Category: Cannabis

FDA Finalizes Cannabis Guidance Focusing on Clinical Research and Quality Considerations

On January 23, 2023, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research” (the Final Guidance). The agency outlines current recommendations for drug sponsors developing cannabis and cannabis-derived compounds for use in human drug clinical research. Cannabis and cannabis-derived compounds include botanical raw materials, extracts, and highly purified substances of botanical origin.[i] FDA published the draft version of the guidance in July 2020 and received 60 public comments. Below, we outline key points from the Final Guidance.

Background

  • The Agriculture Improvement Act of 2018 (Public Law 115-334), known as the 2018 Farm Bill, removed “hemp” from the definition of “marihuana” under the Controlled Substances Act (CSA). Now, hemp is not considered a controlled substance. “Hemp” is defined in the 2018 Farm Bill as including cannabis and derivatives or extracts of cannabis with no more than 0.3% by dry weight of the compound delta-9 tetrahydrocannabinol (THC). The Drug Enforcement Administration (DEA) still regulates as Schedule I controlled substances those botanical raw materials, extracts, and derivatives that contain cannabis or cannabis-derived compounds with delta-9 THC content above 0.3% by dry weight.
  • Cannabis and cannabis-derived compounds – even those meeting the 2018 Farm Bill’s definition of “hemp” – are typically subject to the same FDA clinical research regulatory requirements and standards as human drug products containing other substances.

Cannabis Sources and Quality Considerations

  • Sponsors may use cannabis (including hemp) in human drug clinical research if FDA deems the cannabis to be of “adequate quality.” The agency will review quality issues in the context of an investigational new drug (IND) application.
  • Historically, the National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP) was the only domestic, federally legal source of cannabis for clinical research. That is no longer the case. Human drug sponsors may now source cannabis regulated as a Schedule I controlled substance from other DEA-authorized growers.
  • Human drug sponsors should consider the recommendations in FDA’s final guidance, “Botanical Drug Development” (Dec. 2016). Importantly, the agency does not recommend relying on published literature as a substitute for data from a full toxicology program to support drug product development for phase 3 clinical research (and beyond). Dedicated toxicology studies are specifically recommended for 7-COOH-CBD, the major human metabolite of cannabidiol.

CSA Controlled Status

  • When a drug sponsor submits an IND to FDA as part of cannabis-related human drug clinical research, the sponsor should determine the potential controlled substance status of any botanical raw materials, drug substances, and drug products by taking into consideration the delta-9 THC content. The agency encourages sponsors to calculate the delta-9 THC content in the proposed investigational product early in the drug development process and to consult with the DEA.
  • Generally, the delta-9 THC percentage in botanical raw materials is calculated as the amount of delta-9 THC (and THCA) naturally present in a material sample relative to the sample’s dry weight prior to extraction or other manufacturing steps. For intermediates or finished products containing cannabis or a cannabis-derived compound, sponsors should calculate the total delta-9 THC percentage using the composition of the formulation with the amount of water removed (including water contained by excipients). These calculations should not be used for other purposes (e.g., Chemistry Manufacturing and Controls (CMC)).
  • FDA may have concerns with drug abuse liability. As part of the agency’s review of a new drug application (NDA), FDA may conduct an abuse potential assessment. Such an assessment could impact drug product labeling as well as DEA scheduling or rescheduling.

Copyright ©2023 Nelson Mullins Riley & Scarborough LLP

For more Cannabis Legal News, click here to visit the National Law Review.

FOOTNOTES

[i] Fully synthetic versions of substances occurring in cannabis (e.g., dronabinol) fall outside the Final Guidance’s scope.

Warning Sign? A New Round of FDA Warning Letters Over CBD Consumer Confusion May Signal a Shift in Government Enforcement

FDA warning letters are nothing new in the cannabis industry. In fact, we here at Budding Trends have covered this topic a number of times (here, here, and here). Not resigned to playing the hits, however, the FDA issued a new set of warning letters on November 21 that may signal a shift in enforcement posture away from solely targeting companies that market CBD as a potential medical treatment and towards including companies that market their products in ways that could cause consumer confusion. This is a “Warning Sign” that might cause the cannabis industry “A Rush of Blood to the Head,” much like Coldplay’s multi-platinum album that recently celebrated its 20-year anniversary. So, turn back the “Clocks,” book your flight to “Amsterdam,” and indulge us if you will — just not too much.

