As the cannabis industry continues to evolve, so do the discussions around regulations, particularly concerning flavor additives in inhalable cannabis products. This blog post represents the members of NCIA’s State Regulations Committee current reflections on the successes and shortcomings of existing cannabis vape regulations, focusing on flavor limitations, safety considerations, quality specifications, and labeling practices. While technical, this topic has a tremendous impact on cannabis brands and consumer safety.
First, for those who might question the need to add flavors to cannabis vapes, it’s essential to highlight the following points regarding why flavors are added and the benefits they bring:
Restoration
In some cases, such as with cannabis distillates, processing or manufacturing techniques can alter or remove natural cannabis flavors from vape liquids. Adding cannabis flavors back simply returns the final product back to nature’s intended taste profile, providing consumers with a comprehensive vaping experience.
Mimicking Smoking Sensation
For individuals transitioning from traditional smoking to vaping, flavors can mimic the sensations and tastes they are accustomed to, making the switch more enjoyable and satisfying.
Customizing Preferences
Consumers have diverse preferences, and adding flavors allows them to customize their vaping experience based on their personal taste preferences, whether they prefer fruity profiles or classic cannabis flavors. Akin to aromatherapy, consumers may also predict the mood impression they will experience by vaping a particular flavor.
Providing Consistency
Consumers often expect certain flavors in products based on their product familiarity so it is important for brands to be able to deliver a consistent vaping experience wherever their product is sold despite changes that the consumer may otherwise notice due to harvesting variability of the cannabis or limitations on strain availability across borders.
Meeting Market Demands
The vape industry is driven by consumer demand for a wide variety of flavors. Adding flavors allows vape manufacturers to meet market demands and cater to the preferences of different consumer segments. In regions where certain flavors are restricted or banned due to regulation, the legal vape industry is challenged to compete with the illicit market, where flavors would continue to be available. However, these illicit market alternatives may not undergo the same safety and quality standards as legal vape products, potentially posing risks to consumers’ health. By offering a wide range of flavors, the legal vape industry can provide consumers with safer alternatives and help combat the proliferation of potentially unsafe, unregulated products.
Personal taste aside, the dangers of unsafe flavors in unregulated products are real, as was demonstrated in 2019 through cases of EVALI (E-cigarette or Vaping Associated Lung Injury). As detailed in this piece, manufacturers need to follow best practices to protect vaping consumers no matter if they are in regulated cannabis, unregulated cannabis, or the CBD/hemp markets.
Flavor Limitations
Overall, the addition of flavors to cannabis vapes is not just about enhancing taste but also about meeting consumer expectations and improving consumer safety. Flavors create consistency in products and are common across consumer products we already enjoy daily. Consumers are trained to expect flavor variety and consistency in traditional e-cigarettes, and cannabis vapes should be no different.
What’s Working?
We commend states like Oregon for taking a pragmatic approach by allowing a broad range of natural, artificial, and cannabis-specific flavoring ingredients while rightly prohibiting scientifically known inhalation hazards. This approach provides broad room for innovation while protecting the public from valid safety risks.
What’s Not Working?
Conversely, restrictions on flavor ingredients to only natural sources, as seen in states like Nevada, California, and New York, are unnecessarily limiting and not scientifically justified. Further limiting flavoring terpenes to being cannabis or hemp-derived, like in Connecticut, also hinders creativity, imposes higher costs, and potentially pushes consumers towards unregulated alternatives. Likewise, enforcement actions to prevent adolescent access to vapes should be prioritized over regulations to limit flavors or labels thought to be more appealing to adolescents.
Safe Flavors
Everyone’s goal should be to provide consumers with the safest possible experience when using inhalable products containing flavors. What’s safe to eat isn’t always safe to inhale.
What’s Working?
Responsible suppliers implementing robust quality and regulatory pre-qualification measures for all flavor ingredients is a positive step. Vendors should be vetted, approved, and responsible for the products they supply. Encouraging manufacturers to develop comprehensive toxicological programs tailored for inhalation safety is also crucial.
