Reserve your seat for our virtual open house, Sept. 28-30. Register now.

Reserve your seat for our virtual open house, Sept. 28-30. Register now.

Cannabis Regulations: The Evolving Regulatory Landscape

Industry Advice Regulatory Affairs

The North American cannabis market was estimated to be worth more than $10 billion in 2018. While this seems like a massive number for a relatively new industry—annual growth is projected to be nearly 34 percent, meaning that by 2026, the size of the market will be approaching $100 billion. Along with that growth comes career opportunities, although the specifics are unknown. At the federal level, cannabis is illegal and still classified as a Schedule I drug, meaning it is in the same category as heroin or LSD. The United States government can’t count cannabis jobs as they are not legally recognized. Despite the complications inherent in the drug’s current legal status, the industry is a burgeoning career opportunity—albeit one packed with twists and turns as cannabis regulation and legal issues evolve.

Cannabis: A Rapidly Expanding Market

Current industry growth is coming from expanding medical sales and the smaller but booming recreational market. “There are now 36 states where marijuana is legal for medical purposes,” says Jacquelyn Briggs, lecturer in Northeastern University’s Master of Science in Regulatory Affairs (MSRA) program. “These products typically contain more cannabidiol (CBD) than tetrahydrocannabinol (THC) which is the main cannabis psychoactive compound. In states with legal approval, physicians can prescribe cannabis products to help relieve whatever symptoms they deem appropriate,” Briggs adds. Beyond medical sales, consumers can now legally purchase recreational cannabis without a prescription in 17 states, and non-medical offerings are more focused on THC than CBD.

THC and CBD Products are Just the Beginning

One of the biggest misconceptions of the cannabis industry is that all its potential comes from the above compounds. The reality is a surprise to many. “Cannabis plants contain over 100 cannabinoids,” Briggs says. “I’m currently advising a company that is developing products that contain cannabigerol (CBG), which has shown promise in aiding digestive and inflammation issues. Other compounds have different properties that have the potential for treating common conditions, including depression and insomnia.” Briggs adds, “through progressive legislation in the United States, our knowledge around the benefits of cannabinoids is expanding exponentially.”

While the industry expands through multiple monetized paths, there are many roadblocks and few maps. On the federal level, there is no industry-specific regulation due to the legal status of cannabis—yet government entities are involved in ensuring safe products make their way to the consumer. States that have legalized medical and/or recreational marijuana commerce have created state-based regulatory systems. Interstate commerce is illegal, even among legal states—making it challenging to build scale. Briggs says, “In 2014, the House finally passed the Rohrabacher-Farr Amendment, which eliminated any federal spending on efforts that would interfere with state-level cannabis laws. So even though cannabis is still a Schedule I drug, the federal government has essentially stayed out of the way.”


Download Our Free Guide to Advancing Your Regulatory Affairs Career

Learn how to navigate the discipline and accelerate your regulatory career.

DOWNLOAD NOW


The Challenges of Bringing Cannabis Products to Market

The primary federal regulator of the cannabis industry is the US Food and Drug Administration(FDA). They are responsible for ensuring all drug products are safe and effective for their intended indications. The FDA mandates clinical trials that allow drugs to be approved based on scientific data. As of the writing of this article, the FDA has not approved any applications for cannabis—but it has approved one cannabis-derived and three cannabis-related drug products that are only available with a prescription. The FDA also monitors marketing claims, and they have issued warning letters to several CBD manufacturers and retailers that they deemed to have made unsubstantiated product statements to the consumer.

The US Center for Drug Evaluation and Research (CDER) is part of the FDA. It is the division that is charged with monitoring and regulating the sale and production of therapeutic drugs. CDER evaluates all new drugs before they are available to consumers. Their range spans from pharmaceuticals to toothpaste and sunscreens. Briggs says, “In 2020, CDER issued draft guidance to the industry on approval pathways for cannabis products, which was a significant step. They seem to be following the steps set up for the approval of prescription drugs.”