Congress legalized the production of hemp and hemp-derived products under the 2018 Farm Bill. But federal legalization did not exempt the hemp industry from federal regulation. Indeed, the FDA and FTC retain overlapping enforcement authority over CBD marketing, with the FDA having primary authority over labeling. Far more than “A Whisper,” the FDA and FTC have not been shy about issuing warning letters to hemp companies that fail to follow the FDA’s labeling requirements and guidance.

Since its first set of warning letters to CBD companies in April 2019, the FDA has focused its enforcement activity on companies that market their CBD products as treatment and cures for a variety of diseases and illnesses. But the FDA’s most recent warning letters took a different tack, focusing on potential health risks from long-term CBD use, consumer confusion leading to unintentional or overconsumption of CBD, and CBD products that could be seen as marketed to children.

The basis of the FDA’s five new warning letters was that CBD is neither an authorized food additive nor generally recognized as safe. The FDA noted it had “not found adequate information showing how much CBD can be consumed, and for how long, before causing harm,” and claimed that “scientific studies show” potential harm to the “male reproductive system” and “liver” from long-term CBD use. In the FDA’s words, “[p]eople should be aware of the potential risks associated with the use of CBD products.”

The products highlighted in the warning letters included gummies, fruit snacks, lollipops, cookies, teas, and other beverages. The FDA said these products were targeted because consumers may confuse them for traditional foods or beverages, “which may result in unintentional consumption of overconsumption of CBD.” Further, the FDA noted that gummies, candies, and cookies are especially concerning because they may appeal to children. Likewise, the FDA cited tea, coffee, sparkling water, beverage “shots,” and honey as products similar to traditional food that may confuse consumers into over-consuming CBD.

Keeping its focus on unintended consumption or unintended overconsumption, the FDA also chastised one company for failing to specifically list CBD as an ingredient on the label of its hemp-infused tea. This is particularly important to note for hemp companies, many of which have sought to avoid listing “CBD” on the product labels for full spectrum hemp extracts in an effort to avoid the FDA and FTC’s seemingly CBD-focused enforcement actions.

Given this new enforcement posture, CBD companies may consider avoiding marketing attempts that seek to link CBD products too closely with traditional foods and beverages. This may include limiting references to the similarity of CBD products to traditional ones. And CBD companies should continue to avoid product labels and marketing campaigns that would be enticing to children, especially for CBD products that are in a form children might be likely to consume (such as gummies and candies).

It remains to be seen where the FDA will draw the line between appropriate marketing and marketing that goes too far towards confusing consumers, but, aside from a falsetto Chris Martin, “nobody said it was easy.” Until then, watch this space and remember to follow the marketing dos and don’ts we provided in one of our previous blog posts.

Article By J. Hunter Robinson and Josh Kleppin of Bradley Arant Boult Cummings LLP

© 2022 Bradley Arant Boult Cummings LLP

Employment Tip of the Month – December 2022

Q:  As an employer, am I legally required to allow employees to bring marijuana to an office holiday party?

A:  No.  While adult recreational use of marijuana is now legal in 21 states and the District of Columbia, the use of marijuana remains illegal under federal law and employers with drug-free and smoke-free workplace policies can prohibit marijuana consumption in the workplace and during employer-sponsored events. Employers who wish to prohibit use of recreational marijuana at the office holiday party should remind employees of the policies and ensure that they understand the policies apply at all employer-sponsored events – even if the event is held after work hours and off company premises.

Laws surrounding the recreational use of marijuana differ from one state to another and evolve quickly.  Before taking adverse action against an employee for marijuana use, an employer should consult the specific laws governing their jurisdiction.

Article By Laura Stutz of Wilson Elser Moskowitz Edelman & Dicker LLP

For more labor and employment law legal news, click here to visit the National Law Review.

© 2022 Wilson Elser

Voters in Two States Approve Marijuana Ballot Initiatives on Election Day 2022

Voters in Maryland and Missouri approved laws to legalize recreational marijuana on Election Day 2022.  Recreational marijuana ballot initiatives did not pass in Arkansas, North Dakota and South Dakota.

Maryland

Maryland voters approved a state constitutional amendment that will allow the use of cannabis by anyone over the age of 21 on or after July 1, 2023, subject to the General Assembly passing legislation concerning the regulation, distribution, possession and taxation of marijuana.

Missouri

Missouri voters also approved an amendment to the state constitution.  The amendment addresses both medical marijuana and recreational marijuana.

