Tag Archives: compliance

April 29, 2019

Why International Trade Agreements Are Shaping The Cannabis Industry

By Marguerite Arnold

If you have wondered over the past several years, why the big Canadian companies (in particular) are following the global strategy they are, there is actually a fairly simple answer: Newly implementing trade agreements, particularly between Europe and North America.

More specifically, they are highly technical trade agreements that are also called Mutual Recognition Agreements, (or MRAs).

In fact, look at the schedule of the MRA agreements signed between the U.S. and individual EU countries over the last several years, and it also looks like a map of the countries that have not only legalized at least medical cannabis, but where the big Canadian companies (in particular) have begun to establish operations outside of their home country.

But what is going on is actually more than just CETA-related and also will affect cannabis firms south of the Canadian-U.S. border.

All of these swirling currents are also why the most recent MRA to come into full force in July this year, between the U.S. and Europe, is so interesting from the cannabis perspective. Even before federal reform in the U.S. If this sounds like a confusing disconnect, read on.

What Are MRAs?

MRAs are actually a form of highly specialized trade agreement that allow trading countries to be certain that the pharmaceuticals they purchase from abroad are equivalent to what is produced at home. This includes not only ingredients but processing procedures, production plant hygiene, testing, labeling and more.

When it comes to the EU-US MRA agreement, this means that individual states of the EU can now recognize the American Food and Drug Administration (or FDA) as an effective federal regulator of American pharmaceutical production that is equal to the procedures in Europe. US GMP standards, in other words, will be recognized as equal to those of EU states.

This will now also, by definition, include GMP-certified medical cannabis formulations.

What is so intriguing, however, is how this development will actually place certain American (and Canadian) manufacturers in a first place position to import cannabis into Europe ahead of the rest of the American cannabis industry.

What Are Mutual Recognition Agreements All About?

One of the most important quality and consumer safety aspects of establishing a clean supply chain is tied up in the concept of GMPs (Good Manufacturing Practices). These are procedures, established by compliant producers of pharmaceuticals, to ensure seed (or source) to sale reliability of the medication they make. In the cannabis industry, particularly in the advent of Canadian-European transatlantic trade in cannabis, this has been the first high hurdle to accept and integrate on the Canadian side.

If European countries recognize a country’s GMP certifications are equivalent to its own, in other words, and cannabis is legal for export, a country can enter the international cannabis market without facing bans, in-country inspections and the like. In the interim, imported products still have to be batch tested until the agreements are fully accepted and operational.

Israel, for example, already had an MRA with the EU, and medical cannabis is legal in the country. However, Israel was prevented from selling cannabis abroad until a legislative change domestically, passed on Christmas Day.

That is why the MRA agreement between the US and EU with Canadian companies in the middle also put both Israeli and U.S. firms at an extreme disadvantage in comparison. Both in entering the market in the first place, and of course associated discussions, like the German tender bid. That is now changing- and as of this year.

A Specialized Map Of Global Medical Cannabis Exporters

Ironically, what the new US-EU MRA could also well do is create a channel for pharmaceutical cannabis from the United States to Europe (certainly on the hemp and CBD front) just as Israel is expected to enter the international cannabis export industry (later this summer or fall). It could well be also, particularly given the Trump Administration’s tendency to want to not only “put America first” if not pull off “a better deal” in general and about everything, that this is why President Trump offered the delay to Israel’s president Benjamin Netanyahu in the first place.

Regardless of the international individual developments and subtleties however, what is very clear that from the time the first bid stalled in Germany in the summer of 2017 until now, the U.S.-EU MRA has been in the room even if not named specifically as a driver.

For example, the FDA confirmed the capability of Poland and Slovenia to carry out GMP inspections in February of 2019. It was only last fall that Aurora pulled off its licensing news in the former (on the same day licensing reform was announced by the government). Denmark was recognized in November of last year during the first year of its “medical cannabis pilot progam.” Greece was recognized in March 2018. Italy, Malta, Spain and the UK came online in November of 2017.

Overlay this timetable with a map of cannabis reform (and beyond that, cannabis production) and the logic starts to look very clear.

The upshot, in other words, is that while cannabis still may be “stigmatized” if not still “illegal” in many parts of the world, more generalized, newly negotiated and implementing, specialized global trade agreements between the US, Europe and Canada in particular have been driving the development of certain segments of the cannabis industry globally and since about 2013.

The Biggest News?

As of this year, as a result, expect at least from the GMP-certified front at least, that such international trade will also include medical cannabis from the U.S.

Want an example of the same? First on that list if not early in the game will now undoubtedly be Canadian-based Canopy Growth, with Acreage on board, headquartered in New York.

April 29, 2019

Canopy Growth Makes Multi-Billion Dollar Conditional Acquisition Deal

By Marguerite Arnold

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The first German cannabis bid may have come to an end more or less, and with a whimper rather than a bang (not to mention the inevitable still-to-be-settled legal challenges). However even as the dust settles, one of the biggest “names” in cannabis and the company formerly expected to win at least a few of the tender lots is looking elsewhere.

Namely Canopy Growth, which was a finalist in the first round of the tender, has not shown up as a finalist firm in Germany this time (at least not so far).

However, it is clear the firm has other intentions afoot, namely U.S. expansion.

In an unprecedented move, Canopy announced its intent to buy the largest U.S. based producer of cannabis, a firm called Acreage Holdings, just before Easter. The conditional deal is being consummated in both cash ($300 million) plus stock swaps, and will not finally close until federal reform has come in the U.S. In fact, the deal makes the bet that the entire issue of U.S. federal reform will be solved within the next decade.

