According to a PennLive article, Pennsylvania’s Department of Health approved the first two cannabis laboratories for their medical cannabis program. ACT Laboratories of Pennsylvania LLC and Keystone State Testing LLC are the companies that were approved to perform analytical testing for safety and quality in cannabis products.
Both laboratories expect to be operational before the end of 2017, according to the PennLive article. Those labs are required to test for CBD and THC content, pesticides, moisture content, residual solvents and microbiological contaminants.
The temporary lab testing regulations are somewhat comprehensive, detailing lab reporting, licensing, sampling protocols and ownership stipulations, among other rules. ACT and Keystone, the labs that were approved by the Department of Health, have their approval for two years and can renew their license after.
While the state still expects the program to be fully implemented by 2018, Health Secretary and Physician General Dr. Rachel Levine said last week they are hoping to launch the program sometime next year, according to a press release. December 2017 will mark a full year since the state opened applications for licensing businesses.
January 2018 has long been the goal for the full implementation of the program. “We have made significant progress in getting this program off the ground since Governor Wolf signed the Medical Marijuana Act into law last year,” says Dr. Levine. “These proposed regulations for patients and caregivers to participate are one of the final pieces we need to have in place to launch the program sometime next year.”
Last month, G3 Labs LLC, a Las Vegas-based cannabis-testing lab, had their license suspended for an unknown regulatory compliance issue. According to Stephanie Klapstein, spokeswoman for the Nevada Department of Taxation, the reason why their license was suspended is confidential. “We can’t disclose the details of the suspension, including anything about penalties,” says Klapstein.
When asked about the license suspension, Klapstein told us it was a compliance issue, but could not go into detail. “I can confirm that we did suspend G3’s license for compliance issues,” says Klapstein. “We are working with them to bring them back into compliance. In the meantime, they cannot operate.” Klapstein told the Las Vegas Review-Journal that the Nevada Department of Agriculture tested cannabis samples from the lab to determine if there was a need for a recall. She also confirmed with us that the compliance issue does not necessitate any product recalls.
According to the Las Vegas Review-Journal, this is the first time a cannabis business license is suspended in the state since the beginning of adult-use sales back in July of this year. Nevada’s cannabis regulations require independent lab testing of products before they reach shelves. That required testing includes checking for potency, microbials, pesticides, residual solvents, moisture content, growth regulators, Mycotoxins and foreign matter.
When we reached out to G3 Labs, they did not immediately respond to a request for comment.
Dr. Chao-Hsiung Tung, lab director at G3 Labs, told the Las Vegas Review-Journal that they couldn’t comment, based on advice from their legal counsel. “G3 Labs is actively sorting out the issues with the Department,” Dr. Tung told the Review-Journal in an email.
According to a press release issued on Friday, September 22nd, the Colorado Department of Public Health and Environment (CDPHE), along with the Colorado Department of Revenue (DOR) and the Colorado Department of Agriculture (CDA), issued a public health and safety advisory for cannabis products tainted with pesticide residue.
The advisory was issued after the detection of pesticide residues on retail cannabis plant material and products with cannabis grown by RK Enterprises LTD, doing business as Rocky Mountain Remedies. The CDA confirmed that they detected the pesticide, Avermectin, an insecticide with a relatively high acute toxicity.
When pesticides like this are not on the list approved for use in cannabis cultivation, it is considered an off-label use. According to the press release, some of the products affected include flower, trim, concentrates and infused-products.
Consumers are advised to look at the label of their products and check to see if it matches the license number 403R-00180 and harvest batch numbers r206goldenkush9.11.17 and m206larryog9.11.17. Consumers are told to either dispose of the product properly or bring it back to the retail store where they purchased it.
Back in April of 2016, the Colorado Legislature passed HB 1436 in an effort to make infused products less appealing to children. On October 1st, 2017, the new law goes into effect, which will prohibit the sale of edibles in the shape of a human, animal or fruit.
The THC universal symbol
Colorado has a history of regulating the market like this, with laws designed to limit the dosing, consistency and appeal of edibles to children. In 2015, regulators placed a 100-milligram cap on THC in infused products, separated into 10-milligram servings. In 2016, regulators began requiring the THC stamp on edibles, a symbol with a clear representation of what the product contains.
