Controlled Substances and Regulatory Law

New Cannabis License Categories Will Become Available in New Jersey

Ansell Grimm August 4, 2023

Beginning September 27, 2023, the New Jersey Cannabis Regulatory Committee (“CRC”) will open three new adult-use cannabis license categories- Wholesaler, Delivery, and Distribution- in the Garden State. Ansell Law remains prepared to assist clients seeking to secure one of these new license types as opportunities in this exciting industry develop.

Wholesale-Class Three License: A marijuana wholesaler license, also called a Class 3 license in New Jersey, allows the holder to purchase or obtain, store, sell or transfer, and transport marijuana products for resale or to other cannabis wholesalers or retailers.
Distribution-Class Four License: A cannabis distributor, also a Class 4 license, enables distributors to transport marijuana items in bulk intrastate from one licensed marijuana establishment to another and store the marijuana or marijuana products briefly, if necessary, to fulfill their duties in transporting the goods.
Delivery- Class Six License: A delivery license or Class 6 license offer a cost-effective gateway for many aspiring entrepreneurs to enter the cannabis industry. Similar to food delivery services such as GrubHub or DoorDash, these licenses empower businesses to Transport a consumer’s purchases of recreational use cannabis and related supplies from the retailer to that consumer from cannabis retailers.

With 9 million residents, millions of annual visitors, a higher-than-average national income, and an estimated adult-use market that is projected to generate $850 million-$950 million in annual retail sales by 2024, the CRC’s rollout of Class Three, Four, and Six licenses represents a significant advance in the already lucrative and flourishing State cannabis market.

Starting September 27, social equity applicants—including those with previous marijuana-related convictions and individuals from economically disadvantaged regions seeking wholesale, distributor, and delivery licenses get priority for three months. Then for the next three months, diversely owned cannabis businesses—owned by women, minorities, or disabled veterans—receive priority.

Our Controlled Substances and Regulatory Practice attorneys understand the complex laws related to the production, sale, use, regulation, and legalization of controlled substances, including hemp, cannabis, and psychedelics. A multifaceted area of the law with conflicting regulations from different governing bodies, we help our clients navigate all aspects of this emerging field. We are committed to helping our clients understand their rights and opportunities in this evolving area of law.

New Coalition Ups the Pressure on Biden Administration to Finally Deschedule – or at Least Reschedule — Cannabis From List of Controlled Substances

Ansell Grimm July 26, 2023

By Joshua S. Bauchner –

With most Americans now living in states that have legalized adult-use cannabis, the federal foot-dragging on the removal of cannabis from the list of Schedule I controlled substances is more unsupportable, unsustainable, and illogical than ever. This classification means cannabis is considered to have no accepted medical use, a high potential for abuse, and no accepted safety standards even under medical supervision – all criteria which are unsupported and contradicted by the evidence. But even though grouping marijuana with such drugs as cocaine, heroin, and methamphetamines under the federal Controlled Substances Act (CSA) never made much scientific or societal sense, efforts to correct this long-standing error were consistently met with opposition, inertia, and inaction.

Now, a new coalition of cannabis lawyers, researchers, activists, and businesses is ramping up pressure on the Biden administration to finally address the issue and either remove cannabis from the CSA’s list of controlled substances or reschedule it to a lower tier. On June 26, 2023, the recently formed Coalition for Cannabis Scheduling Reform submitted a comprehensive report to the administration that methodically and persuasively makes a case for the multidimensional benefits of descheduling or rescheduling.

The report comes at a cautiously optimistic time for descheduling advocates, as President Biden has expressed more openness to changing marijuana’s classification than any of his predecessors. But he does not have the power to do so with the stroke of a pen. Accordingly, in October 2022, the president asked the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) to initiate an administrative process to review the propriety of marijuana’s classification under the CSA.

