Tag Archives: regulatory

February 2, 2016

A Q&A With Christian Hageseth: Innovate or Die

By Aaron G. Biros

Christian Hageseth, founder of American Cannabis Partners, Green Man Cannabis and the Colorado Cannabis Ranch and author of “Big Weed,” gave a presentation at the recent High Times Business Summit titled “Innovate or Die.” During the session, he discussed at length why industry leadership in innovation is key in determining the progress and growth of the cannabis industry.

His company, Green Man Cannabis, has won the Cannabis Cup four times and he has been a partner at five dispensaries and six grow operations. He is currently a partner at two dispensaries and two grow operations and he is a founding partner of a medical research group in Israel. Christian Hageseth has years of experience working with cannabis in a number of capacities that has culminated in a keen eye for understanding the cannabis industry. We sat down with Hageseth to learn more about some of his expectations for the industry’s future.

Cannabis Industry Journal: Can you discuss why you decided to take your research group to Israel?

Christian Hageseth: Obviously the United States has barriers to medical research on the plant, so it is seriously lacking the ability to discover more about the plant. We know the NIH [National Institutes of Health] has been helping Dr. Raphael Mechoulam in Israel to study cannabis and THC for the past 35 years, even though this is not permitted in the United States. Israel is willing to allow the research in an open format. We will be able to get an independent review board and the ability to work with institutions in Israel.

Christian Hageseth, founder of American Cannabis Partners, Green Man Cannabis and the Colorado Cannabis Ranch and author of "Big Weed" — Christian Hageseth, founder of American Cannabis Partners, Green Man Cannabis and the Colorado Cannabis Ranch and author of “Big Weed”

CIJ: What kind of research are you looking to accomplish?

Christian: We are researching what cannabis formulation and delivery mechanism would work better than what is available for certain ailments. The research should initiate in March with the goal of reaching clinical trials in the future. We are looking to study the treatment of five ailments with cannabis: migraines, joint pain, insomnia, irritable bowel syndrome and psoriasis.

CIJ: How do you think your research will help people?

Christian: I own dispensaries, and I see people come in and ask for advice on how to treat their insomnia or migraines all the time. We want to be able to recommend something that will accurately treat them. Simply recommending an indica or sativa strain is such a hollow answer for people that are actually in physical pain and need precise treatment. We want to be able to provide the real answers to people seeking help.

The Colorado Cannabis Ranch will be the first cultivation center in Colorado to offer educational tours, similar to a brewery or winery

CIJ: Switching gears a little, how is progress on the Colorado Cannabis Ranch?

Christian: We are ready to break ground on the Colorado Cannabis Ranch (the Weedery) in the beginning of March this year. We expect greenhouses at the Ranch to be operational by July along with a summer concert series a little later.

CIJ: Looking at the cannabis industry as a whole, where do you think innovation will come from in the near future?

Christian: Emerging medical technologies will have the greatest impact on the industry. Nanoparticle delivery systems for sublingual drug delivery are one example of biotechnology that I foresee having a major impact. I can expect some major innovations in some of the process technology around extraction. The technology around extracting specific and separate cannabinoids in particular will get refined more and more. The industry as a whole and market expansion will be driven by product development.

January 15, 2016

Analyzing National Trends for Marijuana Policy: Q&A with Matt Karnes

By Aaron G. Biros, Matthew A. Karnes, CPA

1 Comment

According to Matthew Karnes, founder and managing partner of GreenWave Advisors, LLC, looking toward the growth of the cannabis industry requires analysis of the changes in state and federal laws. “Eventual rescheduling or de-listing of marijuana as a federally prohibited drug, will hopefully lead to consistent and uniform national regulation and taxing authorizations that will ultimately change the structural and economic landscape of the industry,” says Karnes in an article here.

Looking at the sales trends in current legal states is a viable option to make financial projections, but much of that relies on the changing legal and political landscape of our country. According to Karnes, because it is impossible to accurately predict federal rescheduling or full legalization, investors must look at short, medium and long term trends to guide their decision making process. Cannabis Industry Journal sat down with Matthew Karnes to discuss some of the foreseeable trends.

Cannabis Industry Journal: What are some of the trends happening presently, that you can expect to continue?

Matthew Karnes: Just as states continue to pass legislation in some form of legalization measure, there is talk at the federal level of minimizing interference with state policies and removing prohibition statutes. We can see this national progression continuing until rescheduling cannabis eliminates the current obstructions that have limited industry growth.

Where states continue to roll out legislation to legalize cannabis, the rate of retail and cultivation license granting will have a large effect on the growth rates for each given state. Free market approaches as seen in Colorado and California will allow for faster growth rates than more restrictive states.

