Rohrabacher (R-CA), Jared Polis (D-CO) and Don Young (R-AK) announced the creation of the caucus on February 16th. Cannabis advocacy and drug policy groups were quick to commend the formation of the organization.
In a joint statement issued on Friday, the National Cannabis Industry Association, the Marijuana Policy Project, the Drug Policy Alliance, NORML, Americans for Safe Access, Students for Sensible Drug Policy, Law Enforcement Action Partnership, Doctors for Cannabis Regulation, and Clergy for a New Drug Policy expressed commendation and excitement for the new group. “We commend Representatives Blumenauer, Rohrabacher, Polis, and Young for their leadership on the issue of cannabis policy,” reads the statement. “The establishment of a Cannabis Caucus will allow members from both parties, who represent diverse constituencies from around the country, to join together for the purpose of advancing sensible cannabis policy reform. It will also facilitate efforts to ease the tension between federal prohibition laws and state laws that regulate cannabis for medical and adult use.”
The members of Congress that formed the caucus all represent constituents in states where cannabis is legal for medical and adult use. “The formation of this caucus is a testament to how far our country has come on the issue of cannabis policy,” says the joint statement by the drug policy reform groups. “We look forward to working with caucus members to translate this growing public sentiment into sound public policy.” According to their statement, 44 states so far have adopted laws effecting cannabis prohibition on the state level, representing 95% of the U.S. House of Representatives and 88% of the Senate.
Representatives Blumenauer and Rohrabacher have been prominent cannabis policy reform advocates in the past. Blumenauer supported the bill to legalize adult use cannabis in Oregon back in 2014 and Rohrabacher introduced the Rohrabacher–Farr amendment to Congress, which prohibits the Justice Department from spending money on interfering with state medical cannabis laws.
According to an article on Roll Call, Blumenauer says the caucus will focus on more medical research and the tax and banking regulations hurting cannabis businesses.
President-elect Donald Trump nominated Sen. Jeff Sessions from Alabama for Attorney General and Rep. Tom Price from Georgia as the new Health Secretary. Those appointments still require Senate approval before they are officially members of the cabinet. Neither of the picks to head the Department of Justice (DoJ) and the Department of Health & Human Services (HHS) is friendly to cannabis.
What’s the bad news?
Both of those agencies are at the center of any federal regulation of cannabis, including access for research. As Attorney General, Jeff Sessions would essentially have the ability to block any rescheduling efforts, as outlined in the Controlled Substances Act.
Sessions has made inflammatory, racist remarks and showed his disdain for cannabis users on multiple occasions. He disgracefully said at a Senate hearing in April, “Good people don’t smoke marijuana.” When he was a federal prosecutor, Sessions was a prominent advocate for the War on Drugs, and perhaps even still is.
Tom Price, a Republican Congressman from Georgia, has voted repeatedly against pro-cannabis legalization bills, including twice against the Veterans Equal Access Amendment as well as the Rohrabacher/Farr Amendment, which “prohibits the use of funds in the bill to supersede State law in those States that have legalized the use of medical marijuana.” NORML’s Georgia Scorecard gave Tom Price a D grade for his previously voting against pro-cannabis bills.
What’s the good news?
While Sen. Jeff Sessions is certainly no friend to legal cannabis, I believe he is not a serious danger to the cannabis industry. This op-ed on CNN does a terrific job at summing up Sessions’ potential threat to the cannabis industry, but also why it may not be cause for a total panic. The author mentions a laundry list of DoJ priorities over cannabis, but I think the larger issue at hand is states’ rights.
Republicans are historically passionate when it comes to keeping states’ rights sovereign. With cannabis’ big wins on Election Day, a majority of the country’s population now lives in states where cannabis is legal.
There is too much momentum behind legal cannabis for a new administration to waste precious resources and time on trying to disrupt it. States are getting too much tax revenue from regulating cannabis to just let the DoJ interfere with their economies. “Voters in 28 states have chosen programs that shift cannabis from the criminal market to highly regulated, tax-paying businesses,” says Aaron Smith, executive director of the National Cannabis Industry Association (NCIA). “Senator Sessions has long advocated for state sovereignty, and we look forward to working with him to ensure that states’ rights and voter choices on cannabis are respected.” Smith’s words in the NCIA statement are pointed and clear: this is a states’ rights issue at heart and they must respect that.
