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Head of German Police Union Calls for Official Decriminalization of Cannabis

By Marguerite Arnold
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Facing the same conundrum as police everywhere after the start of a medical market only this time with federal authorization, the head of the German police union has called for recreational use of cannabis to also be decriminalized.

On the first Monday of February, the head of the BDK – the Association of German Criminal Officers told The Bild (sort of like the New York Post but a national “tabloid” here) that his group, the largest organized union of German police officers, favoured a change in German cannabis laws. Andre Schulz argued that the current laws stigmatized those charged with minor amounts and created opportunities for “criminal careers to start.”

“The prohibition of cannabis has historically been seen as arbitrary and has not yet been implemented in an intelligent and effective manner,” says Schulz. “My prediction is that cannabis will not be banned for long in Germany.”

Why this sudden pronouncement? It is actually not all that sudden and has been long in the offing. One of the largest contingents at both the ICBC and the IACM last year (the biggest cannabis-focussed business and medical conferences in Germany) were police officers from California and Deutschland. And all were singing the same tune.

André Schulz
André Schulz, chairman of the BDK

However beyond a realistic assessment of changing political reality, there are actually several other concrete reasons for not only the statement but the timing of it. In a country where patients can now pick up bud cannabis from the local apotheke (which is that easy for some, although it is still hard for most), the police have the unappetizing prospect of potentially arresting patients. On top of that, the idea of someone being arrested for CBD flower (rather than THC) gives the German polizei plenty of pause. Not to mention that they face this possibility at a time when many of them potentially could be patients themselves (or their families). The idea of arresting an activist in this situation is also one the police do not relish. Legalization rallies here get formal police protection when they march. Ask the average beat cop what they think about cannabis legalization and they tend to roll their eyes.

Then there is this: In stark contrast to the wars over prescribing medical cannabis at a state level in California in the late 90’s, here in Germany, there is a cultural commitment to the concept of sick people having a moral and civil right to obtain the medication they require. The idea of the police arresting them in the process of obtaining the same or because they might be recreational users, is as antithetic to core German sensibilities as the concept of Donald Trump as U.S. President. So is the idea of branding someone a “criminal” if not “drug user” for possession of a drug that is now used as medicine in Germany.

As has been rumoured for some time now, one of the few things that all political parties in Berlin can agree on is a change on the current cannabis laws.As a result, the very idea of both arresting the sick or labelling someone for the rest of their life with a police record for a drug “crime” that nobody considers as such anymore, causes a shock to the system. In many ways, German culture is far more conservative than the U.S. On another, there is a deeply humanistic, liberal strain to German life that also allows nudity, alternative healthcare and lifestyles to flourish (and not just all in Berlin). The current situation over cannabis, in other words, is becoming a political and legal embarrassment even to the beat officers who have to implement such laws.

And then of course there is this: One of the country’s top judges, Andreas Müller, a man well-known to the senior level of BDK, has recently written a book about the horrible situation that faces his own brother because of drug laws in Germany called “Kiffen und Kriminalität.”

Cannabis also falls into this crevice of cultural questioning if not the national zeitgeist of the moment, in multiple ways. It is, beyond the stigma, a natural medicine that is now federally recognized as such and one that the statutory health insurers (public healthcare) is required to cover. No matter that only 64% of submitted rezepts have been formally approved 11 months into Germany’s foray into this world. There are doctors writing them. And there are insurers picking up the tab.

It also means that there are at least 10,000 legal medical cannabis patients that der polizei have no wish to bother. And 10,000 German patients, who look the same as anyone else, are already too many legal users for current laws to stay in place.

Decriminalization, Cultivation & Changing Culture

There are some who say that Europe is “backwards” if not slower than the United States. Certainly those who experience German culture as Auslanders are struck by the procedural requirements of everyday life. Things do move slower here.

However when things do move, they are determinative shifts. Right now, it is impossible to live in the country and not be aware that Kiffen – a slang term for pot auf Deutsch – is legalizing in the U.S., Canada, the rest of Europe and of course other places. Further, Germans with their distrust of bureaucracy and authority and certainly currently rebellious mood, are looking to a way forward for the country in a sea of uncertainty both locally and regionally not to mention globally on any issue, no matter how “symbolic.”

As has been rumoured for some time now, one of the few things that all political parties in Berlin can agree on is a change on the current cannabis laws. The idea of decriminalization, now suggested by one of the country’s top cops, is a natural solution to political deadlock, if not a changing society.

The idea that other countries are also moving on this topic, from the now Brexiting UK to France next door, not to mention all the cultivation focused reform in many European countries, seems to indicate that decriminalization and even recreational reform are coming and now officially on the schedule, and not just to Germany but the entire continent.

