Committee Insights | 8.16.22 | Cannabis Consumption Lounges & the Next Wave of Hospitality Disruption
In this edition of our NCIA Committee Insights series originally aired on Tuesday, August 23, 2022 members of Risk Management & Insurance Committee convened a panel of cannabis regulators and legal experts alongside leading event and hospitality operators to provide cannabusiness professionals the inside scoop on new regulations being adopted to manage/establish cannabis consumption establishments.
Dive deep into the ins & outs of Michigan’s cutting edge regulatory structure and learn from those operating in the space across the country with our panel of experts.
Learning Objectives
• Review of leading edge regulatory framework providing a model for MI consumption lounges
• Highlight the license structure for temporary events – how do consumption, sales and/or both formats function within this framework?
• How have these regulations evolved since first adoption?
• Review dram shop liability and offer an educationally lensed analysis
• Discuss how that may or may not be a good framework to apply to cannabis?
The Agricultural Improvement Act of 2018 (the “2018 Farm Bill”) helped to further define the pathway by which “hemp-derived” ingredients can be legally incorporated into food. Since then, hemp-ingredient companies have materialized selling purified cannabinoids that are found naturally-occurring in hemp. Despite the young market, these companies are facing difficult times as the buyers for these ingredients are few and manufacturers mostly compete on price. The GRAS path offers a route out of this conundrum.
What is GRAS?
The Generally Recognized as Safe (GRAS) for food-use pathway was established by the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). It delineated how substances that are GRAS for their defined conditions of use in food are different from food additives.
Others have previously delved into why firms might consider pursuing GRAS notifications and/or New Dietary Ingredient Notifications (NDIN) independent of hemp and hemp-derived ingredients so I will refrain from wholesale repetition. Two key points on specificity are nonetheless worth repeating: 1) a substance is deemed GRAS for a specific use under specific conditions and 2) a GRAS notification is specific to the company filing the notification.
Why GRAS?
There are a number of practical reasons why firms that produce cannabinoids would seek to pursue the GRAS pathway. Here are five:
Market Expansion
Currently, firms that produce purified hemp cannabinoids are mostly selling their wares to businesses operating in state-regulated delta-9 tetrahydrocannabinol (THC) markets or to operations that may not be in full-compliance with dietary supplement regulations. Almost all firms that produce food products, including beverages, and most dietary supplement manufacturers, will not use ingredients that do not have a history of use in food or that cannot be legally marketed.
For ingredients such as purified hemp cannabinoids that do not have a history of use as articles used for food, the only way to open-up the food, beverage, and dietary supplement markets is via the GRAS/NDIN pathways.
Safety Demonstration
An integral part of any GRAS dossier is the basic demonstration of acceptable risk (cf. safety) for the named substance and impurities. This includes any byproducts that may be introduced by the manufacturing process. Whether one is interested in pursuing a GRAS Notification for submission to FDA or for a self-affirmed GRAS conclusion, the process involves an evaluation of safety for the conditions of use (e.g. serving size, no-observed adverse event level, etc.).
Beyond the ethical necessity of understanding the hazards of a product meant for human consumption, pursuing GRAS helps protect a firm from product liability in the event that harm is created. But more importantly, GRAS helps guard against product liability by seeking to prevent the potential hazard in the first place. That is always good for business.
Avoiding Drug Preemption
FDA has described in numerous forums, including the Administration’s own website, why it has concluded that cannabidiol (CBD) cannot be used as an ingredient in food or dietary supplements. The key is section 201(ff)(3)(B) of the FD&C Act. This section disqualifies an ingredient from use in food or dietary supplement products if the ingredient is 1) an active ingredient in an approved drug or 2) if substantial clinical investigation of the substance as a drug has been conducted AND made public.
While the situation remains unclear for CBD, the only way to avoid a similar murky situation for other cannabinoids (e.g. cannabigerol, CBG) is for those ingredients to be marketed as a food or dietary supplement prior to the public disclosure of clinical trials directed at the development of that substance as a drug.
It is FDA’s position that “legal” marketing entails more than simple inclusion of the substance in marketed products — the substance must have been the subject of GRAS, food-additive, or NDIN pathways, if required, to be legally marketed. To that point, FDA is highly unlikely to conclude that legal marketing includes the marketing of products in state-regulated cannabis systems while THC remains federally illegal.
Side-Stepping Price Wars
The nascent hemp-derived ingredients market is experiencing significant downward price pressure. The reasons are simple. There is currently more supply than demand (see #1 above) and all commercial offerings are essentially generic.
The GRAS pathway is a mechanism out of this me-too trap. A GRAS cannabinoid would be a premium ingredient by virtue of GRAS status alone. Premium ingredients command premium prices. And the types of sophisticated customers that firms like to do business with do not mind paying premium prices for compliance.
Regulatory Intelligence
While we wait on FDA to draft regulations for manufactured hemp-derived products, it is difficult for businesses to make decisions about what products to pursue. Some firms may not care about internal FDA thinking for hemp-related issues like delta-8 THC or proposed New York State in-process hemp material THC limits of 3%, because they are going to seek to exploit the here-and-now.
For forward-looking firms, engaging with FDA through GRAS or other regulated ingredient pathways can help illuminate what lay around the bend. Effectively navigating bends in a fast-paced, regulated marketplace can be the difference between knowing when to brake… and going broke.
How GRAS?
There are a few ways to go about this, but simply asking the question within your company and with your legal and regulatory counsel will help generate more of a groundswell. There are a few hemp- and cannabinoid-specific intricacies that must be navigated in practice, including FDA’s own policies on hemp. But there is no reason why this cannot be done.
