“By achieving ISO/IEC 17025 accreditation, TEQ Analytical Labs believes that we can address the concerns throughout the cannabis industry regarding insufficient and unreliable scientific analysis by providing our clients with state-required tests that are accredited by an international standard,” says Seth Wong, president of TEQ Analytical Laboratories. According to a TEQ Analytical press release, accreditation to this standard confirms that laboratories have the management, quality, and technical systems in place to ensure accurate and reliable analyses, as well as proper administrative processes to confirm that all aspects related to the sample, analysis and reporting are standardized, measured and monitored.
By implementing ISO 17025 accreditation, the laboratory monitors systems and processes central to analyses in an effort to minimize discrepancies and variability in test results. According to Roger Brauninger, biosafety program manager at A2LA, this type of accreditation demonstrates their competence and commitment to rigorous science. “It is encouraging to have testing laboratories taking ownership of the quality of the work performed,” says Brauninger. “Reliable testing will be imperative to insure safety of the products out on the market as this industry continues to expand.” As the first accreditation of its kind in North America, Brauninger hopes this will open the doors for more cannabis laboratories to acknowledge their role in demonstrating scientific competency for the industry.
Tripp Keber, president and chief executive officer of Dixie Brands, Inc., commends the achievement. “At Dixie Brands, we believe that cannabis is powerful, that quality is important, and that accurate dosing is of supreme importance,” says Keber. “Because Dixie is committed to delivering a safe, consistent, and accurately dosed product, lab testing is a vital component to our manufacturing processes.”
“TEQ’s achievement of ISO 17025 accreditation instills great confidence to Dixie Brands that our consumers’ health and safety is ensured and that they will enjoy a reliable and predictable experience with our product each and every time,” adds Keber. “Dixie’s strategic relationship with TEQ continues to build long-term brand value.” This kind of accreditation helps build trust in laboratories’ clients knowing they can provide accurate results repeatedly.
In May, the National Cannabis Industry Association (NCIA) announced a partnership with BDS Analytics, a cannabis market intelligence and data firm, according to a press release. Beginning in June of this year, NCIA members received access to market and sales data via BDS Analytics’ GreenEdge sales tracking software.
According to Aaron Smith, executive director of NCIA, market intelligence was previously very scarce in the emerging cannabis industry. “We hear from our members all the time that one of their biggest challenges is the scarcity of reliable market intelligence and data in the industry,” says Smith. “Being able to offer this kind of data as an included benefit of NCIA membership is incredibly valuable. We’re proud to partner with BDS and grateful for their support of NCIA’s mission.”
Roy Bingham, CEO of BDS Analytics
The GreenEdge reports span numerous product categories as well as high-level market reporting. According to Roy Bingham, chief executive officer of BDS Analytics, NCIA member-businesses can take part in a tutorial to familiarize them with the interface. Bingham says they have extraordinarily comprehensive data on Colorado and Washington; they will have Oregon’s data ready in less than three months and roll out nationally to all major markets during the rest of 2016 and 2017.
Through using the interactive GreenEdge reports, we were able to identify key market figures and growth percentages, such as percent of the market share held by dry flower, average infused chocolate bar prices and much more. We found that Colorado’s recreational and medical markets totaled $996.5 million in 2015, just shy of a billion dollars. 28% of that market was held by infused products and concentrates, which grew by 111% over the previous twelve months. The average infused chocolate bar sold at retail in Colorado was priced at $14.47 last year. Overall, Colorado’s cannabis marketplace grew by over 41% between 2014 and 2015.
According to Bingham, for most mature industries, a ten percent transaction value of the market is sufficient to scale data so that it speaks to the entire market. “However, this is not a stable, mature industry so we are more comfortable with a sample size of around twenty percent of the total market,” says Bingham. “We are well over those numbers in Colorado and Washington.” In order to get the data, BDS Analytics makes direct arrangements with dispensaries on their panel to get access to their point-of-sale data, which can be done in almost real time or in a download at the end of each month. “It is then standardized with a learning software system, assisted by personnel, that gets better over time at categorizing data points,” says Bingham. “We use algorithms to scale the data to the total industry size, and there are a number of adjustments made to those algorithms to make sure the data is normalized.” The program has recorded more than 20 million transactions to date.
