The federal government is looking to contract a small business to grow, test, store and ship thousands of kilograms of marijuana of varying potencies and concentrations.
No, really. The contract notice was published on the site Federal Business Opportunities last week—not long after a similar listing called for applications from prospective federal joint rollers. The new posting seems quite a bit more comprehensive, though.
The National Institute on Drug Abuse (NIDA) is soliciting “capability statements” from businesses with the space and technology to produce, analyze and distribute cannabis and cannabis products “for research purposes.”
That’s probably in the agency’s best interest. After all, the government has been roundly criticized for failing to expand its marijuana production to meet demand. Since 1968, just one farm at the University of Mississippi has been federally authorized to cultivate cannabis for research purposes—a monopoly the government has taken some steps toward breaking, although it has faced resistance from now-former U.S. Attorney General Jeff Sessions.
Experts have also raised questions about the quality of the “research-grade” cannabisproduced for federal research, as it seems to be significantly less potent and chemically diverse than the flower consumers are getting in legal states.
The listing makes clear that NIDA wants a decently large cultivation operation, including both indoor and outdoor grows. It also emphasized the need to develop marijuana with varying concentrations of THC, CBD and other cannabinoids. Whatever business receives the contract will also be tasked with developing cannabis extracts like oils, capsules and “vaping fluids.”
Here are the full job responsibilities listed on the notice:
-Grow, harvest, process, analyze, and store marijuana for research purposes or procure marijuana and marijuana products from existing commercial enterprises, including from qualified foreign sources, as required by the Contracting Officer’s Representative (COR) to meet program needs.
-Process marijuana to produce a range of standardized and pure extracts containing varying ratios (high, low and equal ratios) of tetrahydrocannabinol (THC) and cannabidiol (CBD) including pure (>99%) delta-9-THC, CBD, and other cannabinoids.
-Store and maintain quality of products, including periodic analyses required to obtain and maintain Food and Drug Administration (FDA) quality requirements for Investigational New Drug (IND) research.
-Develop new methods for growing marijuana plants containing high THC and low CBD; high CBD and low THC; equal ratios of CBD and THC; and placebos as directed by the COR.
-Manufacture standardized marijuana cigarettes.
-Manufacture Current Good Manufacturing Practice (CGMP) human-use marijuana extracts and dosage forms of marijuana extracts (including but not limited to oral solutions, oils, vaping fluids, capsules/tablets) within a range of varying concentrations of delta-9-THC and CBD, and analyze their strength and stability at various intervals.
-Maintain a secure shipping facility, ship marijuana and marijuana products, and establish billing and accounting procedures to allow the collection of fees from product recipients as authorized by NIDA.
There are some basic requirements that applicants have to meet in order to be selected for the job, though. For example, they must prove that they can obtain the necessary licenses to work with controlled substances and also be able to maintain a facility capable of supporting “production of up to 2000 kg of marijuana” and storing “approximately 5000 kg of marijuana stock.”
That’s a lot of federal ganja…
If this sounds like the kind of project your business is willing and able to handle, the deadline to respond to the notice is December 10.
See the original article published on Marijuana Moment below:
Feds Seek New Growers To Produce Thousands Of Kilograms Of Marijuana
Tetrahydrocannabinol (THC)—the marijuana compound known for getting you high—is the most well-know cannabis constituent. In recent years, cannabidiol (CBD) has garnered attention for its non-intoxicating medicinal properties.
Now, the federal government is recruiting researchers to investigate how the dozens of other lesser-known cannabinoids and terpenes work and whether they can treat pain.
It’s going to be a weighty task for any interested parties. There are more than 110 known cannabinoids and 120 terpenes, very few of which have been extensively studied. The federal research project will cover all “minor cannabinoids,” which is defined as anything other than THC, according to a pair of funding notices published by the National Center for Complementary and Integrative Health this week.
“The mechanisms and processes underlying potential contribution of minor cannabinoids and terpenes to pain relief and functional restoration in patients with different pain conditions may be very broad,” the notices state. “This initiative encourages interdisciplinary collaborations by experts from multiple fields—pharmacologists, chemists, physicists, physiologists, neuroscientists, psychologists, endocrinologists, immunologists, geneticists, behavioral scientists, clinicians, and others in relevant fields of inquiry.”
Numerous studies have established that ingredients in marijuana such as THC and CBD effectively treat various types of pain. There’s also some evidence that other cannabinoids and terpenes contribute to the therapeutic efficacy of cannabis, working synergistically to bolster the plant’s overall benefits—a phenomenon called the “entourage effect.”