Recreational and adult use measures being introduced are notable disruptions in the medical sector that once fueled legalization. Medical research and development of strains for specific ailments is still in its early stages due to the impact of federal policy on research.

With an eye forward to eventual federal rescheduling or possible de-listing it is reasonable to assume that uniform national testing and operational standardization protocols will eventually be implemented at least as a baseline binding thread that will steadfastly assure consumers of an expectant consistency of product.

CIJ: Where do you see medium term trends taking the industry?

Matt: With more and more states legalizing cannabis in some form, we can expect the federal government to make a policy change. This will be accomplished via a DEA policy change or through congressional avenues in conjunction with federal agencies like the FDA, USDA and Department of Agriculture administering regulations.

With FDA or Department of Agriculture implementing cannabis policies, we can expect increased interest from outside the industry in research and development of cannabis-based drugs. This will lead to a medical market with more targeted medicine with precise dosing. We can expect more physicians to gain comfort in treating ailments with cannabis as well.

The recreational market will expand greatly with normalized commerce, enabling larger cultivation operations and infused products brands could grow to the national scale with interstate commerce.

CIJ: Where do you see the industry going long term?

Matt: When the cannabis industry matures down the road, we can expect multiple offshoots occurring. The recreational industry will involve local, regional and national policy much like the alcohol industry, and will likely resemble a liquor store model with individual “mom and pop” type businesses.

We anticipate that the medical market will recalibrate as more targeted products with precise dosing and efficacy are developed. At that point it will experience increased competition and consolidation. Without medical research and clinical trials, we cannot accurately project the growth of the medical sector.

Regulations involving tax revenue will most likely use a similar mechanism that states use for alcohol and tobacco taxation. Entities like state liquor control boards will oversee cannabis regulations. When that time comes, the cannabis industry will no longer be a novel idea and will become another conventional ‘consumer staple.’

January 6, 2016

BioTrackTHC Wins Bid for Hawaii Marijuana Tracking Software Contract

By Aaron G. Biros

No Comments

According to Phil Bergman, senior communications consultant at BioTrackTHC, just yesterday the company announced it had surpassed 1,500 locations that its software systems are used in. BioTrackTHC has a traceability software solution that provides “real-time visibility into the seed-to-sale tracking data of licensed medical marijuana dispensaries, including plant and inventory quantities, production activity, laboratory testing results, transportation activity, and dispensing activity.”

The Hawaii Department of Health’s Office of Health Care Assurance selecting BioTrackTHC for the contract marks five state contracts that the company has won. Currently, the software is used by Washington, New Mexico and Illinois and soon to come are New York and now Hawaii.

The software essentially allows private businesses and regulators access to data on cannabis plants in real-time, tracking them through every step in the production process including growing, harvesting, quality and safety testing, transportation and sale. These state-mandated systems have the ability to prevent issues like diversion, theft and contamination, helping with transparency in regulatory compliance.

The software is used in both “medical and recreational cannabis facilities in 23 states, Washington D.C., Canada, Jamaica and South America. “The development of a healthy and successful medical cannabis program is a top priority for Hawaii, and we are extremely proud to have been chosen to be a critical part of it,” said Patrick Vo, chief executive officer of BioTrackTHC.

“We demonstrated significant interest in the state of Hawaii early on, including sponsoring the first ever Cannabis Business Expo there last year,” says Vo. “The Hawaiian people have their own special values and way of life, which is important to understand when working in Hawaii.” Winning the contract means their software will be used to track the production, transportation and sale of all medical marijuana in the state of Hawaii.

December 14, 2015

Marijuana Matters

The Legal State of Cannabis in Florida

By David C. Kotler, Esq.

No Comments

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.

November 11, 2015

Pesticide Recalls an Ongoing Issue for Colorado

By Aaron G. Biros

No Comments

In the wake of investigations this summer in Oregon and Colorado, which found that numerous marijuana products contain levels of illegal pesticides, state regulators, laboratories, manufacturers, and cultivators alike are acting fast to minimize risks to consumers and patients. The largest recall ever to occur in the cannabis industry happened on October 30, when two companies in Denver found potential pesticide contamination in tens of thousands of packages of edible cannabis products.

As of now, it is difficult to find information available on pesticide use and flowering, its effect on the body through combustion and inhalation, and its effect on medical patients with already weakened immune systems. Research suggests up to 69.5% of pesticide residues can stay in marijuana smoke. Of course, there is a need for more research, but it is safe to accept that pesticides already banned for use on foods by the USDA or state departments should not be allowed in cannabis production.

