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FDA Issues Update on CBD: Still Working, Still Waiting

By Aaron G. Biros
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On March 5, 2020, the U.S. Food and Drug Administration (FDA) issued a press release to the public about their work on devising a regulatory framework for cannabidiol (CBD) products. The FDA also submitted a report to Congress on their rulemaking progress.

The main theme of the report is the same story we’ve been hearing from the FDA for a while now: They are still working on figuring out how to regulate CBD products and wants to do more research before they tackle the rulemaking.

The most intriguing new development from this report is the FDA’s newfound interest in regulating CBD products like dietary supplements:

“FDA is actively considering potential pathways for certain CBD products to be marketed as dietary supplements. Under current law, CBD products cannot lawfully be marketed as dietary supplements, but FDA has the authority to create an exemption through notice-and-comment rulemaking that would allow products containing CBD to be sold legally as dietary supplements.”

If you’ve been living under a rock for the past couple years, here’s a recap: In June of 2018, the FDA approved GW Pharma’s drug, Epidiolex, for the treatment of rare forms of epilepsy. This allowed a drug containing CBD to go to market, but only through the agency’s drug approval process. When the 2018 Farm Bill (Agricultural Improvement Act of 2018) was signed into law in December later that year, the federal government removed cannabis (hemp) with less than 0.3% THC from the Controlled Substances Act, essentially legalizing it on a federal level. Congress tasked the FDA with figuring out how to regulate the market. Without any FDA guidance in the early days, the subsequent market growth created mass confusion for the industry and consumers alike, with no one really knowing if selling CBD products is legal or not. In May of 2019, the agency held a comment period and public hearing on CBD, which included a lot of discussion around the benefits, the risks and further research on CBD. Throughout 2019, the FDA sent a large number of warning letters to companies marketing CBD products with unsubstantiated health claims. Towards the end of 2019, Congress passed a bill mandating that the FDA update them on their progress to regulate the market within 60 days. That deadline came and went, and then the FDA issued the public update and submitted the report mentioned above to Congress last week. FDAlogo

The FDA says they intend to take a number of steps towards providing some market clarity, while still protecting the public from unknown risks. Firstly, they want to educate the public more about potential risks associated with CBD. “We remain focused on educating the public about the number of questions that remain regarding CBD’s safety,” reads the update. “There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.” Those concerns mentioned above include potential liver injury, drug interactions, reproductive toxicity and more benign side effects like drowsiness.

The agency also wants to try and close knowledge gaps in the areas of safety and potential benefits. In this section of the update, the agency asks industry stakeholders for help. “We’re seeking reliable and high-quality data.” The agency is requesting data on sedative effects, impacts of long-term use, pharmacokinetics, safety of various drug delivery mechanisms, safety for animals, different processes for full or broad spectrum or isolate derivation, among other areas of interest. They plan to re-open the public docket from the public hearing back in May 2019, extending the comment period indefinitely as a tool for stakeholders to share information with the FDA.

As far as enforcement actions go, the agency wants to take a risk-based approach to it. While there is still no official enforcement policy, the FDA is working on it. Their biggest concern is with companies marketing CBD products using drug and health claims, which could “deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life.” The agency is also worried about potential contamination risk and consumer exposure to things like residual solvents and heavy metals. Their last concern in this area involves truth in labeling, like making false label claims, not listing every ingredient or incorrectly stating the amount of cannabinoids in the product.

“Our ongoing efforts related to CBD, including the steps we’re announcing today, are in line with our mission to protect the public, foster innovation and promote consumer confidence. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products. We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards.”

Overall, the public update and the report don’t disclose anything groundbreaking. They do, however, provide some much-needed guidance for the CBD market on how stakeholders can help the FDA’s efforts. The fact that they are investigating dietary supplements as a path toward a regulatory framework is the by far the biggest take away from all this.

Greece Gets Growing

By Marguerite Arnold
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The Greek government changed the law on medical cannabis as recently as February of this year. Now it has issued its first cultivation license.

Who Is The First Beneficiary?

The lucky (first but far from last) firm to receive a cultivation license? Intriguingly, a South American-Canadian cultivation company called ICC Cannabis Corp.

The most recent agreement received from the Greek government supersedes and augments its previous hemp cultivation license in the country. The license, however is not final yet but rather a conditional pre-approval for medical cannabis cultivation.Things in Greece are proceeding fast with no internal or external opposition.

The company already has secured a 16 acre grow facility in Northern Greece. ICC also has a distribution network of over 35,000 pharmacies spread across 16 countries which it says will “complement” its current Greek victory.

ICC will pay USD $200,000 in connection with the license issuance, pay a finder’s fee and issue 12 million shares.

Company executives are quick to point out that the success is a result of staff cultivating close relationships with local politicians.

The ICC of course is not the only company now engaged in solidifying their business opportunities in Greece. Hexo, a Canadian LP with about a million feet of grow space at home by end of 2018, in partnership with local Greek QNBS, is also rapidly moving to establish a 350,000 square foot growing facility in country as well. With a similar eye, it should be added on the European medical market.

