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CBD 101

CBD 101

Introduction

This CBD 101 series reviews and analyzes the evolution of the law regarding the growing of Cannabis and the manufacture and interstate sell of cannabidiol (“CBD”) products.

Prospective customers call or email PharmaXtracts inquiring whether it is legal to purchase PharmaXtracts’ CBD products.  CBD is one of 60 cannabinoids produced by the Cannabis plant, and CBD shows tremendous promise in treating a variety of medical ailments.  Cannabis also contains another better known cannabinoid called Delta-9 tetrahydrocannabinol (“THC”).  THC is the only psychotropic cannabinoid in Cannabis that produces an euphoric “high.”  Conversely, CBD is not psychotropic, but the long standing prejudices against Cannabis because of THC’s psychotropic properties has held back much needed CBD pharmaceutical research.

The parts of a Cannabis plant that are high in THC are generally referred to as “marijuana,” and marijuana is usually smoked for the purpose of ingesting THC with the expectation of achieving a psychotropic effect.  Marijuana also has various medicinal properties, and medical marijuana has been legalized in twenty-nine states, the District of Columbia, and two U.S. territories.  No local marijuana laws could be found for the territories of American Somoa, the Northern Mariana Islands, and the Virgin Islands, which follow federal law, but in each of those territories smoking recreational marijuana is practically a way of life.

The parts of the Cannabis plant low in THC are generally referred to as “hemp.”  In colonial times, farmers were required to grow hemp to make rope and fabric, and it was grown as a cash crop up to the civil war when cheaper imported hemp became available.  CBD is usually extracted from hemp.

Two separate types of Cannabis plants are now being grown.  Hybrids and cuttings from select plants are being grown for high THC content specifically to produce medical and recreational marijuana.  Other hybrids and cuttings from selected plants are being grown to produce hemp with a high CBD content specifically to produce CBD products.  A full discussion of the history of hemp and marijuana in America, how and why Cannabis became illegal, and the emerging legality of Cannabis is contained in the Hemp 101 series found in the Educational section of this website.

PharmaXtracts’ customers have questioned whether it is legal to have PharmaXtracts’ CBD products shipped to their particular state and, once they arrive, whether it is legal to possess and use them.  CBD holds promise for a number of therapeutic uses, but since marijuana is Cannabis, and since marijuana is still classified by the Food and Drug Administration as a Schedule I drug, anxious customers wonder whether CBD can be legally shipped to them over state lines and into their particular state.

Map of the United States.  Map credit unknown.

As will be shown in this CBD 101 series, PharmaXtracts’ CBD products are fully compliant with federal law.  That said, shipping to some states such as Florida, Hawaii, Maine, Mississippi, Montana, Nebraska, South Dakota, and Wisconsin may be problematic because of idiosyncrasies in their state laws.  It is PharmaXtracts’ stated position based on the legal authorities cited herein that PharmaXtracts can legally ship its CBD products into the states of Florida, Hawaii, Maine, Mississippi, Montana, Nebraska, South Dakota, and Wisconsin and any of the other remaining 42 states, the District of Columbia, and the five major United States territories either because it is not marijuana as defined by the state’s, district’s, or territory’s law or, alternatively, because of the following four legal reasons:

(1)  Pursuant to the Agricultural Act of 2014, 7 U.S.C. §5940 (2014 Farm Bill), a federal statute, the CBD contained in PharmaXtracts’ CBD products is a manufactured derivative of hemp which has been legally grown in the states of California and Nevada pursuant to pilot programs administered by their respective departments of agriculture;

The  Constitution.  Credit Alexander Hamilton, James Madison, John Adams, and Thomas Jefferson

(2)  The Full Faith and Credit Clause found in Article VI, Section 1 of the Constitution requires all other states honor decisions made by California’s and Nevada’s Departments of Agriculture in their administration of their hemp pilot programs, which programs have been formed pursuant to federal law to inter alia study the marketing of industrial hemp;

(3)  The Supremacy Clause found in Article VI, Section 2 of the Constitution requires all states honor the Agricultural Act of 2014 and the pilot programs administered by the states of California and Nevada thereunder, the spirit and purpose of which can only be satisfied if legally grown and manufactured hemp products can be shipped from those states to all 50 states, the District of Columbia, and all United States territories; and,

(4)  The Equal Protection Clause found in Section 1 of the Fourteenth Amendment forbids any state from making and enforcing any law abridging the privileges or immunities of any citizen of the United States or denying to any person within its jurisdiction the equal protection of the law and, therefore, unless and until a state bans the importation of any hemp product, including hemp rope and hemp fabric, and unless and until that state begins prosecuting major retailers such as Amazon.com and Walmart that are shipping into that state various hemp products including hemp oils, then that state cannot selectively prosecute PharmaXtracts from shipping into that state its CBD products.