Some in the industry are welcoming of these new laws, while others think it might be overregulation. Regardless, manufacturers that have previously produced things like fruit candies or gummy bears now need to update their processes to use non-descript shapes for their products in order to stay compliant.
Bob Eschino, founder and president of Incredibles, an infused product manufacturer in Colorado, says these rules are not very effective at preventing kids from obtaining edibles, but it could help. “I believe consumer protection comes from CRP [child-resistant packaging], proper labeling, education and safe storage,” says Eschino. “CDPHE said themselves that stamping or shaping the products is the least effective way to prevent accidental ingestion. It’s a step that will add to consumer protection in a small way, but every little bit helps for now.” There are a number of more effective measures that regulators in Colorado take to prevent edibles from getting in the hands of children, such as child-resistant packaging, prohibiting advertising of cartoon characters, requiring opaque packaging and warning messages on labels.
Products like infused gummy bears will no longer be permitted for retail; Photo: Tamara S., Flickr
According to Peggy Moore, partner of Love’s Oven, an infused product manufacturer, and board president of the Cannabis Business Alliance, the major change companies need to make to stay compliant is ordering new molds. “Depending on the quantity ordered, molds can cost $10,000 or more to fabricate and produce.,” says Moore. “If a company was not using molds previously there is also training that may be required to orient production staff on technique for making molded confections.” She says there are still plenty of options for manufacturers to use like botanical shapes (a cannabis leaf, for example), circles, squares, rectangles and other shapes.
Her company, Love’s Oven, makes caramels, baked goods, crackers and other non-descript shapes already. “At this point I am not aware of any manufacturers who are not already compliant with this rule in advance,” says Moore. “The most common solution is to move to a square, circle or other shape utilizing molds. “ Moore believes it is a producer’s duty to make products that are not enticing to children. “Regardless of the industry (alcohol, cannabis, pharma) I think we should exercise great caution to not produce products that are targeting children,” says Moore. “While I would love to see manufacturers self-regulate in this regard, clearly some guardrail regulations are needed at this point.”
In addition to the rule on using non-descript shapes, HB 1436 prohibits the use of additives in retail cannabis products that are designed to make it addictive, more appealing to children or misleading consumers. The rule does, however, exclude common baking and cooking ingredients. There is also a stipulation that permits local fire departments to perform annual fire inspections at cannabis cultivation facilities.
Emerald Scientific recently announced their proficiency-testing program, The Emerald Test, has been approved by Colorado as a third party provider for proficiency testing in licensed cannabis laboratories. The Emerald Test, held twice annually, is an inter-laboratory comparison and proficiency test (ILC-PT), allowing data to be collected pertaining to the performance of laboratories on a national scale. Proficiency testing is designed to measure how accurately laboratories perform and is a critical tool for quality assurance.
Colorado requires labs to participate in a proficiency-testing program in order to be certified to conduct required testing on cannabis and cannabis products for safety and quality. According to the press release, Colorado’s Marijuana Enforcement Division, under the Department of Revenue, conducted an evaluation process to determine which applicants could meet the performance standards for regulatory compliance concerning proficiency testing. The contract was awarded to Emerald Scientific following this evaluation process.
According to Ken Groggel, director of the Proficiency Testing Program at Emerald Scientific, a number of states have recognized the need for independent proficiency testing as a required piece of regulatory compliance. “The Emerald Test Inter-Laboratory Comparison/PT is state approved in Washington & Colorado for cannabis testing laboratory licensure,” says Groggel. “States with cannabis or hemp production, as well as labs in other countries are now actively participating in the Emerald Test as a tool for quality improvement, efficiency upgrades and product safety.” He says the Colorado Marijuana Enforcement Division has contracted with Emerald Scientific to provide third party PT programs for microbial contaminants, residual solvents and pesticides.
Ken Groggel, director of the Proficiency Testing Program at Emerald Scientific
Beginning in 2014, The Emerald Test has been offered twice a year and, in 2017, over 50 labs participated from 14 states and 2 countries. “Laboratories that have enrolled more than once have seen significant improvement in their results, an indicator of improved performance for industry customers,” says Groggel.
