In Hemp 109 we discuss what the Trump Administration is doing to discourage or slow down the development of medical marijuana for the benefit of Big Pharma and the mixed signals it is presenting regarding the subject, that despite President Donald Trump coming out in favor of state regulation of medical marijuana, Attorney General Jeff Sessions withdrew the Cole Memorandum that previously gave medical marijuana some protection from federal prosecution, and Sessions blocked new applications to grow FDA approved cannabis for medical research. We also discuss how the DEA has from time to time violated the law by raiding CBD distributors, and how the intent of Congress in passing the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014 is to allow CBD to be marketed to customers in all states and territories.
Attorney General Jeff Sessions was an historical opponent of anything cannabis.
Big Pharma is at war with medical marijuana and cannabidiol (CBD). Supporting Big Pharma requires protecting Big Pharma from accepting its responsibility for the opioid epidemic. Supporting Big Pharma requires making it harder for the Drug Enforcement Administration (DEA) to limit Big Pharma’s ability to distribute excessive amounts of opioids in small communities where the supply far exceeds the prescribed demand. Supporting Big Pharma requires discouraging and impeding the growth of medical marijuana and CBD because they both show promise in treating a variety of medical conditions in a superior way to much more dangerous pharmaceutical drugs.
Without question, Attorney General Jeff Sessions is out of touch with cannabis and makes no distinction between marijuana that gets you high and industrial hemp that has no euphoric effect. Two of Sessions famous quotes referencing marijuana are, “Good people don’t smoke marijuana,” and “I thought those guys [in the Ku Klux Klan] were okay until I learned they smoked pot.”
President Trump's Attorney General Jeff Sessions is behind the times when it comes to marijuana or anything cannabis.
Marijuana is not a significant gateway drug.
Sessions wrongfully sees marijuana as a “gateway” drug, having said, “It is false that marijuana use doesn’t lead people to more drug use. It is already causing a disturbance in the states that have made it legal.” Sessions gives no credit to the two primary gateway drugs, alcohol and tobacco. Recent studies indicate marijuana is not the primary gateway drug or that the use of marijuana necessarily leads to the use of harder drugs.
In 1999, the Institute of Medicine of the National Academy of Sciences wrote in a report commissioned by Congress,
“In the sense that marijuana use typically precedes rather than follows initiation of other illicit drug use, it is indeed a “gateway” drug. But because underage smoking and alcohol use typically precede marijuana use, marijuana is not the most common, and is rarely the first, ‘gateway’ to illicit drug use. There is no conclusive evidence that the drug effects of marijuana are causally linked to the subsequent abuse of other illicit drugs.”
And as reported in an October 29, 2010 Time magazine article,
“[N]umerous other studies have failed to support the gateway idea. Every year, the federal government funds two huge surveys on drug use in the population. Over and over they find the number of people who try marijuana dwarfs that for cocaine or heroin. For example, in 2009, 23 million people reported trying pot – compared with 617,000 who tried cocaine and 180,000 who tried heroin.”
If there is any gateway effect, then legalizing marijuana helps curb that gateway effect because then marijuana smokers need not associate with the criminal element who may seek to introduce them to methamphetamine, cocaine or opioid drugs.
Being in favor of legalized cannabis is not childish.
To Sessions, those who favor the legalization of marijuana are simply being childish. He claimed before the United States Senate, “[W]e need grown-ups in charge in Washington to say marijuana is not the kind of thing that ought to be legalized. It ought not to be minimized, that it’s in fact a very real danger. Lives will be impacted. Families will be broken up. Children will be damaged because of the difficulties their parents have, and people may be psychologically impacted the rest of their lives with marijuana.”
The biggest breakup of families caused by marijuana is when a family member is arrested for possessing marijuana and hauled off to jail. If Sessions wants to break up families, then he is on the right track. If Sessions and the Trump administration want to honor the will of the people and Trump’s previous campaign pledges, then they will back off.
Female Republicans are more likely to support the legalization of marijuana than male Republicans.
Donald Trump said he would leave legalization of marijuana up to the individual states.
According to a February 28, 2017 article in Politifact, Trump historically favored drug legalization and while running for president pledged to leave marijuana legalization up to the states. According to Politifact's research,
“Long before running for president, Trump voiced strong opinions on drug legalization. In April 1990, in an article in the Sarasota Herald-Tribune, Trump said the United States should legalize drugs and use the money collected to educate the public on the dangers of drug use. ‘We're losing badly the war on drugs,’ Trump said at the time, ‘You have to legalize drugs to win that war. You have to take the profit away from these drug czars.’”
A 45-year-old Donald Trump favored the legalization of all drugs to take the profit out of dealing in illicit drugs.
After beginning his run for president, Donald Trump came out in favor of states being able to legalize marijuana without federal interference. According to the same Politifact article,
“In a television interview on July 29, 2016 with KUSA-TV in Colorado, Trump said, ‘I wouldn’t do that [using federal authority to shut down recreational marijuana], no … I wouldn’t do that … I think it’s up to the states, yeah. I’m a states person. I think it should be up to the states, absolutely.’
