Tag Archives: licensing

California Manufacturing Regulations: What You Need To Know

By Aaron G. Biros
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In late November, California released their proposed emergency regulations for the cannabis industry, ahead of the full 2018 medical and adult use legalization for the state. We highlighted some of the key takeaways from the California Bureau of Cannabis Control’s regulations for the entire industry earlier. Now, we are going to take a look at the California Department of Public Health (CDPH) cannabis manufacturing regulations.

According to the summary published by the CDPH, business can have an A-type license (for products sold on the adult use market) and an M-type license (products sold on the medical market). The four license types in extraction are as follows:

  • Type 7: Extraction using volatile solvents (butane, hexane, pentane)
  • Type 6: Extraction using a non-volatile solvent or mechanical method
    (food-grade butter, oil, water, ethanol, or carbon dioxide)
  • Type N: Infusions (using pre-extracted oils to create edibles, beverages,
  • capsules, vape cartridges, tinctures or topicals)
  • Type P: Packaging and labeling only

As we discussed in out initial breakdown of the overall rules, California’s dual licensing system means applicants must get local approval before getting a state license to operate.

The rules dictate a close-loop system certified by a California-licensed engineer when using carbon dioxide or a volatile solvent in extraction. They require 99% purity for hydrocarbon solvents. Local fire code officials must certify all extraction facilities.

In the realm of edibles, much like the rule that Colorado recently implemented, infused products cannot be shaped like a human, animal, insect, or fruit. No more than 10mg of THC per serving and 100mg of THC per package is allowed in infused products, with the exception of tinctures, capsules or topicals that are limited to 1,000 mg of THC for the adult use market and 2,000 mg in the medical market. This is a rule very similar to what we have seen Washington, Oregon and Colorado implement.

On a somewhat interesting note, no cannabis infused products can contain nicotine, caffeine or alcohol. California already has brewers and winemakers using cannabis in beer and wine, so it will be interesting to see how this rule might change, if at all.

CA Universal Symbol (JPG)

The rules for packaging and labeling are indicative of a major push for product safety, disclosure and differentiating cannabis products from other foods. Packaging must be opaque, cannot resemble other foods packaged, not attractive to children, tamper-evident, re-sealable if it has multiple servings and child-resistant. The label has to include nutrition facts, a full ingredient list and the universal symbol, demonstrating that it contains cannabis in it. “Statute requires that labels not be attractive to individuals under age 21 and include mandated warning statements and the amount of THC content,” reads the summary. Also, manufacturers cannot call their product a candy.

Foods that require refrigeration and any potentially hazardous food, like meat and seafood, cannot be used in cannabis product manufacturing. They do allow juice and dried meat and perishable ingredients like milk and eggs as long as the final product is up to standards. This will seemingly allow for baked goods to be sold, as long as they are packaged prior to distribution.

Perhaps the most interesting of the proposed rules are requiring written standard operating procedures (SOPs) and following good manufacturing practices (GMPs). Per the new rules, the state will require manufacturers to have written SOPs for waste disposal, inventory and quality control, transportation and security.

Donavan Bennett, co-founder and CEO of the Cannabis Quality Group

According to Donavan Bennett, co-founder and chief executive officer of the Cannabis Quality Group, California is taking a page from the manufacturing and life science industry by requiring SOPs. “The purpose of an SOP is straightforward: to ensure that essential job tasks are performed correctly, consistently, and in conformance with internally approved procedures,” says Bennett. “Without having robust SOPs, how can department managers ensure their employees are trained effectively? Or, how will these department managers know their harvest is consistently being grown? No matter the employee or location.” California requiring written SOPs can potentially help a large number of cannabis businesses improve their operations. “SOPs set the tempo and standard for your organization,” says Bennett. “Without effective training and continuous improvement of SOPs, operators are losing efficiency and their likelihood of having a recall is greater.”