Proficiency testing is important for ensuring quality, safety and product content accuracy. “This should be the priority whether you are a grower, manufacturer, testing laboratory, regulatory entity, medical patient or adult use consumer,” says Groggel. It also helps labs meet regulatory requirements and achieve ISO 17025 accreditation. “Independent proficiency testing helps determine if the lab is able to deliver the services marketed to its customers,” says Groggel. “Regulatory agencies can use this information when licensing, monitoring & enforcing good science for public safety.”
As new states legalize cannabis and develop consumer protection regulations, proficiency testing programs can help labs demonstrate their commitment to responsible and accurate testing. “When PT results show the cannabis testing lab is capable it is up to the government to ensure accountability for performance on behalf of all its citizens,” says Groggel. Labs can enroll starting on September 25th in the Fall 2017 Emerald Test ILC/PT.
Last week, the Cannabis World Congress & Business Expositions announced they have removed Roger Stone from their conference’s keynote talk. The news follows a month-long boycott led by a group of women with the #DisownStone campaign, exhibitors, activists and the Minority Cannabis Business Association (MCBA), among other organizations.
According to the press release, conference organizers met with a number of people and organizations to discuss inclusivity and made the decision to oust Stone, citing the distraction his keynote was causing. “Following collaborative discussions with numerous partners, participants, and interested parties who support the legalization of cannabis in an inclusive manner, Cannabis World Congress & Business Expositions, (CWCBExpo) is announcing that Roger Stone will no longer be featured as a keynote speaker at the upcoming CWCBExpo events in Los Angeles and Boston,” reads the press release. “The forums created by CWCBExpo are crucial to the growth and legalization of the cannabis industry and they supersede the distractions that have surrounded the events.”
When the Minority Cannabis Business Association announced they would boycott the conference unless Stone was removed, support poured in from throughout the cannabis industry and a Change.org petition was created. Shortly after, we published an op-ed in support of the MCBA and their boycott. The boycott received national attention from major news outlets across the country. New Frontier Data, prominent cannabis law firm Greenspoon Marder, Denver Relief Consulting, Cannabis Industry Journal and Dope Media are among the signatories on that petition.
The petition reached 750 signatures in just two weeks and now has 840 signatures. That petition launched the #DisownStone campaign, which was ultimately successful in their mission. According to a statement put out by the #DisownStone campaign, the movement was led Amanda Reiman, Betty Aldworth, Bonita Money, Lauren Padgett, Leah Heise, Tiffany Bowden and Wanda James. It quickly garnered support from organizations involved in the conference. 20 speakers and 11 sponsors and partners signed the petition.
The Facebook post from MCBA where they announced the boycott
The #DisownStone statement praises the CWCBExpo for their decision to remove Stone. “We applaud the leadership at the Cannabis World Congress and Business Expo for their decision to remove Roger Stone from the keynote slot at CWCBExpo in Los Angeles and Boston,” reads the statement. “In choosing to release Roger Stone and to remove the employee that displayed egregious and reprehensible behavior towards members of the industry, the CWCBExpo set an example for the industry to follow. We understand that this decision was a difficult one and respect that the conference chose this route.”
The campaign ended their statement with a forward-looking sentiment, vowing to fight racism in the cannabis industry. “We will continue to denounce racism whenever we see it in the cannabis industry and elsewhere, and look forward to the day when no person can be arrested and jailed for using cannabis,” reads their statement. “We are excited to attend CWCBExpo and continue the conversation in person with their leadership and with attendees.” The campaign is hosting a #DisownStone after party at the LA event to celebrate their victory on September 14th.
Stone told LA Weekly that he plans on suing the conference organizers for $1 million. “The expo is in breach of contract,” Stone told LA Weekly. “I will be suing them for $1 million. I will not be deterred from my efforts to persuade the president to preserve access to legal medicinal marijuana consistent with his pledge to the American people.”
