FDA Products Containing Cannabis or Cannabis-Derived Compounds Public Hearing . Friday, May 31st, 2019
Hoban Law Group is delighted to announce that Managing Attorney Garrett Graff was selected by the U.S. Food and Drug Administration (“FDA”) to testify in Washington D.C. at the Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds Public Hearing on Friday, May 31, 2019.
This monumental hearing is the first time the FDA has requested feedback from stakeholders and the cannabis industry regarding the safety, manufacturing and sale of products containing cannabis-derived compounds, including cannabidiol (“CBD”). The hearing will provide stakeholders an opportunity to advocate for sensible rules and prudent regulation of CBD and other products that contain cannabis.
We encourage stakeholders to take additional steps and to submit a comment to the FDA’s public docket during the open period. If you are interested in submitting comments after the hearing, comments must be posted to the public docket before July 2, 2019. Contact us to see how we can help to ensure that your voice is heard.
Illinois lawmakers came one step closer to legalizing adult use cannabis this week. The Illinois Senate voted 38-17 to pass HB 1438, which is now headed to the House for a vote. Sponsors of the bill, Senator Heather Steans (Chicago-D) and Representative Kelly Cassidy (Chicago-D), along with Governor J.B. Pritzker, have been viewed as the architects of this piece of legislation.
This is not the first time that Democrats in the Illinois legislature have attempted to legalize adult use cannabis. Back in 2017, state Representative Kelly Cassidy and state Senator Heather Steans, the two lawmakers sponsoring this bill, sponsored a legalization bill that failed to garner support.
Regarding the bill that just cleared the Senate, one particularly contentious issue raised was the allowance for “home grow.” The Senate approved the bill after a provision was added allowing just medical cannabis patients to grow their own, not everyone.
If this bill manages to pass through the House, Governor Pritzker is expected to sign the bill immediately. The bill would legalize and regulate sales of cannabis and cannabis products on January 1, 2020.
Good news came to patients using medical cannabis in Arizona earlier this week: Lawmakers in Arizona unanimously passed SB1494 through the state’s House and Senate, the bill requiring mandatory lab testing for medical cannabis products. Arizona Governor Doug Ducey is expected to sign the bill and has ten days to do so.
When Governor Ducey signs the bill into law it will mark the first time since the state legalized medical cannabis in 2011 that a measure to protect patient safety via lab testing will be implemented. According to the bill, beginning November 1, 2020, all cannabis products shall be tested prior to sales “to determine unsafe levels of microbial contamination, heavy metals, pesticides, herbicides, fungicides, growth regulators and residual solvents and confirm the potency of the marijuana to be dispensed,” (Page 6, Section 36-2803).
The bill requires dispensaries to provide test results to patients immediately upon request. Dispensaries need to display a sign notifying patients of their right to see “certified independent third-party laboratory test results for marijuana and marijuana products for medical use,” according to the text of the bill (Page 7, Section 36-2803.01).“There will have to be some serious planning, but other states have achieved this and we can too.”
Under the new bill, the Arizona Department of Health Services will adopt rules to certify and regulate labs, establishing requirements like health and safety protocols, mandatory quality assurance program and standards, chain of custody and sampling policies, adequate records, accreditation, proficiency testing, among other requirements (Page 6-7, Section 36-2803).
Ryan Treacy, co-founder of the Arizona Cannabis Laboratory Association (ACLA) and CEO/Founder of C4 Laboratories, says this is a major turning point for Arizona’s cannabis industry. “We have been devoid of regulations with regard to testing the entirety of the program since it was legalized; This will be a significant change,” says Treacy. “Now patients can make sure they are getting a safe and clean product and getting exactly what they paid for.”
For those in the know when it comes to cannabis testing in the United States, the new requirements will look very similar to other states with testing requirements. One particularly unique aspect of the new program, however, is the establishment of a “Medical Marijuana Testing Advisory Council,” made up of stakeholders representing different interests in Arizona’s cannabis industry. Members of the council will include representatives from dispensaries, labs, cultivators, concentrate producers, edibles producers, as well as registered patients, caregivers, a representative from the Arizona Department of Public Safety, a licensed health care provider and “any other members deemed necessary by the director,” reads the text of the bill (page 16, Section 36-2821).
“Other states like California have complained about detection limits, while Arizona is taking a unique approach with an advisory council with stakeholders in the cannabis industry,” says Treacy. “So that when the Department of Health Services promulgates rules, they are taking into account the challenges in the cannabis industry specifically. We have a chance to do this right and avoid pitfalls we’ve seen in other states.”