In Colorado, “Nearly six months after the city of Denver began a crackdown on unapproved pesticides in marijuana products, a spot-check by The Denver Post found that the chemicals were still being sold to consumers.” This presents a major problem to an industry still trying to change public opinion for wider legalization efforts.

The Oregonian and OregonLive investigation found pesticides in most of the 10 marijuana concentrates that were screened. “Many of the pesticides detected aren’t regulated by Oregon’s medical marijuana rules, which means products that contain these chemicals still can be sold.”

While state regulations on pesticide use continue to get hammered out, the U.S. Department of Agriculture along with the U.S. Environmental Protection Agency is currently working on identifying pesticides that might be safe to use on cannabis. That guidance is crucial for any industry in order to establish safe levels of pesticides allowed, as well as which pesticides are more dangerous to the consumer than others.

Just last week, two of the largest recalls in the cannabis industry occurred in Colorado due to potential pesticide contamination. According to The Denver Post, as many as 30,000 packages of edibles produced by two companies were recalled by the Denver Department of Health.

Alex Garton, a cultivator in Michigan, agrees with many proponents of organic methods, citing the need for close management of the plants without pesticides. “The best way to avoid pests is to keep the grow room clean,” he says. “Mites will come and go, as will temperature and humidity issues, but without using pesticides, there are some safe, natural products that are very effective.”

“I treat my plants with natural compounds that are permitted under the federal government’s guidance for use in vegetable applications for human consumption,” Garton adds. “Never use anything remotely resembling a pesticide on flowers particularly when maturing and in the flowering process.”

Adam Jacques, master cultivator and owner of The Growers Guild in Eugene, Oregon, agrees with the sentiment of caution shared by many in the industry. “I would say, nationwide, there needs to be a more in depth look at pesticides, even organic strawberries can have [the pesticide] Eagle 20 on them,” he says. “With cannabis, we can’t scrub and wash pesticides off like fruit that you take off the vine, and there is a real lack of research on residues and combustion.”

Jacques tests all of his cannabis products for pesticides, molds, microbials and pathogens along with potency profiles, most of which is not required by the state. Growers should take lessons from Garton and Jacques by forgoing any application of pesticides until there is more confident state-level guidance on the dangers associated with pesticides on cannabis.

November 11, 2015

Cannabis Coaching & Compliance

Keep It Professional~Food Safety Musts!

By Maureen McNamara

1 Comment

There are many aspects to the cannabis industry that demand an owner’s attention: Compliance, great products, great people, great location, finances…. So is a focus on food safety a priority?

Yes, yes it is. And not just for infused products.

For starters, in some states like Colorado, it is required. In other states it will be required in the foreseeable future, and generally speaking, it is a vital component for a professional industry that continues to show the community that you are committed to creating safe products.

Have you ever had a foodborne illness? I’m going to assume you just nodded your head or thought yes. Check out this statistic: according to the Center for Disease Control there are about 48 million cases of foodborne illnesses (and 3000 people die) every year in the United States.

A quick reminder about the typical symptoms of foodborne illness: vomiting, diarrhea, headaches and nausea. Experiences we would all like to avoid.

What I know for sure… you do not want your product or your company to ever be associated with making people sick.

Take into account that for medical marijuana patients, they may already have compromised immune systems. This puts them at an even greater risk for foodborne illness. We need to ask questions like “Are my employees doing everything possible to ensure a safe, wholesome product?”

A properly trained staff is a critical necessity in the cannabis industry. Whether it is currently required or not, your commitment to safety for your patients and consumers show that you care and are committed to high standards. Additionally, you may avoid fines, closures and recalls. These all create a drain on your finances… as well as your reputation.

The FDA has identified five key factors that often contribute to outbreaks:

Purchasing Food from Unsafe Sources
Improper Holding Time and Temperature
Inadequate Cooking
Improper Cleaning and Sanitizing
Poor Personal Hygiene

Safe Purchasing:

Be aware of starting with high quality ingredients. Ask your suppliers questions about their inspections and quality controls. If possible conduct a tour of the supplier facilities to verify they meet necessary standards. Are you impressed with their food safety standards and protocols?

Avoiding Time & Temperature Abuse:

Bacteria needs an ideal temperature (between 41°-135°) and a bit of time (4+hours) to grow to harmful levels. Keep your cold food cold and cool your heated foods quickly.

Inadequate Cooking:

If you are infusing oil, I strongly encourage you to work with your local health department for a procedure that will ensure the oil is cooked to a safe temperature (while not interfering with your chemistry) to eliminate potential pathogens or microbials.