Dispensaries provide their data because they get the full service that comes with being a member of the panel, including details down to the brand level, according to Bingham. “This enables dispensaries to offer consumers what they are purchasing on average in their market,” says Bingham. “You get to see a breakdown of the most popular brands and items if you join the panel and submit data.” They have categorized more than 20,000 unique products, such as a number of different types of concentrates, different types of infused products and more.
The interactive data tool holds tremendous value for NCIA members and business owners in the cannabis space, giving them access to market data previously unavailable or difficult to find.
The National Cannabis Industry Association (NCIA) with their California affiliate, California Cannabis Industry Association (CCIA), hosted over 3,000 business professionals at this week’s Cannabis Business Summit in Oakland, CA. According to Aaron Smith, executive director of the NCIA, this event drew their largest-ever gathering of attendees and well over 100 sponsors on the expo floor. In an exclusive interview prior to the event, Smith expected this would be a wildly successful year. “Last year we had just over 2,000 attendees in Colorado and we are expecting over 3,000 this year in California,” says Smith. “There is tremendous interest in the California market and it is so great to be here with all of the excitement leading up to the ballot initiatives in November.”
Aaron Smith, executive director of NCIA
The theme of the conference was set early on from industry progress to sustainable growth. “I am really proud that NCIA’s events always bring out the best and brightest in the industry,” says Smith. “It is mostly members of NCIA attending, which are the folks invested in the future of the industry and not just in it to make a quick buck; they are here to build a new business sector.” On Tuesday morning, Smith gave his opening remarks and introduced the first keynote delivered by Ahmed Rahim, co-founder and chief executive officer of Numi Organic Tea alongside Kayvan Khalatbari, founding partner of Denver Relief Consulting, to discuss the triple bottom line in business, emphasizing the need for social responsibility, which includes environmental stewardship, fair labor and trade laws and community integration among cannabis businesses. California Lieutenant Governor Gavin Newsom also delivered a keynote address that was received with a standing ovation after discussing the November ballot initiative, which would legalize, regulate and tax the adult use of cannabis in the state.
The first keynote panel of the Cannabis Business Summit
Newsom’s speech highlighted the state’s opportunity to make considerable progress in the cannabis legalization arena this November. The substance of his speech echoed that of many attendees focused on moving the industry forward sustainably. “We need to right the wrong of the failed war on drugs in America,” says Newsom. Boisterous cheers and applause followed almost every sentence as he continued to emphasize the need for social and criminal justice reform. “We are not doing this to be the next California gold rush or to make tax revenue; our purpose and focus is social justice,” adds Newsom.
Gavin Newsom, Lieutenant Governor of California, delivering the keynote
The Lieutenant Governor also mentioned the sheer massive size of California’s market opportunity and their pragmatic regulatory framework in development. “The entire retail of recreational and medical [cannabis sales] in Colorado was just shy of $1 billion last year; we are talking about our 58 counties up in the northern part of this state that produce anywhere from $9-13 billion [sic] of wholesale cannabis- it’s a game changer,” says Newsom. “We have had the benefit of seeing where other states have fallen short or struggled [in regulatory frameworks] and will present that to voters this November.” Newsom also mentioned that members of the cannabis industry need to act as stewards of the environment and protect the small farmers.
Panel discussions throughout the afternoon and following day deliberated a wide variety of topics from laboratory testing standards to the state of affairs in education, training and certification across the country. John MacKay, senior director of strategic technologies at Waters Corporation, led a panel titled Validation of Analytical Methods, Lab Certifications and Standard Methods with Cynthia Ludwig, director of technical services at the American Oil Chemists’ Society (AOCS), Shawn Kassner, senior scientist at Neptune and Company, Inc. and David Egerton, vice president of technical services at CW Analytical Laboratories.