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Top 4 Food Safety Hazards for the Cannabis Industry

By Steven Burton
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Steven Burton

As many US States and Canadian provinces approach legalization of cannabis, the question of regulatory oversight has become a pressing issue. While public awareness is mainly focused on issues like age restrictions and impaired driving, there is another practical question to consider: should cannabis be treated as a drug or a food product when it comes to safety? In the US, FDA governs both food and drugs, but in Canada, drugs are regulated by Health Canada while food products are regulated under the CFIA.There are many food safety hazards associated with cannabis production and distribution that could put the public at risk, but are not yet adequately controlled

Of course, there are common issues like dosage and potency that pharmaceutical companies typically worry about as the industry is moving to classifying its products in terms of percentage of chemical composition (THC, CBD, etc. in a strain), much as we categorize alcohol products by the percentage of alcohol. However, with the exception of topical creams and ointments, many cannabis products are actually food products. Even the herb itself can be brewed into teas, added to baked goods or made into cannabis-infused butters, oils, capsules and tinctures.

FDAlogoAs more people gain access to and ingest cannabis products, it’s only a matter of time before food safety becomes a primary concern for producers and regulators. So when it comes to food safety, what do growers, manufacturers and distributors need to consider? The fact is, it’s not that different from other food products. There are many food safety hazards associated with cannabis production and distribution that could put the public at risk, but are not yet adequately controlled. Continue reading below for the top four safety hazards for the cannabis industry and learn how to receive free HACCP plans to help control these hazards.

Aflatoxins on Cannabis Bud

Just like any other agricultural product, improper growing conditions, handling and storage can result in mold growth, which produce aflatoxins that can cause liver cancer and other serious health problems. During storage, the danger is humidity; humidity must be monitored in storage rooms twice a day and the meter must be calibrated every month. During transportation, it is important to monitor and record temperatures in trucks. Trucks should also be cleaned weekly or as required. Products received at a cannabis facilities should be tested upon receiving and contaminated products must always be rejected, segregated and disposed of safely.

Petri dish containing the fungus Aspergillus flavus. It produces carcinogenic aflatoxins, which can contaminate certain foods and cause aspergillosis, an invasive fungal disease.
Photo courtesy of USDA ARS & Peggy Greb.

Chemical Residues on Cannabis Plants

Chemical residues can be introduced at several points during the production and storage process. During growing, every facility should follow instructions for applying fertilizers and pesticides to crops. This includes waiting for a sufficient amount of time before harvesting. When fertilizer is being applied, signs must be posted. After cannabis products have been harvested, chemical controls must be in place. All chemicals should be labelled and kept in contained chemical storage when not in use to prevent contamination. Only food-grade chemicals (e.g. cleaners, sanitizers) should be used during curing, drying, trimming and storage.

Without a comprehensive food safety program, problems will inevitably arise.There is also a risk of excessive concentration of chemicals in the washing tank. As such, chemical concentrations must be monitored for. In general, water (obviously essential for the growing process) also carries risks of pathogenic bacteria like staphylococcus aureus or salmonella. For this reason, city water (which is closely controlled in most municipalities) should be used with an annual report and review. Facilities that use well water must test frequently and water samples must be tested every three months regardless.

Pathogenic Contamination from Pest Infestations

Insects, rodents and other pests spread disease. In order to prevent infestations, a pest control program must be implemented, with traps checked monthly by a qualified contractor and verified by a designated employee. It is also necessary to have a building procedure (particularly during drying), which includes a monthly inspection, with no holes or gaps allowed. No product should leave the facility uncovered to prevent fecal matter and other hazards from coming into contact with the product. Contamination can also occur during storage on pallets, so pallets must be inspected for punctures in packaging material.

Furthermore, even the best controlled facility can fall victim to the shortcomings of their suppliers. Procedures must be in place to ensure that suppliers are complying with pest and building control procedures, among others. Certifications should be acquired and tracked upon renewal.

Pathogenic Contamination Due to Improper Employee Handling

Employee training is key for any food facility. When employees are handling products, the risk of cross-contamination is highest. Facilities must have GMP and personnel hygiene policies in place, with training conducted upon hiring and refreshed monthly. Employees must be encouraged to stay home when sick and instructed to wear proper attire (gloves, hair nets, etc.), while glass, jewelry and outside food must not be allowed inside the facility. Tools used during harvesting and other stages may also carry microorganisms if standard cleaning procedures are not in place and implemented correctly by employees.