What’s Not Working?
Requiring flavors or flavor ingredients to be listed on the pharmaceutical FDA IID for inhalation is inappropriate and does not guarantee a safer flavor. The only reason flavors or flavor ingredients may be in the FDA IID is because they already exist in pharmaceutical products that went through a safety review process. However, the flavors themselves haven’t been evaluated independently for inhalation safety (emphasis added).
Instead of mandating a specific database of flavors, it’s more appropriate to regulate the process of sourcing and validating ingredients.
Quality Specifications
Once a desirable and suitable flavor has been identified, manufacturers need to understand how to maintain quality.
What’s Working?
Adhering to the approach of FDA’s Food Safety Modernization Act (FSMA) for quality plans is best practice, ensuring hazards are identified and controlled by qualified individuals at each manufacturing stage.
What’s Not Working?
Overly broad testing requirements for non-cannabis-derived flavors or multi-ingredient cannabis products are redundant and economically unviable, particularly when hazards are effectively controlled through quality plans at earlier or later stages of a supply chain.
Labeling Practices
Finally, it’s important to examine how manufacturers should disclose when flavoring has been added to products. Consumers have a right to understand if a product is flavored.
What’s Working?
Simple, consumer-friendly labeling, such as using common terms like “Natural and Artificial Flavors,” aligns with other industry standards and will be recognized by the common consumer. Adopting labels familiar to the conventional Consumer Packaged Goods (CPG) industry effectively bridges the gap between industries and aligns with how consumers already make these decisions across all products they buy.
What’s Not Working?
Listing the chemical names of all flavoring ingredients, as mandated in Oregon, New York and Missouri, is excessive and may confuse or intimidate consumers. Consumers are not qualified to assess risk from formula information. Unregulated products that do not list flavor ingredients may become more appealing to some consumers that are intimidated by the chemical names on the flavor label of the licensed product.
Recommendations
Having reasonable and consistent regulations across the country will help to create a safe and level playing field for manufacturers and brands to compete for consumer market share. While nuanced, these regulations materially impact the ability to bring a product to market or make a product economically viable.
Starting with flexible flavor definitions allows for a wide range of internationally recognized flavor ingredients, including natural, artificial, and cannabis-inspired isolates.
Banning known risks is common sense best practice. This process must be dynamic and listen to science. For example, Diacetyl, once a popular popcorn flavoring, was banned after research concluded it was unsafe for inhalation. A known, published inhalation hazard list is critical.
Implementing a safety certification policy based on thorough toxicological risk assessments specific to inhalation exposure ensures accountability.
Finally, adopting simple and recognizable labeling terms like “Natural and Artificial Flavors” and aligning allergen disclosures with established FDA and EU regulations make sense and protect intellectual property. We are advocating for consistency.
These effective regulations prioritize safety without stifling innovation or burdening stakeholders. We welcome ongoing dialogue and collaboration to develop pragmatic, science-based regulations that benefit consumers and the industry.
Committee Insights | 9.28.22 | Cannabis Ballot Initiatives in the November 2022 Election
In this edition of our NCIA Committee Insights series originally aired on Wednesday, September 28, 2022 members of NCIA’s State Regulations Committee convened a panel of government affairs, business development and licensing experts for an in-depth discussion focusing on cannabis ballot initiatives up for a vote this coming November.
They provided a detailed overview on the status of each campaign so that you’ll learn how best to position yourself for success and what you can do to help push these efforts across the finish line. If you’re considering business Arkansas, Maryland, Missouri either of the Dakotas then this session is specifically geared for you.
At the conclusion of the discussion they hosted a moderated Q&A session to provide NCIA members an opportunity to interact with leading minds from the cannabis regulatory and licensing space, join today to contribute to future conversations!