In the meantime, however, what this also does is place one of the world’s largest cannabis companies in the middle of what is largely seen as the world’s most valuable overall cannabis market. Further it does so in an environment where the company benefits from Acreage’s considerable market and political clout. Former speaker of the U.S. House of Representatives John Boehner (a fierce opponent of legalization until it was personally convenient and profitable) is on the board of Acreage.

But there are those who might still be confused about why this deal happened. Canopy after all is fond of saying that its first focus is the “more valuable” medical rather than recreational market. And the U.S. market has many challenges still, that stem from a lack of federal reform. In fact, Canopy has frequently said in the past that they would not enter the U.S. until federal reform occurs. What gives?

What The Deal Also Does…

It is not “just” entry into the U.S. recreational market, albeit still on a state level that is significant about the deal. That starts with its timing.

When trying to understand the motivations of Canadian cannabis companies, especially ones who have eschewed the U.S. market in the past (at least until federal reform passes), it is also necessary to understand that they operate in a shifting world of global strategy that is never as straightforward as one might think. And often has nothing to do with cannabis per se.

Namely, while this deal places Canopy in the middle of the U.S. state industry it also does something else. It positions Canopy as a U.S. producer just two months after a new international pharmaceutical trade deal went into force (on February 8) called an MRA.

MRA agreements, also known as Mutual Recognition Agreements, are essentially trade deals between countries to accept the equivalency of their pharmaceutical production and supply chain.

On the cannabis front, the existence of MRAs between existing countries as cannabis has become legal, has also largely dictated the new international cannabis trade (see Canada and Germany as a perfect example) although this has been held as a closely held secret by the largest cannabis company executives (some of whom have previously denied that this was driving their expansion across Europe).

However, thanks to the agreement on this MRA in February, as of July of this year, Europe and the U.S. will formally kick off a situation where the European and therefore German health authorities will formally recognize American GMP processes.

That means that on the pharma front, Canopy has also essentially re-entered the European market, albeit by a bit of a backdoor. It also means that Canopy can immediately start to import cannabis drugs at least, made in the U.S. into the European and by extension, German market.

Cannabis drugs have been going in the opposite direction across the Atlantic to the U.S. for at least a year now (see the GW Pharma’s Epidiolex adventure last year). And further over the U.S.-Canadian border if now only bound for academic research (see Tilray).

It also may mean that they can import medical cannabis itself to be used as “medicine” or processed into one in Europe.

Does This Mean That U.S. Federal Reform Is Imminent?

Not necessarily. In fact, keeping the U.S. market in general out of the global cannabis trade, while allowing the top companies to participate both in the cross-state market and the global pharmaceutical one benefits the biggest companies. Conveniently, this also allows U.S. cannabis “pharmaceutical” producers to enter the EU in force just as Israel is expected to (third quarter this year). This also puts the “deal” U.S. President Trump and Israeli President Netanyahu cut on the subject to delay Israeli sales in an entirely new light (and one that should outrage both Americans and Israelis in the industry on this front even more). Not to mention every European hopeful producer unaware of the larger game afoot.

That said, what federal U.S. legalization will do is drop the operating costs of the larger U.S. entities now engaged in multi-state operations.

Cannabis in other words is not likely to be legalized in the U.S. before the next presidential elections for reasons that have everything to do with the profits of a few – and for that reason will certainly be a major theme in the next national political race.

And in the meantime, the biggest companies, Canopy included, are not only laughing all the way to the bank (although their shareholders are another story), but setting themselves up to be at the ground floor DNA of the global cannabis business as it establishes itself in every country of the world.

April 23, 2019

Eating Your Words: How to Avoid Legal Issues Marketing Cannabis Consumables

By Jennifer Whetzel

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Selling in a grey market isn’t for the faint of heart. You have to deal with the stigma surrounding your products and services, the potential for legal troubles, along with bureaucratic hurdles that all businesses face.

Acceptable marketing language surrounding consumable THC and CBD products encapsulates all of these issues, and it’s why everyone in the industry needs to pay close attention to what they’re saying. One innocent turn of phrase could have the Food & Drug Administration (FDA) shut down your business faster than you can say, “Oops.”

Avoiding this fate means making some adjustments to how you think about your marketing language, but this knowledge quickly becomes rote. Take a moment to learn how to protect yourself so that you can run your business rather than run afoul of the law.

Food, Drugs and Dietary Supplements

Scroll through Instagram for a few minutes and you’ll encounter a deluge of companies making claims about cannabis and CBD products. Many, if not most, are going about it incorrectly. Part of the confusion surrounds the fact that under the FDA’s rules, foods, drugs and dietary supplements are treated differently.

How does the FDA decide what’s what? Based on how you advertise the product. If labeling suggests the substance is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or is an “article” (other than food) intended to affect the structure or any function of the body of man or other animals,” the FDA will regulate it as a drug.

The language and regulations surrounding drugs are extremely strict. On December 20, 2018, the FDA put out a statement reiterating that these rules are in effect for cannabis products. In other words, you can only make a drug claim if you have received approval from the FDA on your New Drug Application (NDA). Since approval requires hundreds of millions of dollars worth of clinical trials, this option is out of reach for most companies.

