Documents play a key role in the world of regulations and global standards. Documents tell a story on programs development, implementation and verification during an inspection or audit. Documents are used as evidence to determine conformance to the law or standard. However, do you know what kind of documents may be reviewed during a regulatory inspection or a food safety audit? Are you prepared to show that the implementation of regulatory requirements or a standard is done efficiently at your facility?
Inspectors and auditors will look for compliance either to regulations or to a standard criterion. Regulations and standards require that documentation is controlled, secured and stored in an area where they cannot deteriorate. Therefore, writing a Document Management Program (DMP) will help a business owner ensure consistency in meeting this and other requirements.Radojka Barycki will host a a plenary session titled, “Cannabis: A Compliance Revolution” at the 2018 Food Safety Consortium | Learn More
A well-developed and implemented DMP provides control over documents by providing a number sequence and revision status to the document. In addition, ownership for development, review and distribution of the documents are assigned to specific individuals within the company to ensure that there are no inconsistencies in the program. Documents must also have the name of the company in addition to a space to write the date when the record is generated. It is recommended to include the address if there are multiple operational sites within the same company.
There are different types of documents that serve as support to the operations:
Program: A written document indicating how a business will execute its activities. When it comes to the food industry, this is a written document that indicates how quality, food safety and business activities are controlled.
Procedures: General actions conducted in a certain order. Standard Operational Procedures (SOPs) allow the employee to know what to do in general. For example, a truck receiving procedure only tells the employee what the expected conditions are when receiving a truck (cleanliness, temperature, etc.) However, it doesn’t tell the employee how to look for the expected conditions at the time of the truck arrival.
Work Instructions: Detailed actions conducted in a certain order. For example, truck inspection work instruction tells the employee what steps are to be followed to perform the inspection.
Forms: Documents used to record activities being performed.
Work Aids: are documents that provide additional information that is important to perform the job and can be used as a quick reference when performing the required activities within the job.
Are you prepared to face document requirements now and in the future?
The inspectors and auditors base their role on the following saying: “Say what you do. Do what you say. Prove it!” The programs say what the company do. The procedures, work instructions and work aids provide information on implementation (Do what you say) and the forms become records that are evidence (prove) that the company is following their own written processes.
Regulatory requirements for cannabis vary from state to state. In general, an inspector may ask a cannabis business to provide the following documentation during an inspection:
Business License(s)
Product Traceability Programs and Documents
Product Testing (Certificate of Analysis – COAs)
Certification Documents (applicable mainly to cannabis testing labs)
Proof of Destruction (if product needs to be destroyed due to non-compliance)
Training Documents (competency evidence)
Security Programs
As different states legalize cannabis, new regulatory requirements are being developed and modeled after the pharma, agriculture and food industries. In addition, standards will be in place that will provide more consistency to industry practices at a global level. The pharma, agriculture and food industries base their operations and product safety in programs such as cGMPs, GAPs, HACCP-based Food Safety Management Systems and Quality Management Systems. Documents required during an inspection or audit are related to:
Good Agricultural Practices (GAPs)
Current Good Manufacturing Practices (cGMPs)
Food Safety Plan Documents
Ingredient and Processing Aids Receiving
Ingredient and Processing Aids Storage
Operational Programs (Product Processing)
Final Product Storage
Final Product Transportation
Defense Program
Traceability Program
Training Program
Document Management Program
In the always evolving cannabis industry, are you prepared to face document requirements now and in the future?
The 6thAnnual Food Safety Consortium Conference & Expo will feature an entire track dedicated to cannabis. As announced in May of this year, the Cannabis Quality series will feature presentations by subject matter experts in the areas of regulations, edibles manufacturing, cannabis safety & quality as well as laboratory testing.