The Bill of Rights.  Credit James Madison.

The Controlled Substances Act making marijuana illegal was passed in 1970.

Title 21 of the United States Code, Section 812 (21 U.S.C. § 812) sets forth five different schedules of controlled substances, with Schedule I being the most restrictive and Schedule V being the least restrictive.  Those schedules “shall be updated and republished on an annual basis.”  See 21 U.S.C. § 812 (a).  Some substances were scheduled to conform with the “United States obligations under an international treaty, convention, or protocol, in effect on October 27, 1970" when Congress passed the Controlled Substances Act as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 which President Richard Nixon lobbied for and signed into law on October 27, 1970.  See 21 U.S.C. § 812 (b).

President Richard Nixon gives the thumbs up after signing the Comprehensive Drug Abuse Prevention and Control Act of 1970 into law.  White House photo.

To qualify as a Schedule I drug, which includes heroin, methaqualone (Quaaludes), morphine, mescaline, peyote, and lysergic acid diethylamide (LSD), the following three criteria must be satisfied:

(A)  The drug or other substance has a high potential for abuse.

(B)  The drug or other substance has no currently accepted medical use in treatment in the United States.

(C)  There is a lack of accepted safety for use of the drug or other substance under medical supervision.  See 21 U.S.C. § 812 (b) (1).

To qualify as a Schedule II drug, which includes hydrocodone/acetaminophen (Lortab), amphetamine/dextroamphetamine (Adderall), cocaine, meperidine (Demerol), methadone, oxycodone (OxyContin), and oxycodone/acetaminophen (Percocet), the following three criteria must be satisfied:

(A)  The drug or other substance has a high potential for abuse.

(B)  The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.

(C)  Abuse of the drug or other substances may lead to severe psychological or physical dependence.  See 21 U.S.C. § 812 (b) (2).

Down at the bottom of the list are the Schedule V drugs, and to qualify as a Schedule V drug, the following criteria must be satisfied:

(A)  The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.

(B)  The drug or other substance has a currently accepted medical use in treatment in the United States.

(C)  Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.

Schedule IV drugs included diazepam (Valium) and alprazolam (Xanax), both of which have a higher potential for abuse than marijuana, and both of which lead to a higher level of physical and psychological dependence.

Proponents of CBD argue that CBD should not even be classified as a Schedule V drug because CBD not only has a low potential, if any, for abuse, it has an accepted medical use for treatment in the United States, and it leads to no physical or psychological dependence.

Marijuana was initially listed as a Schedule I drug, and it has inexplicably been retained in Schedule I for 47 years.                    

Marijuana has been smoked for 5,000 years.  Famous Oxford archeologist Andrew Sherrat reported remnants of charred hemp seeds found at a Kurgan grave site in the Pontic steppe north of the Black Sea were left behind from the Kurgans smoking the flowers and leaves of the Cannabis plant.  Yet in 5,000 years of use, there has not been a single report of anyone having ever died from an overdose of marijuana.  Millions of people have quit smoking marijuana with no ill effects.  Medical marijuana has been legal and licensed in California since 1996 and has a wide variety of accepted medical uses, not the least of which is to relieve nausea and increase the appetite of people undergoing chemotherapy cancer treatments.  In light of these facts, there is no justification for marijuana being classified a Schedule I drug or remaining in that most-dangerous-of-all-drugs classification.

Editorial photo credit unknown

Because of propaganda catering to racial prejudice, the failure of scientific information to be presented to Congressional committees, and selfish, political manipulations which are discussed in some detail in Hemp 102, in 1937, marijuana was subjected to a tax which resulted in the ending of all research into the medicinal benefits Cannabis has to offer.

In 1968, there was still a substantial amount of racial prejudice which Richard Nixon tapped into just prior to announcing in New Hampshire in February 1968, that he was running to be elected President of the United States.  The month before, in January 1968, Nixon visited San Antonio, Texas, which at the time was a hotbed of prejudice against Mexican-Americans, and Nixon’s “silent majority” message carried well after the Mexican American Legal Defense and Educational Fund formed the previous year had represented the Edgewood Independent School District located in one of San Antonio’s poorer Hispanic sections and challenged the way Texas apportioned public school financing as being discriminatory against students of Mexican descent.  Rioting in San Antonio continued into the 1970's.