By forcing the states’ rights issue to the front, it is possible to put legal cannabis in a bipartisan lens, thus eliminating the possibility of a few old drug war stalwarts disrupting the industry. While rescheduling efforts could be thwarted for the coming years, I have faith that the federal government will not interfere with states that legalize cannabis.
Lezli Engelking founded the Foundation of Cannabis Unified Standards (FOCUS) in 2014 to protect public health, consumer safety, and safeguard the environment by promoting integrity in the cannabis industry through the use of standards. Standards are an agreed upon way of doing things and specify guidelines or requirements for producing goods or providing services, according to FOCUS.
Standards can take the form of a “reference document, which may include specifications, guidelines, conditions or requirements for products, operations, services, methods, personnel and systems on how to design, operate, manufacture or manage something.” Peter Maguire, VP of System Applications for Lighthouse Worldwide Solutions and committee chair of the FOCUS Cultivation standard, joined the organization wanting to make a positive impact on the industry that is in line with protecting people and medical patients. He sees so much variability in the industry and the need to homogenize standard operating procedures (SOPs). “I have worked with multiple cultivation facilities and a few of them have operating procedures in place but having them in place is only half the solution- it’s critical to have the right ones in place,” says Maguire. He has twenty years of experience in contamination control in manufacturing, before entering the cannabis industry.
The FOCUS cultivation standard was created by experts who have years of experience in both cannabis cultivation, good agricultural practices and in the tightly regulated pharmaceutical industry. “FOCUS created these guidelines as a sort of roadmap for success in business; You need to keep your employees healthy and your products safe to survive in the long term,” says Maguire. We sit down with Lezli Engelking to find out how the standards are created, what makes them significant and what businesses can gain by working with them.
CannabisIndustryJournal: Why are standards important?
Lezli: Standards are the international language for trade – they exist in every industry. “The U.S. Department of Commerce estimates that standards and conformity assessment impact more than 80% of global commodity trade.” FOCUS is not reinventing the wheel with what we are doing. We are simply adapting a business model the federal government already uses. In the 80s, when the heroin epidemic swept across the US, methadone clinics popped up in every state in the country within two years. The clinics were all operating under different state, city and county regulations – much like the cannabis industry is today. The federal government took a look at the situation and decided they needed a way to regulate these clinics in order to protect public health and safety. They released a Request For Proposal (RFP) looking for an organization to create voluntary-consensus standards and a third-party certification system for the methadone clinics. Commission on Accreditation of Rehabilitation Facilities (CARF) is the organization that answered and won that RFP. CARF continues to work with Health and Human Services to maintain the standards and provide third-party certification to the clinics today. FOCUS develops international, voluntary consensus standards and a third party certification program for the global cannabis industry based on the CARF model. This is extremely important, because of the National Technology Transfer and Advancement Act, (Public Law 104-115), signed into law March 7, 1996 by President Clinton. The act requires that all federal agencies use standards developed by voluntary-consensus standards bodies, instead of government-unique standards wherever possible. Perhaps even more importantly, the Act includes provisions that encourage federal agencies to partner with the private sector in the development of standards that not only help improve the efficiency and effectiveness of government, but also strengthen the U.S. position in the global marketplace.
CIJ: What exactly goes into developing a voluntary-consensus standard?
Lezli: Voluntary-Consensus refers to the type of standard and how it is developed. Everyone who participates in the development of voluntary-consensus standards does so on a voluntary basis. Committee members must come to a consensus on every point within the standard- down to every comma or semicolon. Once the development process is complete, the standards must undergo a 30-day public review period. The process for developing voluntary-consensus standards is designated by International Organization for Standardization (ISO). ISO has member agencies in 163 countries that participate in the development of standards. The American National Standards Institute (ANSI) is the American body for ISO. FOCUS follows all ISO/ANSI guidelines in the standards development process. This is extremely important because it means FOCUS standards are suitable for accreditation and adoption into regulations according to the National Technology Transfer and Advancement Act. All voluntary-consensus standards are developed under the principles of:
Openness| Participation in the standard development process is open to individuals with a stake in the standard who bring useful expertise along with the spirit and willingness to participate.
Balance| Focus stakeholder groups involve all stakeholder groups: industry, regulatory, quality assurance, medical, law enforcement, business, research, consumers, patients and the general public.
