In a press release published last week, the American Association for Laboratory Accreditation (A2LA) announced that they have successfully accredited East Coast Cannalytics (ECC) to ISO/IEC 17025:2017. ECC Labs, based in Blacksburg, Virginia, is an analytical and microbial testing lab.
The news is rather timely given Virginia’s recent efforts to reform their cannabis laws. Earlier this year, the state passed legislation legalizing medical cannabis and the very first dispensary in the state opened its doors in Bristol, VA last week.
According to Becky Hobden, CEO of ECC, their mission is to support the rapidly growing cannabis industry in Virginia and the greater Southeast. “ECC is thrilled to be ISO/IEC 17025 accredited! In the cannabis industry ISO/IEC 17025 is a beacon for labs that have rigorously validated methods and hold the highest standards for quality,” says Hobden. “As a leading cannabis lab in the southeast, we are honored to work with A2LA and demonstrate that we meet the quality standards set forth in ISO/IEC 17025. Thank you!”
The Collaborative Laboratories for Environmental Analysis and Remediation (CLEAR) at the University of Texas at Arlington (UT-Arlington) and the University of Texas at El Paso (UT-El Paso) has begun collaborating with Curtis Mathes Grow Lights (CMGL), a subsidiary of the Curtis Mathes Corporation, and the hemp genetics company ZED Therapeutics. The research will involve characterizing the phytochemical effects of phytochrome manipulation using various LED horticultural lights of differing light spectrum, and novel high-yielding varietals of hemp. All of the hemp plants will be grown by renowned geneticists Adam Jacques, Christian West, and Oriah Love of ZED Therapeutics under the CMGL Harvester LED lights at their Oregon facility. Drs. Kevin Schug and Zacariah Hildenbrand will oversee the analysis of the corresponding samples for the expression of terpenes, flavonoids, and other classes of therapeutic compounds. The expression of 15 primary cannabinoid species will be performed concurrently by Matthew Spurlock of ZED Therapeutics.
“Since its inception, CLEAR has focused almost exclusively on improving environmental stewardship in the energy sector. It is nice to now diversify into the horticultural industry to better understand how chemically-diverse plants like hemp respond to different environmental-friendly LED lights,” says Professor Kevin Schug, Shimadzu Distinguished Professor of Analytical Chemistry and co-founder and the Director of CLEAR.
Hemp has recently garnered significant attention in the mainstream media as a result of the medicinal benefits of its primary natural constituent, CBD. The collaboration amongst UT-Arlington, UT-El Paso, CMGL and ZED Therapeutics is designed to better understand how the variable of light can influence the expression of other medicinal elements.
“We are incredibly excited about our growing collaborations with UT-Arlington, UT-El Paso, and ZED Therapeutics,” says CMGL’s COO, Robert Manes, “This particular research exploring phytochrome manipulation in hemp may unlock new lighting protocols whereby the modulation of different wavelengths is associated with the expression of different phytochemical profiles.”
This research also has the potential to discover novel molecules that may be present in the ZED Therapeutic hemp varietals using high-resolution exploratory instruments that are unique to the laboratories of CLEAR, such as Liquid Chromatography Quadrupole Time-of-Flight Mass Spectrometry (LC-QTOF-MS).
“We are always searching for new ways to expand our genetic catalogue and it will be interesting to see what sort of effects light modulation have on cannabinoid, terpene, and flavonoid expression,” says Adam Jacques of ZED Therapeutics, “Phytochrome manipulation, and any resulting epigenetic effects, is a poorly understood principle of horticulture and we see a significant opportunity with this research to unearth new knowledge.”
“Hemp is a unique plant both in its light spectrum adaptation and the wide range of phytochemicals it can potentially produce,” says Christian West of ZED Therapeutics, “I’ve been waiting my whole career to be a part of this research and having the lighting knowledge of CMGL combined with the analytical power of UT-Arlington and UT-El Paso is priceless in expanding our understanding of the plant.”