Cleaning and Sanitizing:

Microorganisms grow well at room temperature. Cleaning and sanitizing is important to ensure microorganisms are reduced or eliminated. Certainly all of your food contact surfaces must be cleaned and sanitized whenever you change tasks and at least every four hours. This is not just for making infused products, please keep this in mind at the retail level as well. Think of how many hands (both employees and customers) may be touching the product containers. Avoid cross-contamination by cleaning and santizing thoroughly and often.

Personal Hygiene:

In each food safety class I have facilitated in the last 18 years, everyone admits they or their team could improve personal hygiene. Shout out to any bearded folks… did you know that the FDA food code requires facial hair that is 1-inch or longer to be restrained? Got a beard net?

Because most of the foods manufactured in the cannabis industry are “ready to eat” foods, great personal hygiene and frequent, thorough handwashing is essential. The FDA reccommends a 20 second handwashing procudure with hot water (≥100°), a soapy lather, vigoursly rubbing hands for at least 10-15 seconds, rinsing well and using a single-use towel to dry your hands.

I know… it sounds very basic. However, when I observe people washing their hands it is often for less than 8-seconds. Not only is handwashing a great way to stay healthy ourselves, it is a key way to ensure your products are safe and not putting public health in jeopardy.

I’ll throw down a challenge for you! This month: focus with your team on personal hygiene and hand washing. Whether you are growing, infusing or selling this is a vital component for a professional, responsible industry. When it comes down to it, you make things that go right into your customer’s and patient’s bodies. Create those products on a foundation of food safety and you will more easily create a thriving business.

Cannabis Trainers provides ServSafe® food safety training for edible makers and Sell-SMaRT™ the responsible cannabis vendor program for sellers. (www.CannabisTrainers.com)

We would love to hear from you! Comment below and let us know what your team does to ensure you are making and selling safe products.

November 4, 2015

The Role of 3rd Party Accreditation in Cannabis Safety

By Roger Brauninger

1 Comment

Living in a world of ever-increasing interdependence and an era of limited state government, financial and human resources, it is imperative that those charged with protecting the health and safety of patients and users of medical and recreational cannabis products leverage what private sector institutions and existing frameworks already offer in setting up quality standards for laboratory testing operations. That this moment arrives now – at a point where state governments are being tasked with undertaking the most significant change in the regulation of this substance whilst the federal government appears unwilling to play a substantial role – makes this partnership both inevitable and absolutely necessary.

Accreditation is an internationally accepted conformity assessment tool for ensuring laboratory competence and confidence in the accuracy and reliability test data. The accreditation infrastructure is well-established through accreditation bodies (ABs) and the Mutual Recognition Arrangement (MRA) of the International Laboratory Accreditation Cooperation (ILAC), supported by regional cooperative arrangements, including those of the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the Inter-American Accreditation Cooperation (IAAC). ILAC functions as a forum for harmonization of laboratory accreditation procedures and policies, thus reducing technical barriers to trade and promoting laboratory accreditation as a mechanism for establishing confidence in testing facilities. ILAC MRA signatory ABs are recognized, through a rigorous peer evaluation process, as competent to accredit testing organizations. All signatory ABs must meet the requirements of ISO/IEC 17011 and use ISO/IEC 17025 as the basis for accreditation of laboratories. In turn, under the ILAC MRA and the regional co-operations, competent laboratories are recognized globally, thus facilitating acceptance of the test results that accompany goods across international borders.

In other areas, such as the food supply and energy, both state and federal government have been an active participant in accreditation activities. According to The Administrative Conference of the United States in its Agency Use of Third-Party Programs to Assess Regulatory Compliance*, “…agencies in diverse areas of regulation have developed third-party programs to assess whether regulated entities are in compliance with regulatory standards and other requirements. Through these programs, third parties are charged with assessing the safety of imported food… Third parties also ensure that products labeled as organic and energy-efficient meet applicable federal standards. In these regulatory third-party programs, regulated entities generally contract with third parties to carry out product testing and other regulatory compliance assessment activities in the place of regulatory agencies. Regulatory agencies take on new roles in coordinating and overseeing these third-party actors.” While this reference largely deals with areas outside of cannabis regulation, it remains useful and relevant because of the manner in which cannabis products are used.

