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.

Colorado’s MedPharm Clears Significant DEA Hurdle For Federal Cannabis Research License

COLORADO: MedPharm Research, the leader in cannabis research and formulation development, was notified by the Drug Enforcement Administration (DEA) that it had been selected to move forward as one of the first applicants to be granted a license to grow federally legal cannabis under the terms of a new policy statement issued today in the Federal Register.

“This is something we have been waiting for since we first sent in our application in September, 2016, as one of the first medical grow facilities to apply for a license,” Albert Gutierrez, CEO of MedPharm, said. “Now, finally, the DEA has seen the importance of allowing federally legal grows to get more active in medical cannabis research, and do the work that we really need to do for patients across the country. It is a real game-changer for the whole medical cannabis industry.”

In a letter to Gutierrez, the DEA stated that MedPharm will be issued a Notice of Proposed Rule-making, where the company will be asked to comment on regulations about growing cannabis for medical research. However, the DEA has not provided a timetable for when those regulations will be completed. “We at MedPharm stand ready to assist the DEA in any way we can to help expedite this process, and bring to patients the best quality, FDA-approved cannabis that they need for research and treatment as quickly as possible,” said Gutierrez.

According to the University of Mississippi News, in 1968, the Research Institute of Pharmaceutical Sciences at the University of Mississippi School of Pharmacy was awarded a competitive contract from the government to grow marijuana that could be standardized for research. For over 50 years, it has remained the only cultivation facility licensed by the DEA to provide federally legal cannabis for medical researchers, who have reported that cannabis from the university is of such poor quality that it is essentially useless in conducting the lab work and human trials necessary for a reliable FDA-approved medical research.

As more medical cannabis research ramped up, a growing group of medical cannabis researchers pressured the DEA to open up licensing to other facilities. Then, in August, 2016, the DEA stated that they would begin accepting applications for companies wanting licenses for legal grows, but nothing more happened until this June, when one of the applicants sued the DEA for unreasonable delays, prompting today’s response.

MedPharm is well-positioned to work with the DEA and be among the first providers of federally legal cannabis for medical research. The application for the license included outlining research objectives and creating areas where medical research cannabis is grown specifically for research purposes.

DEA Announces Steps Necessary To Improve Access To Marijuana Research

DISTRICT OF COLUMBIA: The Drug Enforcement Administration today announced that it is moving forward to facilitate and expand scientific and medical research for marijuana in the United States. The DEA is providing notice of pending applications from entities applying to be registered to manufacture marijuana for researchers. DEA anticipates that registering additional qualified marijuana growers will increase the variety of marijuana available for these purposes.

Over the last two years, the total number of individuals registered by DEA to conduct research with marijuana, marijuana extracts, derivatives and delta-9-tetrahydrocannabinol (THC) has increased by more than 40 percent from 384 in January 2017 to 542 in January 2019. Similarly, in the last two years, DEA has more than doubled the production quota for marijuana each year based on increased usage projections for federally approved research projects.

“I am pleased that DEA is moving forward with its review of applications for those who seek to grow marijuana legally to support research,” said Attorney General William P. Barr.  “The Department of Justice will continue to work with our colleagues at the Department of Health and Human Services and across the Administration to improve research opportunities wherever we can.”

“DEA is making progress in the program to register additional marijuana growers for federally authorized research, and will work with other relevant federal agencies to expedite the necessary next steps,” said DEA Acting Administrator Uttam Dhillon.  “We support additional research into marijuana and its components, and we believe registering more growers will result in researchers having access to a wider variety for study.”

This notice also announces that, as the result of a recent amendment to federal law, certain forms of cannabis no longer require DEA registration to grow or manufacture. The Agriculture Improvement Act of 2018, which was signed into law on Dec. 20, 2018, changed the definition of marijuana to exclude “hemp”—plant material that contains 0.3 percent or less delta-9 THC on a dry weight basis. Accordingly, hemp, including hemp plants and cannabidiol (CBD) preparations at or below the 0.3 percent delta-9 THC threshold, is not a controlled substance, and a DEA registration is not required to grow or research it.

Before making decisions on these pending applications, DEA intends to propose new regulations that will govern the marijuana growers program for scientific and medical research. The new rules will help ensure DEA can evaluate the applications under the applicable legal standard and conform the program to relevant laws. To ensure transparency and public participation, this process will provide applicants and the general public with an opportunity to comment on the regulations that should govern the program of growing marijuana for scientific and medical research.

The Notice of Application is available here:

US Attorney General Jeff Sessions Resigns

DISTRICT OF COLUMBIA: United States Attorney General Jeff Sessions on Wednesday announced his resignation from the Justice Department.

Sessions was a longstanding, vocal opponent of marijuana policy reform, who once opined, “Good people don’t smoke marijuana.” As Attorney General, his office rescinded the 2013 Cole memorandum which directed prosecutors not to interfere in state-sanctioned marijuana activity. However, that action encouraged numerous members from both parties to strongly criticize the office, and eventually led to the introduction of The Strengthening the Tenth Amendment Through Entrusting States (STATES) Act of 2018 – bipartisan House and Senate legislation that seeks to protect jurisdictions that have legalized marijuana from federal intervention.

Sessions’ chief of staff Matt Whitaker will serve as acting Attorney General until a permanent appointment is confirmed.


For more information, contact Justin Strekal, NORML Political Director, at (202) 483-5500.

 

Tilray Gets DEA OK To Import Medical Cannabis Study Drug For Clinical Trial At University Of California San Diego Center For Medicinal Cannabis Research

CANADA: Tilray has announced that the U.S. Drug Enforcement Administration (DEA) has granted approval to import a cannabinoid study drug into the United States from Canada for a clinical trial at the University of California San Diego (UC San Diego) Center for Medicinal Cannabis Research (CMCR) examining its safety, tolerability and efficacy for Essential Tremor (ET).

Agreement represents major milestone recognizing medical cannabis as a conventional medicine for patients in need

Tilray is providing a cannabinoid formulation for the trial in capsule form, which will allow researchers to test an investigational drug product containing two active ingredients extracted from the cannabis plant, cannabidiol (CBD) and tetrahydrocannabinol (THC). Dr. Fatta Nahab, a board-certified neurologist and director of the Functional Imaging of Neurodegenerative Disorders Lab at the UC San Diego Health’s Movement Disorder Center, will serve as the principal investigator for the study. It is expected to begin in early 2019 with financial support from Tilray and the International Essential Tremor Foundation.

“Tilray is proud to support this crucial research,” says Dr. Catherine Jacobson, Director of Clinical Research at Tilray. “If this study can identify cannabinoids as a potential treatment for patients suffering from essential tremor, we can conduct further research and potentially provide alternative effective methods of relief for the high numbers of patients with ET.”

Essential Tremor is a neurological movement disorder characterized by involuntary and rhythmic shaking. ET has extremely high prevalence rates; 0.4% of the general population suffer from ET, and that figure rises to 4.6% to 6.3% among those 65 and older. Essential Tremor can have a significant impact on a patient’s quality of life, causing embarrassment, social withdrawal, disability, and loss of occupation. Many patients do not experience relief with the current drugs on the market or find the side-effects of these drugs to be unbearable.