Learning Objectives:
• Provide practical information to NCIA members about the cannabis ballot initiatives and potential new business opportunities.
Sumer Thomas
Director of Regulatory Operations
Canna Advisor
Nicola Batten
CEO & Founder
koLaB Consulting
Larry Luksha
Government Relations & Business Development
Veritec Solutions
Joseph Smith
Senior Managing Associate
Thompson Hine LLP
Webinar: NCIA Committee Insights – Illinois Market – What’s Happening and What’s Next
Join us on Monday, May 11 at 1:00 PM MT for this webinar.
How is the 11th state to permit adult-use cannabis doing, and what’s coming next? Want to get your foot in the door? Join us in a lively conversation about Illinois application and licensing.
Considering expansion to Illinois from another market? Learn how Illinois differs from other markets on some key issues. Think it’s essential that states successfully innovate to promote social equity?
We’ll discuss what Illinois is doing well and where the gaps are in regards to their Social Equity program. Join industry thought-leaders from NCIA’s State Regulations Committee as they discuss these crucial topics and more.
If you want to open and operate a regulated cannabis business, there’s no avoiding local government. Every state grants different amounts of power to towns and cities, with some allowing localities to ban cannabis businesses outright, and others simply giving them the same power over time, place, and manner of operations that they have for other businesses. But since cannabis can be a hot-button issue, a proposal to open a cannabis facility often attracts far more attention than opening any other type of business.
To help NCIA members and other cannabis entrepreneurs navigate local government, we at the State Regulations Committee have launched a series of blog posts, with each taking a close look at a different type of cannabis license. Last month, we published our first post, “Working With Your Local Government as a Cannabis Cultivator.”
Today, we’re moving one step down the supply chain and talking about cannabis processors (sometimes also called manufacturers or infusers). Since state programs vary widely, with some licensing cannabis processors independently and others combining processing with cultivation (or even a single vertically integrated license), we will be focusing on the operations rather than the licenses themselves. If you’re seeking a combined license, be sure to read the blog for each activity your business will be allowed to engage in — while there is some overlap, there are also some major distinctions in how different operations can most effectively interact with municipal officials, and you will need to be well-versed in answering questions unique to each phase of your business.
ECONOMIC IMPACT
Like the three rules of real estate being “location, location, location,” the three rules of economic development are “jobs, jobs, jobs.” When proposing a new business in a town or city, local officials are going to want to know how many jobs it will bring, as employment can put money directly into the hands of their constituents and have ripple effects throughout the local economy.
In addition to the raw number of jobs your business will create, it’s also important to highlight the qualifications for those positions. Processing facilities often need to have highly qualified individuals with PhDs or other certifications to manage production processes, and officials will be happy to see the salaries that come along with such positions. Entry-level jobs, such as working production lines, are also worth talking about — even though they have lower salaries than someone with a doctorate, it’s usually much easier to hire local talent for these positions. Any commitment to hiring locally as much as possible is usually a big plus to politicians. Additionally, be sure to mention how much these new employees will add to the local economy, through all the typical living spending they will do.
Setting up and maintaining your facility will also have a major economic impact, especially in smaller communities. If you’re constructing a building to suit, get estimates from your contractors about the jobs your project is supporting, and let officials know how much you’re investing in the build-out. If you’re moving into an existing space, you’ll almost certainly be doing significant renovations to meet the state’s strict safety standards, which is also worth talking about. Towns and cities that are struggling economically will often be very happy to see unused commercial space become occupied, especially if those properties are being improved. If possible, also identify local contractors (like electricians) or suppliers (like lumberyards) you will use for construction.
Finally, there are direct payments to the local government. While officials love to see any sort of economic development, they still have services to provide and a budget to balance, and will want to know what the municipality will be receiving directly. Calculate your building’s expected property taxes, both on an annual basis and 5-10 years out — since cannabis licenses are usually very difficult to re-locate, emphasize that you are in it for the long haul. Be sure to understand your states’ tax structure, and know whether there are any local taxes that the town will receive, or if towns that host cannabis licensees receive any portion of state tax revenue.
