New FDA Draft Guidance on Cannabis-Related Clinical Research Omits Discussion of Nondrug CBD Products

On July 21, 2020, the U.S. Food & Drug Administration (FDA) issued draft guidance outlining the agency’s current thinking on the development of drugs containing cannabis or cannabis-derived compounds. The new guidance is disappointing to many in the cannabis industry because it does not provide insight into the FDA’s views on the marketing of nondrug, hemp-derived CBD products.

To read the full text of this Duane Morris Alert, please visit the firm website.

Okla. High Court Marijuana Ruling Provides Preemption Guide

Duane Morris attorneys Justin Stern  and Joseph Pangaro authored the July 1 Law360 article, “Okla. High Court Marijuana Ruling Provides Preemption Guide.”

Stern and Pangaro write:

Adult-use marijuana may be coming to Oklahoma sooner rather than later — barring any unforeseen events, legalization of marijuana for adult use will be on the state’s ballot this year.

On June 23, in the case of In re: State Question No. 807, Oklahoma Supreme Court rejected arguments that the proposed initiative was legally insufficient as preempted by federal laws making marijuana illegal. Interestingly, the court explained that state legalization of marijuana would not be “clearly or manifestly” unconstitutional as preempted by the federal Controlled Substances Act, or CSA, despite the apparent conflict.

To read the full article, visit the Duane Morris website.

Addressing Systemic Racism and Barriers to Entry in the Cannabis Industry

By Naina Kamath

While in recent years the main critique of the legal cannabis industry has revolved around its profitability despite high drug-related incarceration rates, a new focus, inspired in part by the Black Lives Matter movement, has been placed on the underrepresentation of Black business owners and executives in the legal cannabis industry. This underrepresentation is thought to be the result of overwhelming barriers to entry, particularly for Black business owners in the cannabis industry, who must initially rely on the discretion of investors and dispensaries. Continue reading “Addressing Systemic Racism and Barriers to Entry in the Cannabis Industry”

Chambers Associate Interviews Seth Goldberg for Cannabis Insight

Seth Goldberg, partner and team lead of Duane Morris’ Cannabis Industry Group, is interviewed by Chambers Associate about the current and future state of the cannabis industry.

From the publication:

A lot can change in a decade. From illicit plumes of smoke cloaking skate parks and college dorm rooms, to a multibillion-dollar legitimate industry, cannabis has come a long way. In 2019, New Frontier Data – an organisation dedicated to providing information on the legal cannabis market – estimated the industry to be valued at $13.6 billion, with over 300,000 jobs involved.

As is common to growing industries like this (we’re here all day!), lawyers are getting very busy within this new revolution. To this end, we spoke with Duane Morris partner Seth Goldberg to unpack some of the realities of working in such an embryonic space. Goldberg leads Duane Morris’ dedicated Cannabis Industry Group and has been at the forefront of the legal cannabis sector.

To read the full article, please visit the Chambers Associate website.

Is this a Trend? A Third Court Stays Class Action Given FDA’s Primary Jurisdiction Over CBD

Seth Goldberg
Seth A. Goldberg

Yesterday, the U.S. District Court for the Eastern District of California stayed the matter styled Glass v. Global Widget d/b/a Hemp Bombs, a consumer class action alleging that Hemp Bombs, which manufactures CBD-infused edibles, tinctures and capsules, falsely advertised the amount of CBD in its gummies, and thereby sold products that were misbranded and adulterated under the Food, Drug & Cosmetics Act (FDCA), on the basis that the regulation of CBD is withing the primary jurisdiction of the FDA, which is in the process of developing regulations and guidance over CBD. We have previously written about two other consumer class actions arising out of similar clams of misbranded CBD products that have also been stayed recently under the “primary jurisdiction” doctrine.