The medical marijuana law will permit nurse practitioners to recommend medical marijuana use to their patients in addition to physicians.  It also will permit the use of “marijuana-infused products,” i.e., products that are infused, dipped, sprayed, coated or mixed with marijuana or marijuana extracts.  Those products may be vaporized or smoked, or may consist of edible products, ingestible products, topical products, suppositories, and “infused pre-rolls” (a type of consumable or smokable product).  Medical marijuana cards will be valid for three years.  While the medical marijuana law does not permit operation of a motor vehicle while under the influence of marijuana, the law is now revised to say that the arrest or conviction of a medical marijuana user will require evidence that the user was in actual physical control of the motor vehicle and may not rely solely on the presence of THC or THC metabolites in the person’s system.

The medical marijuana law still prohibits legal claims against employers based on an employer’s prohibition of being under the influence of marijuana while at work.  However, new provisions state that employers may not discriminate against medical marijuana users unless:  failure to do so would result in the loss of a monetary or licensing-related benefits under federal law, or unless the person was under the influence of marijuana on the employer’s premises or during work hours.

The constitutional amendment also permits the recreational use of marijuana by adults age 21 and older.  Employers are not required to permit or accommodate the use of marijuana at work or on the employer’s property.  Employers are permitted to take adverse employment actions if a person is working while under the influence of marijuana.

The law does not define the phrase “under the influence of marijuana” so it is unclear whether employers may rely on positive drug test results for marijuana to prove an employee was “under the influence.”

Finally, the new law will allow individuals who are serving prison sentences for certain crimes including possession of up to three pounds of marijuana to petition the sentencing court to vacate the sentence, order immediate release and expunge the government’s records.  There are additional provisions addressing expungement of criminal records for those who previously served prison sentences related to certain marijuana-related crimes.

The Missouri constitutional amendment will take effect thirty days after the election.

Employers in Maryland and Missouri should review their drug and alcohol policies to ensure compliance with these new laws.

Article By Kathryn J. Russo of Jackson Lewis P.C.

For more biotech, food, and drug law legal news, click here to visit the National Law Review.

Jackson Lewis P.C. © 2022

Presidential Pardon for Simple Marijuana Possession Leaves Out Many

Severe immigration consequences for certain non-U.S. citizens remain despite President Joe Biden’s pardon of all prior federal offenses for simple marijuana possession.

On October 6, 2022, President Biden took a major step toward the decriminalization of marijuana, pardoning all prior federal offenses for simple marijuana possession. Although this pardon will affect only approximately 6,500 individuals who were convicted of simple marijuana possession under federal law before October 6, 2022, it does not affect the much larger number of individuals who have been convicted of a marijuana possession offense under state law. To the disappointment of immigration advocates, the pardon does not benefit non-U.S. citizens who were not lawfully present in the United States at the time of their conviction, even if their conviction was under federal law.

Moreover, because marijuana is still listed as a Schedule I drug under the federal Controlled Substances Act:

  • Non-U.S. citizens can still be denied entry to the country for use of marijuana or for working or actively investing in the marijuana industry;

  • Immigration authorities may deny a non-U.S. citizen’s application for lawful permanent residence (green card) or naturalization on the ground that they have a conviction for a marijuana-related offense, an admission by the non-U.S. citizen that they have used marijuana in the past, or that they have worked or is actively investing in the marijuana industry; and

  • The Department of Homeland Security can still place individuals, including green card holders, into removal proceedings (deportation) as a result of marijuana-related offenses, unless the conviction was for simple possession of less than 30 grams.

In his order, President Biden urged governors to consider similar state law pardons for simple marijuana possession charges, which might affect many more individuals. President Biden has also asked the Department of Health and Human Services to consider changing the current Schedule I classification for marijuana. If one of these changes occurred, non-U.S. citizens would substantially benefit, as their state convictions for marijuana-related offenses might be pardoned, thus lowering the negative consequences for immigration purposes.

For now, however, non-U.S. citizens should still be wary of marijuana use, or working or investing in the marijuana industry, even in places in the United States or abroad where those activities are legal. While there may not be federal prosecutions for the use and possession of marijuana, there may be severe immigration consequences for non-U.S. citizens, because the use and possession of marijuana remains illegal in certain states.

Article By Carolina Guiral Cuervo of Jackson Lewis P.C.