“In a radio interview with WWJ Newsradio 950 in Michigan on March 8, 2016, Trump said, ‘I think it certainly has to be a state — I have not smoked it — it’s got to be a state decision . . . I do like it, you know, from a medical standpoint . . . it does do pretty good things. But from the other standpoint, I think that it should be up to the states.’
“At a campaign rally in Sparks, Nevada on Oct. 29, 2015, Trump said, ‘The marijuana thing is such a big thing. I think medical should happen – right? Don’t we agree? I think so. And then I really believe we should leave it up to the states. It should be a state situation . . . but I believe that the legalization of marijuana – other than for medical because I think medical, you know I know people that are very, very sick and for whatever reason the marijuana really helps them . . . but in terms of marijuana and legalization, I think that should be a state issue, state-by-state.’”
On October 29, 2015, Donald Trump at a campaign rally in Sparks, Nevada, said he believes in medical marijuana, but since becoming president, Trump has acted in the interests of Big Pharma.
Sessions remains locked in the past.
As for Jeff Sessions, he remains locked in the past as he told reporters on February 27, 2017, "States they can pass the laws they choose. I would just say it does remain a violation of federal law to distribute marijuana throughout any place in the United States, whether a state legalizes it or not." What Sessions does not say is that President Trump has the power to unilaterally deschedule any drug and take it off the list of controlled substances, and Sessions, as the Attorney General could begin the legislative process to deschedule marijuana, which would inevitably pass, but he has failed to do so because he does not want to do so. So marijuana remains illegal based in part on decisions being made by President Donald Trump and his former Attorney General, Jeff Sessions.
On November 7, 2018, Jeff Sessions resigned after being requested to do so by President Trump who was angered because Sessions followed the advice of the Department of Justice's ethics counsel and recused himself from overseeing Robert Mueller's investigation into Russian interference in the 2016 elections. Trump then appointed Matthew Whitaker as interim Attorney General. Whitaker had previously shown himself to be a Trump loyalist, and he refused to recuse himself from overseeing the Robert Mueller investigation contrary to the recommendation of the Department of Justice's ethics counsel. On February 15, 2019, William Barr, who had previously been Attorney General for two years during President George H.W. Bush's administration, was confirmed as Trump's new Attorney General.
According to Forbes, "During his confirmation hearings Barr said that he would not use federal resources to enforce federal marijuana laws in states that have legalized." Weed, J. (2019, Feb. 15). Optimism Mixes With Distrust: Cannabis Industry Reacts to Trump's New Attorney General. Forbes. Retrieved from: https://www.forbes.com/sites/julieweed/2019/02/15/optimism-mixes-with-distrust-cannabis-industry-reacts-to-trumps-new-attorney-general/#2db839ee2496. However, "According to Barr’s statements there is little chance he will legalize marijuana at the federal level." Id.
Without question, marijuana could have been descheduled during President Obama’s administration, but a majority of Americans did not want to legalize marijuana until Obama’s second term, and had Obama, or Attorney General Eric Holder, or Attorney General Loretta Lynch, moved to legalize marijuana, they would have inevitably been accused of doing so not because of the science, but because they were black Americans representing the black community.
Without the guidance of Congress or the President, the people moved forward, and medical marijuana has been made legal by initiative actions in 28 states. In only two states, Connecticut and Delaware, has medical marijuana been legalized by legislative action. Medical and recreational marijuana have been successful in those states where it has been legalized.
A number of declared and prospective 2020 Democratic presidential candidates, Cory Booker, Kristen Gillibrand, Kamala Harris, Beto O'Rourke, Bernie Sanders, and Elizabeth Warren (in alphabetical order) have indicated they would be comfortable with marijuana being legalized on a federal level while leaving the matter up to the states. In one of the more amusing antidotes, when Kamala Harris was asked whether she had ever smoked marijuana, she admitted she had and said, "It gives a lot of people joy, and we need more joy."
California Senator and 2020 Presidential Candidate Kamala Harris when asked if she was opposed to legalizing pot said, ". . . half my family's from Jamiaca. Are you kidding me?"
On February 15, 2019, Senate Minority Leader Chuck Schumer (D-NY) announced he will submit a bill to the Senate aimed at decriminalizing marijuana.
There are six major reasons why marijuana has been allowed to flourish by the federal government in states where it has been legalized. First, medical marijuana and CBD actually work medically. Second, none of the feared dangers have come to fruition even when marijuana has been legalized for recreational purposes. Third, marijuana’s legalization has brought in new taxes. Fourth, jobs have been created. Fifth, legalization has removed marijuana from the criminal element. Sixth, in the total scheme of things, there are hundreds of more important “crimes” requiring the attention of federal and state authorities. Sessions may have thought marijuana was “dangerous,” but the vast majority of people, including many in law enforcement, are tired of all the fuss and dollars spent to punish people for being involved with a relatively harmless plant that has served mankind well for over 5000 years.