The Food Safety Consortium is hosted by our sister publication, Food Safety Tech, and the Cannabis Quality series will be co-hosted by Cannabis Industry Journal. A number of cannabis-focused organizations will participate in the series of talks, which are designed to help attendees better understand the cannabis edibles market, regulations surrounding the industry and standards for manufacturers. Some highlights include the following:
Ben Gelt, board chairman at the Cannabis Certification Council (CCC), will moderate a panel where leaders in the edibles market discuss supply chain, production and other difficulties in manufacturing infused products. Panelists include Leslie Siu, Founder/CEO Mother & Clone, Jenna Rice, Director of Operations at Gron and Kristen Hill, MIP Director, Native Roots Dispensary, among others. “The Cannabis Certification Council believes consumer education campaigns like #Whatsinmyweed are critical to drive standards and transparency like we see in food,” says Gelt. “What better place to discuss the food safety challenges the cannabis industry faces than the Food Safety Consortium”
Radojka Barycki, CEO of Nova Compliance, will discuss the role of food safety in the cannabis industry and identify some biological and chemical hazards in cannabis product testing in her talk, “Cannabis: A Compliance Revolution.”
Cameron Prince, vice president of regulatory affairs at The Acheson Group, will help attendees better understand key market indicators and current trends in edibles manufacturing during his talk on November 15. “With the current trend of legalizing cannabis edibles, medicinal and recreational suppliers alike are looking to quickly enter the edibles market,” says Prince. “Understanding the nuances of moving to food production relative to food safety, along with navigating the food industry’s regulatory environment will be critical to the success of these companies.”
Tim Lombardo and Marielle Weintraub, both from Covance Food Solutions, will identify common pathogens and areas where cross contamination can occur for edibles manufacturers.
The Food Safety Consortium will be held November 13–15 in Schaumburg, Illinois (just outside of Chicago). To see the full list of presenters and register for the conference, go the Food Safety Consortium’s website.
Two weeks ago, the National Cannabis Industry Association (NCIA) hosted the Cannabis Summit and Expo in San Jose, California. At the opening keynote, NCIA leaders spoke to the explosive growth in the cannabis industry to a sold-out audience of more than 7,500 attendees and more than 400 exhibitors. Five years ago, NCIA hosted its first trade show and barely had 1,000 people show up.
When you design your booth think about the key graphic elements that will allow you to visually claim your spaceIf you’re in the cannabis industry, you know that trade shows have become a critical part of the industry with events happening all year long and all over the country. You also know that trade show environments are tough. Leaving a lasting impression and gaining more than your fair share of contacts and leads isn’t easy. Here are a few tips to help you raise your trade show game:
Set Objectives
Start with the basic questions- why are you exhibiting at this trade show and what does success look like when it is over? Be as specific as possible. The clearer you are on what you want to achieve, the more effective you can be in preparing for the show and designing your booth. Or based on your objectives, do you need a booth at the show or is there another sponsorship, event or activity that can accomplish what you need?
Getting your brand to stand out on a crowded expo floor can be tough
Plan Ahead
The earlier you book and plan for the show the better your chances for securing premium locations in the exhibit hall. More time allows you to avoid rush fees and get to a booth design that will support your objectives. If you want to generate quality leads perhaps having some cocktail tables where you can have a meeting with a prospect or visiting customer would be a valuable addition to the booth. If you want to collect email addresses showcasing a game or raffle could attract people into the booth and provide a means for data capture. Most importantly, figure out how to have meaningful interaction with potential customers not just collect cards.
Graphics Matter
Many of the booths in San Jose last week looked pretty dismal. Company names or logos were hard to find or read. Understanding the product and services offered or the point of differentiation was often unclear. When you design your booth think about the key graphic elements that will allow you to visually claim your space; make sure people walking by or up to the booth can actually see them! A simple animation of your logo, tagline and relevant imagery on a quick loop could help separate you from the pack. When you commit to exhibiting, your budget should include the cost of the sponsorship plus enough funds to create a booth experience and graphics that are a strong representation of your brand.
Scenes from the expo floor at the Cannabis Business Summit
Beyond the Booth
Many trade shows offer other sponsorship opportunities in addition to or instead of exhibitor space such as opportunities for visibility in programs, social media, attendee bags or on-site displays as well as special branding at receptions or premium booth space. These can be great ways to stand out from other show sponsors if activated and leveraged effectively. But, before spending money on any sponsorship, go back to your objectives and determine if the execution will get the results you need.
