Clever Leaves Exports Its First Commercial Shipment of THC Flower to the United States to Biopharmaceutical Research Company

NEW YORK: Clever Leaves Holdings Inc., a leading multinational operator and licensed producer of pharmaceutical-grade cannabinoids, announced today the exportation of 30 kg of high-THC cannabis flower from its Portugal facility to Biopharmaceutical Research Company (“BRC”), a DEA-licensed pharmaceutical company that develops federally compliant active pharmaceutical ingredients (API) for plant-based therapeutics in the United States. Not only does this fortify Clever Leaves’ entrance into the U.S. and solidify BRC’s ability to transact internationally, but it positions the two organizations as some of the first companies ever to commercially ship dried cannabis flower from Portugal to the U.S.

Under the agreement, Clever Leaves’ product, which meets strict pharmaceutical standards, will be used for BRC’s pharmaceutical development projects. In addition to this shipment of dried cannabis flower, BRC and Clever Leaves have built a strong partnership over the past year through their collaboration in Project Change Lives, an initiative announced earlier this year to contribute up to USD$25M in medical cannabis products to help advance scientific research in the U.S.

“Exporting THC flower to BRC, a DEA-licensed company located in the U.S., not only represents an important commercial milestone for Clever Leaves, but it demonstrates our capabilities to determine and execute upon a viable regulatory pathway to enter the U.S., the largest cannabis market in the world,” said Kyle Detwiler, CEO of Clever Leaves. “By becoming one of the first companies to commercially export THC flower to the U.S., we are paving Clever Leaves’ path into the U.S. medical cannabis industry through a partner such as BRC. We are honored to provide BRC the high-quality product they need to advance in their research, development, and production.”

“Our partnership with Clever Leaves continues to yield exciting research opportunities that will one day make a difference in the lives of patients,” said George Hodgin, CEO of Biopharmaceutical Research Company. “Both companies share the same values when it comes to DEA compliance—we take it seriously—which is why we believe this partnership is only getting started. We are thrilled to partner with Clever Leaves once again and are eager to begin working with this premium quality product.”

Clever Leaves’ Portuguese cultivation facility is located on approximately 9 million square feet of land and consists of approximately 110,000 square feet of high technology greenhouse facilities with expansion to approximately 270,000 square feet nearly complete. The facility was granted a license from INFARMED I.P., the Portuguese regulatory authority with oversight over the pharmaceutical industry in Portugal, for importing, exporting, and cultivating cannabis. Our state-of-the-art sophisticated facilities in Portugal, which are Good Agricultural and Collecting Practice (GACP) certified, are currently operational and commercially active, with successful exports to various countries, including Australia.

Segra International Completes First Export of Cannabis Plantlets from Canada to the USA

CANADA: Segra International Corp, a leading cannabis agriculture technology company, is pleased to announce its first successful export of Verified Segra Stock™ Cannabis plantlets to the Biopharmaceutical Research Company (BRC), one of the first groups in the USA to receive approval from the DEA to cultivate Cannabis for scientific research purposes.

This shipment marks a tremendous milestone in the evolution of the US cannabis industry, as it represents one of the first imports of live Cannabis plants to a federally licensed US cultivator. In recent months, the DEA has issued a select number of licenses to several groups in the US to allow for the cultivation of Cannabis for scientific research purposes. BRC, based in California, is among the first companies granted a license and is now operational. Segra’s Verified Segra Stock™ plantlets will provide BRC with standardized and validated starting materials produced through plant tissue culture, and backed by extensive agronomic data and Cannabis plant pathogen screening.

BRC works with research groups studying Cannabis and Cannabis flower to understand the plant in a scientific and federally regulated environment. Under the federal licensing regime, BRC is only allowed to source genetics and starting material from DEA-compliant or federally legal sources.

“Segra’s Verified Segra Stock™ guarantee means our plantlets are DNA fingerprinted and pathogen-free with virtually no risk of pathogen introduction to the receiving grow facility.

Starting with this input material is critical to effectively grow replicable crops, something highly valued by researchers who are studying the finished product of the Cannabis plant and its derivatives,” said Jamie Blundell, CEO of Segra International. “Furthermore, Segra’s VNTR DNA Fingerprinting technology allows BRC to order plantlets and cultivars with certainty, knowing they are receiving the same input material with each shipment. The application of VNTR DNA fingerprinting technology can be used throughout the supply chain for track and trace purposes, from plantlet to flower, translating this certainty to researchers who can study the same product repeatedly.”

