How Will FDA Bring Order to the Wild West of Cannabis Regulations?

By Frederick R. Ball and Carolyn A. Alenci, Duane Morris LLP

The cannabis industry is the next frontier, growing rapidly and becoming one of the highest grossing industries in the country. The problem is, through no fault of its own, it is also the “wild west” of industries in many ways operating without guidance or regulation from the federal agencies that have jurisdiction of its products.

On May 31, 2019, the U.S. Food and Drug Administration (FDA) held a public hearing to allow stakeholders to share their experiences and challenges with cannabis or products containing cannabis-derived compounds. For this hearing, FDA requested information, scientific data, and stakeholders’ views on the safety of CBD-containing and cannabis-derived products. FDA hoped to obtain input on possible strategies that will allow for lawful marketing of CBD-containing and cannabis-derived products in a predictable and efficient manner, while still providing incentives for drug development with CBD and cannabis-derived compounds. Over 100 academic, industry, medical, and consumer stakeholders spoke or gave presentations at the hearing to a packed audience of about 500 attendees. In addition, over 1300 written comments have been posted to the FDA’s public docket FDA-2019-N-1482 for this hearing.

The hearing opened with remarks from Acting Commissioner Dr. Norman Sharpless. As expected, he made no new announcements about FDA’s current thinking about regulating products containing cannabis or cannabis-derived compounds. He did restate the FDA’s current position that CBD and THC cannot lawfully be added to a food or dietary supplement and that FDA does not have a policy of enforcement discretion with respect to these products.

To read the full text of this article written by Duane Morris attorneys Rick Ball and Carolyn Alenci, please visit the Food and Drug Law Institute website

NJ Assembly Delay Vote on Medical Cannabis Expansion – likely due to concern over potential Governor’s veto

NJ Assembly leaders announced they would not be voting on the proposed expansion of medical cannabis licenses earlier today – 6-10-19.

Instead, per NJ.com, legislators are going to attempt to work with Gov. Phil Murphy’s office on a plan that’s more amenable to him and the state Legislature, said Kevin McCardle, a spokesman for Assembly Democrats.

The Governor’s team has previously raised objections to a few provisions in the medical expansion bill, including the creation of the Cannabis Regulatory Commission, which would assume oversight of the industry. Currently, the state Department of Health regulates the medical marijuana program.

We will keep an eye out for any collaborative resolution of the medical licensure issue and report back.

#Duane Morris – Brad A. Molotsky, Esq.

NJ Senate and Assembly close in on expansion of medical use Cannabis – Brad A. Molotsky, Esq. – Duane Morris

The New Jersey Senate voted 33-4 yesterday (Thursday) to advance a bill that is intended to increase medical marijuana sales and likely create new business opportunities in the state.

Per Marijuana Business Daily, before the vote, the Senate amended Assembly Bill 10 to allow marijuana workers to become union members.

The Bill will now return to the NJ Assembly for a vote to approve the Senate’s modification.

If the Bill is ultimately signed, the measure will:

– Create a new regulatory commission for medical marijuana.
– Pave the way for the state to issue additional business licenses.
– Allow cannabis home delivery.
– Ease restrictions on the process for recommending medical marijuana.

Currently there are 12 vertically integrated medical cannabis licenses that have been granted in NJ.

We will continue to track this development and report back as it get’s closer to passage in the Assembly. -Brad

Case Sets Stage for Cannabis Patent Infringements Actions

Getting a patent for a cannabis product is no more difficult than getting a patent for any other kind of product. However, with a high number of cannabis patent applications being approved, it is likely that many will be challenged for invalidation in the coming years.

Already one of these patents has gone to court in the U.S. District Court for the District of Colorado. In United Cannabis v. Pure Hemp Collective, United Cannabis Corp. claims that Pure Hemp Collective Inc. used a cannabis extract that United Cannabis had a patent on. Pure Hemp filed a motion for partial summary judgment, arguing United Cannabis should not have had a patent on the extract because it was something that occurred naturally. In April, U.S. District Judge William Martinez found the strain was altered and would not have occurred naturally and denied the motion for partial summary judgment. The case is still pending..

To read the full text of this article including Duane Morris Attorney Vince Capuano,  please visit the Duane Morris website.

Reprinted with permission from law.com, © ALM Media Properties LLC. All rights reserved.

California Cannabis Banking Bill – Moving Along with 35-1 Senate Vote in Favor – Brad A. Molotsky, Esq.

The CA Senate voted 35-1 to allow banks and credit unions to accept cash deposits from marijuana retailers.

Per reporting from the Star Tribune, those banks would be permitted to issue special checks to the retailers that could only be used for certain purposes, including paying taxes and California-based vendors.

State lawmakers are of the view that such banks would make it easier for licensed cannabis retailers to pay their taxes, which fell far short of expectations in the first year after legalization.

“This is as close as we can get until the federal government changes its policy,” said Sen. Bob Hertzberg, a Van Nuys Democrat and the author of the bill that now goes to the Assembly.

Per the Marijuana Law Reporter, Marijuana has been legal in California since January 2018, but it’s still illegal under federal law under the Controlled Substances Act.

-Brad A. Molotsky, Esquire

Patent and Trademark Office Issues New Guidelines for Hemp Following 2018 Farm Bill Legalization

On May 2, 2019, the United States Patent and Trademark Office (USPTO) made available a new examination guide aimed at clarifying the examination procedure for trademarks used in connection with cannabis and cannabis-derived goods and services.