Back in late September, the Oregon Liquor Control Commission (OLCC), the regulatory body overseeing the Oregon cannabis market, issued an “Order of Immediate License Suspension” for Ecotest Labs, based in Phoenix, Oregon. In a press release, the OLCC says that the licensee, Proper Rental Management, LLC doing business as Ecotest Labs, made a number of violations.
The Oregon Environmental Laboratory Accreditation Program (ORELAP) is the regulatory body that oversees cannabis testing labs in the state. Back in July, they told the OLCC that they suspended Ecotest’s accreditations for failing to meet required procedures and standards.
The OLCC said that “continued operation represents a serious danger to the public health and safety.” ORELAP had suspicions that the lab moved testing instruments to an unlicensed location in Hillsboro, just outside of Portland, where they were conducting unlicensed testing. OLCC then launched an investigation into the lab.
Ecotest Labs told the OLCC they were having problems with their accreditation and thought they had been recertified. In August of this year, Ecotest Labs told the OLCC they were moving products for testing to the Hillsboro location, but said (incorrectly) that ORELAP rules allowed that to happen.
After digging into the METRC accounts for tracking cannabis products, the OLCC found the lab was continuing to move products for testing to the unlicensed location. There was no application submitted for the Hillsboro location.
The OLCC expanded their investigation to include other Oregon regulatory agencies in September. But on or around September 9, Ecotest’s lab was destroyed by the Almeda wildfire. At that point, they no longer had a licensed facility to conduct testing, but were still doing so in that Hillsboro location.
The OLCC says more than 160 cannabis businesses in the state sent products for potency testing through the lab after August 21, which now need to be re-tested. Regulators placed an administrative hold in METRC to prevent products from being distributed that were tested by Ecotest Labs.
While the investigation is still ongoing, Ecotest Labs has the ability to challenge the regulators’ actions and call for an administrative hearing. While the OLCC works with licensees impacted by the wildfires to help them in relocating, they said many of the violations occurred prior to the wildfire destroying their business.
ZOSI Analytical, a third-party hemp testing lab based in Georgetown, Texas, announced last week that they have achieved ISO 17025:2017 accreditation from Perry Johnson Laboratory Accreditation (PJLA). ZOSI Analytical is actually the very first hemp lab in Texas to be DEA-registered.
The 2018 Farm Bill has a stipulation for all hemp compliance testing labs to be ISO 17025:2017 accredited by October 2021. ZOSI is a bit ahead of that deadline, but ready to test products for retailers and processors looking to confirm their potency levels below the 0.3% THC federal legal threshold.
According to Amy Lummus, CEO of ZOSI Analytical, they have a turnaround time of about 48-72 hours from receipt of a hemp sample. “Although regulations continue to change at the Federal level and vary widely at State levels, one thing has remained consistent and that has been the understanding that third-party testing laboratories need to show a level of commitment and accountability to quality,” says Lummus. “Our accreditation is one more step in our commitment to helping the industry to produce and sell safe products.”
CannaSafe was allegedly the first to break the news about vaping health issues caused by EVALI, the lung condition responsible for the 2019 vape crisis. According to the press release, they provided testing data that proved black market vapes contained dangerous chemicals, likely including vitamin E acetate, the chemical that the CDC says is linked to EVALI.
CannaSafe say they have plans to expand into a number of states beyond California. They are also planning to build a facility dedicated to CBD testing to meet market needs in the near future.
According to a press release sent out last week, the American Association for Laboratory Accreditation (A2LA) announced the accreditation of Trichome Analytical to ISO/IEC 17025:2017. Trichome Analytical is the first cannabis testing lab accredited to the standard in the state of New jersey.
Based in Mount Laurel, New Jersey, Trichome Analytical is a DEA-registered third-party cannabis testing lab that offers hemp compliance testing for state and federal guidelines.