The panel: Validation of Analytical Methods, Lab Certifications and Standard Methods
The panel addressed many of the current problems facing the cannabis testing space. “It is a very difficult plant to work with and labs are doing their best to provide reproducible results,” says Mackay. Cynthia Ludwig emphasized the need for collaborative studies and method validation in cannabis labs. “We [AOCS] provide official, validated laboratory testing methods, but the cannabis industry really has no official methods to work with,” says Ludwig. Egerton echoed Mackay’s concerns over difficult sample preparation and the difficulty of working with cannabis in the lab. “The problem is the matrix of the cannabis sample; the matrix is a critical aspect of method validation- ensuring we find the signal through the noise,” says David. “In the absence of official methods, cannabis labs need to perform method validation in-house for each type of sample, ranging from dry flower to different types of infused products and concentrates.” In addition to those difficulties of providing robust and reproducible lab tests, the panel emphasized that there is currently no laboratory accreditation program required by California regulators.
The cannabis industry in California is still rather unregulated and lacks consistency in safety standards across the market in almost every sector. Attendees seemed to look forward to the November 8th vote on the ballot initiative in California as a solution for the state’s current problems, hoping consumers and patients alike will find solace in a more regulated, standardized and safe market. The NCIA will be hosting a “Seed To Sale Show” focused on best practices and case studies January 31st and February 1st, 2017 in Denver. The next Cannabis Business Summit will be held from June 12th to the 14th of 2017 in Oakland, CA.
In a New York Times article published yesterday, news broke of Microsoft’s entry into the cannabis marketplace, teaming up with KIND Financial to launch its Microsoft Health and Human Services Pod for Managed Service Providers, which is essentially a seed-to-sale tracking technology. Their goal is to provide local and state governments with software solutions for traceability in the burgeoning cannabis industry.
In a press release yesterday, Kimberly Nelson, executive director of state and local government solutions from Microsoft said, “KIND’s strategic industry positioning, experienced team and top-notch-technology running in the Microsoft Azure Government cloud, made for an easy decision to align efforts.” According to KIND Financial founder and chief executive officer, David Dinenberg, the cannabis marketplace will continue to have strict oversight and government regulations. “I am delighted that Microsoft supports KIND’s mission to build the backbone for cannabis compliance,” says Dinenberg.
This move could represent an opening of the floodgates for corporate interest in the space. According to Matt Karnes, founder of GreenWave Advisors, a cannabis financial data analysis firm, this could potentially result in an increase in capital flow into the cannabis industry. “This signals a wider acceptance of cannabis and perhaps that changes to national policies are more likely now that we see a large corporation stepping in,” says Karnes. “This could certainly mean an inflow of capital from larger, mainstream enterprises that were previously unwilling to take the risk.” Microsoft also made news recently for the acquisition of LinkedIn for $26.2 billion. The move to get into the cannabis space could represent a diminishing stigma associated with the market and a wider mainstream acceptance in business.
According to Nic Easley, chief executive officer at Comprehensive Cannabis Consulting (3C), this is another legitimizing factor for the cannabis industry. “It shows that cannabis is here to stay, and the fact that Microsoft is now spending resources on software, further validates that,” says Easley. “Many of the first mover seed-to-sale companies, entered the industry too early, had problems with their technology and lacked quality customer service, which created opportunities for new companies to emerge to dominate and capitalize upon the first ‘Netscapes’ of the cannabis industry’s failures.” Additionally, this could rationalize the market for other quality software companies such as Compliant Cannabis, according to Easley.