Marijuana is now smoked by millions of ordinary people, easily tolerated by many millions more, and for many millions of people, cannabis, whether marijuana or hemp, provides medical relief sometimes on a level that cannot be replicated by any prescription drug, and almost never can prescription drugs act with the same level of safety. Almost two-thirds of American voters think marijuana should be legal, and 94 out of every 100 American voters think medical marijuana should be legal. It is just a matter of time until the law catches up with the will of the people, and that is happening at a record pace.
The federal government does not completely accept the changes brought about by the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014.
On February 7, 2014, President Barack Obama signed the Agricultural Act of 2014 which contained a section entitled Legitimacy of Industrial Hemp Research, 7 U.S.C. § 5940. The language of 7 U.S.C. §5940(a) begins with the words, “Notwithstanding the Controlled Substances Act (21 U.S.C. 801 et seq.), chapter 81 of title 41, or any other Federal law, an institution of higher education [ ] a State department of agriculture may grow or cultivate industrial hemp . . .”], and the Legitimacy of Industrial Hemp Research section makes clear industrial hemp products when the hemp is initially grown pursuant to 7 U.S.C. § 5940 are exempt from the Controlled Substances Act, 21 USC 801, et seq. Nothing made from industrial hemp, including extracted CBD, can be considered a controlled substance if the industrial hemp from which it is made or extracted is grown pursuant to a state sanctioned pilot program overseen by a state’s department of agriculture. 7 USC §5940(a)(2). PharmaXtracts' CBD begins by being extracted from industrial hemp grown pursuant to one of these state pilot programs and, therefore, PharmaXtracts' CBD is not subject to the Controlled Substances Act.
The Ninth Circuit agreed in its unpublished memorandum opinion in the case of Hemp Industries Association v. Drug Enforcement Administration, 9th Cir. Case No. 17-70162, filed April 30, 2018 (Hemp III). There, the Ninth Circuit found, "The Agriculture Act contemplates potential conflict between the Controlled Substances Act and preempts it.” Id., p. 4. See https://www.scribd.com/document/386665942/Hemp-Industries-Association-v-Drug-Enforcement-Agency-9th-Cir-Case-No-17-70162-Filed-April-30-2018-Hemp-III. This means the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014 controls and takes precedence over the Controlled Substances Act and, therefore, if CBD is legal under the Agricultural Act of 2014, then its legal under federal law.
The Ninth Circuit Court of Appeals held the Agricultural Act of 2014 preempts the Controlled Substances Act when it comes to industrial hemp.
Almost all CBD in America, such as that used by PharmaXtracts, is now extracted from industrial hemp flowers low in THC and high in CBD. If the CBD was extracted from marijuana instead of industrial hemp, then it would be federally illegal. If the plant was marijuana because its flowering parts had a Delta-9 THC level above 0.3 percent, but the CBD was extracted from its mature stalks which are legal because they generally have a Delta-9 THC level at or below 0.3 percent, then it would be legal but not economically viable.
At times the Drug Enforcement Administration and other federal agencies, such as the Department of Treasury and the United States Patent and Trademark Office, inexplicably proceed upon the assumption that no CBD offered for sale is extracted from industrial hemp but is, instead, extracted from marijuana and, therefore, the CBD must be illegal. It is as if the Department of Treasury and the United States Patent and Trademark Office never heard of the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014. Are they really that ignorant, or are they merely being misadvised by the lawyers at the Department of Justice? With Sessions as Attorney General, the later is probably the case.
Because of this bad advice, the Department of Treasury has not assured banks they can deal with companies marketing CBD and, lacking such assurances, banks shy away from dealing with CBD companies. The Department of Treasury may also take the position that CBD manufactures cannot deduct all costs of doing business on their income tax forms, but it looks like the Department of Treasury will save that suppressive punishment for medical and recreational marijuana providers. The United States Patent and Trademark Office is under the impression that all CBD is a Schedule I drug and will not grant trademarks to CBD manufacturers and marketers because it is convinced such products cannot legally enter the steam of interstate commerce.
The Department of Treasury's failure to assure banks they can deal in funds raised through the sales of medical and recreational marijuana has resulted in millions of dollars in cash being stored in various safe houses across the nation -- at least safe until their locations become known, and then robberies will inevitable occur. In short, the Department of Treasury is creating a very dangerous situation, considerably more than an accident waiting to happen.
As for CBD, Trump or Sessions could make it easier for its manufacturers and marketers if the Department of Justice would properly advise the Department of Treasury and the United States Patent and Trademark Office that CBD marketed pursuant to the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014 is legal and, therefore, CBD manufactures and marketers can engage in normal banking activities, deduct normal business expenses when calculating their income taxes, and receive trademark protection. Why isn’t this happening? Ask Jeff Sessions.