Kristen Goedde with Trichome Analytical says they are hoping to provide testing for consumer safety and accurate labeling for the state’s new hemp market. “The evolution of the hemp and cannabis industries increasingly demands rigorous, high quality analytical testing,” says Goedde. “Obtaining accreditation is an essential measure for laboratories seeking to ensure consumer safety and reliable labeling. Trichome is honored to have our quality systems validated by A2LA, and we look forward to elevating cannabis and hemp operations to new heights – right here in our home state.”
Since Arizona legalized medical cannabis in 2011 , regulators have not required testing for cannabis products. That is about to change in a little more than a month.
After a long and hard-fought battle by patients and stakeholders in the Arizona cannabis industry, Governor Ducey signed SB1494 into law last year, a bill that requires independent labs to test cannabis products for contaminants. More specifically, the bill requires that cannabis products be tested “to determine unsafe levels of microbial contamination, heavy metals, pesticides, herbicides, fungicides, growth regulators and residual solvents and confirm the potency of the marijuana to be dispensed.”
Ryan Treacy, CEO/Founder of C4 Labs and co-founder of the Arizona Cannabis Laboratory Association (ACLA), has been a vocal advocate for mandatory product safety testing since 2016. After several failed lobbying attempts and forming the ACLA with three other labs in Arizona, SB1494 finally passed in May of 2019.
Under this bill, the Arizona Department of Health Services has been in charge of building the new laboratory regulations. Those rules include certifying and regulating labs, establishing requirements like health and safety protocols, mandatory quality assurance program and standards, chain of custody and sampling policies, adequate records, accreditation, proficiency testing, among other requirements.
In a press release published by Perry Johnson Laboratory Accreditation (PJLA), they announced that C4 Laboratories was accredited to ISO/IEC 17025 this week, in time for the new requirement in Arizona.
According to Treacy, the Department of Health Services is still in the process of finalizing the technical accreditation for labs in the state. He says C4 Labs will be ready to accept compliance samples in the coming weeks. “There will no doubt be a flood of samples and a lot will be asked of the lab operators to continue to build their business to better accommodate sample volume,” says Treacy. They want to minimize any disruption to the supply chain, keeping patients and clients at top of mind.
C4 Labs has been preparing for the flood of compliance testing samples beyond just their accreditation. “Over the last 16 months we have added a new fully renovated lab space, doubled our lab staff and have invested significant monetary resources in additional state of the art analytical instruments to allow for more analysis and expanded lab sample capacity,” says Treacy. “We intend to make efficiency and capacity our focus while maintaining our commitment to sound science and data integrity for our clients and patients alike.”
C4 Labs is currently in its sixth year of operating and was one of the original labs to serve Arizona patients. “We are very proud of the work we have put in to advocate for safe, lab-tested cannabis products and we intend to continue to lead from the front as Arizona’s premier cannabis testing laboratory.”
By Seth Mailhot, Steve Levine, Emily Lyons, Megan Herr 1 Comment
On August 20, 2020, the Drug Enforcement Administration (DEA) published an Interim Final Rule on industrial hemp and hemp derivatives (the interim rule), which immediately went into effect, to conform DEA regulations with the Agriculture Improvement Act of 2018 (the 2018 Farm Bill).
The 2018 Farm Bill effectively removed industrial hemp from the definition of “marijuana” in the Controlled Substances Act (CSA). Additionally, tetrahydrocannabinols contained in industrial hemp, such as cannabidiol (commonly known as CBD), were also removed from the purview of the CSA.
The 2018 Farm Bill defines hemp as:
the plant Cannabis Sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.
Accordingly, because cannabis and its “derivatives, extracts, [and] cannabinoids” are not considered “marihuana,” so long as their delta-9 tetrahydrocannabinol (THC) concentration is at or below 0.3% on a dry weight basis, the regulation of hemp fell outside the authority of the DEA. However, the DEA’s interim rule attempts to draw a hard line in the sand as to when the plant, and any products derived therefrom, are considered “marihuana,” thereby still subject to the DEA’s purview.