Jackson Lewis P.C. © 2022

Five New Employment Laws that Every California Employer Should Know

A new year brings new employment laws for California employers.  California employers will want to begin revising employee policies and handbooks now, so that they are prepared to comply with these new laws when the majority of them go into effect on January 1, 2023.  Here are five new employment laws that every California employer should know:

AB 1041 (Expanded Definition of “Family Member” for Medical and Sick Leave)

Through AB 1041, the California legislature amended Government Code section 12945.2 and Labor Code section 245.5 to expand the definition of “designated person” for purposes of employee medical leave.  Section 12945.2 provides qualifying employees with up to 12 workweeks in any 12-month period for unpaid family care and medical leave.  Section 245.5 relates to California paid sick leave.  Both sections permit an employee to take protected leave to care for a “family member,” which is currently defined as a child, parent, grandparent, grandchild, sibling, spouse, or domestic partner.  With the passage of AB 1041, the Legislature added a “designated person” to this list of “family members” for whom an employee may take protected leave.  A “designated person” is defined as “any individual related by blood or whose association with the employee is the equivalent of a family relationship.”  In light of this broad definition, employers should be prepared to provide employees with leave to care for a wider range of persons.  An employee may identify his or her designated person at the time of requesting protected leave.  However, an employer may limit an employee to one designated person per 12-month period.

AB 1949 (Bereavement Leave)

AB 1949 adds section 12945.7 to the Government Code, in order to provide employees with protected leave for bereavement.  Under this new law, eligible employees may request up to five days of bereavement leave upon the death of a qualifying family member.  Family member is defined as a spouse, child, parent, sibling, grandparent, grandchild, domestic partner, or parent in law.  Although the employee must complete bereavement leave within three months of the family member’s death, the employer may not require that the five days be used consecutively.  Statutory bereavement leave is unpaid, but the employer must allow the employee to use any accrued and unused paid vacation, personal leave, sick leave, or other paid time off for this purpose.  Section 12945.7 prohibits discrimination, interference or retaliation against an employee for taking bereavement leave; also, the employer must maintain confidentiality when an employee takes bereavement leave. Finally, section 12945.7 does not apply to certain union employees, with an existing agreement regarding bereavement leave.

SB 1162 (Posting Pay Ranges and EEO Reporting Requirements)

SB 1162 modifies Government Code section 12999 and Labor Code section 432.3 to require employers to provide candidates with salary ranges on job postings, report employee compensation and demographic information to the California Civil Rights Department (formerly the DFEH) on an annual basis, and retain relevant records.  For job postings (including those posted by third parties), employers with 15 or more employees will be required to include a pay range, which is defined as the salary or hourly wage range that the employer reasonably expects to pay for the position.  In addition to the current requirement that, upon request, the employer must provide a candidate a pay range, the employer must now also provide existing employees with a pay range, when requested.  Failure to comply with the pay range disclosure or record retention requirements can result in penalties of up to $10,000 per violation.

The new reporting requirement concerns annual employer pay data reports.  Employers must now report the median and mean hourly rate by each combination of race, ethnicity, and sex, within each job category, with the first report due on May 10, 2023, based on 2022 pay data.  Employers with 100 or more employees hired through labor contractors must now produce data on pay, hours worked, race/ethnicity, and gender information in a separate report.  Employers who fail to timely file these required reports face civil penalties of up to $200 per employee.

Finally, employers must retain records of job titles and wage rate histories for each employee for the duration of the employee’s employment and three years after termination.  Failure to comply with these retention requirements can result in penalties of up to $10,000 per violation.

AB 2188 (Off the Job Cannabis Use Protection)

Effective January 1, 2024, AB 2188 adds section 12954 to the Government Code, which prohibits employers from discriminating against a person because of cannabis use while off the job, with some exceptions.  Employers may take action against a person who fails a pre-employment drug test, or other employer-required drug test, that does “not screen for non-psychoactive cannabis metabolites.”  This is because, according to the California Legislature, cannabis “matabolites do not indicate impairment, only that the individual has consumed cannabis in the last few weeks.”  The employer may administer a performance-based impairment test, and terminate any employee who is found to be impaired in the workplace.  This new law does not apply to employees in the building or construction industry, or in positions requiring a federal background investigation or clearance, and does not preempt state or federal laws that require employees to be tested for controlled substances.

AB 152 (COVID-19 Supplemental Paid Sick Leave Extension)

AB 152 modified Labor Code section 248.6 and 248.7 in order to extend COVID-19 Supplemental Paid Sick Leave (SPSL), previously blogged about here, which was expected to expire on September 30, 2022.  This new modification allows California employees to use any remaining SPSL through December 31, 2022.  It does not provide employees with new or additional SPSL.  In a departure from the original version of the law, when an employer requires an employee to take a COVID-19 test five days or later after a positive test result, the employer is now permitted to require the employee to submit to a second diagnostic test within no less than 24 hours.  If the employee refuses, the employer may decline to provide additional SPSL.  The employer obligation to cover the cost of any employee COVID-19 tests remains in effect.