The rule states that you may not say that your product diagnoses, cures, mitigates, treats or prevents any disease, or any recognizable symptom of a disease. Disease is defined as: damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunction it (e.g. hypertension). Examples of diseases would include cancer, multiple sclerosis, epilepsy, autoimmune diseases, Lyme disease and more. In other words, you couldn’t say your product “prevents memory loss due to Alzheimer’s” or “treats symptoms of fibromyalgia.”

If you’re making any claims about curing anything in your cannabis business name, product name, packaging, web copy, advertising or marketing materials, you are at risk for breaking these rules and getting caught. The FDA’s regulations dovetail with the Federal Trade Commission’s truth-in-advertising laws, which state that your claims must be backed by legitimate research (such as peer-reviewed journal articles or double-blind studies) and must not mislead consumers. These rules are already being enforced within the cannabis industry, so pay close attention to what you’re putting out there.

An example of a warning letter the FDA sent to a CBD products company making health claims

However, you can’t avoid penalties by using this kind of language and claiming your product is a dietary supplement or food, either. According to the FDA, products that contain THC or CBD cannot be sold as dietary supplements. Their reasoning for this decision is that THC and CBD are active ingredients in FDA-approved drugs, such as Epidiolex and Dronabinol. Active ingredients in approved drugs may not be introduced into the food supply as dietary supplements or otherwise.

The language rules surrounding food can be equally complex. Foods approved by the FDA can make nutritional claims about how a nutrient impacts the structure/function of the body, such as “Calcium builds strong bones.” The problem for cannabis products is that these statements need to be authorized or qualified by the FDA and have significant scientific evidence and consensus. However, this consensus doesn’t exist for THC and CBD, meaning that you’re barred from making these kinds of claims.

Note that these rules don’t just apply to human supplements. They also apply to ones for pets. Many people don’t realize that a supplement for a pet is considered an “illegal drug of low regulatory concern.” But if you add in THC or CBD, a supplement becomes an illegal drug of—you guessed it—higher regulatory concern.

At a Loss for Words?

By now, you may be wondering what you can actually say to market your product; it may feel as though there are more restrictions than guidelines. Fortunately, the FDA hasn’t left us completely out at sea.

Just because we’re in a strange place under federal law operating our businesses every day doesn’t mean that we should disregard fundamental rules and regulations that all businesses must follow. The FDA published a final rule in the Federal Register in 2000 defining strict rules that govern the types of statements that may be used on a label without prior review of the agency. These are called structure/function claims. According to the FDA, “Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body.” In contrast, statements that claim to diagnose, cure, mitigate, treat or prevent disease require prior approval by the FDA and are only for products that are approved drugs. Don’t use any of those words. Ever.

You can use the following words in your cannabis product names, advertising or marketing, as long as you’re not connecting them to a disease state: restore, support, maintain, raise, lower, promote, regulate, stimulate. You must specifically state that the claim relates to a non-disease condition; otherwise, you’ll be in trouble with the FDA. To go back to an earlier example, you cannot say that your product “prevents memory loss due to Alzheimer’s.” However, stating that your product “helps maintain a healthy brain” is fine.

Just because we’re in a strange place under federal law operating our businesses every day doesn’t mean that we should disregard fundamental rules and regulations that all businesses must follow. Following these rules does more than keep our enterprises out of trouble. It reinforces the idea that our industry is responsible, legitimate, and—perhaps most importantly—here to stay.

April 22, 2019

How Germany Gets Its Cannabis

By Marguerite Arnold

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The German cannabis cultivation bid may be mostly done and dusted (although the last four lots are now up for legal challenge) but the drama is only intensifying on the ground in Germany. Namely, where is the cannabis being consumed on the ground now actually coming from?

For the past several years (in fact since 2016 when a Frankfurt-based start-up called Medcann imported the first Canadian medical cannabis into the German market in partnership with Canopy Growth), the conventional wisdom has been that Holland and Canada were the only two countries allowed to import medical cannabis into the country.

As is usually the case in the cannabis industry, when it comes to such things, there were also multiple and highly creative explanations about this strange state of affairs that sounded oddly exotic enough to be plausible. This is after all, the international cannabis business.

These explanations also usually referenced conventional industry “lore” including such tall tales as these two countries were not signatories to an international drug treaty (not true), to being European (nope) or even a member of the EU (also completely false).

Yet there was always something strange with such urban legends – perpetuated by insiders across the German industry. Starting with a deliberate vagueness about details. Especially as in the summer of 2017 when Tilray announced grow facilities in Portugal, and by the end of it, Canopy was moving into Spain, and later by early 2018 Denmark and more. Italybegan to appear on the radar of multiple big Canadian companies. Clearly all these big companies seemed to know something that those outside did not. See Greece. Not to mention the teeth-gnashing of the Israelis– repeatedly shut out of the German market by not being allowed to export by their own government until Christmas Day, 2018.

The mystery deepened in March in fact, as a furore rocked the German-based cannabis industry over the last weeks. Farmako, a new, Frankfurt-based distributor, not only announced that it was importing 50 tonnes of cannabis into the country– and from Poland (where production of such bulk has not even been seeded) – but then gave additional details on a Bloomberg appearance that appeared to indicate that in fact the medical cannabis they were already selling (sourced from other places) had come from Macedonia.

Certification, and most certainly paperwork are the name of the gameIn fact, no such transfer of cannabis had occurred from the Macedonian side (yet), although the firm in question at the other end of the deal was subjected to considerable harassment in the German canna-specialty press in the meantime.