As the cannabis industry grows, and regulatory bodies like the FDA and CFIA look to protect public safety, we expect that more attention will be paid to other food safety issues like packaging safety (of inks and labels), allergen control and others. In the production of extracts, for example, non-food safe solvents could be used or extracts can be mixed with ingredients that have expiration dates, like coconut oil. There is one area in which the cannabis industry may lead the way, however. More and more often, risks of food terrorism, fraud and intentional adulteration are gripping the food industry as the global food chain becomes increasingly complex. It’s safe to say that security at cannabis facilities is probably unparalleled.

All of this shows that cannabis products, especially edibles (and that includes capsules and tinctures), should be treated the same as other food products simply because they have the same kinds of hazards. Without a comprehensive food safety program (that includes a plan, procedures, training, monitoring and verification), problems will inevitably arise.

Cannabis-Infused Wine Comes to California in 2018

By Aaron G. Biros
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Rebel Coast Winery announced this week the launch of the world’s first cannabis-infused, alcohol-removed wine. The company’s THC-infused Sauvignon Blanc, available only in California, will hit dispensary shelves in 2018.

Co-founders Alex Howe and Chip Forsythe

According to the press release, they plan to be fully compliant with California’s new regulations for the cannabis industry, hence the lack of alcohol in the product, which is a requirement under the state’s new manufacturing rules. “Rebel Coast’s grapes are grown in Sonoma County – California’s wine capital – and fermented through a traditional winemaking process,” reads the press release. “Rebel Coast removes the wine’s alcohol and infuses each bottle of its premium Sauvignon Blanc with 16 milligrams of organic tetrahydrocannabinol (THC)…” In addition to the THC infusion, they also add terpenes to the final product, giving it the cannabis fragrance.

According to Alex Howe, co-founder of Rebel Coast, the winery is in Sonoma, but they’re waiting to see where they’ll be licensed to extract, infuse and package the final product. “The winery is in Sonoma, we make the wine, and remove the alcohol there,” says Howe. “We’re currently waiting for licensing transfer approval in two locations, one in San Bernardino, the other West Sacramento, and exploring an option to infuse in San Benito County with a currently licensed location.” They plan to co-package under a third party license and seek a Type N license for extraction with non-volatile solvents.

Rebel Coast has partnered with a fully licensed outdoor grower, and is looking for an extractor that will be able to handle their volume needs. With regard to their infusion and extraction process, Howe says they combine clear distillate with a surfactant to make the THC liquid soluble and fast acting.

He expects the full infusion and packaging operations to be up and running by early 2018. “The San Bernardino and West Sacramento locations were previously licensed for infusion, packaging, and manufacturing, but with purchase of the building, the change in ownership has caused us to wait for the license to change ownerships too.”

“We’ve continued our disruptive approach to craft the world’s first cannabis-infused, alcohol-free wine,” says Chip Forsythe, co-founder and chief executive officer of Rebel Coast. “We wanted to excite the rebellious spirit in Americans through innovation, so we took two world-class California products – marijuana and wine – and created a proprietary process that resulted in a delicious, crisp and elegantly crafted Sauvignon Blanc that’s teed up to be a game changer for the wine and cannabis industries.”

They plan to start shipping product in early 2018, as well as distribute to over 500 dispensaries throughout the state, via Green Reef Distributing, a licensed cannabis distributor that represents wine and spirit accounts for other CBD products. Later in 2018, Rebel Coast plans on rolling out cannabis-infused Rosé and champagne, as well as CBD-infused wines. In the press release the company teases their products will be available in other legal states in the coming months.

New Drug Delivery Mechanisms For Cannabis Products

By Aaron G. Biros
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Next Frontier Biosciences announced the launch of their new product line, Verra Wellness, in the Colorado market this week. The products are designed with relatively new concepts for the cannabis market, including nasal, sublingual and topical administration.

The company claims their product is the first-ever cannabis nasal mist. Co-founded by biotech executives Marc Graboyes and Dr. Paul Johnson, Ph.D, Next Frontier Biosciences is developing this product line with three formulations, each with a different ratio of THC and CBD. According to a press release, Next Frontier Biosciences is focused on developing cannabis products with these new drug delivery methods, and even offering a microdosing option.

“We believe that leveraging science and research is the key to optimizing product development,” says Dr. Johnson, one of the co-founders. “With the introduction of our Verra Wellness line of products, we are reshaping the cannabis industry by offering trusted products that provide uniform composition, formulation and dosing in highly consistent modes of administration.”

Their topical salves in the Verra Wellness product line are “designed to permeate skin and muscle tissue deeply without penetrating the blood stream or causing psychoactive effects,” reads a press release. In addition to the nasal mist and topical salve, they also launched a sublingual spray.