PUBLIC SAFETY
The top public safety issue in local officials’ minds when it comes to cannabis processing is almost surely to be butane fires and explosions. This is for good reason — while hydrocarbon extractions can be very safe and effective when done properly, when done improperly they can be incredibly dangerous. City councilors or fire chiefs may have read some of the many headlines about butane-related accidents over the past few years, and it’s up to you to address these concerns directly and honestly. Of course, before diving into these conversations, check to see if the municipality or county has already banned such extraction methods, as some state laws allow local control in this area.
If you’re not planning to perform hydrocarbon extractions at your facility, be sure to tell that to your local officials. They may not realize that there are many other types of cannabis extracts that do not present such safety risks, such as CO2 extracts (carbon dioxide is not flammable, and similar processes are used for decaffeinating coffee) or bubble hash (which uses only cold water). If you have zero interest in ever using hydrocarbons in your facility, putting this agreement into writing may make local officials even more comfortable.
If you do plan to perform hydrocarbon extractions, educating officials on the risks and safety measures is paramount. Most states have extensive regulations on how extraction labs must be set up, which you can email or print out for meetings to demonstrate what you’ll need to comply with. Since the vast majority of butane-related accidents have come from illegal labs with makeshift equipment, show officials the equipment you’ll be using, emphasizing the price and professional quality. The manufacturers may even have fact sheets or other information you can share to demonstrate the safety of their equipment. As you educate officials on your methods and equipment, be sure to keep open lines of communication with the fire chief and building inspector, who will have the most expertise and authority on this aspect of public safety.
Beyond the processing-specific concerns about fires and explosions, all cannabis businesses will have to deal with officials’ concerns about theft. These may be particularly acute for processors since your end products have a much higher value-to-weight ratio than raw cannabis plants. To address these concerns, explain the security requirements in state laws and regulations, and any areas where you are going above and beyond what is mandated. Things like external security cameras and floodlights can both protect your own business and your neighboring community, making a cannabis business a net gain to public safety.
COMMUNITY IMPACT
Once economic development and public safety have been considered, local officials will wonder about the broader community impact of your cannabis business in areas like odor or traffic. This is an easy topic for processors, as they arguably have the smallest impact of any type of cannabis operation.
Processors are generally much smaller than cultivation facilities, and since they’re not full of growing cannabis plants, they also have much less odor to address. Unlike a dispensary or retailer, processors are not open to the public, so town planners won’t need to worry about an influx of traffic. Once you explain how you’ll be operating, local officials should be able to rest easy knowing that to an outside observer, your business will be virtually indistinguishable from a commercial kitchen or light manufacturing facility. If there are still concerns about odor, inform them that modern odor mitigation technology can completely eliminate any odor from leaving your facility.
GOING FURTHER
Once you’ve explained what you’d like to do and how you think your facility would fit into the local community, the conversation isn’t over — it’s just beginning! If the local government needs more time to consider your proposal, then it’s good to keep in close touch and address any additional concerns they have as they arise. If the local officials are already comfortable with your business and are welcoming it into their community (or if your state law doesn’t give local officials the power to stop you from opening up), it’s still great to build that relationship and keep an open dialogue.
Elected officials usually need to know a little bit about everything, but don’t have the bandwidth or in-house expertise to go very deep on most subjects. That’s where you, someone working full-time in the cannabis industry, come in — you almost certainly know more about state laws and regulations than they do, which is a great opportunity for you to serve as a resource. If you hear about changes in the law or proposed bills that could impact their town or city, send over news articles or bill text to help keep them informed.
Once you’re open, it’s always great to offer tours of your facility. This will help officials gain first-hand knowledge of what you actually do, and in municipalities where legal cannabis is new, it can help dispel negative stereotypes and demonstrate how professional you and the rest of the regulated cannabis industry are.