Bennett also says GMPs, now required by the state, can help companies keep track of their sanitation and cleanliness overall. “GMPs address a wide range of production activities, including raw material, sanitation and cleanliness of the premises, and facility design,” says Bennett. “Auditing internal and supplier GMPs should be conducted to ensure any deficiencies are identified and addressed. The company is responsible for the whole process and products, even for the used and unused products which are produced by others.” Bennett recommends auditing your suppliers at least twice annually, checking their GMPs and quality of raw materials, such as cannabis flower or trim prior to extraction.

“These regulations are only the beginning,” says Bennett. “As the consumer becomes more educated on quality cannabis and as more states come online who derives a significant amount of their revenue from the manufacturing and/or life science industries (e.g. New Jersey), regulations like these will become the norm.” Bennett’s Cannabis Quality Group is a provider of cloud quality management software for the cannabis industry.

“Think about it this way: Anything you eat today or any medicine you should take today, is following set and stringent SOPs and GMPs to ensure you are safe and consuming the highest quality product. Why should the cannabis industry be any different?”

Biros' Blog

Regulate Marijuana Like Alcohol? Not So Fast

By Aaron G. Biros
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You’ve heard it in a lot of campaigns to legalize cannabis on a state level and even as the name of a bill in Congress for legalization on the federal level. The Marijuana Policy Project through their campaigns in several states, along with activists, politicians and lobbyists, have used the phrase “Regulate Marijuana Like Alcohol” as a rallying cry to pass legislation reforming cannabis laws. This isn’t an attack on them; those campaign names serve the cause well, moreover it was the name of successful campaigns in Massachusetts, Maine, California, Alaska and Colorado among others. It is a relatable and fair comparison, helping to normalize the concept of adults using cannabis in a legal environment.

But that feeling of validation is short-lived after lawmakers write the actual regulations. In reality, I don’t think a single state can confidently say they actually regulate cannabis like alcohol. Most states do not allow public or social consumption of cannabis; many people that would like to enjoy cannabis in a social setting are restricted to the confines of their home.

420 Rally at Civic Center Park, Denver, CO.
Photo: Cannabis Destiny

Voters in Colorado passed Amendment 64 in 2012 with this language in the very beginning of the bill: “In the interest of the health and public safety of our citizenry, the people of the State of Colorado further find and declare that marijuana should be regulated in a manner similar to alcohol.” If you look closely, you can see how important phrasing is when it comes to the specific regulations. The key words here are “a manner similar to alcohol,” not exactly like alcohol. That language is critical to understanding how regulators address the double standard.

The most obvious way lawmakers regulate cannabis like alcohol is through a tiered system of license holders: manufacturers, distributors or wholesalers and retailers. Many states might set a limit on potency, just like they do with alcohol, according to Pamela S. Erickson, former executive director of the Oregon Liquor Control Commission. Both of the drugs are taxed and there are usually regulations for both governing the advertising of products, such as preventing targeting youth or encouraging high consumption. Regulators might limit the store hours or locations for both cannabis and alcohol. Beyond those similarities, there are a number of areas where cannabis is over-regulated and alcohol is seemingly under-regulated. It is very possible that much of this has to do with the power of the alcohol lobby. In 2016, the alcohol industry spent over $26 million on lobbying efforts, according to the Center for Responsive Politics, a non-profit, nonpartisan group that tracks lobbying efforts. During election season, the alcohol industry spent more than $11 million on campaign contributions. There are several examples of the alcohol industry actively fighting legalization efforts, including paying for anti-cannabis ads in a Politico newsletter and even funding opposition campaigns. While this doesn’t exactly pertain to the regulation of cannabis versus alcohol, it gives you a glimpse of how deep their coffers go and the amount of influence they have on politics.

Last year, the city of Denver passed a ballot measure, Initiative 300, which will legalize the social consumption of cannabis in permitted venues. The Denver Social Consumption Advisory Committee met for the final time last week. That committee designed two styles of permits: one for events and one for established businesses, which would receive a designated consumption area permit (DCA). Those permitted venues must be 1,000 feet from schools, child-care centers or drug rehabilitation centers. They need a waste plan, compliance with the Indoor Air Quality Act and they cannot sell cannabis products. Rachel Gillette, attorney in the cannabis law group and shareholder at Greenspoon Marder, says the legal implications of the initiative are still up in the air. “This was a step in the right direction,” says Gillette. “You can’t pass a law to regulate marijuana like alcohol and then say people can only use it in their home. You are going to run into problems like people smoking on the street. This is why this initiative was introduced.”