Marc Graboyes, chief executive officer and co-founder of Next Frontier Biosciences

According to Marc Graboyes, chief executive officer and co-founder of Next Frontier Biosciences, drug delivery mechanisms like a nasal mist are superior to smoking, vaporizing and edible administration. “Nasal administration is among the most effective delivery technologies due to the extensive vascularization and large surface area of the nasal cavity, allowing for rapid uptake and reliable results,” says Graboyes. “The cannabis nasal mist is a novel technology that other brands have not yet tapped into.”

He says this drug delivery mechanism is efficient, fast acting and a healthy alternative to smoking. “For many, nasal delivery is a desirable alternative delivery mechanism because it does not present the health risks associated with smoking,” says Graboyes. “In addition, as previously mentioned, the large surface area of the nasal cavity permits high drug absorption, and the fine-mist sprayer allows for accurate, consistent dosing and an excellent safety profile. Further, nasal delivery avoids first-pass metabolism by the liver, where a large fraction of orally delivered cannabinoids are inactivated.”

While the Verra Wellness product line is available in Colorado starting this week, the company has plans to expand into a number of other states as well. “We are executing a multi-state expansion, with plans to move into the California, Oregon, Washington and Nevada markets in the coming year,” says Graboyes.

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FDA Issues Warning To CBD Companies

By Aaron G. Biros
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On November 1st, the U.S. Food and Drug Administration (FDA) published a press release addressing warning letters issued to four companies. The warning letters, sent to companies marketing cannabidiol (CBD) products with therapeutic claims, cites unsubstantiated claims about their products’ ability to treat or cure cancer and other diseases.

A snippet of the warning letter issued to Greenroads

According to the press release, the four companies that received warning letters are Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC. The press release called their marketing campaigns “deceptive” for “unproven treatments.” Here is the letter they sent to Greenroads Health.

“As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes,” reads the FDA statement. “Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective.”

According to the press release, the FDA has issued ninety warning letters in the past ten years, with around twelve this year, to companies making fraudulent claims about cancer therapies. Here are some examples of claims made by companies that the FDA took issue with:

  • “Combats tumor and cancer cells;”
  • “CBD makes cancer cells commit ‘suicide’ without killing other cells;”
  • “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and
  • “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors,” says FDA Commissioner Scott Gottlieb, M.D. “We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products. There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

 

Enforcement of Intellectual Property Rights for Cannabis Put to Test in Federal Court

By Dr. Travis Bliss
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A number of cannabis businesses have pursued federal intellectual property protection for their cannabis-related innovations, such as U.S. patents that protect novel cannabis plant varieties, growing methods, extraction methods, etc. Enforcement of such federal IP rights requires that the IP owner file suit in federal court asserting those rights against another cannabis company. However, given that cannabis is still illegal under federal law, the industry is uncertain about whether a federal court will actually enforce cannabis-related IP rights. This question might be answered soon.

The potential impact of this case goes way beyond the two parties involvedOrochem Technologies, Inc. filed a lawsuit in federal court in the Northern District of Illinois on September 27, 2017, seeking to assert and enforce trade secret rights against Whole Hemp Company, LLC. According to the complaint, Orochem is a biotechnology company that uses proprietary separation methods to extract and purify cannabidiol (CBD) from industrial hemp in a way that produces a solvent-free and THC-free CBD product in commercially viable quantities.

The complaint goes on to say that Whole Hemp Company, which does business as Folium Biosciences, is a producer of CBD from industrial hemp and that Folium engaged Orochem to produce a THC-free CBD product for it. According to the allegations in the complaint, Folium used that engagement to gain access to and discover the details of Orochem’s trade secret method of extracting CBD so that it could take the process and use it at their facility.

The complaint provides a detailed story of the events that allegedly transpired, which eventually led to an Orochem employee with knowledge of the Orochem process leaving and secretly starting to work for Folium, where he allegedly helped Folium establish a CBD production line that uses Orochem’s trade secret process. When Orochem learned of these alleged transgressions, it filed the lawsuit, claiming that Folium (and the specific employee) had misappropriated its trade secret processes for extracting and purifying CBD.

While the particular facts of this case are both interesting and instructive for companies operating in the cannabis industry, the potential impact of this case goes way beyond the two parties involved.

If it moves forward, this case will likely provide a first glimpse into the willingness of federal courts to enforce IP rights that relate to cannabis. Orochem is asserting a violation of federal IP rights established under the federal Defend Trade Secrets Act (DTSA) and is asserting those rights in federal district court. As a result, the federal district court judge will first need to decide whether a federal court can enforce federal IP rights when the underlying intellectual property relates to cannabis.

If the court ultimately enforces these federal trade secret rights, it could be a strong indication that other federal IP rights, such as patent rights, would also be enforceable in federal court. Since the outcome of this case will likely have a far reaching and long lasting impact on how the cannabis industry approaches and deals with intellectual property, it’s a case worth watching.