“At BRC, we are focused on developing federally compliant active pharmaceutical ingredients for federally compliant researchers examining the therapeutic effects of cannabis,” said George Hodgin, CEO of Biopharmaceutical Research Company. “We’re fortunate to be working with Segra to offer our clients a wide range of clean, high-quality Cannabis of specific chemical expressions and flower types to help them better understand the applications of the Cannabis plant.”

Learn more about Segra’s services and premium cultivars by viewing the 2021 Cultivar and Services Catalogue.

 

 

DEA Continues to Prioritize Efforts to Expand Access to Marijuana for Research in the United States

 

DISTRICT OF COLUMBIA:  On May 14, 2021, the Drug Enforcement Administration took an important step to increase opportunities for medical and scientific research.  DEA is nearing the end of its review of certain marijuana grower applications, thereby allowing it to soon register additional entities authorized to produce marijuana for research purposes.  Currently, the National Center for the Development of Natural Products at the University of Mississippi is the only approved supplier of marijuana for research purposes in the United States, and that production has been exclusively for the National Institute on Drug Abuse.

Pending final approval, DEA has determined, based on currently available information, that a number of manufacturers’ applications to cultivate marijuana for research needs in the United States appears to be consistent with applicable legal standards and relevant laws.  DEA has, therefore, provided a Memorandum of Agreement (MOA) to these manufacturers as the next step in the approval process.

On December 18, 2020, DEA finalized new regulations pertaining to applications by entities seeking to become registered with DEA to grow marijuana as bulk manufacturers for research purposes.  Under these and other applicable regulations, applicants are responsible for demonstrating they have met various requirements, including requirements to possess appropriate state authority, document that their customers are licensed to perform research, and employ adequate safeguards to prevent diversion.

At this time, DEA has presented those manufacturers referenced above, who appear to meet the legal requirements, with an MOA outlining the means by which the applicant and DEA will work together to facilitate the production, storage, packaging, and distribution of marijuana under the new regulations as well as other applicable legal standards and relevant laws.

To the extent these MOAs are finalized, DEA anticipates issuing DEA registrations to these manufacturers.  Each applicant will then be authorized to cultivate marijuana – up to its allotted quota – in support of the more than 575 DEA-licensed researchers across the nation.  As individual manufacturers are granted DEA registrations, that information will be made available on DEA’s Diversion Control website.

DEA will continue to prioritize efforts to evaluate the remaining applications for registration and expects additional approvals in the future.

Biopharmaceutical Research Company Will Be Among First in the Nation to Receive a License for Federal Cannabis Production 

CALIFORNIA: Biopharmaceutical Research Company (BRC), a specialty pharmaceutical manufacturing and analytical company focused on plant-based therapeutics, will soon be awarded one of the first federal production licenses from the Drug Enforcement Administration (DEA) to produce clean, consistent and compliant cannabis for federally approved researchers across the United States.

BRC will be among a select few organizations to receive such a license after the DEA amended regulations within the Controlled Substances Act to begin allowing the cultivation of cannabis for research purposes. Prior to today’s decision by the DEA, only one facility in the United States was federally authorized to cultivate cannabis for research purposes.

“Once finalized, this federal license will forever change the trajectory of our business and the medicinal cannabis industry. The DEA’s leadership will set off a nationwide wave of innovative cannabis-derived treatments, unlock valuable intellectual property and create high quality American jobs,” said BRC CEO George Hodgin, a former US Navy SEAL.

“The BRC team is already familiar with DEA compliance procedures based on our extensive history of controlled substances activity, and our world class staff is ready to hit the ground running on this new business arm that the DEA has authorized. Cultivation and compliance are our bread and butter, and now that we are in a position to receive this license, our best work yet can begin to take shape.”

BRC is already certified by the DEA and United States Department of Agriculture (USDA) to analyze and test controlled substances, including cannabis and hemp.

“We have invested a great deal of money and waited a very long time for this over the last four years, and this is the validation and the holy grail we’ve been waiting for,” added Hodgin. “With this license, BRC can legally produce quality cannabis and cannabis-derived products that can be used to identify new treatments that can help veterans and all patients struggling with chronic pain, cancer, and countless other illnesses. Equally important, we will also gain valuable insights into the potential dangers and misuse associated with cannabis that will help keep all Americans safe and healthy. We are proud and honored to be one of the first federally legal cannabis companies in the United States.”

Minnesota: Congressman Peterson Joins Smith, Craig and McCollum To Urge Federal Agencies To Clarify Hemp Rules

MINNESOTA: Representative Collin Peterson today jointed U.S. Senator Tina Smith (D-Minn.) and U.S. Representatives Angie Craig (D-MN 2), and Betty McCollum (D-MN 4) in calling on the leaders of four federal agencies to streamline hemp rules. Currently, contradictory federal guidelines are leading to uncertainty in the market and preventing Minnesota farmers and Tribes from fully reaping the economic benefits of growing hemp.