Follow Up
Be prepared to quickly follow up with everyone you met at the show. Capitalize on all the excitement coming out of the show by being in position to immediately communicate with them not waiting months and months for the next touchpoint. Having your follow up plan in place before the show will allow you to more effectively turn a trade show attendee into an actual customer.
If you spend time thinking through your trade show plans, you can put your company in a position to walk away from the next trade show a winner.
Ken Epstein is a partner and brand strategist at WYD, a marketing accelerator for trailblazers in the cannabis industry interested in rapid growth and branding. He has built a career in connecting brands with powerful ideas and has deep experience in advertising, branding, social media and public relations. Ken can be reached at ken@wyd.agency.
Federal trademark registrations are invaluable tools for emerging businesses. They put the world on notice of a company’s name; they can secure nationwide priority over others using similar names; they distinguish a product in the marketplace; they provide crucial advantages in trademark infringement lawsuits; and they are instrumental in building goodwill. But if you sell cannabis, a federal trademark registration will not do any of those things for you … because you can’t get one.
Someday, the USPTO policy may change and there could be a gold rush for federal cannabis trademark registrations.The United States Patent and Trademark Office (USPTO) continues to refuse to register federal trademarks for cannabis businesses, even if the sale of cannabis is legal in the state where the businesses are located. The USPTO’s reasoning goes something like this: federal trademark law allows for the registration of trademarks associated with goods in “lawful” commerce, which means that the goods are not illegal under federal law. Cannabis, and its psychoactive component, THC, remain Schedule I substances under the federal Controlled Substances Act (CSA). Therefore, irrespective of state laws to the contrary, and irrespective of whether the federal law is actually enforced, the manufacture and sale of cannabis is not “lawful” commerce.
This reasoning is of fairly recent vintage. In 2009, by which time about fifteen states had legalized medical cannabis, Attorney General Eric Holder announced that the Drug Enforcement Administration would cease raids on state-sanctioned medical cannabis facilities. The USPTO followed Holder’s lead in 2010 and created a new category of acceptable goods and services for marks related to “medical marijuana.” Within months, however, the USPTO had retreated from this “mistake” and changed its practice manual expressly to preclude such registrations.
David Kluft, partner in the Boston office of Foley Hoag, LLP
Many argue that the USPTO’s position is unjustifiable as a matter of public policy. Making it easier to infringe the trademarks of state-sanctioned businesses does not advance the purposes of the CSA, and it directly undermines a key goal of trademark law, which is to prevent the proliferation of confusingly similar trademarks. But the merits of these arguments have been lost on the USPTO, which continues to refuse to register marks for anything it perceives to be prohibited by the CSA.
So if you own a cannabis business, what can you do to protect your goodwill while the federal government maintains its current policy? Below are some ideas. Admittedly, none of them– individually or collectively – is a substitute for federal registration. But each of them is better than nothing, and all of them may help to establish your ownership and priority when and if the USPTO changes its policy.
State Trademark Registrations. Each state has its own trademark registration system. State registration may offer protection from infringers within the state, or at least within the parts of the state where the registrant operates, and for that reason alone it is probably worth the small cost involved. However, state registration will have little to no efficacy outside the state. You cannot use a State A registration to file a lawsuit in State B, or to stop infringement in State B, or even to prevent conflicting registrations in State B. Additionally, most state trademark registrants, unlike federal registrants, do not benefit from presumptions of validity and ownership in the litigation context.