Sessions withdrew the Cole memorandum.
Just when every medical marijuana grower, dispensary, and patient thought they were safe from being harassed by the federal government in the 29 states and District of Columbia where medical marijuana had been legalized (now 30 states), Sessions, issued a January 4, 2018 “Memorandum for All United States Attorneys” addressing the issue of “Marijuana Enforcement” which memorandum appears to encourage the enforcement of federal law that classifies marijuana a Schedule I drug along with heroin, methaqualone (Quaaludes), morphine, mescaline, peyote, and lysergic acid diethylamide (LSD). Marijuana should never have been classified a Schedule I drug. It is questionable whether marijuana should have ever been classified a dangerous drug and placed on one of the controlled substances schedules.
To be classified a Schedule V drug, the least dangerous and lowest classified controlled substance, the drug should have (1) a low potential for abuse relative to the drugs in Schedule IV which include diazepam (Valium) and alprazolam (Xanax), both of which have a higher potential for abuse than marijuana, (2) have a currently accepted medical use in treatment in the United States, which marijuana does, and, (3) have a low potential for abuse leading to limited physical or psychological dependence relative to the drugs in Schedule IV, which requirement marijuana also satisfies. With that said, over 60 percent of the American public now believe marijuana should be legal, but so far, many American politicians are six years behind the times representing their constituencies.
History has shown the federal law with respect to marijuana is not worth enforcing except in circumstances warranting special attention. That was the point of the August 29, 2013 Cole Memorandum which Sessions’ January 4, 2018 memorandum specifically rescinded.
James M. Cole was a Deputy Attorney General during the Obama Administration.
The Cole Memorandum was written by former Deputy Attorney General James M. Cole who acknowledged that several states had enacted laws allowing for medical marijuana. The Cole Memorandum established eight prioritizing circumstances in which prosecution would be warranted; they are to prevent (1) distribution of medical marijuana to minors, (2) revenue from medical marijuana sales going to criminal enterprises, (3) diversion of medical marijuana from states where medical marijuana is legal to states where it is not, (4) medical marijuana being used as a pretext to traffic in other drugs, (5) farming and distributing medical marijuana becoming the cause of violence involving the use of firearms, (6) medical marijuana resulting in drugged driving, (7) growing medical marijuana on public lands and, (8) using medical marijuana on federal property.
Sessions’ January 4, 2018 Memorandum begins by saying the present federal statutes “reflect Congress’s determination that marijuana is a dangerous drug and that marijuana activity is a serious crime.” That would have been a naive, uninformed Congress in 1970 representing a naive, uninformed public, and Sessions is unfortunately, a naive, uninformed Attorney General.
Since Sessions withdrew the Cole Memorandum, there has not been a resurgence in medical marijuana prosecutions as United States Attorneys in all states have resorted to the guidance set forth in the United States Attorneys' Manual.
The United States Attorneys' Manual already contains language that discourages prosecution of medical marijuana or recreational marijuana activities. Consider the following excerpts:
“Under the federal criminal justice system, the prosecutor has wide latitude in determining when, whom, how, and even whether to prosecute for apparent violations of federal criminal law.” U.S. Attorneys’ Manuel, 9-27.100, Comment B.
“[E]ach United States Attorney is specifically authorized to modify or depart from these principles, as necessary in the interests of fair and effective law enforcement within the district.” Id., 9-27.140, Comment B.
“If the attorney for the government concludes that there is probable cause to believe that a person has committed a federal offense within his/her jurisdiction, he/she should consider whether to: . . . Decline prosecution and commence or recommend pretrial diversion or other non-criminal disposition.” Id., 9-27-.200(A)(4).
“The attorney for the government should commence or recommend federal prosecution . . . unless, in his/her judgment, prosecution should be declined because . . . There exists an adequate non-criminal alternative to prosecution.” Id., 9-27-220(A)(2).
“It is important that limited federal resources not be wasted in prosecuting inconsequential cases . . . One factor that is obviously of primary importance is the actual or potential impact of the offense on the community and on the victim(s).
“. . . [W]hether the violation is technical or relatively inconsequential in nature and what the public attitude may be toward prosecution under the circumstances of the case. The public may be indifferent, or even opposed, to enforcement of the controlling statute whether on substantive grounds, or because of a history of non-enforcement, or because the offense involves essentially a minor matter of private concern and the victim is not interested in having it pursued” Id., 9-27.230, Comment B(2).
Any United States Attorney following the standards set forth in the United States Attorneys’ Manual should decline to prosecute any cannabis case. The public is against it, it is inconsequential, the “victim,” whether considered the drug user or the state, is not interested in having the case pursued, and federal resources would be spent on inconsequential matters.