Rachel K. Gillette, Esq., practicing at the cannabis law group in Greenspoon Marder

The general idea here is B.Y.O.P.- bring your own pot. They cannot have a liquor license, the location cannot be accessible to the general public, they have to submit a detailed security plan and patrons have to sign a waiver to get in, according to Westword. Signing a waiver to get into a bar should seem asinine to anyone, but I have been to some dive bars where a waiver could’ve definitely been useful. The point is that cannabis doesn’t lead to violence or destructive behavior, alcohol is the drug that does that. There is plenty of evidence to support that, including a comparative risk assessment of the drugs, which found alcohol’s danger to be strongly underestimated previously.

Senate Bill 63 in the Colorado State legislature would have been very similar, issuing licenses for “marijuana consumption clubs.” However that bill was voted down last Thursday, largely due to the uncertainty of federal policy, according to ABC News.

Amendment 64 also has specific language saying you cannot consume cannabis in a public space, but that is not exactly the case with liquor, even when you consider open container and public intoxication laws. “In my previous interactions with the state and particularly the liquor licensing authority, they consider liquor-licensed premises to be de facto public spaces but you can’t consume cannabis there, which is why hotels, bars and restaurants explicitly prohibit cannabis consumption, they have a liquor license,” says Gillette. “There is a bit of conflict in the law here.”

Yet other rules, such as mandatory childproof containers for cannabis retailers, seem a bit draconian compared with buying a bottle of twist-off wine from the grocery store. “Childproof packaging isn’t required in liquor stores anywhere,” says Gillette. “Why cant responsible adults be trusted to keep it out of a child’s reach? Unfortunately there is a lot of trepidation to allow responsible adults to be responsible when it comes to cannabis.” In some ways, we are seeing states begin to regulate cannabis very closely to how they would alcohol, yet there is a long way to go. “There is still this nanny state mentality where we run the risk of regulating it to the point of absurdity,” says Gillette. For now at least, we need to be cognizant of the age-old stigma and work to normalize social cannabis use in a legal sense. Until that time comes, we will have to tolerate lawmakers regulating cannabis in a manner similar to alcohol, not exactly like alcohol.

Exploring Opportunities in Emerging Markets

By Aaron G. Biros
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This November 8th, voters in five states will head to the polls to decide on legalizing recreational cannabis and another three states have ballot initiatives that would legalize medical cannabis. If any of those five states pass a measure for recreational legalization, including Massachusetts, Maine, Nevada, Arizona and California, (which are all leading in the polls) they could potentially create massive new market opportunities for cannabis brands that have their eye on expansion.

Nancy Whiteman, co-owner of Wana Brands and chair of the Cannabis Business Alliance Infused Product Committee, sees great potential in capitalizing on those markets early. Whiteman has been working with Wana Brands since 2010 in Colorado, starting out in the young medical market there.

Nancy Whiteman holding a batch of cannabis gummies
Nancy Whiteman holding a batch of cannabis gummies

After expanding to the recreational market, Wana Brands saw its sales skyrocket. From January to August 2016, Wana had the best-selling candy brand in Colorado with 21% dollar share, according to BDS Analytics. Wana Brands has already expanded to Oregon and will launch in Nevada on November 15th, with agreements signed to expand in other states as well. “The model we are pursuing is a licensing agreement where we partner with existing or new license holders in their state,” says Whiteman. “In many ways they are doing the heavy lifting, but we are providing an enormous lift by licensing our intellectual property to them.” That model for growth is becoming increasingly common in some of the more established brands, like Steep Hill Laboratories, GFarma Labs, Dixie and others. Whiteman says that Wana Brands also has a partner in Illinois, Massachusetts and a number of other states they hope to reach.