Specifically, the interim rule promulgates the DEA’s position that hemp processors can convert otherwise legal hemp into illegal “marihuana,” thereby bringing it back under the DEA’s authority, if such processing and extraction increases the THC content above the 0.3% THC threshold, even momentarily. Specifically, the interim rule states:
[T]he definition of hemp does not automatically exempt any product derived from a hemp plant, regardless of the Δ9-THC content of the derivative. In order to meet the definition of ‘hemp,’ and thus qualify for the exemption from [S]chedule I, the derivative must not exceed the 0.3% Δ9-THC limit. The definition of ‘marihuana’ continues to state that ‘all parts of the plant Cannabis sativa L.,’ and ‘‘every compound, manufacture, salt, derivative, mixture, or preparation of such plant,’ are [S]chedule I controlled substances unless they meet the definition of ‘hemp’ (by falling below the 0.3% Δ9-THC limit on a dry weight basis) or are from exempt parts of the plant (such as mature stalks or non-germinating seeds) . . . As a result, a cannabis derivative, extract, or product that exceeds the 0.3% Δ9-THC limit is a [S]chedule I controlled substance, even if the plant from which it was derived contained 0.3% or less Δ9-THC on a dry weight basis.
Accordingly, the DEA’s stance creates a substantial risk for processors who will be considered to be in possession of a Schedule I controlled substance during the extraction process if the THC content exceeds the 0.3% THC threshold at any point during processing, an almost inevitable result of the extraction process. Nevertheless, the interim rule states:
the definition of hemp does not automatically exempt any product derived from a hemp plant, regardless of the Δ9-THC content of the derivative. In order to meet the definition of ‘hemp,’ and thus qualify for the exemption from [S]chedule I, the derivative must not exceed the 0.3% Δ9-THC limit.
Although the DEA impliedly recognizes the fact that hemp processing can result in a temporary increase in THC content, it still took the position that, should the THC content exceed 0.3% THC at any point during the extraction process, processors will be considered to be in possession of a Schedule I controlled substance, regardless of whether the finished product complies with federal law.
Consequently, the interim rule creates significant criminal risk for anyone processing industrial hemp, as the DEA has asserted that the processing of hemp into extracts, derivatives and isolated cannabinoids (which are arguably legal under the 2018 Farm Bill) can result in unintentional violation of federal law, thereby subjecting processors to the risk of significant criminal liability. That said, the interim final rule does not appear to be a shift in DEA policy since the passage of the 2018 Farm Bill in December 2018, nor has DEA issued any warnings to industrial hemp manufacturers or otherwise signaled a change in enforcement policy by issuing the Interim Final Rule.
In addition, the DEA took several other steps in the interim final rule towards the deregulation of hemp products:
Adding language stating that the definition of “tetrahydrocannabinols” does not include “any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. § 1639o”.
Removing from Schedule V a “drug product” in an FDA-approved finished dosage formulation that contains cannabidiol (CBD) and no more than 0.1 percent (w/w) residual tetrahydrocannabinols (e.g. Epidiolex).
Removing DEA import and export controls for hemp extract that does not exceed the statutory 0.3% THC limit.
In a press release published last week, the Oklahoma Medical Marijuana Authority (OMMA) announced they have awarded their seed-to-sale traceability contract to Metrc, a national company with contracts for the same service in 14 other states.
According to OMMA Interim Director Dr. Kelly Williams, working with Metrc will help them protect public health, by expediting recalls. “The seed-to-sale system will greatly expand our compliance capabilities and improve the effectiveness and speed of any future recall efforts,” says Dr. Williams. “It will also allow us to detect unusual patterns that may indicate product diversion.”
Metrc has begun work towards their rollout of the system, which they expect to have ready by February 2021. “We know that businesses will have many questions in the coming weeks, and we will answer them as quickly as possible,” says Dr. Williams.
Oklahoma legalized medical cannabis in 2018 and the market has expanded considerably. There are more than 300,000 patients and almost 10,000 licensees. It has the highest number of dispensaries per resident in the country.