Traditionally, ABs have worked with regulators to establish specific technical requirements to supplement the ISO/IEC 17025 accreditation framework. In this partnership, the AB is responsible for executing the assessment and accreditation process but the regulator retains responsibility for the ultimate decisions on the acceptance of that organization’s accreditation. In the example of our food supply and its various sources, governmental recognition of accreditation bodies operating in accordance with international standards is much more practical than government agencies themselves accrediting the individual testing organizations or ABs. Thus the public/private partnership paradigm: To assess regulatory compliance a Regulatory Agency approves ABs that accredit organizations that assess whether Regulated Entities or Regulated Products are in conformity with a Regulatory Standard.*

In this example, all of the organizations are treated equally by the regulatory agency since they use the same recognition criteria for ABs and the same accreditation requirements in the assessment of conformity assessment bodies. This approach would also provide consistency at a point in time where many states are grappling with trying to find the best quality standard to use and which, to date, has resulted in many different standards being chosen or considered for implementation. This is especially true when one looks at the requirements put into place by the “early adopter” states. However, in those states that have entered this area more recently, it seems clear that the consensus is use of ISO/IEC 17025 as the most appropriate quality management standard for testing laboratories.

November 2, 2015

From The Lab

What to Consider When Selecting a Laboratory

By Seth Wong

No Comments

There are many factors to consider when selecting a third party analytical laboratory:

Why are you testing?
Does a governing body require it?
Are you testing to meet compliance with industry trends?
Are you testing as supplemental protection to an in house laboratory operation?
Are your results being used to help you market your product?
Are the results being utilized for internal R&D?
What are you looking to get out of testing?

Perhaps it is a combination of all these things. Regardless, whomever you contract with for whatever reasons, it is important to understand what you are getting, know what you are entitled to, understand your results, and understand where you and your company remain vulnerable. You must also be prepared with a plan to handle adverse results. Testing at a third party analytical contract laboratory does not mean they assume all of your product’s or company’s liability, regardless of the lab’s reputation.

Ask your third party laboratory about any accreditations, certifications, and licenses that the lab should be accredited and/or certified for. Each state has different certifications and licensing requirements; make sure the entity you are using is licensed or certified for the services you need. Additionally, there is an accreditation called International Standards Organization (ISO) 17025 that is the pinnacle of third party laboratory accreditation. ISO 17025 is a set of protocols that your third party lab should follow to do everything it can to ensure your data is accurate and produced with reliable standards, control samples, matrix control samples and proficiency tests to verify the accuracy of the lab’s employees and methods, among a number of other criteria included in the standard. A number of different entities offer accreditation to ISO 17025 but it is important that the the accrediting body is also accredited to their ISO standard. Simply buying ISO 17025 compliant materials or standards does not mean that the vendor service or product is accredited to ISO 17025. Cannabis laboratories are just starting to implement and build systems around ISO 17025 but it has been prevalent in the third party lab business in many industries for decades and should be applied to the cannabis industry.

Visit your lab and understand their background and experience. Start by requesting a tour of the laboratory you choose; you want to know how things look behind the scenes. Is the lab orderly and doing its best to protect sample integrity? There may be a lot of things going on in the laboratory and it may look chaotic but it should be relatively clean. This prevents contamination and sample mix-ups. Further your relationship with your laboratory by understanding the laboratory’s experience and getting to know your laboratory staff. Consider the lab staff as part of your extended team, they are there to help you and help bring your product to market. The more they understand your goals, the more they can help.

Understand your lab’s history and background: Have they worked with products and/or analytes similar to yours? Have they worked with your sample matrix or one similar to it before? Their prior knowledge and laboratory experience, as it relates to your product, will help provide accurate data and navigate complex matrices.

Most importantly, a laboratory should be willing to release the data packet that is used to generate test results to the client. Releasing this data does not divulge any proprietary information of the lab. It is the laboratory’s job to provide you with the data upon request. It is important to note, looking at your raw data is not the same as looking at the laboratory method, also known as a work instruction or operating procedure. The lab most likely won’t give you the method as those are typically trade secrets, but there is no reason not to share with you the chromatography that the HPLC, GC, GC/MS, or LC/MS generated. This will demonstrate the lab’s sound analytical data and increase your confidence in the analysis you are receiving. When you pay for the results, you are also paying for your data and if your laboratory is not releasing that information to you at your request, you should be skeptical. This data needs to be able to stand up to audits and legal action.

Finally, confidentiality: your data is your data. Yes, you may have to report results to a governing body, but your laboratory should not be sharing your name and your data with anyone but your authorized list of contacts without your permission. They should not even disclose that you are their client without your prior authorization. Confidentiality is not just applicable to a few key employees at the laboratory, it is pertinent to everyone from the sample pickup driver, if you have one, to the chemists and upper level management.

Understanding your contract laboratory’s certifications, licenses, and accreditations, requesting and receiving raw data packages, and ensuring that you feel comfortable with the laboratory, its staff and their practices are key elements to ensuring a successful relationship with your laboratory.

October 27, 2015

Marijuana Matters

Food Processing & Cannabis Policy

By Stephen Goldner J.D.

No Comments

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.