One problem worth mentioning for Arizona’s cannabis industry: Dispensaries have not been required to test products for patients since medical cannabis was legalized back in 2011. That means many producers could be very used to operating procedures that don’t account for lab testing. With mandatory lab testing, some producers may be behind the curve when it comes to mitigating contamination.
According to Treacy, this could disrupt the supply chain a little bit. “When testing becomes mandatory in November 2020, dispensaries will need a full panel of tests performed on their samples,” says Treacy. “With the entire market now required to complete a full panel in depth analysis on each product, product testing will become a more time-consuming stop in the supply chain. So companies will need to work that into their plan to meet regulation requirements to prevent a bottleneck and maintain patients’ access to their cannabis medicine.”
Arizona has a chance to prevent that type of bottleneck seen in states that implemented testing requirements, like California for example. “When you have a habitual history of not testing products, it can be very hard to change, which adds to Arizona’s challenges,” says Treacy. “We need to make sure this does not affect access for patients and the ability of the industry to continue to flourish and grow.”
While Treacy thinks the transition will be difficult for some, it’s absolutely necessary for Arizona’s patients to access clean and safe medicine. “There will have to be some serious planning, but other states have achieved this and we can too.”
The consequences of Tuesday’s Arizona Supreme Court decision allowing the sale of high-potency drugs are troubling. The Court’s conclusion that the Arizona Medical Marijuana Act protects hashish (legally termed cannabis) is akin to finding that explosives produced from fertilizer are protected by laws allowing the sale of farm products.
Since 2010 when Arizona voters approved the use of medical marijuana, the potency and variety of products have soared. Smoked marijuana has potency levels averaging 5% to 15% THC, the mind-altering chemical in the marijuana plant. Manmade hashish products, derived from the concentrated resin from the marijuana plant, have potency levels of 70% to 90% THC.
This is the difference between Advil and morphine, and it’s why the Arizona Court of Appeals found that hashish is “susceptible to serious and extensive abuse.”
Sadly, the Supreme Court rejected the Arizona Appeals Court’s common-sense reasoning and its sound conclusion that hashish is a form of cannabis, which state law defines as distinct from the dried marijuana leaves.
Indeed, it’s a difference that dispensaries promote. Their websites advertise “mind-blowing shatter,” “Papa’s OG shatter,” and “mob moss” wax. These are medicines?
Additionally, today’s ruling did not address the fact that any use of marijuana in Arizona continues to be illegal under federal law. The United States Supreme Court has long recognized that Congress controls what is medicine in the U.S., and today the Arizona Supreme Court declined to resolve the continuing conflict between Arizona and federal law.
A plethora of recent peer-reviewed studies document the link between high potency THC and mental health, specifically psychosis. Today’s ruling by the Arizona Supreme Court gives a green light to an industry constantly seeking to market and sell more potent, and thus more addictive and dangerous, products. Communities across Arizona will suffer the consequences of this ruling long into the future.
BACKGROUND ON THE CASE
In March 2013, Rodney Jones was arrested and charged with possession of hashish (cannabis), a narcotic drug under Arizona law. At the time of his arrest, Mr. Jones was on probation for attempting to involve a minor in a drug offense, a class 3 felony. As part of the resolution of this case, Jones received favorable disposition and the dismissal of two criminal charges in another case. The trial court sentenced Mr. Jones to 2½ years in prison.
Mr. Jones appealed, arguing that, as a medical marijuana cardholder, he was entitled to use hashish, the resin extracted from the marijuana plant. The case was argued to the Arizona Court of Appeals. On June 26, 2018, the Court of Appeals ruled that use of hashish is not permitted by the Arizona Medical Marijuana Act. Mr. Jones then appealed this decision to the Arizona Supreme Court.
On Wednesday, Gov. Jared Polis signed six pro-marijuana bills into law, including one that will allow out-of-state visitors and others to safely consume cannabis in regulated hospitality facilities. Polis on Wednesday signed two bills into law that had been vetoed last year by then-Gov. John Hickenlooper.
Under House Bill 1230, marijuana hospitality facilities can be set up to allow consumption of marijuana products. According to the Cannabis Hospital Coalition, “existing dispensaries could apply for a limited consumption license, while entrepreneurs who have found entrance to the cannabis industry difficult will have a new chance to seize opportunities in establishing their own separate establishments. This will create new workforce development and local community impact opportunities.”