The news, that occurred right at a time when Tilray is clearly training pharmacists for the German market, the first bid is concluding, Greece issues even more cultivation licenses, Canadian companies are clearing still stepping up their production game, and South Africa is also getting into the formal licensing act, with all sorts of interesting things afoot in Uruguay, also set off what appears to be an official investigation of the firms involved at the governmental level.

Insiders are tight lipped and nobody is willing to talk on record. However, the distribution firm, Farmako, has subsequently reported that in the month of March, they became the top selling cannabis specialty distributor in Germany. And since they are not out of business, it is also clear that while their PR may have been a little premature if not easily misunderstood, the broader message is very obvious.

What is also very clear at this point, in other words, is that the German door for cannabis and the international industry appears to be opening to product sourced from many places. Further by extension, the German government is in the process of recognizing foreign GMP certification processes from multiple countries all over the world as being equal to its own – at least on the cannabis front.

In fact, this has been going on relatively quietly for the past six months or so.

What Are The Standards, Certifications, and Qualifications?

A press release from January of this year, issued from an Australian firm called MCA, announced they had accepted the first letter of intent to ship to a German firm (in 2020). The company is currently accepting pre-orders as it finishes construction and achieves EU GMP certification. The same (female founded) firm was also present at the ICBC in Berlin this year in March, reporting that German demand from a universe of local distributors was already greater than they could fill. The news that their first sale went to German firm Lexamed, the controversial German wheelchair distributor who helped bring down the first German bid, was also largely unremarked upon at the time by most of the industry press and in fact, ever since.

In truth, it appears that the countries and companies that have the right to import to Germany must first have their own national GMP certification recognized as being equal to German standards – or a so-called Mutual Recognition Agreement (or MRA) must exist between the importer and exporter nations. It still means that to be really EU-GMP compliant, inspectors have to walk your cultivation floors. But first your country has to have the MRA. And that is a matter for lawyers and regulators to decide.

In the Australian case, the GMP equivalence for cannabis production apparently became reality within the last six months although no one is giving exact dates. In the case of Macedonia, this is pending, with German inspectors now apparently scheduled to begin inspecting domestic cultivation facilities within the next month to six weeks.

The biggest news, of course, which makes even more sense on the heels of Canopy’s latest “record breaking” U.S. acquisition, is that the EU and the U.S. will enter into an MRA in July that was finally agreed to in February of this year. This will also mean that cannabis “medicines” potentially even beyond CBD, produced via U.S. GMP processes, will be allowed to enter Europe if not Germany in the near future – and from the U.S. for the first time. Ahead of federal legalization in the U.S.

It also means that Israeli and American firms will be allowed to enter the European and thus German market for the first time (on the ground with product) by at latest, the third quarter of this year.

Caused By The Bid….and Likely Shorter Term Outcomes

What the events of the last several weeks make clear is that the bid is not only insufficient for demand, but the authorities are officially, if quietly recognizing the same. There are already rumours about the next cultivation tenders in Germany, and there is a high likelihood that other countries (see Poland in particular) may also follow suit shortly.

Further, the difficulties in making sure that not only countries but the companies based in the same remain compliant with EU and further German sanctified EU- GMP processes (for one) is likely to be an issue that continues to bubble. Why? It is a problem already in the broader pharmaceutical market here.

The Plusses and Minuses of The News

The first thing that is also obvious is that even Wayland cannot source the entire German market with the product it has begun to grow here no matter who ends up with the last four cultivation licenses this time around. Further, that the other winning bid firms (Aphria and Aurora as known at this point) without cultivation on the ground, are sourcing from somewhere that is also probably at this point, not even Canada. No matter how much expansion is going on in Canada, in other words, what is now entering the German market may bear a Canadian brand but could just have easily been sourced from almost anywhere in the world.

That also means that enterprising firms (see Australian MCA) can skip the Canadian introduction to the German market and sell directly to local producers before they even have crops on the ground, as well as the burgeoning German cannabis distributors across the country.

For such firms now wanting to enter the market, however, it is not all clear sailing. The events of the last few weeks clearly show that the government is watching, including reading English language industry press, and willing to pursue any firms it deems are breaking the rules on both sides of national borders.

Certification, and most certainly paperwork are the name of the game, as well as greater accuracy in company intentions (even if in the near term).

Disclaimer: Nysk, the Macedonian firm referred to in this story, is a sponsor of the MedPayRx pilot to market program

April 22, 2019

Soapbox

Interstate Hemp Transportation: A Cautionary Tale

By Robert M. Kline

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Two bags are sitting on the table in front of you. The first bag contains legal hemp. The second one contains illegal marijuana. Can you tell which is which? Neither can state troopers at a traffic stop.

On January 24, 2019, Dennis Palamarchu, an interstate truck driver, had 6,700 pounds of hemp in his rig. Mr. Palamarchu had picked up the load at Boones Ferry Berry Farms in Hubbard, Oregon. Before he reached his destination at Big Sky Scientific, LLC (“Big Sky”) in Aurora, Colorado, the Idaho State Police stopped him on I-84, outside of Boise. Mr. Palamarchu indicated that he was hauling hemp. He did not try to run or escape, and he never tried to dispose of the load. The bill of lading showed that the shipment consisted of approximately 7,000 pounds of hemp. The Idaho State Police arrested Mr. Palamarchu for felony trafficking in marijuana.

Around the same time, Pawhuska police in Oklahoma seized over 17,000 pounds of hemp on its way from Kentucky to Colorado. The cargo was valued at about $850,000. A spokesman for the Oklahoma Bureau of Narcotics and Dangerous Drugs Control said, “We don’t know if it is marijuana. We don’t know if it is hemp.”