On July 26, 2018, Cole attended the National Cannabis Industry Association’s 2018 Cannabis Business Summit & Expo in San Jose, California, where he delivered the keynote address and said, “What I’ve seen from a prosecutorial standpoint so far … is not much. I haven’t seen a spate of prosecutions [since Sessions withdrew the Cole Memorandum.] Recognizing the growing support for the legalization of marijuana, Cole admitted most U.S. Attorneys are “political animals” who he did not “expect . . . to do much because [the] political reality is going to be a natural barrier to them taking an aggressive approach and really defying the will of the voters.”
James M. Cole was the keynote speaker at the 2018 Cannabis Business Summit & Expo.
Sessions withdrawing the Cole Memorandum just muddied the waters and caused banks and other financial institutions to become more insecure in doing business with firms having anything to do with cannabis. Instead of encouraging state control over medical marijuana, Sessions withdrawing the Cole Memorandum would have had just the opposite effect. And yet the United States Attorneys have uniformly decided to ignore Sessions January 4, 2018 Memorandum recognizing Sessions is too out of touch.
Sessions withdrawing the Cole Memorandum has no effect on CBD products made from industrial hemp.
Sessions January 4, 2018 Memorandum has no effect on PharmaXtracts’ internet sale of cannabidiol (CBD) products since under the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014, cannabis with a Delta-9 THC content equal to or less than 0.3 percent is classified as industrial hemp, and industrial hemp may be legally grown and marketed pursuant to pilot programs approved by a state’s department of agriculture.
In order to outlaw the legal manufacture and distribution of CBD, the Department of Justice’s Drug Enforcement Administration (“DEA”) attempted to literally re-write the law by declaring CBD a new Schedule I drug and then attempted several enforcement actions against people who were in full compliance with Legitimacy of Industrial Hemp Research – even going so far as seizing hemp seeds owned by the University of Kentucky to stifle research into CBD’s medical benefits.
In furtherance of this abuse of power, on December 14, 2016 following Trump’s election, the DEA felt emboldened enough to publish the Establishment of a New Drug Code for Marihuana Extract and created a new code number under the Controlled Substances Act for “marihuana extract” (referred to as the “Final Rule”). According to the DEA, “extracts of marihuana will continue to be treated as Schedule I controlled substances,” and according to the DEA, “if it were possible to produce from the cannabis plant an extract that contained only CBD and no other cannabinoids, such an extract would fall within the new drug code [for marihuana extract, DEA drug number] 7350.”
Amid considerable push back, the DEA backed down, sort of, and on March 14, 2017, the DEA issued a “Clarification of the New Drug Code (7350) for Marijuana Extract” which states in pertinent part,
“The new drug code (7350) established in the Final Rule does not include materials or products that are excluded from the definition of marijuana set forth in the [Controlled Substances Act (“CSA”)].
“ The new drug code includes only those extracts that fall within the CSA’s definition of marijuana.
“If a product consisted solely of parts of the cannabis plant excluded from the CSA definition of marijuana, such product would not be included in the new drug code (7350) or in the drug code for marijuana (7360).
It would seem obvious to the average reader the DEA was acknowledging CBD produced from industrial hemp grown in conformance with state pilot programs is exempt from the new drug code since industrial hemp is excluded from the definition of marijuana. This is consistent with the Ninth Circuit’s finding the Agricultural Act of 2014 preempts the Controlled Substances Act of 1970 so far as the definition of marijuana is concerned. See Hemp III, supra.
However, despite that acknowledgment, the DEA publication begins to discuss the time worn argument that CBD cannot be economically extracted from those parts of the cannabis plant not defined as marijuana under the Controlled Substances Act even though (1) CBD is being extracted from industrial hemp and not from parts of the marijuana plant exempt from the CSA’s definition of marijuana and, (2) the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014 preempts and overrules the definition of marijuana found in the Controlled Substances Act.
As discussed in Hemp 108, Sessions has also held up for two years 26 applications seeking approval of private growing facilities where cannabis, whether marijuana or hemp, can be grown in conformance with federal law for FDA approved testing. Then, in August 2018, five of the 26 applications were finally apparoved.
But then, that same month of August 2018, Buzzfeed News reported,
"The White House has secretly amassed a committee of federal agencies from across the government to combat public support for marijuana and cast state legalization measures in a negative light, while attempting to portray the drug as a national threat . . .
"The Marijuana Policy Coordination Committee, as it’s named in White House memos and emails, instructed 14 federal agencies and the Drug Enforcement Administration this month to submit 'data demonstrating the most significant negative trends' about marijuana and the 'threats' it poses to the country."
“'The prevailing marijuana narrative in the U.S. is partial, one-sided, and inaccurate,' says a summary of a July 27 meeting of the White House and nine departments. In a follow-up memo, which provided guidance for responses from federal agencies, White House officials told department officials, 'Departments should provide … the most significant data demonstrating negative trends, with a statement describing the implications of such trends.'”
It is apparent Trump and Sessions are more concerned with protecting Big Pharma's profits received from selling opioid medications that they are with doing what is best for the American public.
Legalizing cannabis does not necessarily mean FDA approval.