But there’s still a lot of work to be done to fully understand the mechanisms through which each cannabinoid and terpene influences pain. If researchers can pinpoint which ingredients are best suited for pain relief, it could inform new therapies. For example, there’s evidence that certain cannabinoids can enhance the pain-relieving effects of opioids, the notice states, so discovering exactly which ones achieve that end can hypothetically help patients take lower doses of addictive painkillers.
“The development or identification of novel pain management strategies is a high priority and unmet need. Natural products have historically been a source of novel analgesic compounds developed into pharmaceuticals (e.g., willow bark to aspirin). A growing body of literature suggests that the cannabis plant may have analgesic properties; however, research into cannabis’s potential analgesic properties has been slow.”
In addition to CBD, the feds say they are particularly interested in research on the following compounds: cannabigerol (CBG), cannabinol (CBN), cannabichromene (CBC), myrcene, ß-caryophyllene, limonene, a-terpineol, linalool, a-phellandrene, a-pinene, ß-pinene, terpinene and a-humulene.
The estimated deadline to submit an application for research funding is March 8, 2019.
See the original article published on Marijuana Moment below:
The Feds Want Researchers To Study ‘Minor’ Cannabinoids And Terpenes In Marijuana
Mailing numerous cannabinoid samples to U.S. courts and the Department of Justice was a key part of one man’s convoluted lawsuit strategy against the federal government that relied on an obscure Confederate-era statute, court filings show.
Oh, right. This requires some explanation. So, it’s not entirely clear what the end-game in this case was meant to be, but the essential facts are as follows: a man named Jeffrey Nathan Schirripa filed suit in the U.S. Court of Federal Claims, alleging that the government failed to hold up its end of a contract that, in a roundabout way, he attempted to force upon it.
Schirripa first sent cannabinoid samples to the Justice Department and a U.S. district court in 2015 to lay the groundwork for a theoretical “contract” between himself and the government, according to the filings. But the court “dismissed the complaint for lack of subject-matter jurisdiction and for failure to state a claim upon which relief can be granted.”
Then, in an apparent effort to “prove the existence” of a contract, Schirripa attached unspecified parts of marijuana to 18 copies of a confidential petition for rehearing this year. Schirripa seemed to believe that he was creating “subject matter jurisdiction,” a necessary component of an implied unilateral contract that he said the government violated.
The court did not agree that unsolicited mailings of controlled substances constituted the relevant subject matter in an implied contract, though. On Monday, it filed this order:
“The Clerk of Court is directed to transmit these 18 documents to the U.S. Marshals Service for appropriate disposition or alternate action within the purview of the U.S. Department of Justice.”
The judges explained that the specific U.S. statute that Schirripa used as the basis of his subject matter claim was enacted in 1861, and it was exclusively designed to “weaken the Confederate States by authorizing the President to seize property aiding the Confederacy in its insurrection.” In other words, it didn’t apply here.
In his petition for rehearing, Schirripa included a flow chart visualizing of his intended logic.
It starts with the fact that he sent prototypes of “neuroprotecting antioxidants” to members of the U.S. Court of Appeals for the Federal Circuit. Schirripa admits that sending the “gifted” substances directly violated the Controlled Substances Act. So far, so good.
But from there, the petitioner seems to suggest that in both possible scenarios he presents—that the law can be enforced against him for mailing a controlled substance or that it can’t and so the cannabinoids are therefore “subject to prize/capture”—he’s proven to be an “interested party,” thereby validating his claim that the government breached an implied unilateral contract.
“I don’t fully understand the Schirripa’s flow chart, but it appears to be a boot-strap version a catch-22 for the court—the type of argument that you might figure out while high,” Dennis Crouch, a law professor at the University of Missouri School of Law, wrote in a blog post about the case.
The court seemed to agree. The statutes upon which Schirripa rested his contract theory “have no relation to any contract theory or any government bid or procurement practice,” the judges ruled in their denial of his rehearing. “The Court of Federal Claims thoroughly considered Mr. Schirripa’s arguments and theories, and fully explained their inapplicability.”
The appeals process might not have worked out, but it’s hard to imagine that Schirripa will be totally deterred. This marks his third appeal on “related actions” since 2014, court documents show. The legal logic of an implied unilateral contract didn’t hold up this time, but Schirripa—who has described himself as “the world’s most qualified expert in the realm of Cannabinoid Reform”—seems to be nothing if not tenacious.
