medical marijuana – Cannabis Industry

February 6, 2024 by Seth A. Goldberg

PA Gov. Shapiro Calls for Adult-Use Legislation Now!

Citing the facts that Pennsylvania (i) is bordered almost entirely by states that have legalized cannabis for adult use; (ii) loses millions to the black market for cannabis annually; and (iii) projects hundreds of millions in annual revenue gains, in his budget address for 2024 Pennsylvania Governor Josh Shapiro called on Pennsylvania’s legislature to deliver by July 1, 2024, legislation that would legalize cannabis for adult-use in Pennsylvania:

“Well, last year, 57 percent of voters in Ohio supported an initiative to legalize recreational marijuana. And now, Ohio, New York, New Jersey, Delaware, and Maryland – practically all of our neighbors – have legalized marijuana. We’re losing out on an industry that, once fully implemented, would bring in more than 250 million dollars in annual revenue. And our failure to legalize and regulate this only fuels the black market and drains much needed resources for law enforcement. It’s time to catch up. I ask you to come together and send to my desk a bill that legalizes marijuana. But that bill should ensure the industry is regulated and taxed responsibly. That we create jobs and build wealth here in Pennsylvania, especially in the communities that have been disproportionately harmed by criminalization. And that those who have been convicted for nonviolent possession of small amounts of marijuana have their records expunged. Let’s stop hamstringing ourselves and start competing.”

Governor Shapiro’s urgency is not surprising. Pennsylvania should have been leading the way in legalizing cannabis for adult-use, given its successful medical marijuana program, but instead other states have spring-boarded ahead of Pennsylvania. Those states are now enjoying the revenues, job growth and overall economic benefits of legal cannabis, including even profiting from Pennsylvania residents crossing the border to buy their cannabis. It truly is time for Pennsylvania “to catch up” and “start competing” in the legal cannabis market for the good of all Pennsylvanians.

November 23, 2022 by Anna Wills

Medical Cannabis Research Bill Set to Become Law

Last week, the Senate unanimously passed H.R. 8454, or the Medical Marijuana and Cannabidiol Research Expansion Act (the “Act”), sending the bill to President Biden’s desk for signature. The bill passed the House this summer by a vote of 325 – 95, and marks the first time a standalone cannabis bill has been approved by the federal government. Essentially, the Act is intended to simplify and expand research into the medical possibilities of both cannabis and cannabidiol as a treatment for certain serious ailments. However, the Act does not de-schedule cannabis under the Controlled Substances Act, instead keeping cannabis a Schedule 1 drug. This means that cannabis will still be deemed to be a drug with a high likelihood for abuse, with no accepted medical use.

In particular, the Act provides for a streamlined process for the approval of cannabis research applications as follows:

An applicant under the Act must submit a completed application to the U.S. Attorney General, which the Attorney General must approve, deny, or request additional information within 60 days. The application must include: 1) details relating to the applicant’s research protocol, reviewed and approved by the Secretary of the Department of Health and Human Services (the “DHS”), the National Institutes of Health, or another agency, or according to provisions in the Federal Register, and 2) the safety measures to prevent diversion of cannabis substance (including storing it in a locked, constructed cabinet).
If the Attorney General requests additional information and the applicant so provides, the Attorney General must approve or deny the application within 30 days of the applicant providing such additional information. If the Attorney General ultimately denies any application, an explanation of the denial must be provided.
A registrant may update its research protocol without informing the Drug Enforcement Administration, if the quantity and form of cannabis, the source of the cannabis, and the conditions of storage will not change. If any of the foregoing items will change, the registrant must notify the Attorney General via registered mail or an electronic means permitted by the Attorney General.
If the Attorney General does not object to the changed protocol within 30 days, it is considered approved and the registrant may go ahead with the changed protocol.

Moreover, the Act also streamlines the process for applying to manufacture cannabis products for research purposes. The application timeline is similar to the research application process, but will only begin when the Attorney General posts in the Federal Register that the Attorney General’s office will increase the number of entities able to be registered under the Act as manufacturers of cannabis for medical research purposes. Then, entities may submit applications to the Attorney General. The application must show:

The requirements of the Act and the Federal Register have been satisfied.
The applicant will only transfer cannabis to those who are registered under the Act to perform preclinical or clinical research.
The applicant will only transfer or sell cannabis under the Act with the prior written consent of the Attorney General.
The applicant has completed the review process set forth in 21 U.S.C. § 823(a) of the Controlled Substances Act, which discusses general registration requirements for manufacturing Schedule I and II Controlled Substances.
The applicant has established and actually follows a process for storing and handling a Schedule I controlled substance.
A license to operate, if the State in which the applicant operates requires one.