1971 San Antonio Riot.  Photo credit San Antonio Express-News

After Nixon was elected President in November 1968, Congress was barely controlled by the Democrats, but many of those Democrats were old-school Southern Democrats who respected national bigot Alabama Governor George Wallace who carried Arkansas, Louisiana, Mississippi, Alabama, and Georgia when he ran for President in 1968 as the unifying personality of the law-and-order, my-country-right-or-wrong American Independent Party.  By 1970, the time was ripe to further persecute users of marijuana, not only because marijuana was being used by Mexicans and blacks, but because marijuana was being used by “hippie” Vietnam War protesters.  Against this backdrop, and as discussed in Hemp 103, Nixon and the 91st Congress failed to listen to the advice given them by experts and investigative committees and, instead, classified marijuana as a Schedule I drug in the 1970 Controlled Substances Act which was made part of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (“DAPCA”).

DAPCA provided for establishing a National Commission on Marijuana and Drug Abuse.  In 1972, Nixon appointed the members of that Commission which was chaired by Pennsylvania Governor Raymond P. Shafer.  Nixon then ignored the Shafer Commission’s recommendation that possession of small amounts of marijuana be decriminalized and, instead, initiated the War on Drugs.  By 2010, 38 years later, over $1 trillion had been spent on the War on Drugs, and that year 500,000 people were incarcerated on drug charges, and to what end?  By 2015, the United States had entered an opioid epidemic.  Opioid overdose deaths exceeded 59,000 in 2016 and were the leading cause of death of Americans under 50 years of age.  The number of marijuana overdose deaths in 2016 remained constant at 0.

National Commission on Marijuana and Drug Abuse.  File photo.

Despite evidence marijuana’s classification should be downgraded to Schedule V or that marijuana should be removed altogether from the drugs listed in the Controlled Substances Act’s schedules of dangerous drugs, marijuana has been kept in Schedule I because of political reasons rather than because of scientific fact or medical necessity.  Alcohol and tobacco, two other drugs which are substantially more physically and psychologically addictive than marijuana and which cause or contribute to the deaths of more than 800,000 Americans every year are not listed in any of the Controlled Substances Act’s five schedules.

A Quinnipiac University poll of 1,062 American voters from across the country conducted from April 12 to April 18, 2017, showed 60 percent of all American voters believe “the use of marijuana should be made legal in the U.S.,” while only 34 percent of those polled disagreed, and 6 percent remained undecided.  73 percent of those polled believe the federal government should not enforce the federal marijuana law in states that have legalized medical and/or recreational marijuana.  An astounding 94 percent of those polled agreed with “allowing adults to legally use marijuana for medical purposes if their doctor prescribes it.”  The Quinnipiac University poll had a 3 percent margin of error.  See cite.

Quinnipiac University,  Hamden, Connecticut.  File photo.

Support for legalizing marijuana is growing by the month.  A Gallop poll of 1,082 American adults taken from August 4 - 11, 2017, found 64 percent were in favor of making marijuana legal.  The Gallop poll had a 4 percent margin of error at the 95 percent confidence level.

The American College of Physicians and the American Epilepsy Society have asked the Drug Enforcement Administration to reclassify marijuana and to open up research into its potential medical uses. The Controlled Substances Act states: “If the Secretary [of Health and Human Services] recommends that a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance.” See 21 U.S.C. § 811(b). If the Secretary of Health of Human Services Tom Price, who recently resigned over his scandalous use of private and military jets racking up a taxpayer bill of over a million dollars in nine months, had only recommended to Attorney General Jeff Sessions that Cannabis not be a controlled substance before he resigned, then Section 811 of the Controlled Substances Act would require Sessions and the Department of Justice and its Drug Enforcement Agency (“DEA”) to no longer control the use of marijuana.

An October 15, 2017 article in The Washington Post researched and written by Scott Higham and Lenny Berstein entitled, “The Drug Industry’s Triumph Over the DEA” describes just how much influence Big Pharma and drug store chains like CVS have over the DEA in supporting regulation changes easing the ability of Big Pharma and the drug store chains to make large profits off the present opioid epidemic by dictating when the DEA can freeze suspicious narcotic shipments. According to The Post,

“Previously, the DEA could freeze drug shipments that posed an ‘imminent danger’ to the community, giving the agency’s broad authority.  Now, the DEA must demonstrate that a company’s actions represent ‘a substantial likelihood of an immediate threat,’ a much higher bar.” See https://www.washingtonpost.com/graphics/2017/investigations/dea-drug-industry-congress/

With the approval of the DEA, this slight change in the law signaled a green light for Big Pharma to flood small towns with opioids like Vicodin and oxycodone.  So many powerful Senators and Congressmen were influenced by Big Pharma’s and CVS’s campaign contributions that their influence over the DEA resulting in the DEA’s approval of the change of language, caused the change in the law to go unnoticed with it slipping under President Obama’s radar because he thought he could rely on the Department of Justice and the Drug Enforcement Agency making the right call instead of the call Big Pharma and CVS wanted them to make. Obama’s hands-off approach had the effect of keeping marijuana a Schedule I drug while dangerous opioids were dumped upon many communities.