Article By Kate Gold and Wesley C. Shelton of Proskauer Rose LLP

For more employment law legal news, click here to visit the National Law Review.

© 2022 Proskauer Rose LLP.

Biden’s Statement on Marijuana Reform: What Does it Mean?

While states continue moving to legalize cannabis, change has been slower to nonexistent at the federal level. That may have changed last week with President Biden’s statement on marijuana reform, announcing that he was pardoning citizens with federal convictions of simple possession of marijuana. He also directed an administrative review of how marijuana is scheduled under the Controlled Substances Act (CSA).

The cannabis industry has grown into a multibillion dollar industry with recreational use legalized in 19 states and medicinal use legalized in 18 states. In November, voters in five more states (Arkansas, Maryland, Missouri, North Dakota, and South Dakota) will decide whether to legalize recreational use marijuana. While the President’s statement likely represents the largest shift in federal marijuana policy in the last 50 years, significant questions still remain as to what changes will take place, when those changes will occur, and what it means for the cannabis industry.

A Review of Marijuana Scheduling

President Biden’s directive to review scheduling doesn’t change the current federal restriction on marijuana. In 1970, under the CSA, marijuana was categorized, alongside heroin and LSD, in the most prohibitive classification as a Schedule I drug. In the five-tier scheduling, Schedule I drugs are deemed to be “drugs with no currently accepted medical use and a high potential for abuse.”

Health and Human Services Secretary Xavier Becerra has indicated his agency will move “as quickly as we can but, at the end of the day science is going to take us to a solution.” The review of federal scheduling will be tasked to the Food and Drug Administration (FDA) which will conduct a scientific and medical analysis (including to determine currently accepted medical uses and potential for abuse) to make a recommendation on scheduling to the Drug Enforcement Agency (DEA). The CSA authorizes the DEA to move a drug to a lower schedule or remove it entirely. Moving as quickly as possible, the review process will take some time. Even with an administrative rescheduling review, the question remains as to what rescheduling would take place.  Would marijuana be moved to Schedule II (with cocaine, fentanyl, and methamphetamine) or Schedule III (with anabolic steroids) or removed from the CSA entirely?

Aside from the FDA evaluation and DEA rescheduling, Congress could also choose to enact legislation amending the CSA and removing marijuana from Schedule I. While the MORE Act was passed by the US House, the Senate has not yet seen sufficient support to pass legislation to remove marijuana’s Schedule I status.

Presidential Pardons

President Biden’s blanket pardon only impacts those people with federal (or Washington DC) convictions for simple marijuana possession. The impact of this pardon is modest as The White House estimates only 6,500 people will be affected by the decision. The President asked Attorney General Merrick Garland to develop and announce an application procedure for certificates of pardon for these individuals.

The vast majority of marijuana possession convictions are state-level convictions.

The vast majority of marijuana possession convictions are state-level convictions. The President also encouraged governors to offer pardons for state marijuana possession offenses. While he does not have the power to compel states to act, many states that have legalized marijuana have, in efforts to address social equity, already taken steps to remove old state marijuana possession convictions. Additionally, in an election year, several governors or gubernatorial candidates have already reacted to the President’s announcement. Those reactions “run the gamut” from complete support to concerns levied about drug abuse and rising crime.

For example, North Carolina Governor Roy Cooper and Attorney General Josh Stein have called for decriminalizing marijuana use and starting a review to expunge prior state convictions for simple possession. His comments mark the first time Governor Cooper has explicitly endorsed the decriminalization reform recommended by the Task Force for Racial Equity in Criminal Justice he convened in 2020.

Impact and Implications

Aside from the federal pardons, the true impact of last week’s statement on the cannabis industry remains to be seen. White House support may impact voters, governors, and candidates in states attempting to legalize marijuana at the state level. At a federal legislation level, White House support may impact stalled marijuana legislation such as the SAFE Banking Act, which would have significant impact on the cannabis industry by paving the way to greater access to financial institutions and services. While the cannabis industry continues to deal with the patchwork of state legalization and federal regulations, last week’s White House support marks a paradigm shift in a half-century federal policy on marijuana.

For more Food and Drug Law News, click here to visit the National Law Review

Copyright © 2022 Womble Bond Dickinson (US) LLP All Rights Reserved.