In an email to LA Weekly, Jesce Horton, chair of the board at MCBA, told reporters he is now willing to work with the conference organizers, given their decision to remove Stone. “Roger Stone’s deplorable rhetoric was just a piece of our inability to be involved,” Horton told LA Weekly. “More important is his history of advocating for regulations that work directly against an industry inclusive to small businesses and minority entrepreneurs. I look forward to working with CWCBE and support their decision to stand with us.”
Broken Coast Cannabis Ltd., a cannabis business located on Vancouver Island, issued a voluntary recall of three cannabis lots due to the detection of pesticides. According to the safety alert published on Health Canada’s website, the voluntary Type III recall follows an inspection of the facility back in March of this year.
A Type III recall means those products are not likely to cause negative health effects. Sampling of those three cannabis lots found a cannabis oil product in July to contain low levels of Myclobutanil and Spinosad.
Upon further testing, a cannabis leaf sample was found to contain 0.017 parts-per-million of Myclobutanil. A third party laboratory confirmed the presence of that fungicide, leading them to recall three lots of dried cannabis sold between July and December of 2016, according to that safety alert.
Spinosad, an insecticide, and Myclobutanil, a fungicide, are not authorized for use with cannabis plants per the Pest Control Products Act, however they are approved for use in food production. The health risks of ingesting either of those two chemicals are well documented. “Health Canada has not received adverse reaction reports related to Broken Coast Cannabis Ltd.’s products sold affected by the recall,” reads the safety alert. “Health Canada recommends that any individual affected by the recall immediately stop using the recalled product and to contact Broken Coast Cannabis Ltd., at the following number 1-888-486-7579.”
Spectra Analytical LLC, doing business as Steep Hill Hawaii, was the first cannabis-testing laboratory to be licensed by the State of Hawaii and opened for business on August 1st. Today the lab announced they received ISO 17025:2005 certifications in biological and chemical testing from Perry Johnson Laboratory Accreditation, Inc., according to a press release.
Dana Ciccone, chief executive officer of Steep Hill Hawaii, has been a patient advocate and leader in cannabis education in Hawaii, as well as a member of the Hawaii Medical Marijuana Dispensary Task Force, an organization formed by the University of Hawaii College of Social Sciences Public Policy Center to develop regulations for the state. “We are proud not only to be the first cannabis lab to be licensed in the State of Hawaii, but also now the first lab to achieve ISO certification as well,” says Ciccone. “Industry businesses, medical professionals, state regulators, and patients can be confident that our lab and its testing standards will operate to the highest international standards.”
According to the press release, the laboratory will offer services for testing cannabinoid profiles (potency), terpenes, pesticides, heavy metals, biological screening, and residual solvents, testing for 17 Cannabinoids and 43 terpenes. The release states they are locally owned and operated, providing testing services for not just industry businesses, but in-state card-holding patients as well.
“This is a turning point for the industry – we have moved very quickly to raise the industry standards in Hawaii to internationally recognized certification,” says Ciccone. “I am very proud our scientific team for the professionalism and hard work they put in to achieve this certification.”
There is a great deal to be happy about with medical cannabis legalization in Germany. This is the first country that has mandated insurance coverage of the drug – at least at the federal legislative level.
However, as the government evaluates the finalists in the first tender bid for domestically grown and regulated cannabis, a real crisis is brewing for patients on the ground. And further one that the industry not only sees but is trying to respond to.
Spektrum Cannabis GmbH, formerly MedCann GmbH began trying to address this problem when they obtained the first import license for Canadian cannabis last year. They are also one of the apparent five finalists in the pending government bid to grow the plant domestically for medical purposes. According to Dr. Sebastian Schulz, head of communications for Spektrum, “Shortly after the new cannabis law was reformed we experienced a huge increase in demand from the side of patients. We had prepared for that. The German population is very curious about cannabis as a medicine and in general very open to natural remedies.”
People are curious here. But like other places, the law in Germany has evolved slowly. Much like Israel, the government has allowed a trickle of patients to have access to cannabis by jumping through multiple, time consuming hoops. The process of getting cannabis prescribed, much less getting a pharmacy to stock it, was difficult. Patients had to pay out of pocket – a monthly cost of about $1,700. While that is expensive by American standards, to Germans, this is unheard of. The vast majority of the population – 90% – is on public health insurance. That means that most Germans get medications for $12 a month, no matter what they are. Allegedly, German patients were supposed to get about 5oz a month for this price. At least that is what the law says.