The Act further authorizes registered covered institutions of higher education, like medical schools and research schools, to manufacture, distribute, dispense and possess cannabis for medical research, with guidance from the DHS and the U.S. Food and Drug Administration.

Additionally, the Act allows for doctors to discuss with their patients, and their patients’ parents if the patient is a minor, the potential benefits and risks in using medical cannabis under state medical cannabis laws. Prior to the Act, it was unclear whether such an act was a punishable offense under federal law. Senate Majority Leader Chuck Schumer is hopeful this provision, and the Act in general, will help patients with conditions like Parkinson’s, epilepsy, and severe post-traumatic stress.

Lastly, the Act requires the DHS to report to Congress on particular topics of research, including but not limited to, the effects of cannabis on the human body, effects on the adolescent brain, potential impairment of cognitive ability, and barriers and solutions to studying cannabis from states with legal cannabis.

Importantly, there are a few things the Act does not do. The Act does not allow research using state-legalized products for medical research purposes; the Act only allows for using the products manufactured through the Act’s protocols. Therefore, there will not be research into the products people are currently using to treat their medical ailments under state medical cannabis laws. Furthermore, as mentioned above, the Act does not de-schedule or re-schedule cannabis. President Biden issued an executive order in October asking the Secretary of the DHS and the Attorney General to begin the administrative process of de-scheduling cannabis. Presumably, research performed under this Act may lead to either de-scheduling or re-scheduling cannabis, but it is far too soon to tell.

Additionally, the Act does not implement more widespread reform. President Biden issued a pardon last month for simple cannabis possession offenses under federal law, but further reform will not be enacted unless the Senate passes one of several reform bills on the table. Even so, critics and proponents alike across the political spectrum, are lauding the Act as a necessary step for the federal government to catch up to the state legalization wave.

To read the full text of the Act, see https://www.congress.gov/bill/117th-congress/house-bill/8454/text.

November 9, 2022November 9, 2022 by Seth A. Goldberg

Pennsylvania Almost Surrounded With Adult-Use Cannabis

Cannabis had a decent day at the polls yesterday, with voters in Maryland and Missouri legalizing adult-use, bringing the number of adult-use states to 21, but voters in Arkansas and the Dakotas voted against adult-use. With Maryland legalizing adult-use, Pennsylvania, which has a medical marijuana program, is getting closer to being surrounded by states where adult-use is legal. Across it’s northern, eastern, and southern borders Pennsylvania is now adjacent to adult-use states – New York, New Jersey, and Maryland. All three states are predicted to generate billions each in cannabis sales.

The election of Josh Shapiro as Pennsylvania Governor would guarantee the passage of adult-use legislation should it pass in the Pennsylvania senate. However, notwithstanding the tax revenues, job growth, and overall economic boost expanding from medical marijuana to adult-use would create in Pennsylvania, most believe state legislators are not there. Perhaps revenues lost from Pennsylvanians crossing the border to buy cannabis in New York, New Jersey, and Maryland will make the difference.

July 21, 2022 by Hugh H. Jacobson

New York Cannabis Control Board Meeting, July 14, 2022

On July 14, 2022 the New York Cannabis Control Board (the “Board”) met to consider a variety of topics. Most importantly, the Board approved the Conditional Adult-Use Retail Dispensary Regulations and the online application for a retail dispensary license.

The initial focus of the meeting was on the approval of proposed Conditional Adult-Use Retail Dispensary Regulations. (Generally referred to in the meeting as the “CAURD Regulations”.) The Senior Policy Director of the New York Office of Cannabis Management noted that the CAURD Regulations were designed to provide retail dispensary licenses to applicants who met two eligibility requirements. First, the applicant (or family member) must have had a cannabis related legal offense that occurred prior to the passage of the Marihuana Regulation and Taxation Act on March 31, 2021. Second, the applicant must have experience owning and operating a qualifying business. The Board unanimously approved the CAURD Regulations. The Senior Policy Director also provided a form of online application for a retail dispensary license. This sample form fleshes out the CAURD Regulations. The Board unanimously approved the sample form of application. The Board also ordered that a new application period for adult-use retail dispensaries licenses open and close on dates established by the Office of Cannabis Management. The Board did not indicate when the actual application would be made available for filing but notice of the application window must be posted on the Office of Cannabis Management’s website no less than 14 days before the application window opens and the application window must last at least 30 days. Continue reading “New York Cannabis Control Board Meeting, July 14, 2022”