Voluntary-Consensus| Individual subcommittees of volunteers develop each area of the standard, offering their unique expertise to form a consensus. They are not paid for their participation.
Lack of Dominance| No party has dominant representation, or influence to the exclusion of fair and equitable consideration of other viewpoints.
CIJ: More specifically, how are the FOCUS standards developed?
Lezli: To create a baseline standard, FOCUS utilized World Health Organization (WHO) guidelines for Good Manufacturing Practices (GMP), Good Agricultural Practices (GAP), Good Laboratory Practices (GLP), Code of Federal Regulations (CFR) for pharmaceutical GMPs, nutraceutical GMPs, food safety standards, OSHA and HACCP. From there, applicable cannabis regulations from around the world were added. All of this information was compiled into auditor-style checklists. Each committee member was provided time to go edit, remove or add to items in the checklist on their own. Over the next two years, each of the eight committees had monthly meetings, going through and coming to a consensus on each line item of the standard. Once the committees completed development, the standards were open for a 30-day Public Review to collect comments and feedback. The first eight FOCUS standards, completed and ready for use, cover Cultivation, Retail, Extraction, Infused Products, Laboratory, Security, Sustainability and Packaging & Labeling.
FOCUS is currently recruiting committee members to begin development of five new cannabis standards later this year: Advertising/Marketing, Insurance, Banking/Finance, Patient Care and Research. Committees will receive a list of proposed suggestions for what should be considered in developing the standards. Each committee member will develop a list to select criteria they think should be included into the standard. FOCUS will compile the lists, then committees will go through the monthly standards development/vetting process for each line item in the standard.
CIJ: So what does a business have to gain by adopting a FOCUS standard?
Lezli: Compliance becomes easily manageable with the FOCUS software platform, integrating standards, training and SOPs into the everyday operations of the business. FOCUS certified clients could expect to reduce costs, reduce risk and reduce liability by assuring they are producing safe, quality and consistent products. FOCUS certification allows a business to differentiate themselves from their competitors, and prove to their patients and customers they can trust their products. Certification also allows businesses to access reasonable insurance rates and drives interest from investors.
FOCUS is here to partner with cannabis businesses. We are there to hold their hand, by providing guidance and assistance along every step of the way. Unlike state mandated audits that delineate what a business is doing right or wrong, FOCUS is an on-going compliance management system. We are here to make sure a business runs as efficiently as possible and take the guesswork out of compliance. Under FOCUS certification, a business receives ongoing consulting, customized SOPs, employee training and a documentation management software system to track and prove compliance.
CIJ: Can you give us an update on FOCUS’ progress in 2016?
Lezli: A large milestone for FOCUS this year, aside from completing version one of the standards, is choosing an appropriate software platform, (Power DMS) to house the standards and provide an ongoing compliance management system for our clients. Power DMS also houses regulatory standards for law enforcement; health care, federal aviation and fire departments, so most agencies in public health are already familiar with it. The familiarity and access to this platform is a huge benefit on the regulatory side. It allows first responders to access the schematics of a FOCUS certified client in the event of an emergency. This is crucial in the event of an explosion from extraction equipment, or a fire in a cultivation facility, as without first identifying where the hazards are, they will not access the facility. The FOCUS software platform allows first responders access to all pertinent information through computers in police cars, ambulances, or fire trucks.
For the industry, the FOCUS software platform is equally as impressive. Not only does the platform house the standards and all SOPs, it is also complete compliance management system. FOCUS certified clients have a simple management tool that houses all training and documentation, assuring all required compliance documentation can be easily accessed at any time. The platform also allows FOCUS certified clients to provide access to governing bodies in advance of state audits –streamlining the process and minimizing time and interruption caused by state audits. The FOCUS platform tracks all changes to required documents, provides real time updates on employee training, creates appropriate traceability logs, and provides updates on regulatory changes, including which SOPs need to be changed to maintain compliance. The platform allows FOCUS to be way more than an auditing company. FOCUS is a partnership in compliance for cannabis companies wanting to maintain good business practices and stay compliant with regulations.
We have about 140 new committee members that will assist existing committees with standards updates and participate in the development of the next set of FOCUS standards for advertising/marketing, banking/finance, research, patient care and insurance. All committees will convene before 2017.