BREAKING NEWS: Biden to Pardon Federal Marijuana Possession Convictions

In a historic move, today, President Joe Biden announced a three-step program to bring broad changes to federal cannabis policy. As an initial step towards reform, President Biden will pardon all federal offenders convicted of simple marijuana possession. According to administration officials, the pardons will be issued through an administration process overseen by the Department of Justice. Those eligible for the pardons will receive documentation showing they were officially forgiven for their crime.

“No one should be in jail just for using or possessing marijuana,” Biden said in a video announcing his executive actions. “It’s legal in many states, and criminal records for marijuana possession have led to needless barriers to employment, housing, and educational opportunities. And that’s before you address the racial disparities around who suffers the consequences. While white and Black and brown people use marijuana at similar rates, Black and brown people are arrested, prosecuted, and convicted at disproportionate rates.”

“Too many lives have been upended because of our failed approach to marijuana. It’s time that we right these wrongs,” the President said.

As a second step in the program, Biden also encouraged Governors to take similar steps to pardon state simple cannabis possession charges.

And as the last step in this program, President Biden directed the Department of Health and Human Services and Attorney General Merrick Garland to “expeditiously” review the cannabis’s status as a Schedule I controlled drug pursuant to the federal Controlled Substances Act.

Article By Sarah A. K. Blitz and Whitney Hodges of Sheppard, Mullin, Richter & Hampton LLP

For more cannabis legal news, click here to visit the National Law Review.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.

California Enacts Legal Protections for Cannabis Insurance Providers

Several cannabis-related bills were signed by California Governor Gavin Newsom on September 18, 2022, including Assembly Bill 2568 (AB 2568), which clarifies that it is not a crime for individuals and firms licensed by the California Department of Insurance (CDI) to provide insurance or related services to persons licensed to engage in commercial cannabis activities. Though the California Civil Code was amended in 2018 to clarify that cannabis is the legal object of a contract, and it has been tacitly understood that insurance contracts are legal in California, the intent of this new law is to remove any uncertainty and to encourage further growth of admitted insurance products for California cannabis businesses.

AB 2568 adds section 26261 to the California Business and Professions Code, which states in relevant part: “An individual or firm that is licensed by the Department of Insurance does not commit a crime under California law solely for providing insurance or related services to persons licensed to engage in commercial cannabis activity pursuant to this division.”

Intent of the Law

The California Assembly’s Committee on Insurance explained the intent behind AB 2568 in a report issued earlier this year:

“The hesitancy of insurance providers to provide insurance for commercial cannabis is attributed to risk, since cannabis is classified as a Schedule I substance under the Federal Controlled Substances Act. Therefore, much of the insurance available in California is from surplus lines. This does not align with the federal government’s longstanding determination that it is in the public’s interest for states to regulate their own insurance marketplaces. Further, the argument has been refuted in federal case law brought about in Green Earth Wellness Center v. Attain Specialty Insurance Company (2016), which established that federal classification of cannabis is not relevant in an insurance provider’s determination to write an insurance policy.

It is important that commercial cannabis businesses have multiple options for insurance as they pursue licensure. AB 2568 clarifies that writing insurance for commercial cannabis does not constitute a crime, since cannabis is part of a legal, regulated market in California. This clarity will provide assurances to admitted insurers that they will not be in violation of any regulations and encourage them to provide an insurance product.”

In addition, AB 2568 was strongly supported by CDI, which argued that “we must provide commercial cannabis businesses with multiple, affordable options for insurance as they pursue and maintain state licensure.” CDI supports AB 2568 in part to “promote reliable insurance coverage for all aspects of these cannabis businesses to ensure that these businesses can continue to flourish just like any other business in this state.”

In a separate analysis, the California Senate Committee on Insurance inquired as to whether the bill would achieve the intended result of expanding insurance options for cannabis businesses. It concluded:

“This bill expressly states a protection under California Law for CDI licensees. This protection has been implied since the legalization of recreational cannabis in 2016, and in that same year a federal court gave a nod to insurers that writing cannabis [insurance] is permissible, but only one admitted company has fully waded into the market. On the one hand, insurers are famously risk averse, so this express statement of state law may go a long way for some to take the risk to sell cannabis coverage. But, federal illegality of cannabis could always be the larger barrier to entry for some companies than what the state laws say.”

The Senate report concludes that more study is needed to “consider additional efforts to effectuate the stated goal of growing the domestic market for cannabis insurance.”