December 14, 2021 by Seth A. Goldberg

Cannabis Beverages are On Fire! – Ingredients and Labeling

Here’s another installment in this blog series on Cannabis beverages, which are on fire! As an example, as reported in Cannabis Business Executive, just the other day, Curaleaf, a major hemp product manufacturer, announced that it signed an agreement with Southern Glazer’s Wine & Spirits – the world’s largest distributor of beverage alcohol. This blog entry provides a quick snapshot of cannabis beverage ingredients and labeling.

Although the most popular, THC and CBD are not the only cannabinoids the cannabis plant produces. Other cannabinoids are well-known for having potential therapeutic benefits, and cannabis consumers are also highly attuned to the different terpenes produced in cannabis that create different flavors and effects, such as bisabol, which some believe can be fruity and may provide anti-inflammatory and antioxidant benefits; linalol, which some believe can be floral and may provide sedation; and myrcene, which some believe can be fruity and may provide relaxation. Whether and how to include different cannabinoids and terpenes in beverages is going to be important in expanding cannabis product lines.

Likewise, transparency in labeling those ingredients may be necessary to ensure consumers are enjoying cannabis beverages safely and to the greatest effect. Moreover, so that consumers can understand the experience intended with a particular beverage, “claims” about the intended effect, e.g., stimulating, euphoric, relaxing, may be necessary.

Ingredients and labeling are a hot button issue for cannabis products. Those familiar with the FDA’s discretionary enforcement of “claims” in hemp-derived CBD products know this is an area of particular interest for the FDA. State-specific regulation of ingredients in cannabis products is also getting a lot of attention right now. For example, the Pennsylvania Office of Medical Marijuana recently instituted a state-wide “vaporization product review” purportedly to assess the safety of terpenes, like those above, in vape products. Given that they occur naturally in cannabis, many in the industry believe terpenes should not be regulated in the same way, if at all, as other ingredients.

Lastly, on this topic, ingredients and labeling are the focal point of a growing number of products liability and consumer fraud class actions and mass actions, where plaintiffs are asserting physical or economic injuries because, they claim, ingredients did not perform as intended or were not consistent with the labeling. Cannabis beverage manufacturers, distributors and retailers need to particularly mindful of the possibility of such claims, which can deplete resources.

November 10, 2021November 10, 2021 by Seth A. Goldberg

Cannabis Beverages are on Fire! — THC Limits

In the second edition, and first substantive blog, in my series on Cannabis Beverages, entitled Cannabis Beverages are on Fire!, I am writing about THC limits, which is one of the hot-button issues for cannabis beverage producers and consumers. Given its psychoactive effect, there is no denying that the amount of THC in a beverage should be measurable and limited so that consumers can safely ingest them and obtain the experience they are seeking. This means that a serving size of a beverage might have a THC limit, and so might there be a total container limit.

Cannabis beverage manufacturers are not starting from scratch in this area, however. Popular THC serving size limits in edibles and similar products include 5mg and 10mg could likely be applied to THC beverages, resulting in a total container limit based on the container size and number of servings. The current offerings of cannabis-infused drinks vary and the markets within states offer a wide variety of different THC levels. For example, Cann, a bestselling THC drink, contains 2mg THC and 4mg CBD per 12 ounce can. Cann is available in over 200 California dispensaries. Similarly, Tomato Jane drinks have 10mg THC per 12 ounce bottle. Comparatively, Matt’s High Soda offers an infused beverage called Uncle Arnie’s Iced Tea Lemonade with 100mg of THC per bottle—although each bottle is considered to be 10 servings. As the market for cannabis beverages develops, THC limits are certain to be an issue that gets a lot of attention. In the next installment of this series I’ll touch on cannabis beverage ingredients and labeling.

November 4, 2021November 10, 2021 by Seth A. Goldberg

Cannabis Beverages are on Fire!