Rescheduling cannabis to Schedule II would place it in the same category as Vicodin, cocaine, methamphetamine, Adderall, oxycodone, and many more. These substances are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. However, they are recognized as having some potential medical benefits.
If cannabis were to become a Schedule II drug, it would allow further research on the plant. This could be beneficial to the industry because further medical research would finally provide the scientific validation that cannabis does have medical benefits and that it should be accepted as a form of medicine.
Those benefits come with a steep cost.
If cannabis becomes Schedule II it means the federal government finally sees cannabis as a plant (drug) that can provide some medical value. Which, at face value, is good because that is what many advocates have been fighting for. On the other hand, the only reason that larger pharmaceutical companies have largely kept out of the industry so far is because it is a Schedule I drug and the government did not officially recognize that it had any medical value. If this were to change, there is no reason for those pharmaceutical companies to continue watching from the sidelines. There is also no industry better fit than the pharmaceutical industry to run, manufacture, control, and profit from medical cannabis. The infrastructure is already in place.
There is also not another industry that has the money and the historical relationship with the FDA like the pharmaceutical industry. If the FDA were to regulate cannabis, it would have to regulate every single product on the shelf of every single dispensary, which would require more stringent lab testing guidelines. Just because one of your brownies made it through the FDA regulation process, does not mean the cookie next to it will. Entering into this process would take companies years to complete and cost more than $1 billion per product. Think about how many products some dispensaries have. Think about the number of different strains that dispensaries carry. That requires years of testing and multiple billions of dollars, just for the strains.
Big Pharma is positioned perfectly to come in and take control of the entire process if this happens. It will be a mad rush from all pharmaceutical companies to come in and quickly obtain market share. I know that as an industry we think we are seeing a lot of money in sales and profit, but compared to the pharmaceutical industry, it is merely a drop in the bucket. These companies will easily, and willingly, out-spend every company currently in the industry to the point where we can no longer compete. All the work that advocates and business professionals have put in to get the industry to where it is today could be lost.
Schedule II status would also turn the adult-use industry into utter chaos. The only reason we are able to have an adult-use market right now without the interference of the FDA is because cannabis is federally illegal. If cannabis is moved to Schedule II it will be recognized by the government, which means the FDA will have to come in and start the approval process for every product on the shelf. How smoothly do you think that will go for the adult-use retail centers in the industry? The cost alone will force shops to close. There is also not another substance that has a Schedule II classification that we have an adult-use industry for. Could cannabis be the first? I would not want to take that chance with the government or have to go through that process as an adult-use cannabis business owner.
When discussing this matter with several colleagues, some would ask “But what about now? We are in direct violation of the federal law right now, and they are leaving us be.”
Yes, that is for the most part true, but it is true because cannabis is now a Schedule I, federally illegal drug. Meaning the government does not even recognize it. The FDA will not regulate anything that is not recognized by the federal government because they are a federal agency. If the FDA were to implement regulations and an approval process, that would mean that a federal agency is recognizing cannabis as a consumer product. Right now that goes directly against the government’s public stance on the issue. And pharmaceutical companies cannot start selling a drug that is federally illegal and has been classified by the government as having no medical value. But as soon as the government recognizes cannabis as a form of medicine, it opens the doors for these organizations to get involved because it is justifiable now.
If that were to happen all the money that has been generated in this industry, and has made several people very wealthy and successful, will slowly, but surely get stuffed into the pockets of Big Pharma, the FDA and the government.
In my mind, rescheduling cannabis to a Schedule II substance will create more issues for the industry than it will benefits.
If the government were to take any stance on cannabis, it should completely declassify it. It should not be listed on any type of controlled substance list by the government. It is a natural plant, not a man-made substance. If the government will not declassify cannabis, I would rather them keep it as a Schedule I substance. At least this way it protects the industry and keeps it as is, belonging to the people.
Opportunities like the cannabis industry are once in a lifetime. It would be a shame to see it taken by Big Pharma, or controlled by the government.
For those that have made it this far down on this post, please understand that this is a worst-case scenario. A very drastic, but realistic outcome down one of the many paths the industry could go. But the motto in this industry since the beginning was, “prepare for the worst, and pray for the best.” I think we should follow those instructions now more than ever.
Editor’s Note: This article represents the opinion of the author, not necessarily that of Cannabis Industry Journal. We invite all readers who agree or disagree with the author’s opinion to join the conversation in the comments section below the article.