Related Federal Registrations. Many cannabis businesses also pursue federal registrations for whatever aspects of their business are not prohibited by the CSA. For example, even though the USPTO refused the POWERED BY JUJU mark for cannabis vaporizers (because it was CSA-prohibited “paraphernalia”), it allowed the same company to register the same mark for “vaporizers for smoking purposes not for use with cannabis.” The USPTO has also allowed registrations for cannabis-related business consulting (e.g., CANNACARD; PRAIRIEJUANA); investment analysis (e.g., FORTUNE420); clothing (e.g., CANNABIS COUTURE, THE MARIJUANA COMPANY); and for CBD – as opposed to THC – derivatives (e.g., CBD LIQUID GOLD). Once the USPTO permits federal registrations for cannabis marks and the inevitable disputes over ownership arise, such federal registrations for these related products and services are likely to be highly persuasive evidence in the registrants’ favor. Moreover, even in the current legal climate, federal registrations (especially when cited in a demand letter) are of great practical use in convincing others not to use confusingly similar marks.
Common Law Unfair Competition. Unfair competition is a state common law cause of action that was a precursor to modern trademark law, and it is still available to protect commercial goodwill even in the absence of a state or federal trademark registration. However, unfair competition law has similar territorial restrictions as state registration. In some cases, the protected territory may be even narrower, limited only to the area within which the plaintiff can prove consumer recognition of the mark.
Other Intellectual Property Protection. Copyright law, unlike federal trademark law, has no “lawful” commerce requirement, and the U.S. Copyright Office regularly issues registrations for cannabis-related copyrights. While copyright will not protect a short phrase such as a business name, it will protect a creative logo design or original packaging, and can be very effective when it comes to getting infringing uses taken down from the internet. Note also that the USPTO does not appear to have the same qualms about legality when it comes to patents, and it often grants patent protection to useful, new and non-obvious inventions related to the cannabis industry.
Save stuff. Finally, if you do nothing else, save stuff. Document that first sale; keep a copy of that first shipping invoice; and save that file containing your original packaging design. Someday, the USPTO policy may change and there could be a gold rush for federal cannabis trademark registrations. Your lawyer is going to ask you for proof of your first uses of the mark, and you don’t want your response to be a glassy stare. So keep your eyes on the eventual prize and stay ready.
The Canadian cannabis community has just gotten a new member. Tree of Knowledge, Inc. just became Canada’s newest public cannabis company. The company is also planning on raising $10 million in private placement capital. According to the company’s most current pitch deck, the planned use of proceeds includes $6.5 million for new capex expenditures in Canada and Macedonia plus new product development. The rest is slated for patient and doctor outreach including via social media, new hires and working capital.
Who Is Tree of Knowledge Inc.?
Founded originally in Washington State in 2015, today TOK has a global market presence with CBD products on three continents and is already positioning itself to run with the big boys on the international scene, just on its CBD footprint. In the online marketplace, they are doing business as EVR CBD. That includes state markets in the United States, Europe, South America, Australia and China.
The company also has a distinguished board that includes doctors to former professional sports stars. As of April, the company engaged in a reverse merger with Courtland Capital, a Nevada subsidiary company.
And as of July 2018, the company purchased 5% of NYSK Holdings – a rapidly establishing Macedonian start-up with an eye to the European market – starting with Germany.
Who Is NYSK Holdings?
NYSK Holdings is absolutely on an upward trajectory. The company, founded by Americans with strong ties to the home country along with local partners, broke ground in Skopje, Macedonia last year.
Company principals have been exploring entry into the European market ever since (Macedonia may be in the Balkans, but it is technically not part of the EU). Significantly, this also means that producers there are used to meeting European specs for import purposes, if not hopeful EU inclusion.
Like other EU partners in the west however, (notably Spain and Portugal) labour rates are also much lower than in Germany. This creates a new avenue into the EU and the German market, which is now going to be an import-dominant one until 2020.
What is even more interesting about NYSK? They produce GMP-certified product – both THC and CBD. They have been looking for partners for most of this year. They also had a booth at the ICBC in Berlin, an experience that they found highly satisfactory.
Their strategic importance to TOK is also large. NYSK brings, for the first time, THC products and high-tech processing capacity adjacent to the European Union to a firm with a global footprint.
They might, in other words, have been Europe’s most under-priced production facility. Don’t expect that to last long.
What Is Interesting About The Move
One glance at TOK’s founders, board, andadvisors is enough to establish that this is a company of mostly older Gen X and younger Boomer heavy hitters from other industries who are pooling resources and knowledge to step into a global medical cannabis space. Smartly.