These guidelines are a direct response to the signing of the Agricultural Improvement Act of 2018 (2018 Farm Bill) into law on December 20, 2018. The 2018 Farm Bill changes certain federal authorities relating to the production and marketing of “hemp,” defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol [THC] concentration of not more than 0.3 percent on a dry weight basis.” These changes include removing hemp from the Controlled Substance Act’s (CSA) definition of marijuana, which means that cannabis plants and derivatives such as cannabidiol (CBD) that contain no more than 0.3 percent THC are no longer controlled substances under the CSA.

View the full Alert on the Duane Morris LLP website.

Immigrants Can Be Denied U.S. Citizenship for Working in Regulated Marijuana Industry

Last week the U.S. Citizenship and Immigration Services (USCIS) issued guidance indicating that working in the marijuana industry, or even just possessing cannabis, could be grounds to reject a citizenship application—regardless of whether it is done in a state where it is legal. This guidance also would apply to permanent residents or “green card” holders seeking citizenship. The policy guidance is set forth in the USCIS Policy Manual and seeks to clarify that violations of federal controlled substance law, including violations involving marijuana, are “generally a bar to establishing good moral character for naturalization, even where that conduct would not be an offense under state law.” The policy guidance also clarifies that an applicant who is involved in certain marijuana-related activities may lack good moral character if found to have violated federal law, even if such activity has been decriminalized under applicable state laws.

Reports by various news outlets indicate that some lawful immigrants have already been denied naturalization by USCIS because of their employment in the cannabis industry. According to USCIS, as long as marijuana remains illegal under federal law, the agency won’t grant special considerations to individuals whose marijuana activities may be decriminalized under state or local law. The position of USCIS is that “marijuana remains illegal under federal law as a Schedule I controlled substance regardless of any actions to decriminalize its possession, use, or sale at the state and local level, federal law does not recognize the decriminalization of marijuana for any purpose, even in places where state or local law does.”

As we know, the U.S. Customs & Border Patrol has prevented some Canadian citizens from entering the U.S. because of their involvement in the cannabis industry. It remains unclear how strict USCIS will be in enforcing the latest policy guidance on citizenship. For the time being, participation in the cannabis industry will continue to constitute a potential bar to a determination of good moral character for naturalization eligibility, even where such activity is not a criminal offense under state law.

NJ Adult Use Bill – Two Steps Closer to a March 25th Vote – Brad A. Molotsky, Esq.

According to late night reporting from NJ Biz – Dan Munoz, who has been all over this topic, committees in both the NJ Assembly & Senate approved a measure that would legalize adult-use recreational marijuana, setting the proposals for a showdown full-floor vote in 7 days from now on March 25.

Senate Bill 2703 passed by a 6-4 vote with one abstention in the Senate Judiciary Committee Monday evening while its counterpart, Assembly Bill 4497, passed by a 6-1 vote with two abstentions at the Assembly Appropriations Committee.

Both measures would allow for anyone over 21 years of age to possess up to an ounce of marijuana.

The product would be taxed at $42 an ounce and the industry would be regulated by a five-person Cannabis Regulatory Commission, which will function similarly to how the Casino Control Commission operated following the legalization of gambling in the 1970s.

The approval of both measures followed hours of closed-door meetings as lawmakers hammered out last-minute changes to the legislation, including a dramatically increased expungement process for people with marijuana-related convictions.

Stay tuned for a detailed analysis as the final bill is published. – Brad

NJ Adult Use Cannabis Bill Fast Tracked for March 25th Vote

Gov. Phil Murphy and legislative leaders reached agreement on key provisions to legalize marijuana for adult recreational use, including how to tax and regulate it, and expunging past low-level marijuana offenses for certain users as a step toward social reform per reporting from Dan Munoz.

Per a press release issued by key Assembly Senate and the Governor’s office, we should expect to see the introduction of a cannabis bill within days.
Under the terms of the agreement:

• Adult-use marijuana would be subject to an excise tax of $42 per ounce, which will be imposed when marijuana is cultivated.

• Municipalities that are home to a cultivator or manufacturer would receive the revenue from a 2 percent tax on the product within their jurisdiction.

• Municipalities that are home to a wholesaler would receive the revenue from a 1 percent tax on the product within their jurisdiction.

• Municipalities that are home to a retailer would receive the revenue from a 3 percent tax on the product within their jurisdiction.

To start to address social equity concerns, the revised legislation will likely provide an expedited expungement process for individuals convicted of low-level marijuana offenses, and a separate expungement process that would automatically prevent certain marijuana offenses from being taken into account in particular areas such as education, housing and occupational licensing.

Additionally, there are a number of provisions that aim to ensure broad-based participation for women owned and minority owned businesses, low and middle-income individuals, and disadvantaged communities.

Under the proposed legislation, adult-use marijuana would be governed by a Cannabis Regulatory Commission, composed of 5 members—three appointed directly by the Governor to serve terms of at least 4 years, and 2 appointed by the Governor upon the recommendations of the speaker and Senate president.

The commission would be tasked with promulgating all regulations to govern the industry and overseeing applications for licensing of adult-use marijuana dispensaries.

-Brad A. Molotsky, Esq.

California’s Bureau of Cannabis Control Submits Final Regulations for Administrative Review

The three agencies that regulate the cannabis market in California, the Bureau of Cannabis Control, Department of Food and Agriculture, and Department of Public Health, submitted a final version of regulations to the Office of Administrative Law (“OAL”) in California this month. The OAL reviews regulations for compliance with procedural requirements and substantive standards under California law. The OAL has 30 working days — until January 16, 2019 —  to review the regulations.

This blog post will highlight some of the important changes to the regulations made by the Bureau of Cannabis Control (“BCC”). Continue reading “California’s Bureau of Cannabis Control Submits Final Regulations for Administrative Review”

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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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