“The bipartisan 2018 Farm Bill legalized hemp in order to create economic opportunities for farmers. Minnesota farmers appreciate the United States Department of Agriculture’s (USDA) efforts in implementing the Interim Rule on Establishment of a Domestic Hemp Production Program. However, despite the Interim Rule there are still hurdles in place for Minnesota farmers to fully realize the economic benefits of growing hemp,” wrote the lawmakers in their letter to the United States Department of Agriculture (USDA), the Office of Management and Budget (OMB), the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).

Sen. Smith and Reps. Craig, McCollum and Peterson go on to identify some of the inconsistencies that need to be addressed: “The federal regulatory framework has proven to be inconsistent. For example, the USDA’s rule stated that farmers will be held accountable – facing possible revoking of their licenses – if their crops test above a .5 percent THC level three times in a five year period. Despite this somewhat onerous and arbitrary level, the Drug Enforcement Agency (DEA) instituted their own rule saying that exceeding .3 percent THC level deems the crop a controlled substance.

The burdensome competing rules don’t allow for remediation if the crop tests above the deemed inappropriate levels. Farmers should not be penalized for plants that they intended to grow as hemp, but for any number of reasons, the final THC numbers exceeded the arbitrary 0.3% THC level.  At the same time, the Food and Drug Administration (FDA) guidance on CBD is still pending at the Office of Management and Budget (OMB), which adds even more uncertainty to the marketplace.”

Agrozen Opens Indiana’s First Hemp Testing Laboratory

Certified By The U.S. Department Of Agriculture, The U.S. Drug Enforcement Administration, And The Office Of Indiana State Chemist

INDIANA:  Following a year of submissions and reviews by the U.S. Drug Enforcement Administration, central Indiana’s Agrozen Life Sciences today announced that it is expanding business operations by launching Agrozen Labs, now a certified U.S. Department of Agriculture (USDA) analytical hemp testing laboratory.  Agrozen Labs also recently achieved Schedule I Cannabis Testing certification from the DEA and is now an approved hemp testing laboratory through the USDA’s Domestic Hemp Production Program.

In conjunction with the USDA and DEA approvals, Agrozen Labs is the first hemp cooperative analytical testing laboratory approved through the Seed Section of the Office of Indiana State Chemist (OISC) at Purdue University.

The Agrozen Labs announcement follows word that the U.S. Department of Agriculture has approved the Indiana State Hemp plan for commercially growing and processing hemp, a crop that is widely used to produce textiles, rope, carpet, paper, building materials, food, and more.

Hemp production in Indiana is licensed to some 280 growers who farm more than 8,900 acres of the crop.  Farmers are required to have hemp crops tested before harvest and Agrozen becomes one of only about 50 such certified testing labs in the entire country.

“The Agrozen Labs team is honored to be the first hemp testing laboratory certified in the State of Indiana by USDA, as well as the first state-certified lab to be working in the hemp industry.  We’re very pleased to have the involvement of the Seed Section of the Office of Indiana State Chemist, which is based at Purdue, and is working to develop new markets for Hoosier farmers,” said Brian Schroeder, Co-Founder and CEO for Agrozen Life Sciences.  “Our hemp testing process and analytical equipment are managed by a pharmaceutical scientist with more than three decades of experience, and our lab can now produce consistent and reliable results for farmers, extractors, formulators, and finished goods suppliers,” he adds.

“The Office of Indiana State Chemist is looking forward to working with Agrozen Life Sciences as a cooperating hemp laboratory.  Agrozen Life Sciences has built their laboratory with full transparency to the State Chemist while hitting important milestones, such as obtaining a DEA Schedule I registration,” adds Carrie Leach, Quality Assurance Director for OISC.  “It has been a pleasure working with Agrozen Life Sciences building this mutually beneficial relationship that will help hemp growers,” she added.

To learn more about Agrozen Labs cannabis testing services, visit www.agrozen.com/laboratory, email labs@agrozen.com or call (844) 655-6935.

Virginia Congressman Riggleman Sends Letter To DEA In Support Of Hemp Industry

DISTRICT OF COLUMBIA:  Congressman Denver Riggleman, along with eight of his House colleagues, sent a letter to acting Drug Enforcement Agency (DEA) Administrator Timothy Shea to protect hemp producers and clarify hemp regulations due to discrepancies in the DEA Interim Final Rule (IFR).