Mark Slaugh, CEO of iComply
Mark Slaugh, CEO of iComply

According to Mark Slaugh, executive director of the Cannabis Business Alliance and chief executive officer of iComply, a compliance services provider, brands from Colorado expanding to other states need to ask themselves if their reputation is on the line with these new operators. “If you are licensing to companies that are not compliant, the penalties could be huge and they vary state to state- that could potentially hurt the overall brand image nationally,” says Slaugh. “People doing the licensing that are operating with full compliance really need to look at controlling that risk and mitigating that as much as possible.” With brand trust on the line, there are substantial risks that come with expansion. “We help clients ensure quality is consistent so, for example, an edible product would taste the same in Colorado as it would in Nevada or Arizona. They need to follow the intellectual property consistently but more importantly follow those specific regulations in that state to stay afloat.” Managing ongoing compliance in different states requires monitoring regulatory updates across multiple markets, which can get incredibly complex.

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Processing SOPs vary widely stae to state

“Six years ago, it was much easier to get into the market in Colorado,” says Whiteman. “There were no capital requirements, no limits on the number of licenses, but there was still a lengthy application and vetting process- as long as you met those minimum requirements you could get a license.” Other new states put stringent limits on the number of licenses granted and some have extraordinarily cost-prohibitive capital requirements, up to a million dollars, as is the case for New York. “Anyone who becomes a license holder in Massachusetts has to be prepared to embark on three separate business models, which is a massive undertaking,” says Whiteman. Massachusetts requires license holders to cultivate, process and dispense in a vertically integrated model.

In other states, Wana Brands is working with exclusive partners who will have the capabilities to manufacture and distribute throughout the entire state, but in Massachusetts that won’t be the case. “To cover the state, we need several partnerships; the partner we are working with is a little south of Boston,” says Whiteman. But all that could change if voters in Massachusetts legalize it recreationally, opening a much larger market than the current medical program. “With no legislation drafted yet, the regulatory environment is still up in the air in Massachusetts so there is no way of telling what the recreational market will look like.” In terms of ongoing regulatory compliance, Whiteman believes that Colorado still has some of the most stringent rules. The universal symbol printed on every individual edible product serving is one example. “Every state has different lab testing and licensing requirements, but Colorado looks like the most stringent currently,” says Whiteman. “Colorado requires a full gamut of lab testing including homogeneity, potency, residual solvents, contaminants and soon pesticides too.” According to Mark Slaugh, Nevada’s lab testing regulations are fundamentally different from Colorado’s with regard to sampling procedures, but the broader inconsistencies in lab standards need to be addressed. “The lack of laboratory standardization state to state with regard to methods creates a big challenge to get consistent, proficient lab testing across the board,” says Slaugh.

Wana's edibles come stamped with the universal symbol (THC!)
Wana’s edibles come stamped with the universal symbol (THC!) in Colorado, as required by law.

A big differentiator between Colorado and other states is that it was a first mover. “When Colorado came online there were not any established brands to speak of anywhere in the country- we were all pioneers,” says Whiteman. “Because it is so difficult to get a license in another state, either the organization or investor groups are looking to partner with established brands.” The advantages to this business model are many. Expediting your entry to market gets you the advantage of being a first mover. Working with an established brand also minimizes risks and the learning curve. “Bigger players understand that building a brand from scratch is time consuming and expensive so I think we will see a lot of these partnerships.”

As those new states come online, similarities in their regulations might appear in the form of standard operating procedures (SOPs) or good manufacturing practices (GMPs). “We might start to see a standardization from state to state that models FDA GMPs or USDA GAPs, [good agricultural practices] moving toward a framework that is more consistent with the possibility of federal regulation,” says Slaugh. Another commonality among a number of states is the implementation of a statewide tracking system. According to Slaugh, California has no such mandated system in place yet. “They will probably have one eventually but the market is so localized there- we will see if California will be ready with a statewide compliance system for tracking by 2018,” says Slaugh. “With such a weird patchwork of local governments allowing or not allowing certain operations to exist, it is a tough business to be in and it’s getting tougher every day.”