The recent events in Idaho and Oklahoma are inevitable consequences of the passage of the Agriculture Improvement Act of 2018, Pub. L. 115-334 (“2018 Farm Bill”). The 2018 Farm Bill provides that no state shall be allowed to prohibit the transportation of hemp through the state. However, a product that contains more than 0.3% THC – in the eyes of federal law – is marijuana, not hemp. Unlike hemp, marijuana still is subject to state statutes and the federal Controlled Substances Act. The legal distinction between hemp and marijuana is too subtle for the human eye, or a trained K-9’s impressive nose, and it has created a quandary for interstate hemp shippers like Mr. Palamarchu and Big Sky.

When Idaho State Police seized Big Sky’s hemp, Big Sky went to federal court¹. On February 19, 2019, the United States District Court for the District of Idaho recognized that in the 2018 Farm Bill, Congress legalized the interstate transportation of hemp grown in the United States so long as the hemp was “produced in accordance with subtitle G” of the Agricultural Marketing Act of 1946. However, the federal plan is undeveloped and Oregon does not have a federally-approved plan, so no one knows what it means to be “produced in accordance with subtitle G.” The federal court therefore concluded that Big Sky’s hemp could not possibly have been “produced in accordance with subtitle G.”

The court recognized, “[a]t some future date, industrial hemp that has been ‘produced in accordance with subtitle G’ will undoubtedly be transported in interstate commerce across states like Idaho that have not legalized industrial hemp.” In the meantime, however, the court found that Idaho could keep Big Sky’s cash crop, which sits deteriorating in the possession of law enforcement. Big Sky has appealed to the United States Court of Appeals for the Ninth Circuit.

The hemp market is projected to approach $2 billion by 2020. By then, hopefully, federal law will clarify what it means for hemp to be “produced in accordance with subtitle G.” In the meantime, Idaho’s House of Representatives recently passed a bill that would allow hemp producers from the 41 states that have legalized hemp to transport their crops and products through Idaho, so long as they get a permit from the state and do not unload any of their cargo there. Idaho Senators then added a section to that bill, announcing their intent for Idaho to legalize hemp in time for the 2020 growing season. The House, however, never signed off on the Senate amendments, effectively killing the bill. Until such a bill becomes law, transporters of interstate hemp should consider taking the long way home.

References

Big Sky Scientific, LLC v. Idaho State Police, et al., No. 19-cv-00040-REB, Dkt No. 32 (D. Id. Feb. 19, 2019)

April 18, 2019

Georgia Governor Signs Medical Cannabis Cultivation Bill Into Law

By Aaron G. Biros

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On Wednesday, April 17, Georgia Governor Brian Kemp signed HB 324 into law, closing a loophole that has been around for years, which prevented the cultivation of cannabis in-state. Before the signing of this bill, possession of medical cannabis was technically legal, but the cultivation of it was still illegal under state law, preventing legal patient access entirely.

Georgia Gov. Brian Kemp
Image: Georgia National Guard, Flickr

Back in 2015, Georgia’s legislature legalized medical cannabis with less than 5% THC, as well as CBD oil for a number of qualifying conditions. Since then, the state has added more qualifying conditions such as chronic pain and PTSD, bringing the total to sixteen types of illnesses that would qualify patients for medical cannabis.

Governor Kemp signing HB 324 into law sets in motion the process to establish a regulatory framework for six growing licenses in the state. According to WSB-TV Atlanta, the new law goes into effect on July 1, but it could take up to two years to establish legitimate cultivation operations in the state. The law gives a state commission the authority to investigate and establish the regulations further.

That state commission will give priority to pharmacies for distributing cannabis, but reserves the right to establish licenses for independent retail locations as well. According to ABCNews, “The commission can also attempt to legally obtain the oil from other states. Two universities will be allowed to seek federal approval to research and produce the oil.”

April 18, 2019

Federal Funding Is Flowing To Canada’s Cannabis Production

By Marguerite Arnold

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The Canadian federal government is going where the U.S. (for now) is not: namely allowing provinces to channel federal agricultural funds into commercial cannabis production on the provincial level. The program is called the Canadian Agricultural Partnership (or CAP), which is a $2.2 billion annual initiative designed to support agricultural businesses across the country.

So far, not every province has opened this funding to cannabis production, although British Columbia already has, and Alberta is currently considering it.

Even more intriguing of course, are other programs that tie into such agricultural subsidies (including government support for exporting product). See Europe for one.

These programs are of course nothing new, including in the United States.

What is new, different and intriguing, is that unlike the United States, for the first time such government funds are being used to support not only the domestic cultivation of cannabis, but its global export. If there ever was the beginning of a “green new deal” then this might be it.

Canadian companies are certainly seeming to benefit from this federal largesse at the production point. For example, in the first weeks of April, CannTrust Holdings Inc. announced that its entire 450,000 square foot, perpetual harvest facility in Pelham, Ontario is fully licensed and will be online by summer 2019. THC BioMed just announced that it received Health Canada’s permission to begin additional production at its flagship location in Kelowna, B.C. And Beleave has just commenced sales of cannabis oil products at licensed facilities in Hamilton, Ontario.

The Rise of Government Funding In a “Publicly Owned” Company Environment

One of the more intriguing impacts of the rise of government funding for the industry comes at a time when the industry itself, certainly coming out of Canada, is facing a bit of a zeitgeist moment.