While Microsoft publicly announced their entrance into the cannabis marketplace, one can speculate that other large companies are planning their entrance as well. “We are fielding inquiries from Fortune 500 companies, Wall Street investors and even major foreign investors on a weekly basis,” says Easley. “In the past week alone, we received calls from three different Fortune 500 companies asking us how they can get into the industry.” It appears that because Microsoft is in the cloud business and they are offering this ancillary service that not only does this further legitimize the industry, but it could be quelling the dated stigma associated with cannabis.
The American Association for Laboratory Accreditation (A2LA) and Americans for Safe Access (ASA) announced yesterday a collaboration to develop a cannabis-specific laboratory accreditation program based upon the requirements of ISO/IEC 17025 and ASA’ s Patient Focused Certification (PFC) Program. Accreditation under this program will offer the highest level of recognition and provide the most value to the laboratory and users of the products tested, according to a press release published yesterday. ASA is the largest medical cannabis patient advocacy group in the United States. “A2LA is pleased to partner with ASA to offer a cannabis testing laboratory accreditation program to ISO/IEC 17025 as well as the additional laboratory requirements from ASA’s Patient Focused Certification Program,” says Roger Brauninger, biosafety program manager at A2LA.
Pictured left to right: Kristin Nevedal, Program Manager, PFC at ASA; Jahan Marcu, Ph.D Chief Scientist, PFC at ASA; Roger Brauninger, BioSafety Program Manager, A2LA; Michelle Bradac, Senior Accreditation Officer, A2LA
The program affirms that cannabis laboratories are compliant with state and local regulations and ensures that they adhere to the same standards that are followed by laboratories used and inspected by the Environmental Protection Agency (EPA), the United States Department of Agriculture (USDA), and the U.S. Consumer Product Safety Commission (CPSC) among other regulatory bodies. The two non-profit organizations will offer their first joint training course at A2LA’s headquarters in Maryland from July 11th to the 15th. During this course, participants will receive training on PFC’s national standards for the cultivation, manufacture, dispensing, and testing of cannabis and cannabis products, combined with ISO/IEC 17025 training.
The guidelines for cannabis operations that serve as the basis for this accreditation program were issued by the American Herbal Products Association (AHPA) Cannabis Committee, an industry stakeholder panel, and have already been adopted by sixteen states. “We are very excited to see the PFC program join the ISO/IEC 17025 accreditation efforts to help fully establish a robust and reliable cannabis testing foundation,” says Jeffrey Raber, chief executive officer of The Werc Shop, a PFC-certified cannabis testing laboratory. “It is a great testament to ASA’s commitment to quality in their PFC program by partnering with a world-renowned accrediting body to set a new standard for cannabis testing labs.”
According to Kristin Nevedal, program director of PFC, this is an important first in the industry. “This new, comprehensive accreditation program affirms laboratory operations are meeting existing standards and best practices, adhering to the ISO/IEC 17025 criteria, and are compliant with state and local regulations,” says Nevedal. “This program is the first of its kind developed specifically for the cannabis industry, giving confidence to patients as well as regulators that their test results on these products are accurate and consistent.”
“The program will combine the expertise and resources of the country’s largest accreditation body with the scientific rigor and knowledge base of the nation’s largest medical cannabis advocacy group, benefitting the myriad of laboratories tasked with analyzing cannabis products,” says Nevedal. According to Brauninger, a cannabis-specific accreditation program is vital to the industry’s constantly shifting needs. “The ability to now offer a cannabis testing laboratory accreditation program that is tailored to address the unique concerns and issues of the industry will help to add the necessary confidence and trust in the reliability and safety of the cannabis products on the market,” says Brauninger. “Those laboratories that gain accreditation under this program will be demonstrating that they adhere to the most comprehensive and relevant set of criteria by their compliance to both the underlying framework of the internationally recognized ISO/IEC 17025:2005 quality management system standard and the specific guidelines issued by the AHPA Cannabis Committee.” This type of collaboration could represent a milestone in progress toward achieving a higher level of consumer safety in the cannabis industry.