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Best Practices for Submitting a Winning Application

By Leif Olsen
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Even though half of U.S. states and the District of Colombia now permit the possession of medical or recreational cannabis, state regulatory bodies differ greatly in their approaches to managing our industry. In Washington, anyone over the age of 21 can legally possess one ounce of usable cannabis and/or seven grams of concentrate. In Minnesota, patients are only allowed to purchase non-smokable cannabis in pill, liquid or oil form.

Given these substantial differences, it is no surprise that the application process to open a dispensary or cultivation facility also varies from state to state. The question I am most often asked (and catch myself mulling over late at night) is what can applicants do to ensure their success, regardless of where they are applying?

Recently we helped a client secure one of the first 15 licenses issued to grow medical cannabis in Maryland. The Maryland application process was particularly unique because most of the applicants had political or law-enforcement ties, or were connected to successful out-of-state growers. That experience, along with our work in places like Arizona, Colorado and Florida, has shown me the importance of teamwork, diversity and security in developing a winning application.

So here are my suggestions for ensuring a successful submission, regardless of which state you are operating in:

  1. Build the Right Team. My dad likes to say, “Use the right tool for the right job.” I think the same is true about creating the team for your application. Do not assume one or two people will be able to fill all of the required roles. You will need experts in a range of different areas including medicine, pharmacology, capital investment, cultivation, real estate, security and law.
  2. Focus on Diversity. I think one of the reasons we have been successful in helping clients secure applications (we are six for six, in six different states) is our commitment to gender, racial and even geographic diversity. For example, we recently helped a client secure a license in an economically underdeveloped area. I think our choice to headquarter the new business outside of the metropolitan corridor was at least partially responsible for our success.
  3. The Devil is in the Details. According to ArcView Market Research, the cannabis industry is expected to be worth $23 billion by 2020. If you want to be one of the organizations selected by your state to sell cannabis, you need to have your act together. Most applications ask incredibly detailed questions. Therefore it is essential that you answer them thoroughly and accurately. All answers should be in compliance with your state’s regulations.
  4. Put Safety First. You will need a comprehensive plan that takes all aspects of security into account. This includes everything from hiring security guards to purchasing cameras, and implementing internal anti-theft procedures. Regardless of the size of your operation, safety should be a primary consideration.
  5. Secure Funding. Successful cannabis businesses require capital. It’s important to be realistic about the amount of money you will need to have on hand. Application costs typically range from $500,000 to $1 million. This will cover things like hiring an architect or leasing land. Ideally, your organization will have another $5 to $10 million or more available to start your project once you’ve been approved so that you can quickly become operational.
  6. Connect With Your Community. It is essential to consider the impact of your business on the community. Being a good corporate citizen means being transparent and engaging in a two-way dialogue with neighbors, government officials and patients. I strongly recommend that my clients develop a comprehensive community outreach plan that designates which organizations they plan to work with, (hospitals or universities, for example) and what the nature of those partnerships will be.
Marijuana Matters

The Legal State of Cannabis in Florida

By David C. Kotler, Esq.
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It is now December of 2015 and we are one year removed from the loss at the polls of an amendment that would allow for full spectrum medical cannabis in Florida. The defeat of Amendment 2 allowed for the implementation of the Compassionate Medical Cannabis Act of 2014, albeit a rather rocky implementation, thus legalizing low THC, high CBD cannabis strains. I participated in many of the public meetings which took place and watched the different draft regulations set forth by the Florida Department of Health be debated, commented on and ultimately revised. The process underwent legal challenges and as of the publication of this, applications for five license holders were awarded.

As many might be aware, the Compassionate Medical Cannabis Act applicants were required to be nurseries continuously operating for over 30 years with a plant registration of 400, 000 plants as of the time of application. There were other relevant requirements, but the two foregoing were the most restrictive and narrowed the market of potential applicants.

Following in line with legislative means to put cannabis in the hands of a few large, Florida-centric entities, a Bill recently passed the Senate in Florida allowing for the expansion of the use of cannabis with higher THC content for patients with debilitating diseases under Florida Statute 499.0295. Presumably, the five licensees would then be authorized to expand their crop to include THC based plants and provide those to qualifying patients.