Three decisions staying CBD class actions in two months may signal a trend, especially considering that the Courts in these cases refer to the other’s decisions. Such a trend may keep the plaintiffs’ bar at bay, as it would cast doubt on the viability of consumer class actions asserting CBD violations, or at least it could make the cases less appealing to the plaintiffs’ bar because a stay makes the timing of a settlement or resolution even more uncertain.  

Duane Morris Cannabis Industry Group Recognized by Business Insider

Duane Morris has been named a top law firm for cannabis law by Business Insider. The publication reached out to 29 players in the cannabis industry, from VCs to startups to multistate operators, to get their take on the best law firms in the industry.

Firm Profile from the Publication

Founded: 1904

Involved in cannabis: 2015

Recommended by: Panther Opportunity Fund, Salveo Capital

About: Duane Morris’ cannabis industry group, which has been around since 2015, is led by Seth A. Goldberg (Philadelphia), Tracy Gallegos (San Francisco/Las Vegas) and Paul P. Josephson (Cherry Hill, NJ).

Their clients range from those directly cultivating and selling cannabis products to investors in the industry. A spokesperson for the firm said that the group advises clients in a variety of areas, including regulatory, intellectual property, and litigation law.

For more information, please visit the Business Insider website (subscription required).

Judicial Decisions Reflect Need for CBD Regulations and Legal Counsel

Consumer class actions regarding CBD marketing are on the rise. In recent months, a number of federal judges have placed lawsuits concerning the marketing of CBD-infused products on hold because the U.S. Food & Drug Administration—tasked with regulating those products under the 2018 Farm Bill—still has not issued regulations governing how they can be marketed. This further complicates the already confusing federal-state regulatory structure concerning the treatment of CBD products.

To read the full text of this Duane Morris Alert, please visit the firm website.

Cannabis: NJ Department of Health issues 2 New Dispensary Permits bringing the total number of Dispensaries in NJ to 11

Earlier this week, the New Jersey Department of Health (DOH) issued permits allowing Zen Leaf Elizabeth (Verano NJ) in Elizabeth and Columbia Care in Vineland to begin dispensing medical marijuana.

These 2 new operations bring the total number of operating dispensaries in the state to 11. Zen Leaf Elizabeth is scheduled to open Friday, May 29 and Columbia Care will likely open in early June.

The 9 other ATCs currently dispensing medical marijuana include Greenleaf Compassion Center of Montclair, The Botanist (Compassionate Care Foundation) of Egg Harbor and Atlantic City, Garden State Dispensary of Woodbridge and Union Township, Breakwater Alternative Treatment Center of Cranbury, Curaleaf NJ, Inc. in Bellmawr, Harmony Dispensary in Secaucus and Rise in Paterson.

In March, the DOH issued several waivers to improve ATC operations during the COVID-19 pandemic. These included waivers that allowed for curbside pick-up, telephonic consultations (instead of in-person), volume-based discounts and reduced caregiver fees.

Participation in the medical program continues to grow. According to the DOH, there are currently over 77,000 patients, 3,000 caregivers and 1,100 physicians enrolled.
Patients and caregivers can visit the Division of Medicinal Marijuana’s website if they choose to change their preferred ATC.  http://www.nj.gov/health/medicalmarijuana/

The change can also be made by calling the Customer Service Unit of the Division at 844-419-9712 and does not require changing ID cards.

Patients can refer to the FAQ section of the DOH’s website for additional information. http://www.nj.gov/health/medicalmarijuana/pat_faqs.shtml/  Active physicians enrolled in the program are listed by county and medical specialty on the website.

Duane Morris has a robust Cannabis Practice Group to assist clients in all facets of the cannabis arena including formation, licensing, fund raising, regulatory, real estate, and intellectual property. Contact your Duane Morris attorney for more information. Prior Alerts on the topic are available on the team’s webpage.

For Further Information:

If you have any questions about this post, please contact Brad A. Molotsky, Paul Josephson or the attorney in the firm with whom you are regularly in contact.

Be well and stay safe!

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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