The American Oil Chemists’ Society (AOCS) held its annual conference in Salt Lake City this week, with a track focused on cannabis testing and technology. Cynthia Ludwig, director of technical services at AOCS and member of the advisory panel to The Emerald Test, hosted the two-day event dedicated to all things extraction technology and analytical testing of cannabis.
Highlights in the discussion surrounding extraction technologies for the production of cannabis concentrates included the diversity of concentrate products, solvent selection for different extraction techniques and the need for cleaning validation in extraction equipment. Jerry King, Ph.D., research professor at the University of Arkansas, began the event with a brief history of cannabis processing, describing the physical morphologies in different types of extraction processes.
J. Michael McCutcheon presents a history of cannabis in medicine
Michael McCutcheon, research scientist at Eden Labs, laid out a broad comparison of different extraction techniques and solvents in use currently. “Butane is a great solvent; it’s extremely effective at extracting active compounds from cannabis, but it poses considerable health, safety and environmental concerns largely due to its flammability,” says McCutcheon. He noted it is also very difficult to get USP-grade butane solvents so the quality can be lacking. “As a solvent, supercritical carbon dioxide can be better because it is nontoxic, nonflammable, readily available, inexpensive and much safer.” The major benefit of using supercritical carbon dioxide, according to McCutcheon, is its ability for fine-tuning, allowing the extractor to be more selective and produce a wider range of product types. “By changing the temperature or pressure, we can change the density of the solvent and thus the solubility of the many different compounds in cannabis.” He also noted that, supercritical carbon dioxide exerts tremendous pressure, as compared to hydrocarbon solvents, so the extraction equipment needs to be rated to a higher working pressure and is generally more expensive.
John A. Mackay, Ph.D., left at the podium and Jerry King, Ph.D., on the right
John A. Mackay, Ph.D., senior director of strategic technologies at Waters Corporation, believes that cannabis processors using extraction equipment need to implement cleaning SOPs to prevent contamination. “There is currently nothing in the cannabis industry like the FDA CMC draft for the botanical industry,” says Mackay. “If you are giving a child a high-CBD extract and it was produced in equipment that was previously used for another strain that contains other compounds, such as CBG, CBD or even traces of THC extract, there is a high probability that it will still contain these compounds as well as possibly other contaminants unless it was properly cleaned.” Mackay’s discussion highlighted the importance of safety and health for workers throughout the workflow as well as the end consumer.
Jeffrey Raber, Ph.D., chief executive officer of The Werc Shop, examined different testing methodologies for different applications, including potency analyses with liquid chromatography. His presentation was markedly unique in proposing a solution to the currently inconsistent classification system for cannabis strains. “We really do not know what strains cause what physiological responses,” says Raber. “We need a better classification system based on chemical fingerprints, not on baseless names.” Raber suggests using a chemotaxonomic system to identify physiological responses in strains, noting that terpenes could be the key to these responses.
Cynthia Ludwig welcomes attendees to the event.
Dylan Wilks, chief scientific officer at Orange Photonics, discussed the various needs in sample preparation for a wide range of products. He focused on sample prep and variation for on-site potency analysis, which could give edibles manufacturers crucial quality assurance tools in process control. Susan Audino, Ph.D., chemist and A2LA assessor, echoed Wilks’ concerns over sample collection methods. “Sampling can be the most critical part of the analysis and the sample size needs to be representative of the batch, which is currently a major issue in the cannabis industry,” says Audino. “I believe that the consumer has a right to know that what they are ingesting is safe.” Many seemed to share her sentiment about the current state of the cannabis testing industry. “Inadequate testing is worse than no testing at all and we need to educate the legislators about the importance of consumer safety.”