PA Approves First Two Cannabis Labs

By Aaron G. Biros
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According to a PennLive article, Pennsylvania’s Department of Health approved the first two cannabis laboratories for their medical cannabis program. ACT Laboratories of Pennsylvania LLC and Keystone State Testing LLC are the companies that were approved to perform analytical testing for safety and quality in cannabis products.

Both laboratories expect to be operational before the end of 2017, according to the PennLive article. Those labs are required to test for CBD and THC content, pesticides, moisture content, residual solvents and microbiological contaminants.

The temporary lab testing regulations are somewhat comprehensive, detailing lab reporting, licensing, sampling protocols and ownership stipulations, among other rules. ACT and Keystone, the labs that were approved by the Department of Health, have their approval for two years and can renew their license after.

While the state still expects the program to be fully implemented by 2018, Health Secretary and Physician General Dr. Rachel Levine said last week they are hoping to launch the program sometime next year, according to a press release. December 2017 will mark a full year since the state opened applications for licensing businesses.

January 2018 has long been the goal for the full implementation of the program. “We have made significant progress in getting this program off the ground since Governor Wolf signed the Medical Marijuana Act into law last year,” says Dr. Levine. “These proposed regulations for patients and caregivers to participate are one of the final pieces we need to have in place to launch the program sometime next year.”

What’s Happening on Capitol Hill? Part 3: The Medical Bills

By Brian Blumenfeld, J.D., M.A.
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This article continues the bill-by-bill review begun in the August 1st article on cannabis reform legislation proposed in the 115th Congress. In the next article and final piece in this series, we will examine the banking and tax reform bills related to cannabis.

Medical Cannabis Reform Bills 

S. 1008 – Therapeutic Hemp Medical Act of 2017

HR. 2273 – Charlotte’s Web Medical Access Act of 2017

Policy: These bills would amend the CSA to end federal prohibition over all CBD products and all hemp plants with THC content levels of below 0.3%. In other words, people and businesses would be free to grow hemp and/or manufacture CBD products without any fear of federal prosecution. These products would most likely then fall under the regulation of other federal and/or state agencies, but the bills do not specify what agencies they might be or what controls might be put in place.

Impact: The impacts from these bills nationwide have the potential to be massive. Hemp is a plant that can be put to highly effective use in many different industries, from textiles and construction to foodstuffs and seafaring. The efficiency of its growth and the breadth of its utility will make it a highly valuable commodity and a competitor with many other raw materials. For state-legal cannabis businesses, the legalization of CBD and hemp at the federal level could fundamentally change the market for those products. States that legalized cannabis already have provisions in place dealing with hemp and CBD—sometimes alongside their cannabis laws, sometimes handled by a separate state agency—and they could either leave those as they are or open up those markets to interstate activity. In states that have not legalized, CBD and hemp are typically included in the state’s definition of cannabis, and therefore they will remain illegal under state law unless further action is taken. Most likely, if federal prohibition ends on hemp and CBD, state prohibition will follow suit. Because legalization at the federal level will allow for interstate commerce in hemp and CBD, expect the emergence of a nationwide market, driven by online sales and interstate marketing, and developing independently from a cannabis industry still constrained to in-state activities.

Procedural Status:

Senator Cory Gardner (R-CO) Photo: Gage Skidmore, Flickr

S. 1008

  • Introduced: May 2, 2017 by Senator Cory Gardner (R-CO)
  • Cosponsors: 7 Republican, 4 Democrat
  • Referred to Senate Committee on:
    • Judiciary

 HR. 2273

  • Introduced: May 1, 2017 by Representative Scott Perry (R-PA)
  • Cosponsors: 10 Republicans, 10 Democrats
  • Referred to House Committee on:
    • Judiciary
      • Subcommittee on Crime, Terrorism, Homeland Security, and Investigations
    • Energy and Commerce
      • Subcommittee on Health
    • Financial Services

S. 1276 – Cannabidiol Research Expansion Act

Policy: This bill would accomplish two objectives: First, it would open channels for researchers to access and experiment with cannabis and cannabis extracts. Second, it would initiate the process at the end of which the Attorney General must make a determination as to which Schedule of the CSA is most appropriate for cannabidiol (CBD).