Those establishments legalized under House Bill 1230 can open for business on Jan. 1, 2020, and will be licensed by the state’s marijuana enforcement division within the Department of Revenue as well as under the authority granted by local governments.
The second measure Polis signed will allow for regulated delivery of marijuana, primarily to medical marijuana patients. Sponsors of House Bill 1234 pointed out Wednesday that marijuana delivery already takes place but it’s part of the black market. Many marijuana patients can’t leave home to pick up their products, Polis said, and regulated delivery will give them access to medical marijuana for pain instead of using opioids, a bill he signed last week.
Polis also signed into law House Bill 1090, which will allow capital investment in publicly licensed marijuana companies. Sponsored by Gonzales and Republican Sen. Owen Hill of Colorado Springs, the bill also takes aim at black market investment, according to co-sponsor Democratic Rep. Matt Gray of Broomfield. The black market for marijuana can get investment capital from organized crime, for example, he said.
Under House Bill 1090, a publicly-traded corporation can invest in a marijuana business or become a marijuana business. The measure also changes statutory definitions around ownership and investment for medical and retail marijuana.
New York City recently joined Maine and the District of Columbia in passing legislation banning most employers from requiring applicants to submit to a pre-employment test for cannabis. The City Council passed the bill in April by a vote of 40-4, and it became law on May 10, 2019, with an effective date of May 10, 2020. This new law expands the scope of the New York City Human Rights Law’s prohibitions on making pre-employment inquiries, which already preclude employers from seeking information about applicants’criminal conviction,credit andsalaryhistories. New York City employers who conduct pre-employment drug tests should review their practices to ensure compliance with this new ordinance. The New York City Commission on Human Rights, the agency charged with enforcement of the City Human Rights Law, has the authority to issue up to $250,000 in sanctions for intentional violations of the law.
Subject to certain exceptions, thelocal lawmakes it an “unlawful discriminatory practice” to require prospective employees to “submit to testing for the presence of any tetrahydrocannabinols or marijuana” as a condition of employment. Because this legislation is specific to prospective employees, employers remain free to test their current employees for the presence of cannabis, and presumably may test new employees immediately upon hire.
The statute specifically excludes from the scope of the law applicants for employment in the following positions:
Certain construction workers;
Positions requiring a commercial driver’s license;
Providers of care to children, medical patients or other “vulnerable persons” recognized by applicable law; and
“In any position with the potential to significantly impact the health or safety of employees or members of the public,” as specified by the commissioner of citywide administrative services or the chairperson of the City Commission on Human Rights.
The statute also excludes positions for which testing is required under applicable law or regulation, including, for example, regulations promulgated by the Department of Transportation.
Also excluded from the scope of the statute are positions in connection with a government contract which specifically provides for pre-employment drug testing. Employers may continue the practice of testing current employees for the presence of cannabis, and may take appropriate steps when they have reason to believe that an employee is under the influence of cannabis during working hours.
Worth noting, however, is that this provision of the law does not necessarily exclude government contractors who have adopted policies pursuant to the Drug-Free Workplace Act of 1988 (the “DFWA”). The DFWA conditions the award of certain federal government contracts on employers’ commitment to a drug-free workplace through, among other things, the adoption of policies and procedures to further that end. In September 2018, a federal court in Connecticut found that an employer’s refusal to hire an employee with a prescription for medical cannabis constituted a violation of that state’s Palliative Use of Marijuana Act, notwithstanding the fact that the employer was required to maintain a drug-free workplace under the DFWA. The court reasoned that the DFWA does not compel employers to adopt a “zero tolerance” policy with regard to off-duty drug use, but instead mandates only that employers take reasonable steps to ensure that the workplace is free of illegal drugs.Noffsinger v. SSC Niantic Operating Company, LLC, 338 F. Supp. 3d 78 (D. Conn. 2018). By that rationale, government contractors subject to the DFWA would not be excluded from New York City’s ban on pre-employment cannabis testing unless their contract with the government expressly mandated such testing.
Also exempt from the statute are applicants for employment in a position subject to a collective bargaining agreement (“CBA”), where the applicable CBA expressly calls for pre-employment drug testing.
Current New YorkStatelawconsiders certified users of medical marijuana as having a disability under the State Human Rights Law, entitled to all the legal protections of other employees and applicants with disabilities. Employers in New York City are under a duty to engage in acooperative dialoguewith certified users of medical cannabis to determine the extent to which they may perform the essential duties of their job, with or without accommodation. If they have not already, employers in New York City should revise applicable policies to make clear that they will participate in a cooperative dialogue with users of medical cannabis to explore reasonable accommodations. Employers should also revisit “zero tolerance” cannabis policies for consistency with state and local law.