Analysis

AB 2568 does not materially change existing California law since providing insurance services to properly licensed California businesses has been legal under state law since at least 2018. The bill, however, is meant to remove any lingering doubt on the topic and to encourage more insurance service providers to enter the market.

As we have previously reported, it is reasonable to conclude that the risk-benefit calculus has adequately shifted to justify entrance into the cannabis market without an unreasonable fear of prosecution. This certainly is true for the insurance industry.

Congress continues to prohibit the Department of Justice and other federal agencies from spending money to prosecute conduct that complies with state medical marijuana laws. Federal law enforcement, meanwhile, has not initiated any prosecution against a plant-touching or ancillary business involved in either adult-use cannabis or medical marijuana where the underlying marijuana business activity was compliant with state law and there was no other independent violation of law.

Despite this favorable outlook, it must be acknowledged that, without a change to the status quo, some degree of theoretical legal risk remains present for any plant-touching or ancillary business in the marijuana industry. Any decision to provide insurance-related services to the cannabis industry must be based on a well-informed understanding of the legal risks and the very challenging operating environment for state-licensed cannabis companies.

For more Food and Drug Legal news, click here to visit the National Law Review.

© 2022 Wilson Elser

In One Day, California Governor Signs Into Law Ten Cannabis Bills, Including Authorization for Interstate Commerce

Acting in one fell swoop, on September 18, 2022, California Governor Gavin Newsom signed 10 cannabis-related legislative bills into law. These bills, which touch on issues that run the gamut of the cannabis industry, are intended to “strengthen California’s cannabis laws, expand the legal cannabis market and redress the harms of cannabis prohibition.” Senate Bill 1326 is the most widely recognized bill of the group, and authorizes the Governor the power to sign cannabis trade agreements with other states where cannabis is legal. Other bills address employment protection, labelling, use of cannabis in veterinary medicine and taxation. In his press release, Governor Newsom said: “For too many Californians, the promise of cannabis legalization remains out of reach. These measures build on the important strides our state has made toward this goal, but much work remains to build an equitable, safe and sustainable legal cannabis industry.”

Still before Governor Newsom for his signature is SB 1496, which would implement a series of changes to the state’s cannabis tax policy, including authorizing regulators to extend the deadline for tax payments by cannabis businesses located in areas affected by an emergency proclamation by the Governor.

Below is a discussion of the cannabis-centric Senate and Assembly bills adopted during the 2022 Legislative session.

SB 1326 – Cannabis: Interstate Agreements

SB 1326 adds Chapter 25 to the Business and Professions Code and allows for interstate cannabis commerce from California to and from other states that recognize the legality of cannabis cultivation, production, distribution and/or possession. While seemingly revolutionary, SB 1326 is contingent on an official assurance that the activity would not result in federal enforcement action against California – meaning, most likely, that this bill cannot be utilized until cannabis is federally decriminalized.

Historically, California is an industry leader in product quality and innovation, and this bill, according to SB 1326’s author, Senator Anna Caballero, “provides a relief valve for the oversupply of cannabis, an opportunity to grow California’s brand and market share, support job creation, and gives the state a competitive advantage as federal policy develops…SB 1326 is an essential step to ensure that California can fully capitalize on, and remain a leader in, the forthcoming national cannabis market. Furthermore, SB 1326 would allow California to use its own labor, environmental, and product quality standards be adopted in other states.”

SB 1186– Medicinal Cannabis Patients’ Right of Access Act

SB 1186 prohibits a local jurisdiction from adopting or enforcing any regulation that prohibits the delivery of a medicinal cannabis retail sale to medicinal cannabis patients or their primary caregivers by medicinal cannabis businesses, or that has the effect of prohibiting such delivery. The bill’s author, Senator Scott Weiner, states this bill is a victory for seniors living with chronic illness, and will both improve patient access and help fill voids throughout the state where no cannabis license types have been authorized.

AB 1646 – Cannabis Packaging: Beverages.

AB 1646 authorizes cannabis beverages to be packaged in containers of any material that are clear or any color.

AB 1706 – Cannabis Crimes: Resentencing.

If an eligible cannabis conviction was not challenged by July 1, 2020, AB 1706 requires the California court system to process record sealing and other forms of relief for such convictions by March 1, 2023. AB 1706 also requires the Department of Justice to complete an update of the State’s summary criminal history information database, and ensure that inaccurate state summary criminal history is not reported. The Department of Justice is also required to conduct an awareness campaign so that individuals that may be impacted by this process become aware of methods to verify updates to their criminal history. The bill would make a conviction, arrest, or other proceeding that has been sealed pursuant to these provisions deemed never to have occurred.