Before initiating proceedings to schedule, reschedule, or deschedule a drug, the U.S. Drug Enforcement Administration (DEA) must gather necessary data, request a scientific and medical evaluation from HHS, and request a scheduling recommendation from HHS. This process also includes a review by the Food and Drug Administration (FDA) as to appropriately regulating cannabis.

In its report, the CCSR said that “Descheduling is the optimal outcome and the one that would mark the greatest improvement over the status quo possible without congressional intervention,” It argued that “Descheduling marijuana is sound public policy, supported by both the science and the law, as recent and compelling medical and public health data clearly demonstrate that marijuana simply does not belong in the CSA at all.”

However, the authors continued, if the FDA “determines that it cannot find its way to recommending marijuana descheduling, the Agency should instead recommend rescheduling to schedule III, IV, or V.”

HHS Secretary Xavier Becerra recently said that he hopes his agency will be able to present the president with a scheduling decision by the end of this year. While most observers believe that the FDA is more likely to reschedule cannabis than deschedule it entirely, any progress on the federal front would be better than the current state of affairs.

Ansell’s dedicated Controlled Substances & Regulatory Law Practice Group has an in-depth understanding of the laws related to the production, sale, use, regulation, and legalization of controlled substances, including hemp, cannabis, and psychedelics. Controlled substances law remains a multifaceted and complex field with, at times, conflicting regulations from different governing bodies. Our attorneys are prepared to assist in all aspects of this emerging field. They are committed to helping our clients understand their rights and the opportunities in this complex and evolving area of law. For additional information, please contact Joshua S. Bauchner at (973) 247-9000 or jb@ansellgrimm.com.

Joshua Bauchner and Kelsey Barber Present on New Jersey Marijuana Business Operations

Ansell Grimm July 20, 2023

Shareholder Joshua S. Bauchner and associate Kelsey M. Barber will present during the National Business Institute’s Marijuana Operations in New Jersey seminar. They will address critical human resources, labor, and employment issues affecting marijuana and cannabis businesses operating in New Jersey. Their session includes key considerations for hiring and training employees, navigating 401k issues specific to the industry, and understanding corporate governance. Bauchner and Barber also will provide an ethics presentation exploring rules of professional conduct, the duty to pursue justice, attorney use of cannabis, and attorney ownership of cannabis businesses.

The full-day seminar will be offered live online on August 21, 2023, and available to view on demand. Learn more and register for this information-packed program presented by cannabis industry leaders.

As one of the most rapidly evolving industries today, lawyers in the cannabis space must be educated on licensing, operations, and employment issues such as drug testing. Contact an attorney in our Controlled Substances and Regulatory Law Practice Group with any questions about this emerging area of law.

In Major Advancement, FDA Issues First-Ever Draft Guidance on Clinical Trials for Psychedelic Drugs

Ansell Grimm July 10, 2023

By Josh Bauchner –

Maligned, stigmatized, and marginalized for decades, psychedelic drugs have long been off-limits for researchers and others who wanted to explore the potential therapeutic uses of these substances for various conditions, including PTSD, depression, substance abuse, and anxiety. Now, in a significant step that offers the promise of new medical treatments and advancements, the U.S. Food and Drug Administration (FDA) issued its first-ever guidance for those wishing to study and test psychedelics for medicinal use.

Released on June 23, 2023, the FDA’s draft guidance contains non-binding recommendations for designing clinical trials for psychedelic drugs. According to the FDA, the draft guidance aims to “advise researchers on study design and other considerations as they develop medications that contain psychedelics.” As used within the guidance, the term “psychedelics” refers to “‘classic psychedelics,’ typically understood to be drugs such as psilocybin and lysergic acid diethylamide (LSD) that act on the brain’s serotonin system, as well as ‘entactogens’ or ’empathogens’ such as methylenedioxymethamphetamine (MDMA).”