Impact: The impact on this legislation to state-legal cannabis businesses is rather remote—in both time and practice. The research access provisions will certainly create an uptick in medical and psychological research activity, the outcomes of which will add to our knowledge of how consuming cannabis in different forms and amounts effects the brain and body. This type of government-regulated research takes many years to process and complete, as both bureaucratic and scientific standards must be met. As for initiating the re/de-scheduling review process for CBD, this is a direct response to the 2016 denial by the DEA to re/de-schedule cannabis. That determination, published in the Federal Registrar on August 12, 2016, was made following a comprehensive study of the medical benefits and harms of cannabis conducted by the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). Although such an in-depth study and its resulting negative determination pronounced so recently would normally rule out the chances of success for another re/de-scheduling attempt so soon after, the DEA did leave the door open with its statement that it “did not focus its evaluation on particular strains of marijuana or components or derivatives of marijuana.” It is just this door that S. 1276 seeks to exploit. By focusing the re/de-scheduling process on CBD specifically, the presumption is that the outcome of the scientific CBD studies would have a far better chance at satisfying the re/de-scheduling criteria set forth in the CSA. If such a determination was made, then the impact would come in two potential varieties. One, CBD would be rescheduled and become available for medical use according to FDA rules applicable to other prescription drugs. Two, CBD would be descheduled and would fall under the prerogative of the states, in which case the above analysis for S. 1008 and HR. 2273 would pertain.

Senator Dianne Feinstein (D-CA)
Photo: Daniel Torok

Procedural Status:

S. 1276

  • Introduced: May 25, 2017 by Senator Dianne Feinstein (D-CA)
  • Cosponsors: 3 Republican, 2 Democrat
  • Referred to Senate Committee on:
    • Judiciary

S. 1374 – Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2017

HR. 2920 – Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2017

HR. 715 – Compassionate Access Act of 2017

HR. 714 – Legitimate Use of Medical Marijuana Act (LUMMA) of 2017

Policy: All four of these bills would make an exception to the CSA for state medical cannabis laws. Federal prohibition, in other words, would end for medical cannabis in those states that have legalized, and it would be left to those states to devise how it would be regulated. In states that have not legalized, both state and federal prohibition would remain. The companion CARERS Acts in the House and Senate, along with HR. 714, would also amend FDA rules to widen access to cannabis for research purposes.

Impact: The impact of these bills on the rules for state-legal medical cannabis businesses would be relatively minor in terms of functionality. This is so because they leave not only the determination to legalize up to the states, but they leave the design of the regulatory system up to the states as well. In other areas, however, big changes will be seen that benefit the industry: banking will open up for state medical businesses, and so will the opportunity to write-off ordinary business expenses. Investment risks over legality will end, making for easier access to capital. Questions about contract enforcement and risks of federal prosecution will become moot, and when state regulatory bodies make decisions on how to govern the industry, they will no longer have to concern themselves with U.S. DOJ enforcement and/or prosecutorial policies. Enactment of any of these bills would be a big win for medical cannabis.

Senator Cory Booker (D-NJ) Photo: David Shinbone, Flickr

Procedural Status:

S. 1374

  • Introduced: June 15, 2017 by Senator Cory Booker (D-NJ)
  • Cosponsors: None
  • Referred to Senate Committee on:
    • Judiciary

HR. 2920

  • Introduced: June 15, 2017 by Representative Steve Cohen (D-TN)
  • Cosponsors: 1 Republicans
  • Referred to House Committee on:
    • Judiciary
      • Subcommittee on Crime, Terrorism, Homeland Security, and Investigations
    • Energy and Commerce
      • Subcommittee on Health
    • Veterans’ Affairs
      • Subcommittee on Health

HR. 715

  • Introduced: January 27, 2017 by Representative Morgan H. Griffith (R-VA)
  • Cosponsors: 2 Republicans, 1 Democrat
  • Referred to House Committee on:
    • Energy and Commerce
      • Subcommittee on Health
    • Judiciary
      • Subcommittee on Crime, Terrorism, Homeland Security, and Investigations

HR. 714

  • Introduced: January 27, 2017 by Representative Morgan H. Griffith
  • Cosponsors: 1 Democrat
  • Referred to House Committee on:
    • Energy and Commerce
      • Subcommittee on Health

HR. 2020 – To Provide for the Rescheduling of Marijuana into Schedule III of the CSA

Policy: As its wordy title indicates, this bill would bypass the schedule review process and by legislative fiat move cannabis from Schedule I to Schedule III of the CSA.