46 cannabis laboratories participated in The Emerald Test’s latest round of proficiency testing for potency and residual solvents. Cynthia Ludwig sits on the advisory panel to give direction and industry insights, addressing specific needs for cannabis laboratories. Kirsten Blake, director of sales at Emerald Scientific, believes that proficiency testing is the first step in bringing consistency to cannabis analytics. “The goal is to create some level of industry standards for testing,” says Blake. Participants in the program will be given data sets, judged by a consensus mean, so labs can see their score compared to the rest of the cannabis testing industry. Proficiency tests like The Emerald Test give labs the ability to view how consistent their results are compared to the industry’s results overall. According to Ludwig, the results were pleasantly surprising. “The results were better than expected across the board; the vast majority of labs were within the acceptable range,” says Ludwig. The test is anonymous so individual labs can participate freely.
The AOCS cannabis working groups and expert panels are collaborating with Emerald Scientific to provide data analytics reports compliant with ISO 13528. “In the absence of a federal program, we are trying to provide consistency in cannabis testing to protect consumer safety,” says Ludwig. At the AOCS annual meeting, many echoed those concerns of consumer safety, proposing solutions to the current inconsistencies in testing standards.
Philly Tech Week held its first cannabis industry conference this past weekend, hosted by Greenhouse Ventures, a cannabis startup accelerator based in the Northeast. The Innovation in the Cannabis Industry conference brought leaders in cannabis technology, investing and medical research to discuss the changing landscape of the cannabis marketplace in the Northeast.
Tyler Dautrich, co-founder of Greenhouse ventures, welcomes attendees; the event sold out.
Kicking off the event, Tyler Dautrich, co-founder of Greenhouse Ventures, welcomed attendees to the first ever Philadelphia cannabis conference. The initial panel of the day reviewed investment trends and included Scott Greiper, president & founding partner of Viridian Capital Advisors, Marc J. Ross, Esq., founding partner of Sichenzia Ross Friedman Ference LLP, Jim Fitzpatrick, advisory board member at Kodiak Capital Group and John Kagia, director of industry analytics at New Frontier Data Analytics. The panel, moderated by Kevin Provost, co-founder of Greenhouse Ventures, examined various financial trends in the marketplace, roadblocks to raising capital for startups and emerging markets.
The Investment Trends Panel from left to right: Scott Greiper of Viridian Capital, Jim Fitzpatrick of Kodiak Capital, Marc Ross, Esq., John Kagia of New Frontier and moderated by Kevin Provost.
John Kagia of New Frontier provided useful tools in comparing cultivation models as well as industry projections. “It [the legal cannabis market] has largely been dominated by the West Coast,” said Kagia. “The East Coast is very well poised for success.” Scott Greiper, president of Viridian Capital, discussed his top performing markets. “Biotech is definitely the top performing category and a close second is cultivation and retail –production and sale is at the root of every industry,” said Greiper. “At its core, cannabis is an agricultural commodity.” He went on to list infused products as the third top performing market, noting that edibles account for over half of retail sales.
Future Business Outlook Panel from left to right: Steven Schain of Schain Law Firm, Leslie Bocksor of Electrum Partners and Matt Karnes of Greenwave Advisors.
In looking at emerging markets, Leslie Bocksor, president and founder of Electrum Partners, echoed Scott Greiper’s advice for new businesses to stay grounded in the numbers and operations. “Stay focused on solid, tangible data,” Bocksor said. The two also shared a similar view in opportunities in hemp. “Hemp is a very underserved niche and there are ample opportunities for new businesses,” said Bocksor.
State Senator Daylin Leach (D- Montgomery/Delaware), co-sponsor of the bill for Pennsylvania’s medical cannabis legalization, delivered the keynote address. He lauded the bill, mentioning that patient advocates were instrumental in swaying the legislature. “This is the most important piece of legislation for PA in thirty years,” said Leach. “I have always believed in moving this bill forward and very recently, we passed it with a huge bipartisan majority.” Attendees gave Senator Leach a standing ovation in response to his positive outlook on Pennsylvania’s future with cannabis. “This will be a huge new industry and medical technology is vital to moving it forward.”