People are curious here. But like other places, the law in Germany has evolved slowlyAs in other countries, no matter what Germans think about recreational reform, the clear majority of them at this point support medical use. And at this point, both legislatively and via the courts, the government has said and been required to provide the drug to Germans patients at low cost.
Unintended Effects & Consequences
Since the law went into effect in March of this year however, things have suddenly turned very dire for patients.
The handful of people who had the right to grow at home – established under lawsuits several years ago – were suddenly told they could no longer do so. They had to go to a doctor and regular pharmacy. Even regular patients in the system found that their insurance companies, allegedly now required to pay, are refusing to reimburse claims. Doctors who prescribed the drug were abruptly informed that they would be financially responsible for every patient’s drug cost for the next two years (about $50,000 per patient).
Photo: Ian McWilliams, Flickr
To add a final blow to an already dire situation, German pharmacies that carried the drug, then announced an additional fee. It is about $9 extra per gram, added at the pharmacy, pushing the price of legitimate cannabis north of $20 dollars per gram. This is justified as a “preparation fee.” Cannabis bud is technically marked as an “unprocessed drug.” This means the pharmacies can charge extra for “processing” the same. In reality this might be a little bud trimming. If that. The current distributors in the market already prep and pre-package the drug.
What this bodes for a future dominated by infused products, oils and concentrates is unclear. However the impact now is large, immediate and expensive in a country where patients also must still go to the pharmacy in person for all prescription drugs.
There is no mail order here, by federal law. Online pharmacies are a luxury for Auslanders.
At minimum, this could mean that without some relief, German patients will go right back into the black market and home grow.While nobody has challenged this situation yet en masse, it is already a sore point not only for patients but across the industry. It means that an already expensive drug has gotten even more expensive. It also means that the government regulations are not working as planned.
At least not yet. For the large Canadian companies now coming into the market with multimillion-dollar investments already sunk in hard costs, Germany will be a loss-leader until the system sorts itself out.
According to Schulz, whose company is now in the thick of it, the new law is very vague. “Currently, there are almost no cannabis flowers available in German pharmacies because companies like us are not allowed to sell them,” says Schulz. “Various different regulatory demands come up that seemed to change on a monthly basis. We are ready to deliver even large amounts of cannabis for a market that might well explode soon – but we first need to overcome the regulatory nightmare that leads to the suffering of so many patients here these days.”
At minimum, this could mean that without some relief, German patients will go right back into the black market and home grow. Black market costs for cannabis are about $10-15 a gram. In other words, exactly the situation the government was hoping to avoid.
What Is Causing The Situation?
The intended effect of the legislation was twofold, according to industry insiders: To legalize cannabis in such a way to meet a rising public demand and, in the face of a court decision, to limit the home grow movement. The latter of which, despite federal regulations, is thriving here. Germans like to grow things, and cannabis is a rewarding plant to nurture.
High attendance at the Mary Jane Grow Expo in Berlin in June is just one sign that the genie is out of this particular bottle. BfArM – the federal agency in charge of regulating narcotics and medical devices – cannot stuff it back.Patients are going back to the way things were
However home grow does not build a professional, high volume cannabis market, much less a highly regulated medical one make. The government also made clear that it is going to have strict inspections and quality controls, and will technically buy all the cannabis produced, per the terms of the bid application process.
However, it is not entirely clear when the government will start actually doing the buying. And why the buying has not started yet. If insurance companies are refusing to pay, this means the government is not reimbursing them. The same government, which has also agreed to do so, as of March 2017.
What Gives On Good Old German Efficiency?
On the streets, patients are going back to the way things were. Many are used to fighting for the only drug that makes them feel better. The euphoria in May, for example, has been replaced with weary acceptance that things might get a bit worse before they really improve.
That said, there is also a realization that more activism and lobbying are required on just about every front. If an extrapolation of data from say Colorado or California is applied to Germany, there are already at least a million eligible patients here, based on the qualifying conditions. The government is planning for an annual increase in medical patients of about 5-10,000 a year, including in the amount of cannabis they are planning on buying from the licensed producers they choose. The numbers, however, are already not matching.Even existing patients are literally being forced into the black market again.