Sure, the industry has gained legitimacy, and there might be nascent cannabis funds in the UK, Switzerland and Germany, but the entire “public cannabis company” discussion is hitting a bit of a reset at the moment.

It was after all, ostensibly “public” Wayland that just dusted much higher fliers from the stock price perspective on winning the German cultivation bid. In fact, some insiders on the ground have commented that it is precisely because Wayland is not a stock market favorite, rather focused on fundamentals that they got chosen in the first place. Starting with the old-fashioned idea of committing resources and elbow grease to create production on the ground, locally.

There are also firms who are benefitting from the first tax funds that have flowed to promote the hemp industry (those are available from state governments here).

However, it is not just Germany where this discussion is going on in Europe right now. In Spain, there is political discussion about ensuring that the nascent and valuable cannabis industry does not end up in the control of “outsiders.” Namely international firms who have more of an eye on profit than community building. The idea of the cannabis industry as an economic development tool has certainly caught on in Europe (see Greece and Macedonia). And core in that idea is that the euros generated by this still remarkably price-resilient plant, and the products produced from it, should stay local.

Cannabis Socialism?

For now, and certainly in Canada, federal public funding looks pretty much like a fancy agricultural grant. But in the future as prices drop and the wars over strains and “medical” vs. “recreational” really begin to rage in Europe, the idea of government-funded cannabis cultivation may be an idea whose time has come.

The German automobile industry, for example, did not come from nowhere – and even today receives massive government funding. For now, certainly in Deutschland, that is not the case with cannabis, but things may be changing with the resolution of the first tender bid.

In the future, in other words, as countries across Europe begin to think about posting their own production bids and Germany contemplates additional ones, government funding of the industry and certainly incentives to help its growth will become much more widespread.

April 16, 2019

First Lab Authorized for Cannabis Testing in North Dakota

By Aaron G. Biros

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According to a press release published on April 3, Keystone State Testing (doing business as Dakota State Testing) became the first laboratory authorized to test cannabis in North Dakota. The lab also obtained their ISO 17025 accreditation for cannabis testing from the American Association of Laboratory Accreditation (A2LA), which is another first achievement for cannabis testing in the state of North Dakota.

Dr. Kelly Greenland, chief science officer at Keystone State Testing, says the North Dakota Department of Health set a high standard for the cannabis lab testing industry in the state. “Keystone State Testing is once again proud to of this monumental achievement and critical milestone in the company’s history to have met the highest levels of standards set forth by both A2LA and the North Dakota Department of Health,” says Greenland. “Keystone chose A2LA as its Accreditation Body due to their reputation in the industry, their diverse clientele, and the quality of their assessors. A2LA’s assessors have spent decades in their respective fields, which helps to ensure that Keystone is providing the best services possible to their clients, regulators and patients.”

Keystone State Testing’s ISO 17025 accreditation scope covers 11 testing methods at their facility in Fargo, North Dakota. Those methods include: Cannabinoid potency analysis, cannabinoid profile, moisture content, residual solvents, water activity, along with microbiological tests like total yeast and mold count, E. coli, Salmonella, total aerobic microbial count, among others.

April 16, 2019

Water Policy in California: Six Key Takeaways from the State Water Board’s New Cannabis Cultivation Policy

By Amy Steinfeld

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Cannabis is the most highly regulated crop in California, and the state just added another layer of regulation. This article breaks down the State Water Resources Control Board’s (SWRCB) recently updated Cannabis Cultivation Policy – Principles and Guidelines for Cannabis Cultivation (“Policy”) into six key takeaways.¹ These guidelines impose new rules on cannabis cultivation activities that have the potential to impact a watercourse (stream, creek, river or lake). Most of these rules apply to cultivation of sun-grown cannabis, which is currently allowed in some form in 12 counties. Compliance with these new requirements will be implemented through the CalCannabis Cultivation Licensing Program.

When developing farmland, hillsides should be avoided and erosion must be controlled.

The Policy provides specific rules for growing pot on undisturbed land. To prevent erosion, numerous limitations are placed on earthmoving and activities in sensitive areas, and cultivators are not allowed to grade hillsides that exceed a 50% slope.²

Cultivation prepping activities must minimize grading, dust, soil disturbance, erosion, and impacts on habitat, especially during the winter season.³ No vehicles or heavy equipment may be used within a riparian setback⁴ or watercourse,⁵ and cultivators must avoid damaging native riparian vegetation⁶ and oak woodlands.⁷ All farm equipment, fuel, and hazardous materials must be carefully stored away from creeks and sensitive habitat.⁸ The Policy also governs road construction.⁹

Cultivators should avoid work in or near a surface waterbody.¹⁰

If a cultivator’s activities impact a river, stream, or lake, they must consult with the California Department of Fish and Wildlife (CDFW).¹¹ Cultivators must maintain minimum riparian setbacks for all cannabis activities, including grading and ancillary farm facilities. Before grading land, a biologist must identify any sensitive flora or fauna, and if any is located, consult with CDFW and provide a report to the Regional Board.¹² No irrigation runoff, tailwater, chemicals or plant waste can be discharged to a waterbody.¹³ Diversion facilities for the irrigation of cannabis may not block fish passage, upstream or downstream, and must be fitted with a CDFW-approved fish screen; new facilities are subject to all applicable permits and approvals.

During the dry season, cultivators may not use surface water.