Under the newCitylaw, New York City employers who conduct pre-employment tests for cannabis may continue to do so until May 2020, the effective date of the recent legislation. However, their testing practices should be adjusted accordingly in anticipation of that effective date.
Businesses that use the services of third-party staffing agencies or professional employment organizations should ensure that those entities’ pre-employment screening practices are consistent with New York City law.
Similarly, businesses should review their agreements with testing labs to ensure that the labs with which they contract do not screen for cannabis as a matter of course.
New York legislators are mounting a final bid for an adult-use cannabis bill before the current legislative session ends on June 19.
If this effort fails, legislators probably won’t have another shot at adult-use legalization for at least two years.
Last Friday, a group of State Senators unveiled Bill 1527A, which aims to merge the progressive Marijuana Regulation and Taxation Act (MRTA)—which has been introduced several times since 2013—with the legislation thatfailed to passas part of this fiscal year’s budget.
Although Governor Cuomo has recentlystatedthat he won’t use his political clout to persuade on-the-fence lawmakers to support the bill, the bill’s compromises may be enough to convince him to “twist arms.” 1527A presents a sort of final shot at legalization for the moment; if it fails to pass, it’s unlikely that legislators will have another stab at cannabisfor at least two years.
The Arizona medical marijuana community and business industry can finally exhale: The state Supreme Court decided a crucial appeal on Tuesday by siding 7-0 with patients and state voters on marijuana resin extracts.
Parties in the case of State of Arizona v. Rodney Christopher Jones received word just after 10 a.m. on Tuesday that Jones had won his appeal.
“We hold that [Arizona Medical Marijuana Act’s] definition of marijuana includes both its dried-leaf/flower form and extracted resin, including hashish,” the court stated in its unanimous ruling.
The positive ruling for the medical marijuana industry means no change — vape-pen cartridges, concentrates like shatter and wax, infused food and drinks, patches, tinctures, and topicals will not be banned, as had been feared.
The question of whether the AMMA applies to resin extracts is now settled.
If the high court had ruled instead that the voter-approved 2010 Arizona Medical Marijuana Act (AMMA) doesn’t cover extracts, some of the most popular and medically efficacious products would have been taken from dispensary shelves and relegated to felony status.
The suspense over what the state Supreme Court would do has had many patients and business operators in the industry on edge for nearly a year, ever since the state Court of Appeals upheld the conviction of marijuana patient Rodney Jones for possession of hashish.
The tension over resin began long before that, actually. Disputes between the patients and law enforcement trace back nearly all the way to 2010, when voters approved the state marijuana program.
Soon after the law went into effect, Maricopa County Attorney Bill Montgomery and Yavapai County Attorney Sheila Polk took the position that the law didn’t cover the THC-bearing resin that can be extracted from marijuana and consumed independently, often in food, drinks, or vaporizers.
Decades-old Arizona law defines marijuana and extracted resin separately in state statute, with the latter unscientifically termed as a “narcotic” called “cannabis.” While all marijuana is a felony in Arizona for nonpatients, people who possess cannabis resin and products containing it are subject to a more serious felony prosecution with greater penalties.
The medical marijuana law doesn’t specifically exclude patients from prosecution in resin cases, which created a loophole exploited by Montgomery and Polk. They decided that if a patient was in possession of cannabis resin, the medical marijuana law protections didn’t apply. Yet, the 2010 law does seem to cover extracts by defining marijuana as “the dried flowers of the marijuana plant, and any mixture or preparation thereof.”
After the parents of an epileptic child challenged Montgomery’s position with a court action, Maricopa County Superior Court Judge Katherine Cooper ruled that patients could legally buy and use extracts. But the ruling didn’t apply statewide.
Jones was indicted in Yavapai County a few weeks after Cooper’s ruling. Police in Yavapai County had found Jones with 1.4 grams of hashish in a jar in his backpack. Jones presented his valid medical marijuana card, but cops arrested him anyway, and the Yavapai County Attorney’s Office charged him with possession of narcotics.
Already on probation for a 2012 conviction for “attempted involving a minor in a drug offense (marijuana),” Jones was sentenced in 2014 to 2.5 years for possession of the hashish, possession of paraphernalia, and a violation of probation in the 2012 case, court records show.