AB 1885 – Cannabis & Cannabis Products: Animals: Veterinary Medicine

AB 1885 expands the purpose of the comprehensive system established by Medicinal and Adult-Use Cannabis Regulation and Safety Act (MAUCRSA) to include the control and regulation of the cultivation, distribution, transport, storage, manufacturing, processing, and sale of cannabis products intended for use on, or consumption by, animals. The bill makes various related revisions to the definitions under MAUCRSA, would exclude livestock and food animals, as specified, from the definition of “animal,” for these purposes, and would specify that cannabis concentrate and edible cannabis products are not considered processed pet foods as defined under the Pure Pet Food Act of 1969.

AB 1885 would also prohibit the Veterinary Medical Board within the Department of Consumer Affairs from disciplining a veterinarian who recommends the use of cannabis on an animal for potential therapeutic effect or health supplementation purposes, unless the veterinarian is employed by or has an agreement with a cannabis licensee. Under this bill, the Veterinary Medical Board is required to adopt guidelines, by January 1, 2024, for veterinarians to follow when recommending cannabis within the veterinarian-client-patient relationship, and would require the Veterinary Medical Board to post the guidelines on its internet website.

Lastly, AB 1885 would require that cannabis products intended for animals comply with additional concentration and other standards adopted by regulation. These regulations must be promulgated no later than July 1, 2025, and would prohibit the marketing or sale of those products before the regulations take effect.

AB 1894 – Integrated Cannabis Vaporizer: Packaging, Labeling, Advertisement, & Marketing

AB 1894 requires the advertisement and marketing of a cannabis cartridge and an integrated cannabis vaporizer to prominently display a specified message to properly dispose of a cannabis cartridge and an integrated cannabis vaporizer as hazardous waste. This bill also prohibits the package, label, advertisement, and marketing from indicating that the cannabis cartridge or integrated cannabis vaporizer is disposable or implying that it may be thrown in the trash or recycling streams.

AB 2210 – Cannabis: State Temporary Event Licenses: Venues Licensed by the Department of Alcoholic Beverage Control: Unsold Inventory

AB 2210 prohibits Department of Cannabis Control (DCC) from denying an application for a state temporary event license solely on the basis that there is a license issued pursuant to the Alcoholic Beverage Control Act for the proposed premises of the event. It also prohibits the Department of Alcoholic Beverage Control from taking disciplinary action against a person licensed pursuant to the Alcoholic Beverage Control Act on the basis of a state temporary event license issued by the DCC to a licensee that utilizes the same premises.

AB 2210 requires all on- and off-sale privileges of alcoholic beverages at the venue to be suspended for the day of the event until 6 a.m. on the day after the event has ended, and would prohibit all alcohol consumption on the venue premises for the day of the event, until 6 a.m. on the day after the event has ended. All inventory of cannabis or cannabis products to be sold by a state temporary event license to be transported to and from the temporary event by a licensed distributor or licensed microbusiness. A state temporary event licensee, upon completion or cessation of the temporary event, is authorized to reconcile unsold inventory of cannabis or cannabis products and return it to the licensee’s retail premises.

AB 2188 – Discrimination in Employment: Use of Cannabis[1]

AB 2188 makes it unlawful for an employer to discriminate against a person in hiring, termination, or any term or condition of employment, or otherwise penalize a person” solely because of off-duty, off-site cannabis use. The bill will also eliminate employment-based THC testing, with exceptions for certain positions, such as federal employees or those working in the building and construction trades. AB 2188 does not preempt state or federal laws requiring applicants or employees to be tested for controlled substances as a condition of employment, receiving federal funding or federal licensing-related benefits, or entering into a federal contract.

AB 2568 – Cannabis: Insurance Providers.

AB 2568 provides it is not a crime for individuals and firms to provide insurance and related services to persons licensed to engage in commercial cannabis activity.

AB 2925 – California Cannabis Tax Fund: Spending Reports.

AB 2925 requires that the State Department of Health Care Services submit reports to the legislature, starting no later than July 10, 2023, that accounts for cannabis tax revenue that has been distributed to the Youth Education, Prevention, Early Intervention and Treatment Account, as required under MAUCRSA.

For more Biotech, Food, & Drug Law news, click here to visit the National Law Review.

FOOTNOTES

[1] AB 2188 is discussed in further detail here.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.