Representative Matt Gaetz (R-FL)

Impact: Businesses handling drugs in Schedule III must register with the DEA and comply with DEA record keeping and security requirements. Doctors would be permitted to prescribe cannabis products. Importing/exporting will become available by permit, which would bring state businesses into competition with foreign cannabis firms. The biggest impact will be that cannabis sold pursuant to federal law will have to undergo the FDA’s New Drug Application process conducted by the Center for Drug Evaluation and Research, the largest of the FDA’s five centers. This includes clinical testing and a comprehensive chemical/pharmacological review. The drug would then be subject to FDA regulation for marketing and labelling. For states that wanted to maintain their legal medical cannabis systems, a conflict would remain because cannabis cultivators and dispensaries could operate in compliance with state law while simultaneously failing to meet new FDA and DEA requirements. States will then have a choice: bring state laws into line with federal laws, creating all of the advantages of federal legality discussed above, yet causing major disruptions to the industry; or retain the status quo, allowing the industry to grow as is with all of the in-state advantages but without the advantages of federal legalization. This all would of course leave behind recreational cannabis which would remain in the legal gray zone.

  • Introduced: April 4, 2017 by Representative Matt Gaetz (R-FL)
  • Cosponsors:
  • Referred to House Committee on:
    • Energy and Commerce
      • Subcommittee on Health
    • Judiciary

HR. 331 – States’ Medical Marijuana Property Right Protection Act

Policy: Section 881(a)(7) of the CSA subjects to federal forfeiture all property involved with cannabis activities. This bill would make an exception to that provision for all property in compliance with state medical cannabis laws.

Impact: Although not legalizing medical cannabis, this bill would be a strong step in the direction of legitimizing state-legal medical cannabis businesses. As a result of the property forfeiture clause of the CSA, two impediments faced by the medical cannabis industry is that investors are hesitant to invest and land lords are hesitant to lease or otherwise engage the medical cannabis market. By eliminating the risk of such property loss due to the federal-state conflict, this bill would have the very welcomed impact of easing access to capital and expanding opportunities for land use.

  • Introduced: January31, 2017 by Representative Barbara Lee (D-CA)
  • Cosponsors:
  • Referred to the House Committee on:
    • Judiciary
      • Subcommittee on Crime, Terrorism, Homeland Security, and Investigations
    • Energy and Commerce
      • Subcommittee on Health

Cannabis-Infused Beer Goes Mainstream

By Aaron G. Biros
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Lagunitas Brewing today unveiled a new beer infused with cannabis, making it the first large national brewery to experiment with cannabis. Lagunitas, now owned by Heineken, announced the launch of their “Supercritical Ale,” an IPA brewed with terpenes extracted from cannabis.

The brewery chose to partner with AbsoluteXtracts and CannaCraft, based in California, for their cannabis extract and will use hops from Yakima, Washington. “We’ve long known about the close connection between cannabis and hops,” reads their website. “Now Lagunitas is excited to partner with a like-minded neighbor in Sonoma County, AbsoluteXtracts, to close the gap further with tandem innovations on the topic.” Hops and cannabis belong in the same taxonomic family, Cannabinaceae, and they also have a number of physical similarities, which helps explain the “close connection” they are referring to. The website says the beer will only be available in California—for now. According to Fortune Magazine, the terpenes come from two strains, Blue Dream and Girl Scout Cookies (known as GSC in some states).

The name “Supercritical” comes from the state that carbon dioxide is best used as a solvent for extracting compounds from plants. Terpenes are responsible for the aromatic properties of plants, giving hops the piney and citrusy flavors that come in IPAs, and giving cannabis the same flavors and smells as well. Limonene, for example, is a cyclic terpene molecule that gives us a citrusy smell and flavor.

Coalition brewing Co.’s Two Flowers IPA

They’re not the first brewery to experiment with cannabis-infused beer; smaller craft breweries have been doing it for some time now. Coalition Brewing Co., based in Portland, Oregon, sells a cannabis-infused beer called Two Flowers IPA, with 3mg of cannabidiol (CBD) in a 12oz glass. Dad and Dudes Breweria, based in Aurora, Colorado, also put out a CBD-infused beer last year, called General Washington’s Secret Stash. According to Westword, Dad and Dudes was the first brewery to receive federal approval for a CBD-infused beer, but since the DEA declared cannabis oil illegal last winter, the Alcohol and Tobacco Tax and Trade Bureau rescinded their approval.

The common denominator between these three beers is that none of them contain THC, the popular psychoactive ingredient in cannabis. Perhaps Lagunitas is taking a safer approach with regard to federal legality by only using terpenes, not CBD, and only offering it in state. Coalition’s Two Flowers IPA is also only available in Oregon, but does, however, contain CBD. Check out the video on Lagunitas’ Supercritical Ale below.

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Clear vs. Pure: How Fallacies and Ignorance of Extraction Misrepresent the Cannabis Flower

By Dr. Markus Roggen
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Demand for cannabis extracts, in particular vaping products, is at an all-time high. People want good oil, and they want to know something about the quality of it. It is therefore time to take a step back and consider the process from plant to cartridge. What is the current industry standard for cannabis extraction, what constitutes quality and where might we need to make some adjustments?