Jeff Wells, CEO of Metrc, says Oklahoma has done a good job so far in developing one of the fastest growing markets in the country. “We’re honored Oklahoma selected Metrc to implement the state’s first cannabis tracking system,” says Wells. “With one of the fastest growing medical cannabis markets in the United States, the OMMA has done a tremendous job developing this new industry, and we’re excited to support its ongoing success. We look forward to working with state regulators and licensees to launch our system and ensure cannabis products are safe and secure for patients.”
In September of 2019, Charles Wilcoxen fell seriously ill after vaping cannabis oil from a cartridge. Just days after he began experiencing symptoms he was hospitalized and later diagnosed with lipoid pneumonia, the mysterious lung illness now known as EVALI associated with the 2019 vape crisis.
Wilcoxen spent three days in the hospital and ever since he was diagnosed, he has been unable to exercise, return to work full time or even play with his daughter. Attorneys for Herrmann Law Group representing Wilcoxen filed a product liability lawsuit, Wilcoxen v. Canna Brand Solutions, LLC, et al., in Washington State Court, naming six cannabis companies as defendants: Canna Brand Solutions, Conscious Cannabis, Rainbow’s Aloft, Leafwerx, MFused and Janes Garden.
Canna Brand Solutions, the primary defendant named in the complaint, is a packaging supplier and distributor for CCELL vaping products (heating elements, pens and batteries) in the state of Washington. The complaint alleges that Wilcoxen believes he used a CCELL vape. CCELL is a Chinese company, which makes it notoriously difficult to pursue legal action against them, hence why Canna Brand Solutions was listed as a defendant instead.
On August 31, 2020, Judge Michael Schwartz dismissed all claims against Canna Brand Solutions. “All claims asserted by Plaintiff against Canna Brand in the above-mentioned matter shall be voluntarily dismissed without prejudice and without costs or fees to any of the parties to this litigation,” Judge Schwartz says in the dismissal. Judge Schwartz dismissed the case without prejudice, meaning it could be brought to the court again should the plaintiff’s attorneys decide to do so.
With the allegations against Canna Brand Solutions focusing on CCELL products, it seems that the case was dismissed largely due to a lack of evidence connecting exactly which product resulted in the illness, as well as the lack of culpability for a distributor of products they did not manufacture.
Daniel Allen, founder and president of Canna Brands Solutions, claims that the product mentioned in the complaint did not come from his company. “We stand by our high quality and customizable CCELL vaporization products,” says Allen. “We feel vindicated in this case by the judge’s decision, which shows the claims against our company and products were completely unfounded from the beginning.”
He also added that the quality and safety of the products they distribute is their highest priority. “The product in question involved in this case did not come from Canna Brand Solutions,” says Allen.
Wilcoxen’s illness and subsequent long-term lung injury is extremely unfortunate. Thousands of people have been hospitalized and 68 deaths have been confirmed by the CDC. The CDC is still calling the illness EVALI (e-cigarette, or vaping, product use-associated lung injury). According to the CDC, there is no real known cause of EVALI, but they have found that vitamin E acetate is “strongly linked” to the outbreak. Knowing that, it is entirely possible that Mr. Wilcoxen’s illness was a result of one of the cannabis products he consumed, just most likely not anything that came from Canna Brand Solutions. A closer look at the contents with an independent lab test of the THC oil he consumed could shed some more light on what exactly caused the illness.
I would venture to guess that one of the products he consumed did have vitamin E acetate. Because the case was dismissed without prejudice, it could be brought to the court again if, say, Mr. Wilcoxen’s attorneys were to obtain more evidence, such as an independent lab report showing vitamin E acetate in the contents of one of the products he consumed. If Mr. Wilcoxen’s attorneys can figure out which product actually contained vitamin E acetate, perhaps the lawsuit could get a second shot and Mr. Wilcoxen could have a greater chance at getting some long-overdue and much-deserved restitution.
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