EAS Independent Consultant, Brad Douglass, Ph.D., evaluates FDA and FTC compliance of dietary supplement materials including review and audit of dietary supplement labels and labeling. He is experienced in multiple technical, quality, and formulation roles in the dietary supplement and cannabis industries which lends perspective not only regulatory requirements but also the realities of real-world business. Brad’s previous positions include VP of Regulatory Affairs and Director of Advanced Botanical Strategy at the Werc Shop in Los Angeles. He has a doctorate in Organic/Medicinal Chemistry from USC. EAS Consulting Group, a member of the Certified Group of companies, is a global leader in regulatory solutions for industries regulated by FDA, USDA, and other federal and state agencies. Our network of over 150 independent advisors and consultants enables EAS to provide comprehensive consulting, training and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp and CBD. easconsultinggroup.com
If you represent a firm that creates hemp-derived cannabinoids, are a regulator that has responsibility over products that incorporate non-THC cannabinoids, or are just an interested reader that has been intrigued by this blog post, do not hesitate to reach out to me at bdouglass@easconsultinggroup.com.
Sponsored Blog: What A Cannabis Focused Insurance Agent Knows That You Should
Our agency decided to enter the world of cannabis insurance in August of 2016. We made this decision partly because we saw the financial potential of the industry but mainly because we wanted to contribute our talents and services as insurance agents to a culture and industry we believed in. An industry we knew that could one day be seen on the same level as any “main street” business if given the opportunity. Our goal has always been to provide an executive level of professionalism to our clients and to provide the most up to date solutions in protecting their businesses.
While most insurance companies continue to exclude cannabis risks in their offerings, we are proud to say the few insurance carriers who have stepped up to insure cannabis have done a great job of understanding the operations of licensees and their risk exposures. Although cannabis insurance products have improved, gaps in coverage and limited availability for certain risks is still an issue for our clients.
As someone who is championing for each licensee to succeed, I thought I would share some insight in areas of risk cannabis businesses have in order to help protect their business.
Insurance Companies
Since 2016, we have seen two admitted insurance companies offer coverage for California cannabis risks with a third option being offered soon. Three standard workers comp carriers began placing coverage along with the various State Funds each state offers.
More insurance companies are offering commercial auto coverage to states where cannabis is now legal. For the more complicated areas of coverage like Directors & Officers Insurance and Employer Liability Insurance, the insurance industry is being cautious in extended commonplace coverage with premiums and terms being offered at rates much higher than typical policies by comparison.
Policy Exclusions
This is the area of insurance that can get ugly really fast.
An exclusion to a policy removes coverage from the insurance. Each cannabis approved insurance company has their own specific exclusions and no two policies are the same. When an insurance policy has a defined and specific exclusion within it the insurance company will have no duty to defend such claim. This means your company will be on the hook to investigate the claim, prepare and defend yourself in court and possibly settle financially.
Here is a sample of some of the exclusions to be aware of: class action, cancer, redefined bodily injury, vape pens, health hazards, and criminal acts.
Employee vs Employer – (Employer Practices Liability Insurance)
Managing employee workplace environments is a balance of people management and navigating law with employer responsibilities. Both areas even the most seasoned business person or company might find difficulty in doing. The reality is even with full-time HR management in place handling high turnover rates and the difficult job of firing and hiring HR cannot prevent employers from claims of employee misconduct. If a current or former employee claims discrimination or harassment, wage theft or other unlawful acts the company having coverage in place for these claims should be essential for cannabis operators.
Product Liability
While most people in the cannabis industry would agree that consuming cannabis is safe, the potential for product liability claims are massive. With the limited clinical research on cannabis long term physical and mental use and the legal ability to consume it means claiming a cannabis product is dangerous or caused injury or illness has yet to be tested in court. Although we haven’t seen lawsuits many in the industry thought we would see as of yet, my feeling is this will be the next wave of problems for cannabis operators with class-action status and illness being at the forefront of claims.
Delivery & Distribution Risks
High employee turnover and limited insurance options are driving up commercial auto insurance costs. Due to COVID-19 we have seen delivery operations grow rapidly and expand and with this the cost to cover more drivers are pushing down much-needed profits. While background checks are a best business practice at hiring, driving records checks should be done as well to verify any impact on premiums a new hire may have.
OG Cannabis Insurance began offering cannabis insurance in 2016 and quickly has become a recognized industry leader. From the beginning, our agency’s focus has been on developing an in-depth understanding of cannabis insurance products as well as being up to date on state and local cannabis license compliance requirements. Since then, we have worked with local municipalities on the shortfalls of cannabis insurance and have worked with insurance carriers who were interested in insuring cannabis but needed to know more about cannabis risks.
We decided to bring our talents and services to cannabis because we believed for the industry to thrive it must have access to knowledgeable and credible professionals representing cannabis. It is our goal to provide the cannabis industry with the most trustworthy and knowledgeable staff.
Manuel started in the insurance industry for an independent agency located in Chino CA in 1998 and was with that same agency until it sold in 2008. As his career grew, so did his knowledge of insurance products, coverage, exclusions, and terms. He began to sell Commercial Line’s policies including Workers Compensation, General Liability, and Property Insurance. His clients include Trucking Companies, Bail Bond Companies, Staffing Companies, and Contractors just to name a few industries.
When the agency he worked for sold, he started his own agency, So. Cal’s Best Insurance in 2008. Manuel has been married since 2008 and has 2 boys who keep him busy at home. He is an avid sports fan who loves boxing, the Dodgers and Lakers.