Want to know where the cannabis industry is going? How about the beverage industry? The answer is cannabis beverages! The hottest new product segment in both markets. Don’t believe me… just run an internet search for “cannabis beverages” and you’ll see cannabis-infused beverages tied to major beverage companies like Constellation Brands, such as Canopy Growth’s Quatreu water, and Molson Coors, with its Truss brand, and dozens of smaller cannabis beverage brands, such as Forth, Kikoko, and Recess.

A cannabis beverage generally contains either THC derived from marijuana grown pursuant to state adult-use marijuana and/or medical marijuana laws, or containing CBD derived from marijuana or derived from hemp grown pursuant to a state’s hemp laws. Given the federal prohibition on marijuana, the federal legality of hemp, and the FDA’s current restriction of CBD in foods and beverages, the federal and state regulatory framework for producing, distributing, and consuming cannabis beverages is complex, to say the least. In the coming weeks I will be covering in a series of short blogs some of these issues, including product labeling, THC and CBD percentages, serving size, and social consumption.

October 11, 2021October 12, 2021 by Michael D. Schwamm

Notes from New York Cannabis Control Board Meeting, October 2021

By Michael D. Schwamm and Joy Karugu

There were several outcomes of the inaugural New York Cannabis Control Board (CCB) Meeting held on October 5, 2021. The Meeting revealed that the CCB and the Office of Cannabis Management (OCM) will be increasing their staff and taking steps to extend the medical cannabis program and cannabinoid hemp licensing. Also during the Meeting, Jason Starr was announced and voted in as the Chief Equity Officer of the OCM. He will work with Executive Director Chris Alexander in building New York’s social equity program. Continue reading “Notes from New York Cannabis Control Board Meeting, October 2021”

March 19, 2021 by Seth A. Goldberg

SAFE Banking Act Reintroduced in the House with Broad Support

With the explicit support of the American Banking Association, and after passing in the House during the last congress, the SAFE Banking Act was reintroduced in the House on March 18, and a companion Act is expected to be introduced in the Senate next week. The proposed legislation would allow financial institutions to provide their services to cannabis – marijuana and hemp – clients without fear of federal sanctions. The proposed legislation enjoys bi-partisan support, and is in “position A” for passing in 2021.

Given the billions of dollars of revenues, including tax dollars, generated by the industry, which are generated by cannabis companies and companies that provide services to the industry, cannabis banking is truly a public concern. The very laws that seek to create transparency as to the public fisc, such as the Bank Secrecy Act, have forced cannabis to be a cash business, which means not all of the cannabis dollars may be accounted for as in other industries, thereby undermining the objectives of those laws. The SAFE Banking Act would resolve those concerns by allowing core and ancillary companies to utilize all of the electronic banking, checking, payroll, and accounting functionality that businesses in all other industries enjoy. There is no question the passage of this legislation would provide a game-changing boost to the cannabis space.

February 25, 2021 by Seth A. Goldberg

Bipartisan Adult-Use Bill To Be Introduced in Pennsylvania

Senators Dan Laughlin (R) and Sharif Street (D) are introducing legislation that would legalize marijuana for adult recreational use in Pennsylvania. This is the first time a republican senator has backed such a bill. The proposed legislation will attempt to generate revenue for the commonwealth and to promote social equity by way of increasing the number of licenses to operate, imposing a 6% sales tax, and imposing a 10% excise tax that would go toward a Cannabis Business Development Fund to provide aid, grants, and technical assistance to businesses and individuals in areas that have been disproportionately impacted by criminal prosecution for cannabis violations. Expungement of cannabis crimes would also be available.

Laughlin’s pragmatic views may encourage his republican colleagues in PA’s legislature to join him. As Laughlin stated during a press conference: “Our proposal prioritizes safety and social equity. And furthermore, it will let Pennsylvania’s robust agricultural industry participate in marijuana cultivation.” And both Laughlin and Street encouraged PA legislators to keep pace with lawmakers in New Jersey and New York, stating in their co-sponsorship memo: “This year our neighbors in New Jersey have signed adult use marijuana into law and our neighbors in New York are likely to legalize. It is our duty to taxpayers to seize the initiative and legalize marijuana concurrently with bordering states. Failure to do so risks permanently ceding hundreds of millions of dollars of new tax revenue as well as thousands of jobs at a time when taxpayers can least afford it.”