Be sure to stay tuned for future installments in this series, where we will be addressing other cannabis license types. Our next blog will focus on retail.
Committee Blog: California Social Consumption Leads the Way
It was January 28, 2020: It’s a full house at the Berkeley City Council meeting, with comprehensive changes to the city’s marijuana regulations on tonight’s agenda. The biggest issue, with supporters of both sides attending, is the vote to consider legalizing cannabis consumption at specially designated licensed dispensaries.
The proposal to allow smoking, vaporizing, and consumption of edible goods is supported on one side by a phalanx of marijuana advocates and dispensary operators, and on the other side, it’s the city Health Department and Berkeley’s famously NIMBY neighbors. This conflict runs deep; cannabis users want dignified, legal facilities where they can gather and use marijuana, and several dispensary neighbors and the health department want this idea squashed, full stop.
Fact is, people have long gathered together to share cannabis, as shown by an extensive recorded history of use. This spans from ancient Sumerians, who built huts and vaporized cannabis on burning coals inside, to underground marijuana smoke-ins in the 70s and 80s, to now, where cities are licensing legal cannabis consumption facilities for adults.
California is helping lead the United States consumption lounge movement. For example, California’s Bureau of Cannabis Control (BCC) regulations (Section 5025) explicitly contemplate the possibility of consumption lounges, stating that “this section shall not be interpreted to prohibit cannabis consumption on the premises of a licensed retailer or licensed microbusiness authorized to engage in retail sales,” as long as they are locally licensed and approved.
The state law also created Temporary Cannabis Event Licenses, where onsite consumption is allowed at festivals like the High Times Cannabis Cup and the Emerald Cup. Yes, with city or county and state permission, it is possible to throw your cannabis dream event, but there are a limited number of locations in only a handful of places that allow these uses (including my hometown, Oakland). This makes it hard to get these licenses, and the costly and complicated regulations are hard to meet once you have one. Anyone hosting a Temporary Cannabis Event can expect to interact closely with the BCC regulators, who will surely attend to ensure compliance.
Cannabis consumption facilities are nothing new in California. They have long existed, ever since Dennis Peron opened his first dispensary in San Francisco in the early-1990s. His famous location on Market Street was five stories high, literally, as each floor contained tables, couches, and chairs where patrons could hang out and consume cannabis. When the Compassionate Use Act of 1996 passed, collective dispensaries started opening across the state, despite federal illegality and the occasional raid because of it (Dennis was raided by the feds and forced to close in 1998).
I opened my first cannabis consumption lounge at Berkeley Patients Group in 1999, which was long before it was legal to do so. This was under the cover of tolerance provided by Proposition 215; after all, not even dispensaries were actually made legal by this groundbreaking initiative. That didn’t happen until the state legislature passed the aptly named SB 420 in [year], after which most cities grandfathered in their existing cannabis dispensaries. (Not all, though. Some municipalities used this transition as an excuse to ban dispensaries, or to close existing ones, during long periods of regulatory contemplation.) Berkeley allowed onsite consumption until the early 2010s, when the local regulatory processes changed. Hence, the City Council vote tonight to decide the fate of onsite consumption here once again.
Now, I own Magnolia Wellness dispensary in Oakland, where local regulations have allowed cannabis consumption at specifically licensed dispensaries since 2017. Magnolia’s Dab Bar and Vapor Lounge was the first legal consumption lounge in the East Bay. We have café style tables, a gorgeous full, copper top bar, glass dab rigs with e-nails, Vapexhale and Volcano vaporizers, and a variety of tasting events where people can try samples. Unfortunately, Oakland’s dispensary law only allows vaping, edibles, and topicals, limiting smoking to additionally permitted outdoor patios, none of which currently exist. (Full disclosure: I also co-own Hi Fidelity dispensary in Berkeley, too.)
