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.

Statement From FDA Commissioner Scott Gottlieb On Researching Medical Uses Of Cannabis

By Scott Gottlieb, MD

DISTRICT OF COLUMBIA: Over the past decade, we’ve seen a growing interest in the development of therapies derived from marijuana and its components. Proponents of “medical marijuana” advertised its uses for a wide number of medical conditions, such as cancer, multiple sclerosis, post-traumatic stress disorder and anxiety – just to name a few of the touted conditions. The FDA has been supportive of research in this area for many years. But marijuana is a Schedule I compound with known risks. Research to demonstrate that marijuana or its components could be safe and effective in the treatment of medical disorders should be held to the same standard as other drug compounds. And certainly it should not be held to a lower standard, as some proponents would suggest. The FDA has an active program to assist drug developers who want to investigate marijuana or its components through properly controlled clinical trials, to demonstrate the potential for safe and effective uses.

Today, the FDA approved a purified form of the drug cannabidiol (CBD). This is one of more than 80 active chemicals in marijuana. The new product was approved to treat seizures associated with two rare, severe forms of epilepsy in patients two years of age and older.

This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. This new treatment provides new options for patients.

This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.

So today, in addition to celebrating this scientific achievement and the medical advance that it represents for these patients and their families, we should also reflect on the path that made this possible. It’s a path that’s available to other product developers who want to bring forth marijuana-derived products through appropriate drug development programs.

That pathway includes a robust clinical development program, along with careful review through the FDA’s drug approval process. This is the most appropriate way to bring these treatments to patients. This process also includes a review of the purity of a new drug and manufacturing controls. Before a high-quality drug can be developed, evaluated, and eventually approved by the FDA; it’s critical that the necessary work is done to identify drugs of potential medical benefit and conduct rigorous scientific research through adequate and well-controlled clinical trials. This is true for all drugs, including ones derived from plant materials, like marijuana. And the FDA remains committed to collaborating with federal and state agencies, researchers and product developers on advancing this type of important and conscientious work.

This research process – from early development through preclinical and clinical research – gives us a comprehensive understanding of a new drug. That includes an understanding of whether the new product is safe and effective for treating a particular medical condition, what the proper dosage is and for what populations it is safe and effective, how the new compound could interact with other drugs, or whether the new drug has side effects or other safety concerns.

This work also helps product developers identify the appropriate dosage needed to achieve the desired therapeutic effect while minimizing toxicity and risk. Taken in totality, the scientific evidence generated by these studies forms the basis of the FDA’s evaluation of benefit versus risk. And it’s because of this careful, scientific and evidence-based evaluation by the FDA that health care providers can rely on having a quality product that delivers a consistent, uniform dose of an effective medication that is able to deliver a predictable treatment to patients. This is especially important when considering treatment for serious medical conditions that will be utilized in the clinical care of patients who may have any number of health vulnerabilities. The purified form of the drug CBD approved today by the FDA has been shown to meet these rigorous standards.

Research on the therapeutic effects of marijuana and its components involves a number of federal agencies in addition to the FDA, including the National Institute on Drug Abuse, part of the National Institutes of Health, and the Drug Enforcement Administration.

MMJ International Holdings Pursuing Legal FDA Cannabis Medicine Approval

MMJ International Holdings Pursuing Legal FDA Cannabis Medicine Approval

The FDA has taken several specific steps to support this research.

We meet regularly with researchers as they plan and carry out their trials. We have also formed a Botanicals Team that provides scientific expertise on botanical issues for researchers developing drugs derived from plants, such as marijuana. That team published guidance for industry on clinical studies involving botanical drugs, as well as quality controls for lot-to-lot consistency. In recent years, the agency also has recommended to the DEA the approval of several hundred Schedule I research protocol licenses for research on marijuana or its constituent compounds.

