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

Seth Goldberg
Seth A. Goldberg

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.   

Cannabis Beverage Companies Need to be Aware of PFAS in Local Water Supplies

Ethan Feldman

Imagine that a cannabis beverage manufacturer’s plant draws water from a public watershed that is contaminated with a synthetic chemical or chemicals that are classified as probable human carcinogens.  Unbeknownst to the manufacturer, the advertising and labeling for their beverage products include a marketing campaign focused around the phrases “organic” or “all natural.”  This scenario is more than a hypothetical.  Synthetic compounds known as per- and polyfluoroalkyl substances (PFAS) are found in public water supplies across the United States.  There are about 15,000 different chemical compounds that fall under the PFAS umbrella.  The International Agency for Research on Cancer (IARC) has classified certain of these chemicals carcinogenic, as well as possibly carcinogenic to humans.

PFAS are commonly known as ‘forever chemicals’ because of the time it takes for them to degrade.  Not only have PFAS been linked to cancer, but also to immunodeficiencies, reproductive harm, and developmental defects in children.

According to the Centers for Disease Control, exposure to PFAS can occur from eating food packaged in PFAS-containing material, eating food grown or raised near places that used or made PFAS, but, most significantly, from drinking water.  Here is a link to PFAS contamination sites in the United State as of November 28, 2023, and it is estimated that drinking water for 26 million U.S. citizens may be contaminated with PFAS.

PFAS litigation is on the rise.  The past few years have seen many lawsuits filed by attorneys general and private citizens against PFAS manufacturers stemming from public water supply contamination.  Additionally, over the past few years, the Environmental Protection Agency (EPA) has worked to establish uniform permissible PFAS levels as it pertains to public water supplies.

In 2018, the cannabis beverage market was valued at over $900 million, and is projected to grow by 17% until 2033.  The emulsification process used to create cannabis infused beverages involves creating water-soluble cannabinoids that are then mixed into water-based solutions, and the final product can appear in the form of a soda, sparkling water, or juice, to name a few.

The EPA, state and local governments, and plaintiffs’ attorneys are keeping a close eye on the evolution of PFAS, and additional litigation is almost certain.  The scenario presented above may potentially lead to not only personal injury claims, but also presents a classic situation on which consumer fraud class actions are based.

Cannabis beverage manufacturers must be vigilant in complying with not only state regulations pertaining to cannabis manufacturing, but also must be mindful to appropriately handle PFAS contaminated water the company uses to manufacture cannabis beverages.

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.

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.

 

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”

Cannabis-Related Reimbursement Claims Hit Healthcare Insurers

Healthcare insurers are used to dealing with claims for reimbursement by hospitals, providers, and patients. Medical marijuana treatment provides another vehicle for such claims.

New Mexico passed the Behavioral Health Services Equity Act (BHSEA) last April, effective January of 2022, which mandates that health insurance must cover in full the cost of services or medication used to treat behavioral health services. In February, New Mexico Top Organics – Ultra Health sent a letter to several insurers and the Office of the Superintendent of Insurance seeking affirmation that the insurers will provide coverage as prescribed by the act for the 74,000+ patients currently enrolled in the medical marijuana program as a result of PTSD. The request was denied. Now, several New Mexico health insurance companies are defending against a class action lawsuit filed by New Mexico Top Organics – Ultra Health, and six medical marijuana patients, seeking “recovery for themselves, and for every other similarly situated behavioral or mental health patient unlawfully subjected to paying for the entire cost of medically necessary cannabis in violation of state law” for failing to pay for the cost of medical marijuana as provided under the act.

Other legislatures are discussing similar laws that provide for insurance coverage of medical marijuana programs. For example, New York has pending legislation that if passed, would define medical marijuana as a “prescription drug,” “covered drug,” or “health care service” that would qualify for coverage under public programs. The United States Supreme Court recently denied certiorari for a pair of cases concerning workers’ compensation for medical marijuana, an issue that has not been decided uniformly amongst the states. For example, Minnesota and Maine have determined that the Federal Controlled Substance Act preempts the state law requiring reimbursement for medical marijuana due to a work-related injury, while New Hampshire and New Jersey have ruled in favor of reimbursement regardless of federal preemption.

The passage of New Mexico’s Act mandating behavioral health coverage in full and subsequent lawsuit brings a new wrinkle into cannabis litigation, with broad implications across the healthcare industry. Indeed, early clinical reports and case studies have shown positive results from the use of medical marijuana to treat PTSD, a disorder that effects an estimated 12 million Americans, and with medical marijuana available in 37 states, the class action lawsuit seeking reimbursement under the BHSEA may serve as a preview of a type of cannabis-related litigation that may be brought against healthcare insurers.

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.

 

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.

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.

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”

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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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