His lawyer, Craig Williams, had filed a motion to dismiss the case based on Jones’ patient status. But Polk filed a counter-motion, arguing that the AMMA had not legalized hashish.
He spent 2.5 years in prison, finally being released in mid-2017.
In June 2018, the Arizona Court of Appeals finally issued its long-awaited ruling in Jones’ appeal: In a 2-1 decision, the court ruled to uphold Jones’ conviction.
The news hit the Arizona cannabis scene like a butane explosion. Concentrates have become a large, crucial part of the dispensary business; some dispensary operators described the potential banning of concentrates as as doomsday scenario for the industry. Patients worried that medicine that works for them would be available only on the black market.
Both dispensaries and patients, in a flagrant display of civil disobedience, completely ignored the appeals court ruling, continuing to manufacture, sell, purchase, and consume vape cartridges, infused sodas, anti-pain cream, dabbable shatter, and other products with THC extracts.
Yet both before and after the ruling, police and prosecutors in Yavapai County continued to work together to hassle medical marijuana patients for possession of cannabis extracts, apparently solely due to the anti-marijuana stance by Polk and her supporters in the county. While Polk never got up the nerve to raid the dispensaries in her county for the products with extracts they sold, she directed cops to go after people who were less likely or able to challenge their prosecutions. More patients in Yavapai County faced potential felony charges for products they bought in dispensaries, with several taking plea deals that resulted in convictions.
Polk’s prosecutions for extracts were needlessly painful experiences for patients, and farcical policy for the county. Patients typically were allowed to take a drug-treatment program in lieu of prosecution, but because they were medical marijuana patients, the patients were allowed to pass the program in spite of regular urine tests that showed they were using marijuana.
The state currently has just over 200,000 people participating in the program, including more than 196,000 patients who are served by about 130 dispensaries. Patients bought 2.5 tons of edibles in 2018, state records show, plus another 2.5 tons of products containing concentrates, like vape cartridges.
The state Supreme Court heard oral arguments for the Jones case in March.
As the opinion states, the ruling came down to basic terms: “AMMA defines ‘marijuana’ as ‘all parts of [the] plant,’” the court wrote. “The word ‘all,’ one of the most comprehensive words in the English language, means exactly that … Taken together, ‘all parts’ refers to all constituent elements of the marijuana plant, and the fact the resin must first be extracted from the plant reflects that it is part of the plant.”
The court also noted that patients and dispensary companies under the law are immunized from prosecution in regard to “the acquisition, possession, cultivation, manufacture, use, administration, delivery, transfer or transportation of marijuana or paraphernalia relating to the administration of marijuana to treat or alleviate a registered qualifying patient’s debilitating medical condition,” and “manufacture” clearly means extracting resin from the plants.
In addition, the ruling settled the question, raised by Polk’s office, of whether dispensaries and patients could consider 2.5 ounces of resin extracts legal under the law, which allows possession of 2.5 ounces of marijuana. The court ruled that the possession limit was based on the amount of flower needed to create a certain amount of extract: “AMMA’s weight limitation is based [on flower] regardless of the weight of the product manufactured from those flowers.”
“We reverse the trial court’s ruling denying Jones’s motion to dismiss, vacate the court of appeals’ opinion, and vacate Jones’s convictions and sentences,” the court continued.
Statement from the ACLU: “The court got it right. Today’s ruling means that qualifying patients no longer have to fear being prosecuted for using their medicine in the form most helpful.”
Statement from Rob Mandel, Jones’ attorney: “We are gratified that the Arizona Supreme Court has honored the intent of the electorate to make marijuana in any form available to AMMA-compliant patients.”
This article has been update to add reaction and more information about the ruling.
The Arizona Supreme Court is scheduled to decide Tuesday 28 May 2019 whether medical marijuana patients can face arrest for possession of hashish.
The case centers on the 2013 arrest of medical marijuana card holder Rodney Jones at a Prescott hotel on charges of possession of cannabis and drug paraphernalia.
Police say Jones had 0.05 ounces of hashish in a jar.
He was convicted and later sentenced to two years in prison.
Last summer, the Arizona Court of Appeals ruled against Jones and found medical marijuana patients still face arrest for hashish possession because the drug isn’t mentioned or included by name in the state’s 2010 voter-approved medical cannabis law.
The court concluded hashish is recognized under state law as a narcotic distinct from marijuana by the Legislature because of its potency levels.