The guidance discusses basic considerations throughout the drug development lifecycle, including trial conduct, data collection, participant safety, and new drug application requirements. Emphasizing psychedelics’ potential for abuse and psychoactive effects such as hallucinations and mood and cognitive changes, the FDA notes that this creates “a drug safety issue that requires careful consideration and putting sufficient safety measures in place for preventing misuse throughout clinical development.” This includes addressing potential interactions with drugs like antidepressants or lithium and “the role of psychotherapy in psychedelic drug development, considerations for safety monitoring and the importance of characterizing dose-response and the durability of any treatment effect.”

Outlining the needed steps for psychedelic drug testing and study, the FDA provides recommendations for nonclinical safety and toxicology studies, with examples of when extensive previous trial data could substitute typical animal toxicology testing in trials under an Investigational New Drug Application (INDA). The guidance notes that since psychedelics are Schedule I controlled substances, activities associated with investigations under an INDA must comply with applicable Drug Enforcement Administration regulations.

The FDA released its guidance days after legislation was introduced in Congress with bipartisan support directing the agency to do so. While it is unclear what the guidance will look like in its final form after the 60-day public comment period, the legislative and regulatory movement to allow for more research and testing of psychedelics for therapeutic use is a positive development for individuals seeking relief from a wide range of debilitating conditions.

If you have questions or concerns about the FDA’s draft guidance, please contact an attorney in Ansell.Law’s Controlled Substances and Regulatory Law Practice Group.

Congratulations to Joshua S. Bauchner on His Achievements as the New Jersey State Bar Association’s Cannabis Law Committee Co-Chair

Ansell Grimm June 9, 2023

Ansell Grimm & Aaron, PC congratulates shareholder Joshua S. Bauchner on his many achievements as co-chair of the New Jersey State Bar Association’s Cannabis Law Committee. Along with co-chair Lisa A. Gora, a partner at Epstein Becker & Green, Joshua led the Committee in making significant advancements, including:

Hosting eight CLEs at the Law Center on a range of cannabis-related topics.
Hosting three CLE panels at the State Bar Convention.
Expanding the Committee to include psychedelics.
Preparing two Reports and Recommendations to the New Jersey Cannabis Regulatory Commission on its initial Rules and Regulations.

The Committee also laid the groundwork for new initiatives in the 2023-2024 term, including promoting expungements of cannabis-related convictions and developing guidelines for Workplace Impairment Recognition Experts (WIREs).

We commend Joshua Bauchner and Lisa Gora, and all of their colleagues on the Committee, and thank them for their leadership and commitment to the practice of controlled substance and regulatory law. You can read their letter to the Committee here.

The New Jersey State Bar Association’s Cannabis Law Committee was formed to bring together attorneys to examine the many legal issues that stem from the medicinal and adult-use access to cannabis.

New Jersey State Bar Association Cannabis Law Committee Announces New Initiatives

Ansell Grimm June 8, 2023

The New Jersey State Bar Association recently welcomed new co-chairs of its Cannabis Law Committee. The Committee also announced vital new initiatives related to the cannabis industry which are being pursued in the 2023-2024 term. The committee was previously co-chaired by Ansell Grimm & Aaron shareholder Joshua S. Bauchner and Epstein Becker & Green partner Lisa A. Gora. Bauchner and Gora chaired the Committee for two terms concluding on June 30, 2023.

The new initiatives, announced at the May NJSBA convention in Atlantic City, will promote expungements of cannabis-related convictions and develop guidance for Workplace Impairment Recognition Experts (WIREs). The new committee co-chairs also plan to support increased education at local bar associations. Bauchner, in his role as outgoing co-chair, is quoted in an article discussing these new appointments and initiatives. Read the article here.

As one of the most rapidly evolving industries today, lawyers in this space must be educated on licensing, operations, and employment issues such as drug testing. Contact an attorney in our Controlled Substances and Regulatory Law Practice Group with any questions in this emerging area of law.

Ansell Grimm & Aaron Client Secures Cannabis Licenses

Ansell Grimm June 6, 2023

Ansell Grimm & Aaron is pleased to congratulate its latest client on securing a cannabis license from the New Jersey Cannabis Regulatory Commission. Mule Extracts LLC was awarded an Annual Class One Cultivator License.