Right now, “clear” oil is hot. Customers have been led to believe that a pale gold extract is synonymous with the best possible cannabis concentrate, which is not necessarily the case. Producing a 95% pure THC extract with a translucent appearance is neither a great scientific feat nor a good representation of the whole cannabis flower. Moreover, it runs counter to the current trend of all-natural, non-processed foods and wellness products.

“My carrots are organic and fresh from the farmers market, my drink has no artificial sweeteners and my honey is raw, but my cannabis oil has undergone a dozen steps to look clear and still contains butane.”Cannabis is a fascinating plant. It is the basis of our livelihood, but more importantly, it enhances the quality of life for patients. The cannabis plant offers a plethora of medicinally interesting compounds. THC, CBD and terpenes are the most popular, but there are so many more. As of the most recent count, there are 146 known cannabinoids1. Cannabinoids are a group of structurally similar molecules2, including THC and CBD, many of which have shown biological activity3.

Then there are terpenes. These are the smaller molecules that give cannabis its distinct smell and flavor, over 200 of which have been identified in cannabis4. But wait, there’s more. The cannabis plant also produces countless other metabolites: flavonoids, alkaloids, phenols and amides5. All these components mixed together give the often-cited entourage effect6,7.

Current industry standards for cannabis oil extraction and purification stand in marked contrast to the complexity of the plant’s components. Due to an unsophisticated understanding of the extraction process and its underlying chemistry, cannabis oil manufacturers frequently produce oil of low quality with high levels of contamination. This necessitates further purifications and clean up steps that remove such contaminants unfortunately along with beneficial minor plant compounds. If one purifies an extract to a clear THC oil, one cannot also offer the full spectrum of cannabinoids, terpenes and other components. Additionally, claiming purities around 95% THC and being proud of it, makes any self-respecting organic chemist cringe8.

Precise control of extraction conditions leads to variable, customized concentrates. THC-A crumble, terpene-rich vape oil, THC sap (from left to right).

The labor-intensive, multi-step extraction process is also contrary to “the clean-label food trend”, which “has gone fully mainstream”9. Exposing the cannabis flower and oil to at least half a dozen processing steps violates consumer’s desire for clean medicine. Furthermore, the current practice of calling supercritical-CO2-extracted oils solvent-less violates basic scientific principles. Firstly, CO2 is used as a solvent, and secondly, if ethanol is used to winterize10, this would introduce another solvent to the cannabis oil.

We should reconsider our current extraction practices. We can offer cannabis extracts that are free of harmful solvents and pesticides, give a better, if not full, representation of the cannabis plant and meet the patients’ desire for clean medicine. Realizing extracts as the growth-driver they are11 will make us use better, fresher starting materials12. Understanding the underlying science and learning about the extraction processes will allow us to fine-tune the process to the point that we target extract customized cannabis concentrates13. Those, in turn, will not require additional multi-step purification processes, that destroys the basis of the entourage effect.

The cannabis industry needs to invest and educate. Better extracts are the result of knowledgeable, skilled people using precise instruments. Backroom extraction with a PVC pipe and a lighter should be horror stories of the past. And only when the patient knows how their medicine is made can they make educated choices. Through knowledge, patients will understand why quality has its price.

In short, over-processing to make clear oil violates both the plant’s complexity and consumers’ desires. Let us strive for pure extracts, not clear. Our patients deserve it.


[1] Prof. Meiri; lecture at MedCann 2017

[2] ElSohly, Slade, Life Sciences 2005, 539

[3] Whiting, et. al., JAMA. 2015, 2456

[4] Andre, Hausman, Guerriero, Frontiers in Plant Science 2016, 19

[5] Hazekamp, et. al., Chemistry of Cannabis Chapter 3.24; 2010 Elsevier Ltd.

[6] Ben-Shabat, et al.; Eur J Pharmacol. 1998, 23

[7] Mechoulam, et al.; Nat Prod Rep. 1999, 131

[8] Medical and Research Grade chemicals are generally of purities exceeding 99.9%

[9] Bomgardner, Chemical & Engineering News 2017, 20

[10] Winterization is the industry term for what is correctly referred to as precipitation.

[11] Year-over changes to market shares in Colorado 2015 to 2016: Concentrates 15% to 23%; Flower 65% to 57%, BDS Analytics, Marijuana Market Executive Report, 2017

[12] Further reading about the whole extraction process: B. Grauerholz, M. Roggen; Terpene and Testing Magazine, July/Aug. 2017

[13] Further reading about optimizing CO2 extraction: M. Roggen; Terpene and Testing Magazine, May/June 2017, 35