Tag Archives: United States

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Israeli Cannabis Brand Tikun Olam Expands to US

By Aaron G. Biros
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Tikun Olam is a Jewish concept that addresses social policy, promoting acts of kindness to better society. In Hebrew, it literally means, “repair of the world.” The company by the same name, Tikun Olam Ltd, and now in the United States as T.O. Global LLC, was the first medical cannabis provider in Israel back in 2007. Working with patients, doctors and nurses in clinical trials, they developed 16 strains over the last decade that target alleviating symptoms of specific ailments.

Tel Aviv, Israel, where Tikun Olam has a dispensary

In November 2016, they launched their United States brand, Tikun, in the Delaware medical cannabis program with their partner, First State Compassion Center, a vertically integrated business of cultivation, extraction and retail in Wilmington. After the success of their pilot program, Tikun announced their expansion into the Nevada market with their licensed partner, CW Nevada LLC. Tikun is leveraging its experience with clinical trials and medical research to launch a line of cannabis products focused on health and wellness in the United States. According to Stephan Gardner, chief marketing officer at Tikun Olam, they have the largest collection of medical cannabis data in the world. “Tikun Olam started out as a non-profit, working to bring medication to patients in Israel,” says Gardner. “Opening nursing clinics gave us a tremendous amount of knowledge and data to work on the efficacy of strains developed specifically for targeting symptoms associated with certain conditions.” For example, their strain, Avidekel, was developed years ago as the first high-CBD strain ever created.

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The strain Avidekel being grown in Israel.

In a single-strain extraction, Avidekel has been used to successfully mitigate the symptoms associated with neurological conditions, like epilepsy in children, and they have the data to demonstrate that efficacy. “The American market needs some sort of guidance on how these cannabinoid and terpene profiles in certain strains can truly assist patients,” says Gardner. “We have been tracking and monitoring our patients with clinical and observational data in one, six month and annual follow ups, which are data we can use to guide the needs in the US.”

Their expansion strategy focuses heavily on the health benefits of their strains, not necessarily targeting the recreational market. “As a wellness brand in Nevada, we are positioned to work first and foremost in the medical market,” says Gardner. “Our wellness brand can cater to people looking for homeopathic remedies for things like inflammation issues, sleep disorders or pain relief for example,” says Gardner. “You will not see us going out there catering to the truly recreational market; the benefits of what our strains can do is marketed from a wellness perspective.” A cannabis product with high-THC percentages is not unique, says Gardner, but their approach using the entourage effect and proven delivery mechanisms is. “While higher THC might appeal to the rec market, that is not exactly how we will promote and position ourselves,” says Gardner. “We want to be a dominant force in the wellness market.”

Best practices include quality control protocols

That effort requires working within the US regulatory framework, which can be quite complicated compared to their experience in Israel. “We have to understand the Israeli market and American market are completely different due to the regulatory regimes each country has in place,” says Gardner. “We understand the efficacy of these products and want to educate customers on how they might benefit. We don’t want to make claims looking to cure anything, but we found in our data that a lot of symptoms in different ailments, like cancer, PTSD, Crohn’s disease, colitis and IBS, can be alleviated by strains we developed.” In addition to the medical research, they are bringing their intellectual property, cultivation methodologies, evidence-based scientific collaboration and best practices to their partners in the US.

So for Tikun’s expansion in the US, they want to get a medical dialogue going. “We will launch a fully accredited AMA [American Medical Association] program, educating medical practitioners, giving the doctors the understanding of the capabilities of cannabis and what our strains can do,” says Gardner. “We will also share our observational data with doctors so they can work to better guide their patients.” Right now, they are working on the education platform in their pilot program in Delaware. “We plan on using that as a platform to expand into other markets like Nevada,” says Gardner. “And we will be launching the Tikun brand in the Washington market this summer.” Based on the high demand they saw in the Delaware market, Gardner says they plan to launch six unique strains in the American market, with delivery mechanisms like vape products, tinctures, lozenges and topicals in addition to dried flower.

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Rows of cannabis plants drying and curing before processing.

While Tikun expands throughout the United States, their sights are set on global expansion, living up to the true meaning of the concept Tikun Olam. They entered a strategic partnership with a licensed producer based in Toronto, bringing their strains, including Avidekel, to the Canadian market. The company they are partnering with, MedReleaf, recently filed for an initial public offering (IPO) on the Toronto stock exchange. Tikun Olam is actively seeking to expand in other parts of the world as well.

Biros' Blog

Trump’s Cabinet Not Cannabis-Friendly, But Don’t Panic Yet

By Aaron G. Biros
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President-elect Donald Trump nominated Sen. Jeff Sessions from Alabama for Attorney General and Rep. Tom Price from Georgia as the new Health Secretary. Those appointments still require Senate approval before they are officially members of the cabinet. Neither of the picks to head the Department of Justice (DoJ) and the Department of Health & Human Services (HHS) is friendly to cannabis.

What’s the bad news?