The letter, led by Rep. David Joyce (R-OH-14), asks Administrator Shea to address the discrepancies between the 2018 Farm Bill and the DEA Interim Final Rule which was issued in August 2020. The IFR issued specific restrictions regarding hemp derived material that appears to contradict the legalization of hemp and hemp derivatives under the 2018 Farm Bill. According to the newly released IFR, provisions of the Farm Bill can result in criminal liability.

“The DEA must specify their requirements and streamline hemp directives by clarifying the legal means of processing hemp products,” said Congressman Riggleman. “The Farm Bill created new venues of business in this country, and we need to ensure that our hemp farmers have clear directives when it comes to their products.”

The 2018 Farm Bill is a critical piece of legislation that opened the door for hardworking hemp farmers by legalizing hemp and hemp derivatives so long as they contain less than 0.3% of THC on a dry weight basis. This bill has allowed states across America to start to build a new industry in hemp production, and expand their markets to CBD products and other related material. The DEA must revise the IFR to protect hemp farmers from overly harsh regulation and ensure that the hemp industry is safeguarded.

Background:

Congressman Riggleman has fought for hemp producers throughout his time in Congress. He is a lead supporter of the U.S. Domestic Hemp Production Program and has worked with USDA Secretary Sonny Perdue to expand economic opportunity for hemp farmers in the 5th District and beyond. Earlier this year he also introduced the Hemp Opportunity Zone Act which would designate certain low-income areas as “opportunity zones” and provide economic incentives to grow the hemp industry and encourage long-term investment in rural communities. The hemp industry has the potential to be a game changer for farmers in America and the 5th District can lead this effort.

Learn more about the industrial hemp industry from the USDA here. Learn about how a new hemp processing facility will strengthen the economy and bring more than 20 new jobs to South Boston, VA here.

 

Vicente Sederberg Representing Hemp Industry In Federal Lawsuit Against The DEA

DISTRICT OF COLUMBIA:  A national hemp trade association and a South Carolina-based hemp company have filed a federal lawsuit against the Drug Enforcement Administration, challenging a rule the agency implemented last month that could have far-reaching consequences for the U.S. hemp industry.

The petition filed Friday afternoon in the U.S. Court of Appeals for the District of Columbia Circuit asks the court to review an interim final rule, “Implementation of the Agriculture Improvement Act of 2018,” which was promulgated by the DEA on August 21. The lawsuit claims the rule is unlawful because it exceeds the DEA’s legal authority and violates the Agriculture Improvement Act of 2018, also known as the farm bill. The petitioners also argue that acting DEA administrator Timothy Shea, who is individually named as a respondent along with the agency, issued the interim final rule without observing procedures required by law.

The DEA’s interim final rule clarifies that all hemp derivatives or extracts exceeding 0.3% THC shall remain Schedule I controlled substances. This could be interpreted to include intermediate hemp derivatives that temporarily exceed 0.3% during processing, but contain less than 0.3% in final products. As such, it improperly establishes the DEA’s authority over legal hemp activities, which is contrary to the plain language and intent of the 2018 farm bill, according to the petitioners.

The petitioners in the lawsuit are RE Botanicals, Inc. and the Hemp Industries Association.

RE Botanicals, Inc. is a hemp manufacturer and retailer based in South Carolina. In 2019, it acquired Palmetto Synergistic Research LLC (dba Palmetto Harmony), which was founded to provide lawful, reliable, and high-quality hemp products.

“We are a small, woman-operated company,” said Janel Ralph, CEO of RE Botanicals. “The DEA’s new rule could put us out of business overnight.”

HIA is a trade association that represents approximately 1,050-member hemp businesses, including approximately 300 hemp processors and individuals involved in, or impacted by, the manufacture, distribution and/or sale of hemp extract and other products lawfully derived from industrial hemp. HIA successfully challenged DEA rulemaking in 2003, when the agency amended federal regulations to include naturally occurring THC within the definition of “synthetic THC,” thereby treating it as a Schedule I substance despite it falling outside the definition of marijuana in the Controlled Substances Act.

“When Congress passed the 2018 farm bill, it explicitly carved hemp and its derivatives out of the Controlled Substances Act so that hemp can be regulated as an agricultural commodity,” said HIA President Rick Trojan. “The DEA’s interim final rule could create substantial barriers to the legal manufacturing of hemp-derived products, a critical component of the hemp supply chain, and devastate the entire hemp industry. Although the DEA states that is not its intention, the rule must be amended to ensure hemp remains an agricultural crop, as Congress intended.”