My fear all along has been that Florida would abandon the possibility of having a robust economic, yet patient-centric model not dissimilar to Colorado, Washington or Oregon, but more akin to what one might see in New York or what was narrowly avoided in Ohio. In fact, I have considered the possibility that should the new Amendment supported by United for Care passed, since that Amendment allowed for the Department of Health to promulgate the rules and regulations, that the Department could, assuming the five licensees are operational, merely give responsibility to the five licensees, allowing them to expand.

Alas, I believe, and I am happy to admit it, I may be wrong. In Florida, constitutional amendments require a review by the Office of Economic and Demographic Research. It is the focus of this body to analyze and report the economic impact that a particular amendment might have upon passage and effectuation. Data from numerous sources are reviewed and integrated into the Committee’s opinion. Of note, during my review of the October Economic Estimating Conference Meeting and Reports was the position taken by the Department of Health. Specifically, the Department of Health did not indicate that it could implement a system by merely expanding or working off of the framework it has for the Compassionate Medical Cannabis Act. Instead, the Department took the approach that a new set of regulations and guidelines, as well as departmental operations, would need to be implemented. In fact, it would need to be implemented to comply with the MMTC system authorized by the amendment. Whether one believes in the vertical model or one which licenses similar to Maryland and a few other states, the important point is that the Department of Health seemingly recognizes that a more robust model will have to be implemented.

So what does all this mean for patients and potential businesses in Florida? In regard to patients, I wish I could say that the potential for treatment through cannabis is foreseeable in the short term. However, I am not convinced of this. I do believe that the selections and process for which applications were selected under the Compassionate Medical Cannabis Act will be challenged, thus resulting in more delays. With regard to the Amendment and implementation should it pass, it will not be until the middle of 2017, approximately one and one-half years away. Should businesses begin preparations in Florida currently? In my honest opinion I believe it is hard to say. In the summer of 2014, I spent a lot of time counseling individuals and businesses on planning for the legalization of medical cannabis in Florida. Some clients were more aggressive than others and ultimately spent time and money, perhaps unnecessarily. On the flip side, I participated in the application process in Maryland and am of the belief that individuals who made application for Maryland cultivation licenses benefitted from an early start and preliminary planning.

I know a number of successful cultivators in legal states who moved on Maryland as a last minute decision once recognizing that although scored as part of an application, residency or lack thereof was not a bar to licensure. I am therefore of the opinion that certain preparation in advance is advantageous and allows alteration of the plan and adaptation at a later stage without wasting resources to accomplish much of the work that is capable of being accomplished in advance. I do believe there are a good deal of uncertainties, depending on how things move forward, as to what our model will look like and if that model will get into place, depending on the rollout of the Compassionate Medical Cannabis licenses as well as the possibility of some of the legislative initiatives catching wildfire, much as the Compassionate Medical Cannabis Act of 2014 did at the very end.

G FarmaLabs Brand Poised for Expansion, Recreational Sales

By Aaron G. Biros
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Patients in California have had access to medical marijuana since it was legalized in 1996. Two decades of legal medical marijuana in California, the world’s eight largest economy, has formed a thriving market of producers, processors and dispensaries. Propositions on the state’s ballot for 2016, such as the Control, Regulate and Tax Adult Use of Marijuana Act, promise measures to introduce the recreational market into the state regulatory system.

G FarmaLabs, a family-owned and operated business, has been operating in California since November of 2013, when they launched at a Marijuana Business Conference in Seattle that year. Ata Gonzalez, founder of G FarmaBrands and chief executive officer of G FarmaLabs, has been in the cannabis industry since 2009, cultivating in California and operating marijuana dispensaries, when he took notice of the changing industry and consumer trends shifting toward consumption of edibles and concentrates.