Legalizing marijuana (which assumes the legalization of all cannabis) should result in products extracted from cannabis, such as cannabidiol (CBD), being perfectly legal to sell for any reason, but like any other food product, CBD cannot be advertised as being intended to diagnose, treat, cure, or prevent any disease unless it has been approved as a drug by the United States Food and Drug Administration.
Because of marijuana’s euphoric effects, it has been exceedingly hard to convince the FDA that cannabis has important medical properties. The FDA is not about to accept 5,000 years of anecdotal evidence showing hemp effective at treating a variety of ailments and maintaining good health. The FDA is not going to accept cannabis is non-toxic even though no one has ever overdosed from consuming it in any manner.
For the FDA to license any form of cannabis as a drug, the FDA needs be convinced CBD is safe and effective at treating a specific disease, and CBD would then slowly but surely be licensed as a drug to treat one disease after another. However, in consideration of how exceedingly difficult the United States government has made it to procure research grade cannabis or receive a license to conduct cannabis research, it should come as no surprise that the only company to receive FDA approval for a CBD product needed to conduct its cannabis research in the United Kingdom.
According to the FDA website,
“The FDA is aware that marijuana or marijuana-derived products are being used for a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, treatment of spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.
* * * *
“To date, the FDA has not approved a marketing application for marijuana for any indication. The FDA generally evaluates research conducted by manufacturers and other scientific investigators. Our role, as laid out in the Federal Food, Drug, and Cosmetic (FD&C) Act, is to review data submitted to the FDA in an application for approval to assure that the drug product meets the statutory standards for approval.
Epidiolex became the first drug containing CBD approved by the Food and Drug Administration but only for treating seizures associated with Lennox-Gastaut syndrome or Dravet syndrome. Because Epidiolex is FDA approved, doctors can prescribe it, and insurance companies can be billed for it.
“The FDA has approved Epidiolex, which contains a purified drug substance cannabidiol, one of more than 80 active chemicals in marijuana, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. That means the FDA has concluded that this particular drug product is safe and effective for its intended indication.
“The agency also has approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of marijuana. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.”
It is not enough that hemp is one of the oldest medicines known to man and has never killed anyone. So far as the FDA is concerned, “a study of marijuana in clinical trial settings is needed to assess the safety and effectiveness of marijuana for the treatment of any disease or condition.”
The instant the FDA approved CBD being used to treat a medical condition, CBD no longer qualified as a Schedule I drug on the controlled substances list because it then had a provable, accepted medical use in America. Nevertheless, CBD has not yet been downgraded from Schedule I which would allow it to be much easier researched. It only makes sense this is being done for the benefit of Big Pharma
The commercial cannabis industry has some major players, but compared to the big pharmaceutical companies, medical marijuana and hemp are grown and CBD is extracted and sold by a lot of mom and pop operations, all of whom have been instrumental in changing the political landscape opening the way for cannabis-based medical remedies to gain wide-spread acceptance. CBD has the potential of becoming the medical breakthrough of our era, and it has taken a lot of mavericks to row against a tide of public opinion shaped by decades of government sanctioned false propaganda and criminal penalties. Now, the word is finally getting around that the medical benefits of marijuana and CBD are for real. Meanwhile, the horror stories surrounding cannabis are all being debunked.
The FDA website claims, “The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of marijuana.”
This has not been the case. The FDA has not approved more facilities for growing cannabis for research. Twenty-six applications have been sitting around for going on two years with no new research cannabis grower's licenses being approved.
CBD should not be on any of the schedules of dangerous drugs. It has no potential for abuse because it results in no high. It is currently accepted for medical use in the treatment of epilepsy, a fact the FDA cannot deny with its approval of Epidiolex, and CBD has dozens of other medical uses the FDA is not yet willing to admit. CBD has no potential for abuse or physical or psychological dependence beyond seeking the relief CBD is meant to provide. Pain relief and anxiety relief are but two examples. No drug is required to be placed in any of the five controlled substances schedules. For example, two of the most dangerous drugs which together account for more than 600,000 American deaths every year, alcohol and tobacco, are not placed within any of the five schedules. It's all politics.
Senate Republican majority leader Mitch McConnell has introduced the Hemp Farming Act of 2018 as a further attempt to keep the DEA and FDA from impeding the rise of industrial hemp products.
The Hemp Farming Act of 2018 was introduced to the Senate by Mitch McConnell (R-KY), Ron Wyden (D-OR), and Jeff Merkley (D-OR), and the House version will be introduced by James Comer (R-KY). Pursuant to the Hemp Farming Act of 2018, industrial hemp (cannabis with a Delta-9 THC level not exceeding 0.3 percent by weight) would be removed from Schedule I of the Controlled Substances Act and would be regulated as an agricultural crop. The bill passed the U.S. Senate on June 28, 2018, by a vote of 86 to 11.