On the state level, regulation is a complicated patchwork.  States typically have an entity responsible for licensing cultivators, producers, and dispensers. Using Massachusetts as an example, the state established its Cannabis Control Commission in 2017 after Massachusetts voters approved adult-use products in 2016. The commission “is responsible for the safely, equitably, and effectively implementing the laws governing the adult-use marijuana industry in the Commonwealth.” In Massachusetts, cities and towns have their approval process for cannabis distributors and facilities. Local growth has been rapid as communities realize the income opportunity—a key driver of legal production and sales across the country.

Booming Career Opportunities Ahead

Staying on top of evolving regulations and requirements is a challenge for most companies, regardless of size and scope. Briggs says, “whatever part of the cannabis industry that you’re in, wherever your location, everything is based on licensing. Whether you’re a start-up or an established company, you need to know what the right licenses are for your intent and how to get them for your company. The licenses required to grow are going to be different from formulation or selling and dispensing.”

Students often ask Briggs what type of experience cannabis companies are looking for when they hire, primarily related to regulation. “If you want to get into the cannabis industry, this is the time to do it,” says Briggs, “companies are hiring without having the requisite experience because it’s all-new, and there is not an established cannabis talent pool to pull from.” Briggs adds, “the experience you offer today might not be the experience that you need next year because everything keeps changing. It’s an exciting time for professionals that want to learn and evolve with the industry. If you have a science, botany, or agriculture background, and you’re a problem-solver, then you’re well-positioned. These companies also need marketing and sales experience, so that’s another entry point.”

Briggs sees another ample career opportunity with established pharma companies that see the potential of the cannabis market as an ongoing revenue stream. Briggs says, “Greenwich Biosciences is the only pharmaceutical company with an approved cannabinoid product. They were acquired by Jazz Pharmaceuticals earlier this year for more than $7 billion. More pharma companies will be jumping on the cannabis bandwagon.”

Staying Up-to-Date on Cannabis Trends and News

For those considering or already in the industry, the National Cannabis Industry Association (NCIA) is an excellent resource for keeping up with the changing landscape. NCIA represents the interests of legal cannabis businesses and helps advance federal policy. Members can access industry reports, publications, podcasts, webinars, and ongoing market intelligence.

The Food and Drug Law Institute (FDLI) hosts webinars focused on evolving cannabis regulation. They also offer career resources and other learning opportunities for students.

The Practising Law Institute (PLI) publishes and updates its Legal Guide to the Business of Marijuana annually. It covers cannabis, CBD, and hemp regulation. The guide is directed to legal professionals but is available to all.

An Advanced Degree in Regulatory Affairs is a Career Advantage

Because industry experience is in short supply, an advanced degree can be an advantage for cannabis careers. Comprehensive knowledge of issues related to regulatory affairs and compliance is in demand due to the complexities of bringing products to market. Northeastern University’s Master of Science in Regulatory Affairs program (MSRA) gives graduates a deep understanding of what it takes to develop and market drugs, biologics, food, and other regulated consumer products. Briggs says, “students are interested in cannabis industry issues. The topic is relevant and relatable. Cannabis is becoming a larger part of the discussion.”

Digital Badge Credentials are an Emerging Certification Opportunity

Northeastern has also expanded its digital badge program in partnership with Credly—a leading organization providing digital credentials to individuals worldwide. Northeastern offers a digital badge in Navigating the Cannabis Regulatory Landscape. The university has plans to add a second cannabis regulatory badge certification in the months ahead. Digital badges are a great way to expand knowledge and gain a tangible indicator of accomplishment that can be displayed online, enhancing your résumé.

In summary, cannabis regulation is a complicated topic and this article barely scratches the surface. There are few industries with so much potential and such a complex history. If you want to explore the industry in more detail, the links throughout this article are a great starting place.

Learn more about what it takes to get ahead in regulatory affairs, compliance, and quality assurance by downloading our guide below.

Download Our Free Guide to Breaking into Regulatory Affairs“ width=