Our Controlled Substances and Regulatory Practice attorneys understand the complex laws related to the production, sale, use, regulation, and legalization of controlled substances, including hemp, cannabis, and psychedelics. A multifaceted area of the law with conflicting regulations from different governing bodies, we help our clients navigate all aspects of this emerging field. Contact one of our attorneys if you have questions about this evolving area of law.

Ansell.Law Secures Micro-license and Zoning Site Approval for Cannabis Retailer in Monmouth County

Ansell Grimm May 19, 2023

Establishing a retail cannabis facility in New Jersey is a long and complicated process. Although adult recreational cannabis use is now legal in New Jersey, local municipalities have their own regulations limiting or prohibiting recreational-use retailers. Before opening a retail location, recreational cannabis retailers must first successfully navigate through a complex and rigorous licensing process with the State of New Jersey.

After obtaining a license from the state, retailers are then faced with the arduous task of working through the maze of local regulations and zoning rules to secure approvals for a suitable location for their store.

The firm’s Controlled Substances and Regulatory Practice Group, led by attorneys Joshua S. Bauchner and Kelsey M. Barber, secured a “Micro” license for its client, Canopy Crossroad, which classification requires, among other things, that ownership of the cannabis retailer consists of local residents. After clearing that first hurdle, Canopy Crossroad needed to find and secure a location for its store and then undertake the challenging local municipal zoning approval process. They decided on Red Bank, a town that had agreed to opt-in to New Jersey’s law allowing the sale of cannabis. But before opening their dispensary, Canopy Crossroad needed approval from the Borough’s Planning Board.

As a full-service firm with cross-disciplinary practice areas, our client then was able to work with Rick Brodsky, of the Land Use and Zoning Law Department, who appeared before the Red Bank planning board on Monday, May 1^st, and Monday, May 16^th, for hearings on Canopy Crossroad’s application for site plan approval to open their retail outlet. After a heated debate among Brodsky, representatives of Canopy Crossroad, the Red Bank Planning Board, and opponents to opening a cannabis retailer in Red Bank, the Planning Board approved Canopy Crossroad’s conditional use site plan application on an 8-1 Board vote.

“Red Bank opted in, and cannabis is legal in the state,” said Brodsky. “By opting in, the town was required to specify districts where cannabis can be sold as a permitted use. The Red Bank Planning Board correctly interpreted the law, and we are delighted that they approved our site plan.”

Bauchner further noted that the Firm was a “one stop shop” for cannabis, and other clients, servicing all our clients’ needs: “From corporate formation and operating documents, to lease agreements or site acquisition, to preparation of applications before the State CRC and Townships, to zoning approvals, all the way through to vendor and employee agreements once operational, our attorneys collaborate across disciplines to fulfill all client needs.”

Joshua S. Bauchner Named a NJ Cannabis Insider 2023 Award Finalist

Ansell Grimm May 1, 2023

Ansell Grimm & Aaron is pleased to announce that Joshua S. Bauchner is a finalist for the NJ Cannabis Insider 2023 Awards! He has been nominated in the Excellence in Cannabis Law: Employment Lawyer category.

Voting is now open and can be done once per day through May 8, 2023. Please join us in supporting Josh by submitting as many votes as possible for him. Click here to cast your vote.

As head of the Controlled Substances and Regulatory Law Practice Group, Josh co-hosted on behalf of the Firm the first-ever Cannabis Symposium in New Jersey which drew nearly a thousand people (two other Symposia followed). He is co-chair of the New Jersey State Bar Association Cannabis Law Committee, a member of the NORML Legal Committee and Amicus Committee, has spoken at the Cannabis World Congress and Business Expo at the Jacob Javits Center, and has presented CLE’s on cannabis at the NY and NJ State Bar Associations, among other fora across the country. He also was honored with the New Jersey Law Journal’s Innovator of the Year Award for his work in the cannabis space and also publishes regularly on the topic.