Along the way, when the Hemp Farming Act of 2018 was before the Senate Committee on Agriculture, Nutrition and Forestry, Iowa’s conservative Senator Charles Grassley, a long time opponent of marijuana reform, wanted extracts and derivatives such as CBD to remain illegal. It seems as if anyone against cannabis has to be three times against any extracted cannabinoid from cannabis which might be concentrated, even if they have no knowledge of what it is or for what it is used. Grassley never filed his floor amendment, and the Hemp Farming Act of 2018 easily passed through committee 20-1.
Senator Charles Grassley (R-IO) was the only Senator in committee who objected to passage of the Hemp Farming Act of 2018.
A Congressional Research Service report released before the Senate vote said, "global market for hemp consists of more than 25,000 products." Of course, the real benefit of legalizing industrial hemp is not fabric or rope or paper or building materials, it is the production of CBD for medical purposes.
Former Secretary of Agriculture Tom Vilsack unsuccessfully conspired with the DEA to re-criminalize CBD.
While Obama was still president, the DEA plotted behind his back to negate the effect of the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014 by appealing to former Secretary of the United States Department of Agriculture Tom Vilsack to rewrite the USDA’s definition of industrial hemp. The USDA and the DEA then issued a joint statement usurping Congress’s intent by unilaterally rewriting the federal definition of industrial hemp.
As drafted by Congress, Section 7606 of the 2014 Farm Bill, 7 U.S.C. §5940(b)(2), defines industrial hemp as follows:
“The term ‘industrial hemp’ means the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
The USDA and DEA’s definition of industrial hemp as contained in their Statement of Principles on Industrial Hemp (“SOP”), 21 C.F.R. §1308.11(d)(58), mangles this definition as follows,
“The term ‘industrial hemp’ includes the plant Cannabis sativa L. and any part or derivative of such plant, including seeds of such plant, whether growing or not, that is used exclusively for industrial purposes (fiber and seed) with a tetrahydrocannabinols concentration of not more than 0.3 percent on a dry weight basis.”
The USDA and DEA’s definition of industrial hemp as found in their joint SOP does two things in their attempt to outlaw CBD. First, it tries to define industrial hemp as something to be used exclusively for fiber or seed, as if the only thing hemp is good for is for making rope and a highly nutritious cooking oil. Second, it tries to define industrial hemp as containing 0.3 percent or less of all tetrahydrocannabinol compounds, not just Delta-9 THC. The USDA and the DEA were attempting to add the percentage weight of Delta-8 THC, Delta-7 THC, THCV, and THCA, all of which are not psychoactive, to the weight of the Delta-9 THC to make it that much harder for hemp to be grown with a THC level not exceeding 0.3 percent by weight.
In addition, the SOP went on to say, “‘tetrahydrocannabinols’ include all isomers, acids, salts or isomers of tetrahydrocannabinols” just to make sure these additional THC cannabinoids were included in the percentage weight.
The U.S. Department of Agriculture’s statement carried no force of law and was, in actuality, contrary to law in an attempt to stall CBD research for the benefit of Big Pharma. After Valsack refused to rescind or change the USDA’s definition of industrial hemp to comply with the definition set forth in the 2014 Farm Bill, the Hemp Industries Association (“HIA”) sued the DEA in a petition for a review of its rules in an attempt to force the DEA to interpret Section 7606 of the 2014 Farm Bill as it was written, not as a few people in the DEA wish it had been written, if written at all.
When considering cases involving matters of statutory interpretation, courts rely heavily on Congressional intent as evidenced by what was said at the hearings and debates before Congress. On January 11, 2018, in Hemp III, three United States Senators and 25 United States Representatives filed an Amicus brief with the Ninth Circuit telling the court exactly what their intent was in passing Section 7606 of the 2014 Farm Bill. In Hemp III, the DEA might think they walked away with a victory because their new code for CBD was upheld, but only for CBD not made from industrial hemp as the Ninth Circuit held the Agricultural Act of 2014 “contemplates potential conflict between the Controlled Substances Act and preempts it.” Id., p. 4, emphasis added.
The Congressional Amicus brief was not mentioned in the Ninth Circuit’s memorandum opinion in Hemp III because the lower district court did not have it to consider before rendering its decision, but the Amicus brief may now be used in all further cases as conclusive evidence of congressional intent in passing the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014. According to the Amicus brief,
“This brief addresses the evident fact that DEA did not properly interpret the text of the statute. . . .
“Despite Congress passing clear text on industrial hemp into law, the DEA now seems to be effectuating the opposite . . . .
“. . . . the DEA has asserted that all cannabinoids are controlled substances by virtue of the fact that they are concentrated in the flower of Cannabis plants. This argument may have had merit prior to the Farm Bill, but it is blatantly contrary to the text of the Farm Bill, which explicitly exempted all parts of industrial hemp, including its flower, from the definition of marijuana. The DEA’s position in the Final Rule that industrial hemp extracts ‘will continue to be treated as Schedule I controlled substances’ therefore exceeds the DEA’s authority, and also subverts the Congressional definition of industrial hemp contained in the Farm Bill . . . .