Added to this wrinkle is the other reality that is also looming, particularly now.
With one exception, all of the firms now apparently in contention as finalists for the German government bid will also be supplying a domestic market in Canada that is going rec next summer. One year, in other words, before the German companies even begin producing.
What Is The Upshot For Patients?
Guenther Weiglein is one of the five patients who sued for home grow rights in 2014. He is now suing again for the right to extend home grow privileges until the government figures out its process. He is not the only one. Earlier this year he was told he had to stop his home grow and integrate into the “mainstream” system. So far, he, along with other patients who are suing, including for insurance coverage, have not been able to get cannabis easily through the system, although they are starting to make progress.
Weiglein’s situation is made even more frustrating by the fluidity of the situation. As of late July, he had finally gotten agreement from his insurance company to cover the drug. But now he cannot find a doctor willing to accept the financial risk of prescribing it to him. And in the meantime he has no access to medication.
Talk to any group of advocates right now, and there is one ongoing story. Even existing patients are literally being forced into the black market again.
And those that can’t afford it? They are out of luck. Some patients say a tragedy like someone dying will create the impetus to move this into public eye. A hunger strike here by a leading cannabis doctor earlier this summer has so far not had much impact on policy. There is a great deal of pessimism here, as promised change earlier this year has turned into a long and drawn out multiyear question mark.
If this sounds like a bubbling and untenable situation, especially before a national election, it is. The prospect of another four years of Angela Merkel does not bode well for fast cannabis reform.
That said, the German government is now in an interesting situation. The law has now clearly changed to say that sick Germans are allowed to use cannabis as a drug of choice for chronic diseases when all else fails. Further, the national government has bound the insurance industry to cover it. So far, every patient who has sued for coverage has won. That has not, however, moved the insurance industry altogether. Nor has it solved the problem with doctors prescribing the drug.
Many now ask what will? It is clear, however, that it will change. The question is when, how fast, and in what situations.
The problem will undoubtedly ease by 2019, when the first German crops are finally ready, although it will be far from completely solved.
The Senate Appropriations Committee approved the amendment to continue protecting state-legal medical cannabis markets from the Department of Justice. The amendment, previously known as the Rohrabacher-Farr Amendment, prevents the DOJ from using funds to target medical cannabis operations, patients and businesses in states where it is legal.
Every time Congress reviews the budget, this amendment needs to be included to keep protecting the medical cannabis community. While the rider still needs to make it through the final version of the appropriations bill, it is a big win for the status quo.
According to Aaron Smith, executive director and co-founder of the National Cannabis Industry Association (NCIA), this indicates that Congress is resisting Attorney General Jeff Sessions’ calls to end the protections. In a letter sent back in May, Sessions urged the Senate on both sides of the aisle to stop protecting medical cannabis.
Many see this morning’s vote as Congress standing up to Jeff Sessions, and standing up for medical cannabis patients. In a letter to NCIA members, Smith says that a lot of work still needs to be done, but this is an important first step. “This is not the end of the story. There are still many steps to go before a new budget is finalized,” says Smith. “But this is an important indicator that our allies in Congress are standing up for us, even in the face of DOJ opposition.” In an official NCIA statement, Smith acknowledges the hurdles that still face the amendment. “Now it’s time for the House to do the same,” says Smith. “Patients deserve access to care, states deserve respect, and members of the House deserve the opportunity to vote on amendments like this that have the strong support of their constituents.” Bipartisan support like this in Congress is needed to prevent the current administration and the DEA from meddling in states with legal medical cannabis.
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Both laboratories expect to be operational before the end of 2017, according to the PennLive article. Those labs are required to test for CBD and THC content, pesticides, moisture content, residual solvents and microbiological contaminants.
While the state still expects the program to be fully implemented by 2018, Health Secretary and Physician General Dr. Rachel Levine said last week they are hoping to launch the program sometime next year, according to a press release. December 2017 will mark a full year since the state opened applications for licensing businesses.