Ata Gonzalez, CEO of G FarmaLabs and founder of GFarmaBrands
Ata Gonzalez, CEO of G FarmaLabs and founder of GFarmaBrands

“Once the Cole Memo hit in August of 2013, the cannabis industry took off and so did we through a combination of great timing and well thought out regular market packaging and marketing,” says Gonzalez. “With our background in cultivation, we use quality flower as the foundation of our brand, and our proprietary cannabis oil formulations are the backbone of the brand, we use that oil to infuse all regular market edibles products.” They are vertically integrated, beginning with their cultivation of seven strains, so they monitor every blend going into their products and test for potency and pesticides in a consistent manner.

Another key ingredient in their brand recognition seems to come through great product diversity. G FarmaLabs has twenty flavors of infused chocolate bars, a variety of chocolate truffles, pretzels, brittle, chocolate covered cherries, teas, lemonades and other forms of infused edibles. They manufacture a variety of cannabis oil concentrates that come in a syringe to refill cartridges or put on your dry flower or joint but they also sell pre-filled vape cartridges, and pre rolled cannabis cigarettes called G Stiks.

The GFarmaLabs logo, an integral part of their branding, is emblazoned on their packaging.
The G FarmaLabs logo, an integral part of their branding, is emblazoned on their packaging.

Luigi De Dominicis, chief technology officer of G FarmaBrands, says their extraction process is another essential factor in the brand’s success. They run their raw plant material through supercritical fluid extraction (SFE) with CO2. “We do not use solvents like butane to extract our oil because CO2 is proven to be safe for both the operator and end user; we pride ourselves in putting out a safe and quality product,” says De Dominicis. “The same product that goes into our cartridges and syringes goes into our edibles with a different refinement process, which are all tested for potency, microbials and pesticides to ensure consistency, safety and quality.”

In building a successful recreational brand, their expansion model will play a crucial role in keeping their reputation for quality and consistency. David Kotler, Esq., regulatory counsel for global territories at G FarmaBrands, cites their licensing model as the primary distinction between G FarmaBrands and other large marijuana brands looking to expand across state lines. “We are trying to own and control every operation and keep it consistent with production and manufacturing versus giving up control via the licensing process and giving it to others,” says Kotler. This distinction means that G FarmaLabs producers and processors in different states will all operate under the same best practices regardless of location, ensuring consistency from one state to the next.

A glimpse into the new G FarmaLabs facility: The site plan in the city of Desert Hot Springs w3here they are applying for a permit
A glimpse into the new G FarmaLabs facility: The site plan in the city of Desert Hot Springs where they are applying for a permit

“While most states have some form of residency requirements, we are planning to grow organically and self contained, ideally expanding to areas where G FarmaBrands can hold licenses,” adds Kotler. For example, Maryland does not have a residency requirement in their licensing application so that is one of the states they are actively pursuing.

Moving forward, G FarmaBrands is positioning itself for national recognition. “It is difficult in this current regulatory state to state structure to have a national brand, but national recognition is certainly attainable through our great in-house marketing team,” says Kotler.

Running an expansion model of keeping everything very internal, along with their dedication to safety and quality, G FarmaBrands is very well-positioned to be the premier cannabis brand for the state of California, and possibly the nation. They recently harvested a crop in Washington State and in 2016, their products will come to market there. As GFarmaBrands attempts to expand into Maryland for manufacturing, cultivating and operating a retail dispensary, Gonzales keeps his mind set on sustainable growth through 2016 and beyond.

Steve Goldner
Marijuana Matters

Food Processing & Cannabis Policy

By Stephen Goldner J.D.
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Steve Goldner

We have not seen food processing opportunities in the 45 years I’ve been in the industry like we are seeing in the cannabis food segment. There are still many legal, regulatory and policy misconceptions and this column is devoted to giving you some clarity. I hope this helps you make sensible business plans based on sound marketing opportunities.

It’s hard for many people to make the leap from thinking marijuana is illegal to knowing that food infused with marijuana is legal in 50% of the US, and quickly moving toward national legality. Any food processor that does not consider this opportunity to meet changing market dynamics risks losing a huge opportunity.