The petitioners are represented by leading hemp industry attorneys at Vicente Sederberg LLP, Kight Law Office PC, and Hoban Law Group, along with appellate attorneys from Yetter Coleman LLP, which has received national attention for its work against the DEA in the realm of cannabis research.

“The DEA implemented this rule without following proper rule-making procedures, such as providing the public with notice and the opportunity to comment,” said Shawn Hauser, a partner at Vicente Sederberg LLP and chair of the firm’s hemp and cannabinoids practice. “The petitioners believe legal action is necessary to protect the lawful U.S. hemp industry that Congress intended to establish when it enacted the 2018 farm bill.”

DEA releases 2020 Drugs of Abuse Resource Guide

Digital guide issued as a tool for law enforcement, practitioners, and the public

DISTRICT OF COLUMBIA: The U.S. Drug Enforcement Administration has released the 2020 edition of Drugs of Abuse, A DEA Resource Guide, which is designed to be a reliable resource on the most commonly abused and misused drugs in the United States.

Released on a periodic basis, Drugs of Abuse provides important science-based information about the harms and consequences of drug use, describing a drug’s effects on the body and mind, overdose potential, origin, legal status, and other key factors.  In addition, the guide outlines U.S. drug regulation, including drug scheduling and chemical controls.  The 2020 digital edition updates the 2017 Drugs of Abuse publication with the most current information on new and emerging trends in drug misuse and abuse, including fentanyl, marijuana and marijuana concentrates, vaping, and stimulant drugs.

Because education plays a critical role in preventing substance abuse, this comprehensive guide is intended as a tool not just for medical practitioners and law enforcement officials, but also for educators, families, and communities.  Drugs of Abuse also offers a list of additional drug education and prevention resources, including the DEA websites: www.DEA.govwww.getsmartaboutdrugs.com for parents, www.justthinktwice.com for teens, www.campusdrugprevention.gov for colleges and universities, and www.operationprevention.com for school and work curriculum.

USDA, DEA Provide Options For Labs, Disposal Of Non-Compliant Hemp Plants

usda-logoDISTRICT OF COLUMBIA: The U.S. Department of Agriculture (USDA) today announced the delay of enforcement of certain requirements under the interim final rule (IFR) establishing the U.S. Domestic Hemp Production Program.

Under the new guidance, USDA will delay enforcement of the requirement for labs to be registered by the Drug Enforcement Administration (DEA) and the requirement that producers use a DEA-registered reverse distributor or law enforcement to dispose of non-compliant plants under certain circumstances. Enforcement will be delayed starting this crop year and until Oct. 31, 2021, or the final rule is published, whichever comes first.

“Because currently there isn’t sufficient capacity in the United States for the testing and disposal of non-compliant hemp plants, USDA has worked hard to enable flexibility in the requirements in the Interim Final Rule for those issues,” said USDA Under Secretary for Marketing and Regulatory Programs Greg Ibach.

Laboratory Testing

Laboratory testing for the purposes of determining compliance under the U.S. Domestic Hemp Production Program can be conducted by labs that are not yet registered with DEA. The laboratories must still meet all the other requirements in the IFR.

All laboratories engaged in the testing of hemp through this interim period will be subject to the same compliance requirements of the IFR. Specifically, labs must adhere to the standards of performance as outlined within the IFR, including the requirement to test for total THC employing post-decarboxylation or other similarly reliable methods. All labs will have to make arrangements to be compliant with registration requirements before this period of delayed enforcement expires. DEA will evaluate all applications using the criteria required by the Controlled Substances Act (21 U.S.C. 823(f)).

Disposal

Based on feedback from states and tribes, and in consultation with DEA, USDA has identified additional options for the disposal of “hot” hemp plants. Some of these new options include, but are not limited to, plowing under non-compliant plants or composting into “green manure” for use on the same land. The new methods are intended to allow producers to apply common on-farm practices for the destruction of non-compliant plants.

Hemp that tests greater than 0.3% THC on a dry weight basis must be disposed of onsite according to the disposal methods approved by USDA. The state, tribe or the state’s department of agriculture will be responsible for establishing protocols and procedures to ensure non-compliant hemp is appropriately destroyed or remediated in compliance with applicable state, tribal and federal law.

A list of allowed disposal techniques and descriptions is available on the U.S. Domestic Hemp Production Program web page.

“One of the top considerations in making these changes was the desire to provide additional options that minimize, to the extent possible, the resource impact to state and local law enforcement in handling hemp that is out of compliance,” said Under Secretary Ibach.

“We look forward to partnering with producers, states, tribes and other stakeholders to deliver regulations that work for everyone,” said Under Secretary Ibach.