Both of those agencies are at the center of any federal regulation of cannabis, including access for research. As Attorney General, Jeff Sessions would essentially have the ability to block any rescheduling efforts, as outlined in the Controlled Substances Act.

Gage Skidmore, Flickr
Sen. Jeff Sessions, (R), 69.          Photo: Gage Skidmore, Flickr

Sessions has made inflammatory, racist remarks and showed his disdain for cannabis users on multiple occasions. He disgracefully said at a Senate hearing in April, “Good people don’t smoke marijuana.” When he was a federal prosecutor, Sessions was a prominent advocate for the War on Drugs, and perhaps even still is.

Rep. Tom Price (R-GA) Photo: Gage Skidmore, Flickr
Rep. Tom Price (R-GA)
Photo: Gage Skidmore, Flickr

Tom Price, a Republican Congressman from Georgia, has voted repeatedly against pro-cannabis legalization bills, including twice against the Veterans Equal Access Amendment as well as the Rohrabacher/Farr Amendment, which “prohibits the use of funds in the bill to supersede State law in those States that have legalized the use of medical marijuana.” NORML’s Georgia Scorecard gave Tom Price a D grade for his previously voting against pro-cannabis bills.

What’s the good news?

While Sen. Jeff Sessions is certainly no friend to legal cannabis, I believe he is not a serious danger to the cannabis industry. This op-ed on CNN does a terrific job at summing up Sessions’ potential threat to the cannabis industry, but also why it may not be cause for a total panic. The author mentions a laundry list of DoJ priorities over cannabis, but I think the larger issue at hand is states’ rights.

Republicans are historically passionate when it comes to keeping states’ rights sovereign. With cannabis’ big wins on Election Day, a majority of the country’s population now lives in states where cannabis is legal.

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Aaron Smith, executive director of NCIA

There is too much momentum behind legal cannabis for a new administration to waste precious resources and time on trying to disrupt it. States are getting too much tax revenue from regulating cannabis to just let the DoJ interfere with their economies. “Voters in 28 states have chosen programs that shift cannabis from the criminal market to highly regulated, tax-paying businesses,” says Aaron Smith, executive director of the National Cannabis Industry Association (NCIA). “Senator Sessions has long advocated for state sovereignty, and we look forward to working with him to ensure that states’ rights and voter choices on cannabis are respected.” Smith’s words in the NCIA statement are pointed and clear: this is a states’ rights issue at heart and they must respect that.

By forcing the states’ rights issue to the front, it is possible to put legal cannabis in a bipartisan lens, thus eliminating the possibility of a few old drug war stalwarts disrupting the industry. While rescheduling efforts could be thwarted for the coming years, I have faith that the federal government will not interfere with states that legalize cannabis.

 

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Biros' Blog

Election Day is a Decisive Moment for the Cannabis Industry

By Aaron G. Biros
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In less than two weeks on November 8th, voters in five states will head to the polls to decide if they want to legalize recreational cannabis. California, Nevada, Arizona, Massachusetts and Maine all have initiatives on the ballot that could legalize recreational cannabis for adult use. Polls in each state show a majority of voters support the initiatives.

This New York Times article suggests that November 8th could be a major turning point in the movement to legalize cannabis in the United States. Even if the initiatives fail in most of those states, California’s initiative, which is expected to pass, could be the linchpin for federal legalization. California’s giant economy, coupled with its ability to drive national policy on social issues, sets the stage for rapid industry growth.

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Matt Karnes, founder of GreenWave Advisors

According to Matt Karnes, founder of GreenWave Advisors, the significance of California’s measure also lies in the merging of medical and recreational regulatory schemes. His firm sees a trend where “initially bifurcated marijuana markets will merge under a shared regulatory system into substantially larger enterprises.” Karnes believes the California market will conservatively reach $2.6B in 2016 and grow to $6.7B by 2021, which represents a 5-year compound annual growth rate of roughly 21%. “Should California vote to legalize recreational use this November, we expect implementation of a combined regulated market as soon as 2018,” says Karnes. “A combined California market is significant, not only because of its sheer size (~55% of the U.S. market), but it would also mark the first state to implement regulations for a fully legal market without initial oversight of medical use purchases.”

The presidential election is equally as important for the future of the legal cannabis industry. According to Hillary Clinton’s campaign, if she is elected into office then she will “reschedule marijuana from a Schedule I to a Schedule II substance.” This would have a dramatic impact on the growth of the industry, most notably by easing banking and financing restrictions. Whether she will actually follow through with her plans, if elected, to reschedule cannabis is yet to be known. Regardless, this is the first time in history that a candidate with a majority of the country’s support is introducing this concept. That represents a serious shift in mainstream attitude toward cannabis. That represents the normalization of cannabis.