Editorial cartoon credit Island Stage.

In 2016, Insys Therapeutics, which had its synthetic marijuana drug Syndros recently approved by the DEA contributed 10 percent of all funds supporting the opposition to a marijuana legalization referendum in Arizona.

Cannabis remained a Schedule I drug, and this stagnation appears to have more to do with Big Pharma’s influence over the DEA and the Food and Drug Administration than with legal reasoning and scientific fact which would also explain why the United States Department of Health and Human Services patented synthetic CBD for the treatment of a number of diseases and then kept it under wraps and why the Food and Drug Administration failed to grant hardly any licenses for universities to study the curative effects of any Cannabis derivative and why the Food and Drug Administration failed to recognize CBD as a drug useful in the treatment of disease contrary to what the Department of Health and Human Services wrote in its patent application.  The FDA even ignored the decision of an administrative law judge ruling that marijuana should be moved out of Schedule I.

A simple act of Congress could easily reschedule Cannabis to a lower classification or out of the controlled substances schedules entirely, but old fashioned lawmakers catering to a non-existent electorate have so far rejected all attempts to pass such a bill, the will of the American people be damned.

There are two exceptions which remove some Cannabis products from the federal definition of marijuana, and PharmaXtracts’ CBD products fall within one or both exceptions.

Not all portions of the Cannabis sativa L. plant are included in the federal definition of marijuana now found in 21 U.S.C. § 16.  The federal definition of marijuana (which misspells marijuana as “marihuana” to match the misspelling of marijuana as it is found in the Marihuana Tax Act of 1937) states,

“The term “marihuana” means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.  Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.”

In addition, the Agricultural Act of 2014 (“2014 Farm Bill”) defines “hemp” which may be legally grown under federal law as Cannabis with a THC content less than 0.3 percent by weight.  See 7 U.S.C. §5940(b)(2).  A THC content of 0.3 percent or less is too low to produce an euphoric high.  In fact, any THC content less than or equal to 1.0 percent is too low to produce a noticeable euphoric effect.  The 0.3 percent cutoff was admittedly an arbitrary standard which was drawn from a 1976 taxonomic report by Ernest Small and Arthur Cronquist, two Canadian plant scientists who wrote in Taxon,

“It will be noted that we arbitrarily adopt a concentration of 0.3% Delta 9-THC (dry weight basis) in young, vigorous leaves of relatively mature plants as a guide to discriminating two classes of plants.  This is based on standard-grown material in Ottawa in gardens, greenhouses and growth chambers, and of course on our analytical techniques.  Dr. C.E. Turner, who has conducted extensive chemical analysis of Cannabis at the University of Mississippi, has agreed (pers. com.) that this is a reasonable figure to discriminate two classes of plants.  We found that generally approximately 2% of the dry weight of young leaves of mature plants, or of the average dry weight of the softer parts of the female flowering plant (leaves, small twigs, flowers) is comprised of cannabinoids.  Since CBD (cannabidiol, the most common non-intoxicant cannabinoid) and THC collectively, usually compose the bulk of the cannabinoids present, one can crudely adjust literature reports of cannabinoid concentration for comparison with our values on the basis that the concentration of CBD and THC should sum to roughly 2%.”  See Ernest Small and Arthur Cronquist, Taxon, Vol. 25, No. 4 (Aug. 1976), pp. 405-435, 408.

Arthur Cronquist.  File photo.

There has been quite an evolution in Cannabis cultivation since Small and Cronquist compiled their report.  THC has reached levels of over 24 percent in plants with less than 1 percent CBD, and CBD has reached levels over 17 percent in plants with less than 0.3  percent THC (an amazing advancement).  The variety of marijuana Acapulco Gold which was readily available in 1976 when Small and Cronquist performed their research and which is sold at a medical marijuana stores in Las Vegas has a THC level of 8.97 percent and a CBD level of 13.46 percent, the lowest THC level and the highest CBD level of any marijuana sold for medical and recreational purposes.