State Senator Daylin Leach was welcomed with a standing ovation.
In the afternoon, a panel on medical technology discussed the need for more comprehensive diagnostic tools and crowd-sourced data for treatment with cannabis. David Goldstein, chief executive officer and founder of PotBotics, expressed concerns over bringing consistency to patients. “We need to understand how cannabinoids are affecting patients,” said Goldstein. “We want patients to feel confident in their medication.”
David Goldstein (center) sat on a panel discussing med-tech and how it can help the cannabis industry.
The conference closed with a panel of physicians discussing their clinical experience with recommending cannabis and the gaps in medical research. Among them, Dr. Scott Gottlieb, board-certified anesthesiologist and pain management specialist from Pearl River, New York, discussed some of his experience in recommending cannabis in treating neuropathic pain. The closing panel emphasized the need to educate more physicians and some of the obstacles to physicians recommending cannabis. The conference highlighted the Northeast as a quickly emerging cannabis market ripe with business opportunity.
Kush Bottles, a packaging provider specific to the cannabis industry, recently launched the product BudGloves aimed at reducing the amount of human contact to cannabis products. The company is known for their child-resistant, regulatory compliant packaging.
The product BudGloves is the first glove of its kind engineered specifically for cannabis. The nitrile gloves do not contain any powder and are designed to prevent any transfer of resin, latex or powder to the cannabis. They are also slightly thicker than most other gloves to avoid getting caught or tearing, extending their life to withstand the typical shift of a trimmer or processor.
Nick Kovacevich, chief executive officer of Kush Bottles, wants to see a standard for preventing human contact with cannabis products to reduce the risk of contamination or loss in quality. Whether it is during cultivation, trimming, inspection, processing, transferring cannabis to instrumentation or even at the point of sale, it is important to minimize human contact to the cannabis.
“In California, we see bud tenders in dispensaries actually reach in a jar and grab cannabis to show the patient without gloves, which is a terrible standard operating procedure,” adds Kovacevich. “I would want all bud tenders to handle cannabis with gloves on.”
Particularly when handling food-grade products, most health code regulations require the use of gloves like these. According to Kovacevich, oils and extracts can be at a greater risk of contamination. “It is imperative that concentrates and extracts, especially those with activated THC, are handled with gloves to prevent any outside materials or contaminants from sticking to them,” says Kovacevich. The gloves are manufactured to meet stringent quality standards. To promote safety and quality of cannabis, reducing human contact with the product should be an important part of any company’s employee manual.
HARRISBURG, PA– On Wednesday, the Pennsylvania Legislature approved a bill to legalize medical cannabis. Pennsylvania will be the 24th state to legalize cannabis in the United States. The House voted 149-46, passing bill SB3 and sending it to Governor Tom Wolf, who signed the bill into law on Sunday.
The bill, with a list of seventeen qualifying conditions, will allow for certifying physicians by the Pennsylvania Department of Health and licensing growers and dispensaries. The bill also requires standards for traceability in regulatory oversight, establishing criminal penalties for diversion or falsification of identification cards issued to caregivers and patients.
House Majority Leader Rep. Dave Reed
House Majority Leader, Rep. Dave Reed (R-Indiana), believes the bill allows for robust regulatory oversight. “[…] I am confident Senate Bill 3 provides all the necessary protections to prevent the abuse of medical cannabis, including its unavailability in leaf form,” says Reed. “This new health care program will be closely monitored and if there are found to be weaknesses in the law down the road, we can certainly make any necessary revisions.”
The measure’s prohibiting the distribution of cannabis in dry flower form follows New York’s policy of only allowing patients to use it in forms other than smoking, such as vaporizing or consuming orally in capsules.