For example, the focus on dosing control, trials and an operational, GMP-certified production facility in Macedonia, plus their Canadian footprint, makes TOK and their partners well suited for “European invasion.” So does their first product – a CBD-based sleep aid.
The cultivation of cannabis at the NYSK facility in Macedonia
This creates, in other words, a company with Canadian and Macedonian production, American entry and global reach, including into countries other cannabis companies have so far not breached (see China), with an interesting, low-cost, lower risk entry profile. Their expanded market entry is also occurring right at a time when Europe, including the about to be Brexited UK, is now moving forward on medical reform sans very much local production.
Perhaps this comes from the experience of the principals. TOK Cofounder Michael Caridi started his involvement in the cannabis industry in Washington State in 2014 after a successful real estate and promotions career on the East Coast (New York) and experience in ex-im. However, Caridi rapidly grew disillusioned with the state’s focus if not an obsessionon a more recreational space than medical users. He and Brian Main, now president of US operations, founded TOK a year later. Current CEO, John-Paul Gaillard, has a history that includes the creator of the Marlboro Classics brand and a stint as the CEO of Nestle Nespresso who put the idea on the map if not kitchen counters globally.
No newbies here when it comes to global market strategies, penetration and experience.
GW Pharmaceuticals scored a significant victory in the United States with its cannabis-based epilepsy drug Epidiolex in mid-April. The company received approval from a U.S. Food and Drug Administration (FDA) panel for its use in treating two forms of drug-resistant epilepsy.
The drug was granted “orphan drug” status in the EU a year ago.Will this be enough to move the conversation forward about cannabis as medicine in the United States?
So what does the future hold for this drug and a company, which has visited this space before? Remember Sativex?. The Company now faces real competition from a raft of companies moving into this space from just about everywhere – both from Canada and of course Europe itself.
The FDA Might be on the Verge of Approving its First Cannabis-Based Drug
It is not like this is either the FDA’s or GW Pharma’s first discussion about the medical efficacy of cannabinoids. Sativex, a mouth spray containing THC, was never granted approval in the United States for the treatment of MS – although it received such approvals in Europe.
If the FDA approves Epidiolex (made from CBD), it will be the first cannabinoid-based drug approved in the United States by the federal agency.
Will this be enough to move the conversation forward about cannabis as medicine in the United States? What will happen in the EU?
A Divergent and Highly Different Drug Market
Will the FDA finally approve at least one form of a CBD-based drug? The chances are that Epidiolex might finally move the agency to approve. However,this is not, despite the hype that the company has made in the press about this, the first cannabinoid-based drug to be approved in the United States. It might be, however, the first drug based on actual natural cannabinoids rather than synthetic ones that it approves for some purpose. Both Cesamet and Dronabinol (or Marinol) are synthetic cannabinoid drugs approved for several conditions from chronic pain caused by chemo to Parkinson’s.
But those who are hoping that this drug approval might open the floodgates at the FDA for startersshould take a pew. While Sativex was not approved in the United States, it was made available after 2011 for MS patients, particularly in Germany, which has the highest rate of MS of any European country. The problem? It was just too expensive for most people to afford – since their insurance would not cover it. And doctors were even more resistant to prescribing than they are now. So even getting a prescription was almost impossible.
That conversation was different in Europe post-2013, and there were people who managed to get a doctor to write a prescription not to mention afford the eye-watering prices sans insurance coverage.
That said, given the choice between whole plant meds, most people still prefer bud cannabis to the spray variety. And in Europe right now, that is what is on the table.
What Will This Mean in the US vs Europe?
In the US, the first thing that FDA approval will mean is drug sales for only one branded drug. That is the cynicism at play here. Furthermore, it also neatly dodges the THC issue.
In Europe? Particularly Germany? This development is not likely to make much of a dent. GW is competing with every single Canadian producer with flower-based oil – and on both the medical and non-medical CBD front. That also now includes local producers. Further, this is a market which prizes genericized drugs over name brands. In France, the distribution of Sativex was held up, primarily because of the row over cost. And who would pay.
