SUMMARY
- Protecting consumers’ safety, health, and well-being are arguably the most crucial considerations for regulators when evaluating approval for any new product. One of the issues included in the forthcoming Cannabis Administration and Opportunity Act (CAOA) is a provision that will create a federal regulatory framework for the marijuana industry.
- The complexity of the U.S. cannabis industry has been exacerbated by the consequences of states operating within the confines of closed economies that have thus far striven for their interpretations of legitimacy under the shadow of existing federal laws. Accordingly, there has been ineffective oversight of cannabis and cannabis-derived products because they are not considered legal additives by the U.S. Food and Drug Administration (FDA). Consequently, the variation of standards from one state to another carries an inherent inconsistency in ensuring the safety of products brought to market.
- With rescheduling now in play, resisting interests have begun leaning in with rhetoric aimed at some of the perceived dangers of Cannabis, particularly when it comes to testing and product safety. The ongoing efforts to develop federal standards for product testing, safety, and quality assurance have yet to gain traction but will likely accelerate upon the final Schedule 3 ruling.
- Uniform national testing and operational standardization will help assure consumers of an expectant, safe product consistency. Because of federal illegality, Interstate commerce is disallowed, which has understandably led to inefficiencies affecting consumer safety. Also, limited capital availability has led to a lack of Good Manufacturing Practice (GMP) standards. Eliminating the punitive 280E burden upon rescheduling should facilitate the larger MSOs’ taking a more proactive approach to product safety.
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SPACE JAM
When Colorado implemented the first recreational use market in 2014, it sparked a wave of entrepreneurs and other interested parties eager to establish a foothold in the cannabis industry. FOCUS (Foundation of Cannabis Unified Standards) was founded in 2014 by Lezli Engelking to address the many shortcomings at the federal level in quality, consistency, and safety that became evident with the industry’s explosive growth. At the state level, ProVerde Labs (2014), founded by Dr. Chris Hudalla and based in Massachusetts, is one of the first facilities to take on the lead in developing universal testing protocols.
Earlier this year, we hosted an X (formerly Twitter) “Space” Jam with Lezli Engel and Chris Hudalla to get an update on this critical topic.
Leslie brings over two decades of experience in the healthcare and nonprofit sectors, including tenure at Eli Lilly. She also opened the first chain of vertically integrated medical cannabis operations in Phoenix, Arizona, where she observed firsthand the critical need for cannabis-specific quality and safety standards.
Chris is a Ph.D. analytical chemist with more than 30 years of research experience in analytical chemistry. He is active in numerous scientific organizations, contributing to efforts for the development and standardization of cannabis testing methodologies aimed at ensuring consumer safety.
Takeaways:
- Limited progress has been made over the past ten years, mostly due to 1) a lack of federal involvement, 2) a multitude of varying state regulations, and 3) a lack of consensus on what constitutes best practices.
- To move forward on a federal level, the Cannabis industry must work aggressively with regulators to develop a standard protocol for product testing, safety, and quality assurance. Collectively, this is paramount for federal legalization.
- Many groups/states are in the “gummie” jar (FDA CDC FOCUS USP AHPA US HEMP AUTHORITY), each bringing a different perspective and complexity. All parties want to be “heard”. The common goal is establishing a national protocol that remains difficult without federal involvement.
- Interstate commerce: We need to figure out what is acceptable across state lines, but first, we need a nomenclature. No effort has been made in this regard. The group wants to be sure that everyone has a voice. This area has yet to receive much, if any, attention.
- Nonetheless, there has been progress but an overwhelming need for data analytics. Cannabis is now a topic of discussion at scientific conferences – in the early years, it was not discussed as stigma was still heavily associated with Cannabis.
- Regulators are lagging—regulatory ambiguity. Many are unfamiliar with the properties of Cannabis and THC. There has been little to no training and an abundance of misinformation.
- Cannabis regulatory associations seem to lobby for their interests.
- Lab shopping is ramped up in every state market. None would qualify for Schedule 3 if GMP standards were required.
- The Illicit market used to be underground; it now operates entirely transparently.
- Testing is critical to identify hemp-derived products (converting CBD into synthetic Delta).
- The loophole in the farm bill is being addressed state by state but has to be addressed from a safety perspective.
- Evaluation of brands and the variance from state to state.
- An Executive Order at the state level requires the proper assessment. There have been no indicators at the Federal level to regulate—all at the state level. This would likely come once moved to Schedule 3.
WORKING GROUPS ESTABLISHED
FOCUS and the Association of Food and Drug Officials (AFDO) united their efforts. The two groups have been collaborating since 2017, with the aim of presenting a solution to the regulatory inconsistencies that threaten the industry and the public.
This partnership led to the establishment of the Federal Regulatory Framework (FRF) Working Group. This collaboration was established to guide Congress and U.S. federal regulatory agencies in developing a federal cannabis regulation approach. It brings forward insights not tainted by corporate interests and prioritizes public health and safety to develop a comprehensive regulatory framework for Cannabis in all its forms.
It also functions as a crucial link between all industries intersecting with Cannabis, uniquely positioning itself to offer an impartial, comprehensive solution for effective and all-encompassing federal cannabis regulation. It serves to educate the government.
The Workgroup aims to:
- Create an impartial forum focused on public health and safety in U.S. cannabis regulation
- Engage a wide range of stakeholders, leveraging their operational knowledge and experience
- Establish a sustainable model emphasizing technical excellence, comprehensiveness, durability, and suitability
- Foster broad consensus among numerous stakeholders
- Educate on the current public health and safety risks stemming from federal non-involvement
- Allow for state-specific regulations
- Consider the downstream effects of state and federal legalization, including impairment and public safety risks.