The attorneys in the group understand the complex laws related to the production, sale, use, regulation, and legalization of controlled substances, including hemp, cannabis, and psychedelics. A multifaceted area of the law with conflicting regulations from different governing bodies, we help our clients navigate all aspects of this emerging field.

CONTROLLED SUBSTANCES & REGULATORY LAW UPDATE – JANUARY 2022

Ansell Grimm January 6, 2023

New York Lawmakers Introduce Psychedelics Legalization Bill

New York state lawmakers introduced a bill to legalize natural psychedelics including psilocybin. A.B. 114, originally intended to be introduced in the 2023-2024 legislative session, was proposed last week by Democratic Assembly members Linda Rosenthal, Jo Anne Simon, and Karines Reyes, according to a report from Marijuana Moment.

If passed, the bill would amend New York state law to legalize the “possession, use, cultivation, production, creation, analysis, gifting, exchange, or sharing by or between natural persons of twenty-one years of age or older of a natural plant or fungus-based hallucinogen.” Included in the “plant or fungus based hallucinogens,” covered by the bill are DMT, mescaline, psilocybin and psilocin.

In recognition of the rapidly evolving perception of plant and fungus-based hallucinogens, the proposed bill also seeks to remove these drugs from Schedule 1 of New York’s list of controlled substances, offers legal protections to individuals who lawfully use natural psychedelics, and prohibits state and local law enforcement agencies from cooperating with U.S. agencies which criminalize natural psychedelic drugs.

New Jersey’s Psilocybin Behavioral Health Access and Services Act Seeks Legalization and Home Growth of Psilocybin

New Jersey Assembly Bill 4911, introduced to the Senate and Assembly, would decriminalize psilocybin, authorize personal use, and expungements for certain offenses involving psilocybin production, possession and distribution.

Titled the “Psilocybin Behavioral Health Access and Services Act,” the legislation would legalize the possession and distribution of up to 4 grams of psilocybin for adults 21 and over, and allow adults to cultivate mushrooms capable of producing psilocybin for personal use.

The proposed law also would create the Department of Health Psilocybin Behavioral Health Access and Services Advisory Board to oversee the process, a legal and regulatory structure to establish psilocybin service centers for treating patients, and for the commercial production of psilocybin.

Ansell’s Psychedelics Practice

On the heels of its successful cannabis practice, which has included numerous granted licenses for its clients as well as successes in Court litigating cannabis matters, last year the Firm expanded into the realm of psychedelics.

The Firm has an established record in the cannabis space enabling us to serve our clients unlike any other area law firm. By example, we co-hosted the first-ever Cannabis Symposium in New Jersey which drew nearly a thousand people (two other Symposia followed). Joshua S. Bauchner, head of the practice group, is co-chair of the New Jersey State Bar Association Cannabis Law Committee, has spoken at the Cannabis World Congress and Business Expo at the Jacob Javits Center, and has presented CLE’s on cannabis at the NY and NJ State Bar Associations, and at the NORML Legal Conference in Aspen, among other fora across the country. He also recently was honored by the New Jersey Law Journal as one of its “2022 Innovators of the Year” for his work in the controlled substances space.

The Firm also was honored by the New Jersey Cannabis Insider as one of three finalists for Excellence in Cannabis Law and has been covered by numerous media outlets and published widely on the topic.

Please contact Joshua Bauchner (jb@ansellgrimm.com) or Kelsey Barber (kbarber@ansellgrimm.com) or call (973) 247-9000 if you are interested in exploring opportunities in the legalized psychedelics arena.

Controlled Substances and Regulatory Law

By Josh Bauchner –

New York Lawmakers Introduce Psychedelics Legalization Bill

New Jersey’s Psilocybin Behavioral Health Access and Services Act Seeks Legalization and Home Growth of Psilocybin

Ansell’s Psychedelics Practice

Recent Posts