Thousands Respond To FDA’s Marijuana Rescheduling Comment Request
See the original article published on Marijuana Moment below:
Man Sends Marijuana Samples To Feds… To Make A Legal Point
In 1978, the federal government of the United States launched the Compassionate Investigational New Drug (IND) Program, an initiative intended to provide medical cannabis grown by the government to those with serious diseases and health issues — for life. The program, however, wasn’t launched as a result of a curiosity regarding the medicinal efficacy of cannabis on the part of the nation’s leaders. Rather, it was the culmination of two lawsuits by Robert Randall, a pioneering patient from Sarasota, Florida.
In 1976, Randall sued the government and won in a federal court the right to use medical cannabis to treat his glaucoma. A Federal District Court ruled that Randall’s use of marijuana was a necessity for his health. In fact, it was this case that established the precedent of medical necessity as a plausible legal defense for prosecuted patients. However, according to the New York Times:
“Two years later, the government cut off his access to the drug, but he sued for reinstatement and won.”
Randall’s second legal battle and victory resulted in the creation of the Compassionate IND Program, which — although it serves a very small number of patients — is still in effect today. Roughly 1,200 low-quality cannabis joints (cigarettes) are distributed to patients around the United States each month.
Although Randall died in June 2001, several other patients continue to each month receive large tins containing 300 low-grade pre-rolled joints from the federal government. The cannabis is grown on a farm at the University of Mississippi that has been managed by the National Institute on Drug Abuse (NIDA) since 1968. Unfortunately, the Bush administration closed enrollment to the IND Program in 1992. Existing participants, however, remain within the program until death and continue to receive their canisters of low-THC cannabis joints.
Many are shocked to learn of this 37-year-old program and its participants. Upon first gaining knowledge of the program, it is easy to dismiss the story as an urban legend or internet clickbait. What is most problematic, however, is the hypocrisy illustrated by this effort. While government officials can arguably defend themselves by noting that it was a court decision that forced them to begin producing and delivering cannabis medicine to a small group of patients, the fact that cannabis continues to be categorized as Schedule I by the federal government is a blatant example of illogical and hypocritical public policy.
The FDA doesn’t reveal the number of patients participating in the IND Program, but some believe that between two and four remain. Two of these patients reside in Florida, including Irvin Rosenfeld, a 61-year-old stockbroker who has a tumor disorder, and Elvy Musikka, a 72-year-old glaucoma sufferer and cannabis legalization activist.
Rosenfeld began receiving cannabis under the program in 1982 and has written a book about his experience entitled My Medicine, the cover of which features him holding a large tin of low-grade government joints from the Compassionate IND program (grown on the NIDA-managed farm). He is probably the most publicized and interviewed of the participants. Echoing the perception that the government’s actions are hypocritical, Rosenfeld said:
“The United States federal government has been supplying me 10 marijuana cigarettes per day for almost 33 years, and in the same vein arresting people for possessing marijuana they give me for medical use.”
Rosenfeld uses cannabis to treat a rare bone tumor disease and has calculated his consumption of legal government cannabis over more than three decades, estimating that he has smoked more than 120,000 joints provided by the government’s pot farm at the University of Mississippi. Mussika, who has been highly critical of the IND Program and prohibition overall, notes that many federal lawmakers are completely unaware of this program.
“They’re very surprised — [most] didn’t know the government ever supplied anybody,”
Irvin Rosenfeld smoking one of the cannabis joints provided to him by the U.S. Government.
Until the government allows robust clinical research and human trials into the therapeutic benefits of medical cannabis, access to the drug for patients in states that have yet to legalize adult use will lag. It is currently the Schedule I status of cannabis that officially categorizes it as a highly addictive and dangerous drug with zero medical value (along with bath salts and heroin). Schedule II, a Controlled Substances Act category intended for less dangerous drugs, features methamphetamine and cocaine, both of which can be prescribed by a physician.
Because of its Schedule I status, doctors — even those in states with medical or adult use laws — cannot prescribe cannabis. Instead, they are limited to writing a recommendation. Many medical cannabis advocates are insisting on a Schedule III categorization, or lower, to ensure that ample research can be conducted that involves human trials and high-quality cannabis, such as that which can be purchased in states like Washington, Oregon, and Colorado.
Eventually, attrition will dwindle the patient population of the Compassionate IND Program to nothing and it will cease to exist. Although this will reduce the government’s hypocrisy, it will do little to provide safe access to cannabis medicine for millions of sick patients like Rosenfeld and Mussika.
“If I didn’t have my medical marijuana, most likely I’d be dead. If I was still alive, I’d be on disability and homebound. Instead, I’m a stockbroker here in Fort Lauderdale.”
Photo credit: wptv.com; philly.com