San Francisco, on the other hand, has more than a dozen shops where cannabis smoking, vaping, and edibles consumption are all allowed. SPARC, one of the first lounges in the city, has tasteful tables and chairs right in the main dispensary, where volcano vaporizers can be used onsite. Vapor Room, a few blocks away, is a smaller neighborhood joint, with a handful of seats for people to sit and enjoy smoking or vaping. According to owner Martin Olive, it was a costly HVAC system, at a near six-figure expense, that allowed his facility to host its cannabis smoking patrons. Moe Greens, the latest licensed lounge to open in the city, took four long years to get licensed, but is now a beautiful facility, with cushy booths for smoking and a counter service dab bar with top-of-the-line e-nails and dab rigs for patrons to use.
West Hollywood is the biggest news on the California consumption lounge scene, as the city recently licensed 16 facilities for on-site consumption. Half of these facilities will allow retail sales and consumption, while the others are allowed to sell only single-use items, designed to be consumed café style, while patrons are on-site. This plan has been controversial, though, because in issuing these licenses, the city took permits away from several of the long-existing dispensaries, re-issuing them to new operators. The ensuing lawsuits and legal battles will surely play out through 2020.
There is another big problem in West Hollywood: the state law does not match up with their rather forward-looking ideas for cannabis cafes. For example, cannabis cannot be blended into café food and served on the spot, as the city imagined when creating this law; Cannabis can only be sold pre-packaged and tested, per BCC regulations. Furthermore, state-licensed cannabis businesses are not allowed to sell anything but cannabis products (and a shortlist of branded items like mugs, lighters, and pipes). In other words, they can’t sell non-infused foods or beverages like coffee, soda, or tea (or, since we are talking West Hollywood, kombucha and smoothies).
Until state law changes, the plan is stuck in limbo, with facilities looking for creative workarounds to allow food and beverage service.
So, despite the West Hollywood ordinance passing in late 2018, only one facility has opened there, and even this has hit roadblocks. In fact, they recently re-branded after only a short time in business, from Lowell’s Café to the Cannabis Café, after a regulatory crackdown hit the Lowell’s brand hard. It remains to be seen when the other 15 cannabis lounges will open there.
Back in Berkeley, staff from the Health, Planning, Police and Economic development offices joined forces with the Berkeley Cannabis Commission to present the City Council with a comprehensive plan to update the city’s cannabis ordinance. Diverging opinions meant that the agenda contained competing proposals on several of the ten proposed ordinance changes, with the Cannabis Commission leading efforts to create progressive changes, and the Health Commission stuck on the old trope, “we need more research.”
Elizabeth Greene, City of Berkeley Senior Planner, explained to Council that these proposals have been in development since 2017, with the goal of expanding the rules to protect the entire cannabis supply chain, from seed to sale. This includes development of two new license types, cannabis consumption lounges and non-retail dispensary licenses.
“State law allows for consumption lounges as part of a retail license, as these are the only facilities open to the public,” Greene says. “Currently, consumption lounges are not permitted in the City of Berkeley.” Her presentation made it clear that city staff recommended cannabis lounges be permitted, despite the worries of the Health Commission, whose representative commented that “legalization is new,” despite that cannabis sales have been regulated by the city for around 20 years.
Long time senior advocate, and ICANN dispensary owner, Sue Taylor spoke eloquently in support of the proposal to allow lounges. “Seniors need a place to learn about cannabis, how to use it and dosing, and you could do that in a vape lounge. I can’t go into their homes, but I can provide this education at a lounge,” says Taylor. “It’s not like a bar; at a bar, you just get sicker. A vape lounge helps people.”
Ultimately, the City Council agreed. By 11:30 PM, Mayor Jesse Arreguín called the vote, with the Council unanimously approving the entire proposal. Supporters filled the room with cheers, and long-time advocates like myself reflected on the fact that, yes, hard work and determination do pay off. Together, we may just end prohibition, once and for all — and have some fun, too.
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