It is also unlikely that the FDA approval in the United States will change the discussion either in the US on a federal level – or in Europe.
The most important place this news already made a dent? GW Pharma’s stock price – at least temporarily. It is also a spot of good news the company really needs. In February, the company’s GWP42006 drug designed for focal seizures (drug resistant epilepsy) failed to outperform placebo results and wiped 5% off the company’s stock.
In a move that seems to shed more doubt than certainty on domestic cannabis cultivation and the date that it will start auf Deutschland, the Higher Regional Court (or OLG) in Dusseldorf formally stopped the pending bid procedure for the first crop on March 28th. BfArM, the federal agency in charge of regulating all narcotic drugs, initiated that procurement bid. The tender bid was launched after the German Parliament and federal legislators changed the law last year to mandate that cannabis be available via prescription, and further that public health insurers were required to cover it.
That bid announcement was supposed to come as early as last September. Criticisms about the process and requirements began immediately thereafter. For starters, the bid’s requirements excluded all German-only respondents to the bid and left both Canadian and Israeli firms in the front positions to obtain these valuable licenses. However, there were other gripes, including the fact that the amount of cannabis requested (about 6.6 tonnes) was far too low to even begin to meet real demand. Namely, there are easily 1 million German patients who could qualify for the drug.
In the space of the last year, in fact, the number of “official” German cannabinoid patients has shot up from 1,000 to about 15,000. That said, the top three covering insurers also report a mere 64% approval rate. This means that there are more doctors writing prescriptions than insurers are covering.
That, at least for patients and their advocates is a bit of good news despite the blow that any delay in domestic production has created. Doctor resistance to prescribing cannabinoids even when there are no other alternatives has been used as an excuse in many media reports for the speed of market development. That clearly is not true. The attitude on the ground in Deutschland is rapidly changing.
That bid announcement was supposed to come as early as last September. At that point, however,the agency was then forced to extend the response date, which it did, but apparently not for long enough.
Throughout the fall, it was impossible to understand, from any direction, what was going on. Four lawsuits against the bid were launched around September, each with differing complaints that ranged from criticizing the agency for the lack of extension and response time to monopolistic business practices.
The OLG dismissed all but the criticism about the extension.what this decision has done most clearly is slowed down the production of domestically grown medical cannabinoids
The one clear thing to come out of Düsseldorf? BfArM has been banned from awarding its contract to anyone to produce medical cannabis in Germany starting in 2019. The first letters to bid finalists announcing the bid had been canceledbegan arriving the day after the court’s decision.
Reading Between the Lines
There have been rumors since last fall that the bid would end up in such waters. However,all the major producers widely suspected to have applied for the bid also began announcing themselves as finalists in press releases. For this reason, the official line from everyone that the bid was still, in fact, on track.
Nobody could understand why anyone would want or even be able to halt the production of direly needed, locally sourced, high-gradecannabis. That includes BfArM, which made an impassioned response, via their attorney to the OLG in Dusseldorf. Attorney Heike Dahs warned the court that any interruption of the bid was “very bad for the care of patients.” He was similarly pessimistic about the ability to begin production domestically by the previously set 2019 deadline.
In fact, what this decision has done most clearly is slowed down the production of domestically grown medical cannabinoids (although potentially not by much) while giving officials at BfArM a rather nasty black eye that might yet lead to further legal action.
It also means that there will be another bid process. In the meantime, the ex-im market is, if anything, taking off.
This is a Shock And Opportunity – but not a Surprise
No matter the opinionated emails and IM’ing going on in several languages all over the world right now about the implications legally in the future, the major producers are all taking this in stride. And appear to be well positioned to respond.