Jane West, CEO of lifestyle brand Jane West and co-founder of Women Grow
Jane West, CEO of lifestyle brand Jane West and co-founder of Women Grow

Jane West, chief executive officer of the lifestyle brand Jane West and co-founder of Women Grow, believes this represents the country finally taking cannabis legalization seriously. “Given the poll results that have been publicly available, it seems likely that three or more of the initiatives will pass,” says West. “By November, about 20% of Americans will be living in states where it is legal to consume cannabis. This will accelerate the process of bringing marijuana out of the shadows, and more adults will be comfortable using this enjoyable, relatively benign substance socially and openly.” Normalizing cannabis can look like a lot of things, but mainly it takes away the counterculture stigma and puts it in a light where its regular use is not frowned upon, which could be instrumental in gaining public support.

Leah Heise, CEO of Women Grow
Leah Heise, CEO of Women Grow

Leah Heise, chief executive officer of Women Grow, agrees with West’s prediction that at least three of those states will vote to legalize recreational cannabis, citing Maine, Massachusetts and California as favorites. “Additionally, with the likelihood that more than half the states in the United States support some type of cannabis program within their boundaries, a clear message is being sent to the federal government regarding legalization on a federal level,” says Heise. “I don’t think the federal government will be able to continue to enact its cannabis policy through executive orders and funding bills. Real legislative attention will have to be given to the issue.” That legislative attention could come in the form of the CARERS Act, which would reschedule cannabis.

If you are in favor of legalizing cannabis and want to see some change within your lifetime, what can you do to help? Vote. There has never been a more important election year for legal cannabis.

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Quality From Canada

The Great Green North: Canada vs. US in Cannabis Regulations

By Tegan Adams
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A lot has been changing quickly in the world of cannabis across North America. While international drug treaties sit back and watch in horror, cannabis and cannabis-infused products have been popping up in households across Canada, on retail shelves and in private delivery services across the US. How each jurisdiction in North America accepts and regulates (or draws a blind eye) to the sale of cannabis is different depending on where you are located. Here are a few key distinctions between the current Canadian and US regulatory approaches to marijuana.

In Canada, cannabis is regulated at the federal level by Health Canada through the Marihuana for Medical Purposes Regulations, (MMPR). The MMPR allows persons to obtain dried cannabis for their own personal medical purposes or for another person for whom they are responsible. To obtain dried cannabis, a person must obtain a medical document from a physician, or nurse practitioner to register as a client with a licensed producer of their choosing. After registering as a client, they are able to order dried cannabis and possess up to a maximum of 150 grams at any one time, depending on the recommendation of their physician. More recently, in 2015, regulations allow the distribution of not only the dried form of cannabis but also their extracted forms.

In the US, at the federal level, cannabis is still 100% illegal. Public statements from the federal administration dictate that they steadfastly oppose legalization of cannabis and other drugs. They are concerned that legalization would increase the availability and use of illicit drugs, and pose significant health and safety risks to all Americans, particularly young people. At the state level, legalization laws are rapidly changing. The office of National Drug Control Policy lists 23 states (a rising number) and Washington DC that have passed laws allowing cannabis to be smoked for a variety of medical conditions. The state laws do not change federal regulation. Many local governments are creating zoning and other restrictions that prohibit dispensaries from operating in their communities. That being said, voters in Alaska, Colorado, Oregon and Washington state support legalizing the sale and distribution of cannabis to adults over 21. There are many differences in the regulation of marijuana within each state, municipality and within the country itself.

Internationally, Canada has a platinum reputation for delivering and regulating quality consumer products. Within the Canadian cannabis industry, many feel Health Canada’s regulatory regime is inaccessible, restricts production to large corporations and limits distribution channels. The average start up cost of even a small licensed facility is around $4-5M CAD. On top of the financial costs, production companies have to compete with the other 2000 or so applicants who have been waiting, in some cases up to two years, to hear back from Health Canada if they will succeed in the licencing application process. In response, Canada has seen many tolerances made to allow dispensaries to distribute marijuana at the municipal level, even though not allowed as per regulation.

Many Canadian dispensaries operate with professional policies and procedures including providing customers with access ID cards and offering physician consults. Vancouver became the first city in Canada to license and regulate marijuana dispensaries. The number of licenses within the city exceeds both Tim Hortons and Starbucks Franchises combined. Many dispensaries provide bar and café settings for people to enjoy a “bong shot” or café au lait infused with cannabis. Licensing dispensaries has become a great financial resource for the city, charging $30,000 CAD per licence. Vancouver’s dispensaries have been a topic of debate across all levels of government. The Health Minister asked Vancouver to shut the dispensaries down, while other municipalities have started to expand the same concept. The Royal Canadian Mounted Police (RCMP), Canada’s federal police force, has started raiding various dispensary locations. Part of the new Prime Minister, Justin Trudeau’s, political platform and claim to fame is to legalize cannabis recreationally across Canada. How the framework will unfold is still in the works and subject not only to local jurisdictional reform but also to international negotiations.


 

Editor’s Note: Eurofins-Experchem has helped submit over 150 MMPR applications to Health Canada and continues to work with 10 of the 27 licensed MMPR producers in Canada. Their regulatory affairs division has started working with companies applying to produce and distribute cannabis in those states, which are new to its sale and distribution. They offer services include writing SOPs, training staff and performing mock inspection audits.