With this statement the Ninth Circuit agreed by finding the 2014 Farm Bill preempted the Controlled Substances Act.
The Amicus brief continues,
“. . . . Congress passed a law that chose a path of non-interference with industrial hemp legalization in States that wished to explore economic growth opportunities with the crop. Congress made this decision in the face of DEA’s longstanding views. While Congress and DEA disagreed, Congress resolved the disagreement through the plain language of the Farm Bill . . . .
“The Farm Bill was, in places, intentionally broad in order to encompass activities including the study of the market for industrial hemp (‘a pilot program to study the growth, cultivation, or marketing of industrial hemp’) and to permit states to select partners to assist with the growth and cultivation of industrial hemp. . . .
“Congress recognized the need for research and development to investigate market potential of domestic industrial hemp agriculture, including hemp agronomics, the economic impart of hemp-derived cannabinoids such as CBD, diversion controls, and the overall hemp products retail market. . . ."
Right there is proof the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014 was to protect the marketing of CBD.
The Amicus brief continues,
“. . . . Through the marketing provision, Congress legalized the underlying commercial activity. This included any commercial marketing of industrial hemp extracts and derivatives, so long as the products fell under the THC threshold level. . . .
“The fact that the Farm Bill clearly contemplated experimentation with a commercial market for industrial hemp is underscored by passage of the Spending Bill provisions, which prohibit DEA from spending funds to ‘prohibit [the] transportation, processing, sale, or use of industrial hemp that is grown or cultivated in accordance with Section 7606 of the Agricultural Act of 2014, within or outside the State in which the industrial hemp is grown or cultivated.’ . . . . This language assumes that industrial hemp grown pursuant to the Farm Bill will be sold and transported within and between states. This structure inevitably allowed for commercial activities. It is hard to imagine how States might accomplish the foreseen ‘marketing of industrial hemp’ without public-private partnerships . . . .
This is proof Congress intended for CBD to be marketed to consumers in all states, including states where industrial hemp is not grown.
The Amicus brief continues,
“As Senate majority Leader Mitch McConnell noted in his October 6, 2016 letter to then-Secretary of Agriculture Thomas Vilsack, the DEA, in the SOP, narrowed the Congressional definition of ‘Industrial Hemp’ beyond what Congress explicitly prescribed in the Agriculture Act of 2014 [the Farm Bill].’
“. . . . The Farm Bill did not limit the definition of legal industrial hemp to fiber and seed, nor did it limit non-industrial use. . . . DEA did not intend to follow the direction of Congress.
“The [USDA’s and DEA’s] SOP states:
“‘For purposes of marketing research by institutions of higher education or State departments of agriculture (including distribution of marketing materials), but not for the purpose of general commercial activity, industrial hemp products may be sold in a State with an agriculture pilot program or among States with agriculture pilot programs but may not be sold in States where such sale is prohibited. Industrial hemp plants and seeds may not be transported across State lines.’
“This, of course, contravenes not only the Farm Bill but the Spending Bill as well, which prohibits DEA from spending any funds to interfere with the interstate transportation of industrial hemp grown pursuant to the Farm Bill. For these reasons, Senator McConnell noted in his October 2016 letter that, ‘Federal law, however, does not limit the ability to sell lawfully grown industrial hemp products only to states with agricultural pilot programs.’ Senator McConnell’s understanding of the Farm Bill – consistent with the text Congress passed – presumes that sales of industrial hemp products are part and parcel of a pilot program authorized by law.
“The SOP implies that the DEA is the body to appropriately determine what Congress meant.
“. . . . While the DEA clearly believes that all extracts of the Cannabis flower fall under the definition of controlled substances, such an assertion blatantly subverts the Farm Bill, which explicitly permits any part of the Cannabis plant, including the flower, with ‘not more than 0.3 percent’ THC, from being deemed permissible industrial hemp under an approved pilot program. The DEA is wrong to treat cannabinoids as evidence that a compound was derived from marijuana since legal cannabinoids also come from the flower of the plant.
“ . . . . DEA’s implied argument that Congress intended to conditionally legalize industrial hemp, but at the same time criminalize a derivate therefrom, is flawed logic and an incorrect interpretation of the statute.
“In enacting the Farm Bill, it was Congress’s purpose that industrial hemp and any derivatives, extracts, and uses thereof would be exempted from the definition of “marihuana” under the [Controlled Substances Act]. We know this because many of us helped draft the provisions and voted for them.”
It is PharmaXtracts’ legal position that the congressional Amicus brief clearly states the intention of Congress in passing the 2014 Farm Bill. The congressional interpretation is the present law, not the version made up for the USDA and the DEA by a few individuals who happen to disapprove of CBD being marketed to the public in multiple states, including states without industrial hemp pilot programs. The law controls. Personal opinions of the uninformed do not.
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