According to Dr. Pierre Debs, the managing director of Spektrum Cannabis (the global medical brand of Canopy and based just south of Frankfurt), who responded to CannabisIndustryJournal a day after the court decision, the company is not affected by this development. “Spektrum has a steady and constant supply and we do not anticipate any problems supplying patients through their pharmacies,” he says. Debs received the first German medical import license to bring Canadian cannabis into the country a mere two years ago and has continued to carve a leading path in the discussion across Europe. “In addition to our supply from Canopy Growth Corp, our partnership supply agreement with Alcaliber in Spain will see Spektrum importing sun-grown medical cannabis products starting towards the end of the summer,” says Debs.
Dr. Pierre Debs, managing director of Spektrum Cannabis Photo: ICBC, Berlin
But it is not just the big guys in the mix anymore. And there are many who see opportunityto a situation, which is frustrating.“As the second-largest country by population in Europe and a leader within the EU, the German market represents a new frontier for the cannabis industry in general in the region,” says Zlatko Keskovski, chief executive officer of NYSK Holdings, a Macedonian firm now in its second harvest of GMP-certified cannabis and holding EU export rights.
For such firms, even though NYSK is a surprise entrant to the conversation this year and outside the EU, the current situation represents an unbelievable chance to enter a market literally starving for qualifiedproduct. The firm is currently looking for German distributors who cannot access medical grade cannabinoids via other routes including attending the ICBC in Berlin in April. “This year’s ICBC looks to be a seminal moment for NYSK,” says Keskovski. “We have taken the appropriate steps to ensure our high-quality standards have led to products that our customers, and eventually patients, can rely on. We look forward to the chance to showcase our achievements that we’ve worked so hard for. The ICBC will also present us with the opportunity to meet with potential distributors and future partners.”
German Patients are Going to be on the Front Lines of This Discussion
The difficulties that German patients have already faced in obtaining a drug that is now legal in their own country for medical use (and even for recreational purposes across an open border in Holland) are legion. While to a certain extent, German patients are in the same boat as patients elsewhere and their problems, in fact, there are still huge access issues that remain. For starters, the drug is much more expensive here, so those without health insurance approval face bills of about $3,000 per month. Why the eye-watering price? All medical grade cannabis is still imported, although increasingly this is now just via other EU countries, not just from Canada.
“One of the reasons we organized the national German Patient Roundtable is to give patients a voice in all of this supply and demand discussion and to help BfArM and others formulate workable solutions for all,” responded Philip Cenedella IV when reached for a response by CIJ. Cenedella, an American expat and the organizer of the Roundtable, a nationally focussed, umbrella group that is kicking off its campaign this year, spoke for many who are far from court and boardrooms where the decisions are being made.
Philip Cenedella, pictured left, at the Deutsche Hanfverband (DHV) conference in Berlin last November. Photo: @MedPayRx, Instagram
“While there are very talented firms who will now take up this discussion with the government and reissue a response for the tender, what we continue to see on the ground is that patients simply do not have the access granted them in the law which was passed over a year ago,” Cenedella says, with more than a note of frustration. “We again are calling on all government officials, industry executives and patient advocates to band together to immediately establish workable protocols that directly help the patients.”
Indeed, despite the frustration and delay, if not new costs and opportunities that this decision creates, one thing is very clear on the ground here. The current status quo is unacceptable. That alone should also put pressure on the powers that be to remedy the situation as quickly as possible. And via several routes, including widening import quotas or even issuing new licenses as a new solution to domestic cultivation is implemented.
“Patients are not being served and do not have access to a medicine that has been proven to improve lives,” says Cenedella. “Our simple request is for BfArM to finally invite patients into their discussions, to work with patients to formulate workable cultivation and distribution solutions, and we humbly request that this happen now before they go down another dead-end road, ending in another court defeat, and resulting in even more delays to the patients that are still lacking the care afforded them by the German Federal Court’s decision of 2017.”
RJ Palermo has joined Innovative Publishing Co. (IPC) as Director of Sales – Events. In this newly created position at IPC, RJ will be managing the business development activities of the company’s food safety medical device and cannabis industries, working on both conference sponsorships and booth sales.