23 states, the District of Columbia and Guam now have comprehensive cannabis programs in place and many more are expected through Q4 of 2016. The voter approval, tax aspects and improved law enforcement profiles are highly favorable towards legalization and regulation. While marijuana itself can’t be shipped across state lines legally at this time, food-processing equipment is being sold, shipped, and installed every day of the week with no legal ramifications. The remaining problematic business aspects are rapidly moving through the solution phase, specifically labeling, tamper-evident and child resistant packaging, and payment methods.

Unlike other technology introductions, a mass market already exists and is clamoring for these food products. Therefore the ‘early movers’ are developing business relationships state by state to prepare food production lines that incorporate cannabis food production into cannabis processing companies. 

Essentially, any state that allows cannabis dispensaries to exist will require food-processing equipment. In addition, states like Michigan where I reside, there are over 200,000 medical marijuana licenses issued to individuals, and over 250 unlicensed dispensaries. Michigan is getting ready for dispensary licensing and food production. We should anticipate inquiries from companies applying for food production licenses from any and all states as they are carefully attuned to their local state rules.

You can always contact me at this publication by clicking here and I’ll do my best to answer you that day or visit my website, Regulatory Affairs Associates.

Jurisdictions with active cannabis food production in USA: Arizona, California, Colorado, Connecticut, Delaware, Washington, D.C, Guam, Illinois, Maine, Maryland, Massachusetts, Michigan [coming soon], Minnesota, New Hampshire, New Jersey, New Mexico, New York, Rhode Island, Vermont, Washington

The next few articles in this series will focus on making certain your food production equipment will meet cannabis food production regulatory standards, the unusual payment procedures in this new industry, and relationship building since many of the new companies and their advisors will be new to you. Plus you really want to know their expectations of you. 

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Marijuana Business Planning: A Q&A with Mike McCulley

By Aaron G. Biros
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MasterPlans, a business planning firm based in Portland, Oregon, has more than 13 years of experience in the emerging cannabis industry. The firm has worked to develop financial models and business plans for new and existing companies that are looking to secure funding, grow partnerships, and manage their long-term strategies for success. They have created business plans for more than 100 companies at every level of the market, from cultivators to dispensaries, to businesses in packaging, security and tourism. They work with nonprofit ventures, investor propositions, commercial lending and self-funded companies.

“We know how difficult it is to launch a business in the cannabis industry, because we work with businesses in this field every day,” says Mike McCulley, VP of Sales at MasterPlans. Cannabis Industry Journal spoke with McCulley to learn more about some of the challenges that marijuana businesses face.

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MasterPlans Cannabis Business Plans

Cannabis Industry Journal: What are some of the biggest hurdles in launching a new grow operation?

Mike McCulley: Many of our cultivation clients say that the largest hurdle they face is in identifying the ideal location for their business. Grow operations need to factor in a wide range of concerns including cost, zoning, security, soil viability (for outdoor operations), energy costs (especially for indoor operations), and proximity to schools and similar buildings. Location can really make or break the success of any grow operation, and this is often the single largest cost incurred when launching this kind of business.

CIJ: What are some key ingredients in a successful marijuana business plan?

McCulley: It probably goes without saying that a successful business plan for a company in the marijuana field first has to execute all of the elements that every business plan needs to include: Detailed financial projections, accurate market analysis, [and] a comprehensive overview of strategies and goals. Marijuana business plans in particular need to also address the key issues and challenges that are unique to operators in this industry. How will your company be impacted by state-level regulations, and how will your operational model address those? What steps will you take to ensure the security of your product? How will you accommodate the complicated issue of accounting while federal regulations are still impacting the way marijuana companies manage their banking? These issues should be acknowledged and addressed if you hope for your plan to be compelling.

CIJ: With the growing schism between recreational and medical markets, how do you determine your target market and meet those customers’ needs?

McCulley: Determining a target market can be difficult before launching operations, but it’s not impossible. A key tool to help work through this question is up-to-date census information or demographics for the area in which your company is serving. Recreational markets provide a much broader audience to become potential clients, but medical markets can also offer lucrative opportunities if an operator can launch in an area with a high concentration of eligible patients. Accurate market data plays a key role in this process, and close analysis of that data can help operators determine their best course of action.