Additionally, the FDA also works with companies to provide patients access to experimental therapies while clinical trials are ongoing through expanded access provisions. These approaches help protect patients while also allowing for the collection of data necessary to support the FDA approval of safe and effective therapies for use in the broader population. Through this process, hundreds of children were able to get access to investigational CBD products while this product was being studied.

Drugs derived from marijuana also are eligible for several programs that are intended to facilitate and expedite development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions. Much of the work we’ve done to encourage research in this area has led to the approval action we took today.

The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels. However, we remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims.

The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. The FDA has taken recent actions against companies distributing unapproved CBD products. These products have been marketed in a variety of formulations, such as oil drops, capsules, syrups, teas, and topical lotions and creams. These companies have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientific evidence to support such claims. We’ll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims. We’re especially concerned when these products are marketed for serious or life threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other therapies that have proven benefits.

Today’s approval demonstrates our commitment to the scientific process and working with product developers to bring marijuana-based products to market. We remain committed to our gold standard for product development and review. Such a process ensures that any new therapies from marijuana and its constituents are safe, effective and manufactured to a high and consistent quality. And most importantly, that these products have been proven safe and effective for patients.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

DEA: Marijuana Seizures Fell Nearly 40 Percent In 2017

DISTRICT OF COLUMBIA: Seizures of indoor and outdoor cannabis crops in the United States fell nearly 40 percent between 2016 and 2017, according to annual data compiled by the US Drug Enforcement Administration.

According to figures published in the DEA’s Domestic Cannabis Eradication/Suppression Statistical Report, the agency and its law enforcement partners confiscated an estimated 3.38 million marijuana plants nationwide in 2017. This total represents a 37 percent decrease from the agency’s 2016 totals, when it eradicated some 5.34 million plants.

As in past years, the majority of seizures nationwide (72 percent) took place in California, where law enforcement seized and estimated 2.45 million plants. That total was 35 percent lower than in 2016, when law enforcement confiscated an estimated 3.78 million plants. California voters in November 2016 legalized adult use marijuana possession, cultivation, and sales.

Law enforcement seized 472,927 plants in Kentucky (down 15 percent from 2016), 74,599 plants in West Virginia (down 40 percent), 62,323 plants in Arkansas (up 93 percent), 60,658 plants in Indiana (up five percent), and 34,646 plants in Tennessee (down 73 percent).

The agency and its partners reported making 4,502 arrests in conjunction with their cannabis eradication efforts – a 20 percent decline from 2016.

The DEA also reported seizing some $20.5 million in assets during their confiscation efforts – a 60 percent reduction from the previous year.


Full data from the DEA’s 2017 report, as well as past years’ reports, are available online. For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org.

DEA Clarifies Stance: Not All CBD Is Prohibited

Drug Enforcement Administration confirmed this month that CBD does not fall under the Controlled Substances Act

CALIFORNIA: The Drug Enforcement Administration (DEA) has issued a statement further clarifying their interpretation and enforcement of the Controlled Substances Act (CSA). In their statement, they make clear the critical difference between CBD and THC, a distinction that cannabidiol retailers have been fighting to bring to light.

The DEA agrees that the CSA targets marijuana specifically because of the psychoactive properties found in THC, its primary active ingredient. Because THC is an intoxicating agent, and CBD is not, the DEA now sees fit to clarify that “Products and materials that are made from the cannabis plant and which fall outside the CSA definition of marijuana… are not controlled under the CSA. Such products may accordingly be sold and otherwise distributed throughout the United States without restriction under the CSA.”


“Products and materials that are made from the cannabis plant and which fall outside the CSA definition of marijuana… are not controlled under the CSA. Such products may accordingly be sold and otherwise distributed throughout the United States without restriction under the CSA.”


The statement by the DEA now means that:

  • CBD may be imported/exported to and from the USA without restriction, and;
  • CBD may be lawfully purchased and sold throughout the country

Although in practice this was already the case, there was a perceived gray area due to widespread misunderstanding and conflation of CBD versus THC as well as the effects (or lack thereof) of each compound.