Tom Santanna, director of government relations at the Pennsylvania Medical Cannabis Society, is confident the PA Department of Health is the right organization to regulate medical cannabis. “An important part of the regulatory process includes providing for the safety of cannabis via laboratory testing, and it is our feeling that the PA Department of Health is the correct agency for that task,” says Santanna. “The legislation gives the Department of Health the authority to create standards for safety and it is our goal as an organization to work with them to make sure the proper safeguards are in place.”
State Senator Daylin Leach introduced the bill.
The passing of this legislation will undoubtedly encourage more doctors to consider recommending cannabis as a treatment option in Pennsylvania. Dr. David Casarett, professor of medicine at the Perelman School of Medicine, University of Pennsylvania, believes this could help a number of his patients. “When it becomes legal in Pennsylvania, I will certainly discuss it as an option for some of my patients,” says Casarett. “If it is legal, then at least I will know my patients are getting it from a safe and reliable source, without supporting the illegal drug trade and organized crime.”
State Senator Daylin Leach (D- Montgomery/Delaware) introduced the bill and has introduced medical cannabis legislation in every session since 2009. Steve Hoenstine, spokesperson for State Senator Leach, believes the measure will have the most intensive protections for safety in the country. “Our goal was to create a system that helps as many patients as possible, as soon as possible and as safely as possible,” says Hoenstine. “The seed-to-sale tracking system and the bill’s other protections do just that.” State Senator Leach will deliver the keynote speech at the Innovation in the Cannabis Industry; Technology, Medical & Investment Conference in Philadelphia on April 30.
It is expected to take up to two years to begin the implementation of regulations and allow retailers to open their doors to patients.
In a letter sent to lawmakers last week, the Drug Enforcement Agency (DEA) announced plans to make a decision on rescheduling cannabis by mid-2016. The announcement could represent the culmination of a shift in the federal government’s attitude toward cannabis legalization.
Currently, cannabis is a Schedule I narcotic, meaning the government views it as lacking medical benefits and have a high potential for abuse. The rescheduling of cannabis has the potential to open the floodgates for research, including much needed clinical trials.
Derek Peterson, chief executive officer at Terra Tech, a cannabis-focused agriculture company, believes this bodes well for the growth potential of the cannabis industry. “From the perspective of quality and safety standards, I find it unlikely that rescheduling it would negatively impact the degree to which cannabis is examined,” says Peterson. “It’s unnecessarily high position on the DEA drug schedule does nothing but limit the industry’s potential for growth, stall any meaningful pharmaceutical testing and increase law enforcement’s ability to prosecute non-violent drug offenders,” adds Peterson.
The rescheduling could also potentially allow for the prescribing of cannabis for patients. Stephen Goldner, founder of Pinnacle Labs and president of Regulatory Affairs Associates, is hopeful this will lead to a greater shift in public attitude towards cannabis. “The DEA’s announcement is a clear message to all States and possibly even to United Nations policy makers: even the DEA is willing to reconsider cannabis,” says Goldner. “Since the DEA is reconsidering cannabis, state politicians and local police departments can also be flexible and move away from prohibition, towards the regulation of cannabis.”
The rescheduling of cannabis could have a tremendous impact on the growth of the cannabis industry, including more clinical trials, medical research and physician participation. It could also open the door for more federal agency involvement, as the Schedule I status inhibits any EPA research on cannabis pesticide use or FDA guidance on food and drug good manufacturing practices. When reached for comment, the FDA’s press office said they could not speculate on any involvement in the matter.
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By implementing ISO 17025 accreditation, the laboratory monitors systems and processes central to analyses in an effort to minimize discrepancies and variability in test results. According to Roger Brauninger, biosafety program manager at A2LA, this type of accreditation demonstrates their competence and commitment to rigorous science. “It is encouraging to have testing laboratories taking ownership of the quality of the work performed,” says Brauninger. “Reliable testing will be imperative to insure safety of the products out on the market as this industry continues to expand.” As the first accreditation of its kind in North America, Brauninger hopes this will open the doors for more cannabis laboratories to acknowledge their role in demonstrating scientific competency for the industry.