RJ will work side by side with Marc Spector, Director of Sales – Publishing. Marc had been responsible for all events and publishing sales, as well as for the year-after-year growth in these areas. The addition of RJ to the IPC team will support the company’s growth in sponsorship and exhibit sales, and allows Marc to continue supporting growth in digital advertising sales across all three of IPC’s digital publications, Food Safety Tech, MedTech Intelligence and Cannabis Industry Journal.
For many of IPC’s customers who leverage IPC’s unique position of conference sponsorships and digital advertising, they will be serviced in tandem by Marc and RJ.
“We saw a 25% growth in total revenue in 2017 and see tremendous growth potential in the three industries that we serve. Bringing RJ onto the team provides us the bandwidth to capitalize on the opportunities facing us,” said Rick Biros, president and co-founder of IPC. “Plus, RJ’s years of B2B conference and trade show management experience complements the IPC team’s current skill sets.”
RJ has more than 20 years of media, conference and agency experience. He was most recently a biopharmaceutical equipment contributor for the Pharma’s Almanac publication, and delivered several branding and research projects for pharmaceutical and medical device contract manufacturers. For 17 years RJ served as vice president of Interphex, the largest pharmaceutical manufacturing event in North America and was a key contributor of a successful launch of Medical Device Puerto Rico, which created the largest life sciences event in the Caribbean. RJ is an avid NY sports fan, and enjoys working out and spending time with his family and friends. RJ is married to his wife Beth, has a daughter Nora and dog Beau, and resides in Norwalk, CT.
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.
As 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.
Building brand loyalty should be a goal of any business. However, before a business can build brand loyalty, it has to have a brand. Before beginning our discussion on branding, let’s spend a moment speaking the same lingo. A brand is usually built around a trademark. A trademark can be a name, a logo, a color or a sound for example, something that inspires a consumer to think about a product originating from a particular business. The Feds won’t let you register a trademark for cannabis on the federal register because of its Schedule I status. However, most states where cannabis is legal will allow businesses to register a trademark on the state registry. Now that we are all using the same lingo, let’s get to the interesting stuff.
What Not to Do
The cannabis industry has been known for piggybacking on the trademarks of other brands. And, when cannabis started becoming legal, shoppers where able to find strains like: Dirty Sprite, Candyland, AC/DC, Trapitio, and Starbucks, to name a few. Boy were those brand owners mad- suing over trademark infringement. Not getting sued is a good reason to find your own, unique trademark. There are other reasons.
First, a trademark is an intangible asset having value. A strong, registered trademark will have more value than one that is not. A strong trademark is one that is creative and/or fanciful. Descriptive trademarks are not creative or fanciful. So, for example, “Seattle Canna” is not a strong trademark. Seattle is a geographic identifier and Canna describes the product. Really, do you need to use the word cannabis in your trademark? Be creative here.
One of my favorite canna trademarks belongs to Tumbleweed Farm a grower here in my home state of Washington.
This trademark is creative using the quintessential denotation for a useless weed, Tumbleweed, for something that brings pleasure and happiness.
Second, a business should not tie itself to another brand. What if that other brand has a public relations nightmare as we’ve seen happen periodically in 2017? Does your company really want to be associated with that?
What to Do
Register your trademark. Register your trademark. And, in case you didn’t hear me the first few times, register your trademark. Why is this important? A business having an unregistered trademark only has rights to that trademark in the region it sells products. A cannabis retailer contacted me recently about a store on the other side of the state using the same or similar trademark. Under common law, trademark rights within a certain territory are based on priority of use of a mark within that territory.
If you are like many in the cannabis industry, you are preparing for the day that its use becomes federally legalized. One strategy to protect your brand is to get copyright protection on your trademark; that’s right ladies and gentlemen, the US Copyright Office is not restricted by the same arcane laws the USPTO must function under.
As a Side Note
Any company who does not have hands on a cannabis plant may register their trademark at the USPTO. For example, a company selling a vaporizer, grow lights, fertilizer, etc., are selling legal products. Get your federal trademarks.
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Strictly Necessary Cookies
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.
We also use cookies to store your preferences regarding the setting of 3rd Party Cookies.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