The use of surface water supplies in California requires a valid water right and the use of water for cannabis cultivation is no different.¹⁴ Anyone seeking to appropriate “water flowing in a known and defined channel” or from a watercourse must apply to the SWRCB and obtain a permit or license.¹⁵ Alternatively, a landowner whose property is adjacent to a watercourse may have a riparian right to divert the water for use on her land. Riparian users do not need permission from the SWRCB to divert water, but they must report water use annually.¹⁶

The biggest obstacle that growers face under this Policy is that they cannot divert anysurface water during the dry season—the growing season (April 1 through Oct. 31). It should be noted:

The seasonal prohibition of surface water diversion applies regardless of the nature of the water right or what has been historically used to irrigate other crops.
During the dry period, cultivators may only irrigate using stored water (see no. 5 below) or groundwater.
It remains to be seen whether a legal challenge will be brought against the state for their draconian prohibitions on irrigating cannabis during the six-month growing season. Because this prohibition applies to all watersheds in California, singles out one low-water use crop, and ignores established water rights, it is overly broad and may constitute a constitutional “taking” of property rights.

During the wet season, surface water diversions must be monitored closely.

Cannabis-specific restrictions also apply during the wet season. From Nov. 1 to March 31, cultivators must comply with instream flow requirements and check in with the state daily. All surface water diversions for cannabis are subject to “Numeric and Narrative Instream Flow Requirements,” to protect flows needed for fish migration and spawning. To ensure diversions do not adversely impact fish flows, cultivators must also “maintain a minimum bypass of at least 50% of the streamflow.”^17,18

While valid appropriative right holders may divert more than 10 gal./min. for cannabis irrigation during the wet season, riparian right holders are not allowed to exceed that diversion rate.¹⁹ All cultivators (including small diverters <10 acre-feet (“AF”)/yr) are required to employ water-saving irrigation methods, install measuring devices to track diversions daily, and maintain records on-site for at least five years.²⁰ Cultivators must inspect and repair their water delivery system for leaks monthly,²¹and inspect sprinklers and mainlines weekly to prevent runoff.²²

Cannabis cultivators may obtain a new water storage right for use during the dry season.

To address dry season irrigation limitations, cultivators are urged to store water offstream during the wet season, including rainwater, for dry season use. Growers may not rely on onstreamstorage reservoirs, except if they have an existing permitted reservoir in place prior to Oct. 31, 2017.²³ Alternatively, small growers (storage is capped at 6.6 AF/yr) may benefit from the new Cannabis SIUR Program, an expedited process for cultivators who divert from a surface water source to develop and install storage offstream. Only diverters with a valid water right that allows for diversion to storage between Nov. 1 and March 31 qualify.

Groundwater is less regulated, but cultivators should avoid drilling or using wells near waterbodies.

Groundwater is generally the recommended water supply for cannabis because, unlike surface water, it may be used during the dry season and is not subject to many of the restrictions listed above. It should be noted however:

Many groundwater basins are now governed by California’s Sustainable Groundwater Management Act (“SGMA”), which requires water agencies to halt overdraft and restore balanced levels of groundwater pumping from certain basins. Thus, SGMA may result in future pumping cutbacks or pumping assessments.
In some counties, moratoriums and restrictions on drilling new wells are on the rise.
Under this Policy, the state may step in to restrict groundwater pumping in the dry season in watersheds where there are large numbers of cannabis groundwater, wells located close to streams, and areas of high surface water-groundwater connectivity.²⁴

In short, groundwater pumpers are at risk of cutback if the state deems it necessary to maintain nearby creek flows.Noncompliance can bring lofty fines, revocation of a grower’s cultivation license, or prosecution

Final Takeaways

This cannabis policy presents one of California’s most complex regulatory schemes to date. Before investing in a property, one must understand this Policy and have a robust understanding of the water rights and hydrology associated with the cultivation site. Growers looking to reduce permitting time and costs should invest in relatively flat, historically cultivated land with existing wells and ample groundwater supplies, or alternatively, grow indoors.

This article attempts to synthesize the maze of water supply and water quality regulations that make compliance exceedingly difficult; more detailed information can be found here. Noncompliance can bring lofty fines, revocation of a grower’s cultivation license, or prosecution. Growers are encouraged to contact a hydrologist and water lawyer before making major investments and to designate a water compliance officer to monitor and track all water diversions and water used for irrigation. Growers should also consult with their local jurisdiction regarding water use restrictions and stream setbacks before moving any dirt or planting cannabis.

References

The Policy is available at: https://www.waterboards.ca.gov/water_issues/programs/cannabis/cannabis_policy.html (will go into effect on or before April 16, 2019.)
Policy, Appendix A, Section 2, Term 4. The Policy defines “Qualified Professional” as a: California-Licensed Professional Geologist, including Certified Hydrogeologist and Certified Engineering Geologist, California-Licensed Geotechnical Engineer, and Professional Hydrologist. (Policy, Definition 72, p. 11.)
Policy, Appendix A, Section 2, Terms 4 and 10.
Policy, Appendix A, Section 2, Term 3.
Policy, Appendix A, Section 2, Term 40.
Policy, Appendix A, Section 2, Term 33.
Policy, Appendix A, Section 2, Term 34.
Policy, Appendix A, Section 2, Term 7.
Policy, Appendix A, Section 2, Terms 15 to 29.
Policy, Appendix A, Section 1, Term No. 41.
Policy, Appendix A, Section 1, Term No. 3; see also 1602.
Policy, Appendix A, Section 1, Term No. 10.
Policy, Appendix A, Section 1, Term No. 326.
Policy, Appendix A, Section 2, Term 69.
Wat. Code §1225; See alsoWat. Code §1201 [providing that the state shall have jurisdiction over, “[a]ll water flowing in any natural channel” except water that is appropriated or being used for beneficial purpose upon land riparian to the channel.”]
Wat. Code §§ 5100–02.
Policy, p. 12.
Policy, Attachment A, pp. 60, 63.
Policy, Section 2, Term 78.
Policy, Section 2, Term 82.
Policy, Section 2, Term 95.
Policy, Section 2, Term 99.
Policy, Section 2, Term 79.
Policy, p. 11.