European Legal Cultivation Is Exploding

Medical cultivation, in other words, is getting underway regionally, with authority. And the bulk of such crops not consumed locally, are already being primed for export to more expensive labour markets across the continent with increasing demand for high quality, low cost, medical grade.

Not only is this procedural development fast and relatively efficient, it sets up a serious competitor within the EU to provide cheap flower, oil and other processed cannabis products to a continent that is now starting to place bulk orders as individual countries struggle with the issue of how much local cultivation to allow and what patient conditions should be covered.

Even more interesting, at least so far, are a lack of punitive punishments being meted out to the country from the EU for considering this economic route to self-sufficiency again. That is not true for Albania, in direct contrast, which is being penalized with its membership to the Union on the line, for the level of black market cannabis grown in the country.

That said, it might also be the progress of Greek cultivation that has caused such a furore – led by France in Brussels within the EU. A country far behind regional leaders on reform it is worth noting. Even on medical.

A Quick History Of Cannabis Reform In Greece

Greek politicians decided fairly early as the cannabis ball got rolling in Europe that the industry was the perfect cash injection to an economy still emerging from troubled times and massive financial defaults. In fact, Greek officials are estimating that legalizing the medical industry here will inject approximately USD$2 billion into the country’s economy.

It could be, of course, much higher. Especially when exports are added to medical tourist consumption.

The amazing thing so far, for all the other issues in just about every other legalizing country within the EU of late? Things in Greece are proceeding fast with no internal or external opposition.

Who Is ICC?

The firm used to be known by the hard to pronounce Kaneh Bosm Bio Technology and Shogun Capital Corp. The firm has an interesting footprint with production in Uruguay but already exporting CBD and other derivatives to the Canadian market, including via a deal with Emblem Cannabis.

The company began trading on the TSX Venture exchange in November 2016. In late September, the company announced that it was also securing a 55-acre grow facility in Denmark, with other Canadian cannabis heavyweights like Canopy, Aurora and Green Dutchman Holdings.

Marguerite Arnold

Mainstream Media Picks Up On Cannabis

By Marguerite Arnold
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Marguerite Arnold

The British online newspaper, The Guardian, has just begun to cover cannabis. The regular feature, part of their “society” section, is clearly attempting to cover cannabis a bit more consistently and regularly as the California rec market begins to gain (legal) steam.

The writer now helmed to lead this effort is Alex Halperin, a business journalist in the U.S., who landed the gig apparently on the success of Weedweek – a highly cryptic weekly summary blog of mostly U.S.-based industry events and updates.How the Guardian will cover the industry and related issues will be interesting to follow.

This is also not The Guardian’s first foray into the topic. The media outlet, which got its start in the 1800’s in Northern England and expanded dramatically to reach a global digital audience over the past decade, has covered cannabis legalization on a fairly regular basis for the last four years. This new focus also comes at an interesting time. Apart from events in the U.S., Canada is moving forward with recreational this summer. And in Europe, the medical discussion continues apace. That said, it appears the Guardian is going to focus on the U.S. market, at least initially.

It will be interesting to see if that focus shifts (and if they allow other journalists outside of the U.S. to participate in the expanded coverage). While California might well be the largest state economy in general, the Canadian market is already larger and more developed, being regulated nationally across multiple provinces.

Another Mainstream Media Cannabis Column?

This is hardly news. The Guardian is actually treading on ground established already by most of the big news and business publications – including niche publications, blogs and of course, the trade press.

How the Guardian will cover the industry and related issues will be interesting to follow.

The purpose of the column apparently is to spark an “adult conversation” about cannabis – and how it is “changing modern life.” The initial focus on the U.S. market (and California in particular) may have seemed to make sense to a media outlet looking for outrageous stories. But as everyone knows, the U.S. is only one market – and further one still without federal protection.

However, the Guardian is also now competing with other business and mainstream publications that are already in this space. Main Street, the online business ‘zine helmed by Jim Cramer, created one of the first mainstream specialty cannabis sections almost four years ago with the coincidence of the Colorado rec market. Other notable publications and media outlets have significantly increased their coverage of cannabis as well. CNN has been reporting consistently on cannabis topics like legalization and U.S. federal reform efforts for some time now. Business Insider and Forbes have covered ongoing and growing investments and the financial side of things for several years. The Denver Post has its own entirely cannabis-focused subsidiary, The Cannabist.

And as public companies, in both the U.S. and elsewhere have begun to move through the legal thickets of legalization, business-focussed journals and blogs are even beginning to cover cannabis stocks. Starting with Motley Fool and Seeking Alpha (although again, most of this coverage is of companies outside the United States). Specialty publications are also of course, flourishing online, particularly with the beginning of an advertising market that is also beginning to establish itself, albeit around some still thorny regulatory issues.

In general, although the Guardian has a reputation as critical of the British monarchy, with strong left-leaning tendencies, its coverage of the industry has been fairly mainstream – so far at least.

Will that begin to change? And what will really be tackled and covered? And while the ostensible focus is what is going on in the world of cannabis in California (and presumably other foreign markets) could the Guardian’s ostensible new feature also be geared to drive reform at home? The U.K. has yet to even approach the topic of criminalization.