April 15, 2019

Taxes & Cannabis: 280E, R&D Credits, 199A & Qualified Opportunity Funds: Part 2

By Zachary Gordon, Jason Hoffman

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Editor’s Note: This is the second piece in a two-part series delving into tax issues. Part one discussed tax code 280E as it pertains to cannabis businesses. Part two will go into research and development credits, 199A and a discussion of risk as it relates to Qualified Opportunity Zones.

While 280E is the most influential code section for the cannabis industry, structuring never happens in a vacuum. There are many open questions that each business must answer for themselves without court adjudication. We believe that among the riskiest of questions is whether a cannabis business can claim research and development credits.

There is no clear legal authority that either allows these credits or disallows them but certainly utilizing such credits comes at great risk. At the beginning of this article we talked about Congress and the purpose of 280E. Congress’s intention was to make sure that only the minimum required tax deductions were available to Schedule 1 and 2 sellers. A cannabis business receiving a research and development credit would not be with the intension of Congress. While the credits would be computed based on COGS expenditures, at this time we do not believe that a cannabis business should take this credit. Disallowance of COGS would create a constitutional challenge which is why Congress allowed the COGS deduction. Disallowance of Research and Development Credits does not open up the same constitutional issue since the credit is not part of COGS although calculated based on COGS expenditures. 280E states very clearly that credits arising from other code sections are disallowed in the entirety.

More recently the Tax Cut and Jobs Act (TCJA) opened up new issues for cannabis companies that are still unfolding. Two of the most publicized are Qualified Opportunity Funds and Section 199A, the 20% deduction (Qualified Business Deduction).

The 199A deduction allows eligible pass-through entities to claim an additional deduction of 20% of the income (subject to certain limitations) at the individual level potentially lowering the tax rate from 37% to 29.6%. While the American Institute of Certified Public Accountants (AICPA) and others have asked the IRS to clarify if 280E would make a cannabis business ineligible, the final regulations on the subject did not address this issue. There are other significant limitations and hurdles in 199A regulations that any business would have to first pass to be considered for the rate deduction. If a cannabis business meets all other eligibility and limitation criteria, should the pass-through income to their investors be qualified income under 199A? The answer will depend on whether the courts will treat this “deduction” as falling under the general prohibition of 280E.

We believe that there is a reasonable chance that the courts will allow the 199A deduction for cannabis companies. That does not mean, however, that we advise cannabis companies to claim this on their pass-through returns as Qualified Business Income. Much like everything else, it depends on the particular business and the risk profile that management is willing to tolerate. This is one area of tax law that is sure to be challenged in court. The more risk-averse business should pass on claiming this deduction on their returns, but monitor development with an eye to amending at a later date if favorable precedent emerges. If the amounts are large enough, consideration should be given to applying for a Private Letter Ruling, but that also has its own tax risks.

Another new tax incentive that was in the TCJA was Section 1400Z or Qualified Opportunity Zones (QOZ). The incentive allows for the deferral of capital gains until December of 2026. The use of 1400Z also results in up to a 15% decrease in capital gains tax- and tax-free appreciation if all requirements are met. While the IRS has only released proposed regulations and we anticipate significant changes to them when they are released as final, there was nothing in the proposed regulations limiting cannabis businesses from using Qualified Opportunity Funds (QOF) in their structure. It is interesting to note that the TCJA and proposed regulations did list other types of businesses that could not make investments under 1400Z along with all its benefits. Liquor stores, golf courses and sun tan parlors were among those listed but cannabis growers and dispensaries were not.

As the industry continues to mature, new issues and precedents will require CPAs and attorneys to find new solutions to best serve the industry.Using Opportunity Zones to entice investors sounds like a great opportunity, but there are significant risks. The first risk is that the proposed regulations, while currently proposed, may not be final. There is always a chance that the IRS will take a different position when the final regulations are released and add cannabis to the type of businesses that do not qualify. Another risk, and one that was previously mentioned as part of 199A and other areas of structuring, is that the IRS and the courts can always disagree with the taxpayer’s position. This is a new area of tax law and will eventually be litigated. The loss of the Opportunity Zone benefits can significantly change the return to the investors and lead to other issues.

All of these issues come into play when structuring businesses in this industry. These issues must be evaluated as they pertain to the business needs. This can be very complex and requires a great deal of research for each business opportunity. We have found that professionals operating in this industry like to know about all of their options. The most important thing we can do for the industry is to continue to educate the professionals working in it.

Accountants should be available to assist their clients and their clients’ attorneys with structuring techniques aimed at asset protection and minimizing 280E disallowances. Accountants should also be ready to speak to the questions outlined above and be prepared to explain the risks associated with each choice. As the industry continues to mature, new issues and precedents will require CPAs and attorneys to find new solutions to best serve the industry.