Small and Cronquist continue,

“It has been shown that two widespread classes of plants can be discerned with respect to intoxicant properties (Small and Beckstead, 1973a, 1973b).  Plants originating from fairly southern countries (approximately south of latitude 30 degrees N.), where there has been a long history of use of Cannabis for drug purposes, are characterize by (a) resin containing a relatively high proportion of intoxicating cannabinoids, often more than half of the total, usually mostly THC, (b) considerable resin in male plants as well as in females (on a relative weight basis; females are usually larger than males) and (c) relative slowness of induction of flowering by short day length.  In contrast, plants originating from more northern locations, where Cannabis has been used primarily as a source of fibre and oil, are characterized by (a) resin composed primarily of non-intoxicating cannabinoids, usually mostly CBD, (b) notably higher resin concentration in female plants than in male plants, and (c) relative rapidity of induction of flowering by short day length.  It should be understood, however, that chemically intermediate plants are widespread (Small and Beckstead, 1973a; Krishnamurty and Kaushal, 1974).”  See Id. at 408-409.

If the Government were to raise the permissible THC level in plants considered hemp to 1.0 percent or less, then CBD production would become more economical and efficient.  As it is, for some growers, such as those affiliated with PharmaXtracts, flowering parts of the hemp plants are already being grown with high CBD levels and THC levels at or below 0.3 percent THC by weight.  These hemp flowers can be legally smoked the same as marijuana except the hemp flowers would be smoked for their medicinal CBD content rather than their euphoric THC content, something which might be difficult to explain to the average police officer since the flowers from the hemp plant and the flowers from the marijuana plant look similar except for crystals of resin which can usually be seen on the marijuana flowers.
                    
The pure, white, crystalline CBD powder PharmaXtracts’ uses in its CBD products is a derivative of the mature stalks of the Cannabis sativa L. plant or from hemp plants with THC contents not exceeding 0.3 percent by weight and, therefore, PharamaXtracts’ CBD can fall within either exception to the federal government’s definition of marijuana.

PharmaXtracts Tincture

“Hemp oil,” or as some of PharmaXtracts’ competitors prefer to call it, “CBD oil,” inevitably contains some THC, whether the Cannabis plant is classified as marijuana or hemp.  But using a proprietary process developed through years of research, PharmaXtracts first extracts pure CBD from mature hemp stalks and then sells it as crystalline powder or dissolves it in a non-Cannabis oil to produce its Crystalline Tinctures and its Crystalline Vape Pen Cartridges.  That way, PharmaXtracts’ CBD products contain no THC. 

PharmaXtracts is experimenting with producing CBD products to which a certain amount of hemp oil is added for those who prefer a “full spectrum” product high in CBD, but any full spectrum tincture must still satisfy the definition of hemp since its THC level, if any, would need remain at or below 0.3 percent by weight.

The Ninth Circuit’s decisions in Hemp I and Hemp II blocked the Drug Enforcement Administration’s attempt to expand the law defining marijuana, and those two decisions support the legality of PharmaXtracts’ CBD products.

Ninth Circuit Court of Appeals, San Francisco, California.  File photo.

In the case of Hemp Industries v. Drug Enforcement Admin., 357 F.3d 1012 (9th Cir. 2004) (“Hemp II”), the United States Court of Appeals for the Ninth Circuit directly addressed the issue of when a portion of the Cannabis plant and the products made therefrom are legal under federal law.  This required the court to interpret the federal definition of marijuana in consideration of THC having been separately listed as a Schedule I drug.  Hemp II was decided before the 2014 Farm Bill allowed hemp to be legally grown in the United States if licensed by a state’s department of agriculture.  In Hemp II, the Appellants imported their hemp supplies and “manufactured and sold food and cosmetic products made from hemp seed and oil.”  Hemp II, 357 F.3d at 1013.

According to the Ninth Circuit, by the plain language of  21 U.S.C. § 812 (c), Schedule I, §(c)(10)(17) [now 21 U.S.C. § 16 cited above], the Appellants’ products in Hemp II clearly fell within the exception to marijuana specified in the federal definition, and the Appellants’ products made from hemp could not be classified as marijuana because Appellants’ products were “mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of the plant which is incapable of germination.”  Nevertheless, the group of appellants headed by the Hemp Industries Association were forced to challenge the validity of an “Interpretive Rule” (it wasn’t) the Drug Enforcement Administration (DEA) published on October 9, 2001, “stating that ‘any product that contains any amount of THC is a schedule I controlled substance. . . .,’”  Hemp II, 357 F.3d 1014, citing 66 Fed.Reg. 51530, 51533 (Oct. 9, 2001).  According to the Ninth Circuit, “this rule would have banned the possession and sale of Appellants' products.”  Hemp II, 357 F.3d at 1014.

The DEA took the position that because THC was separately listed in Schedule I, any Cannabis product made from sterilized Cannabis seeds or mature Cannabis stalks, although they may have contained only trace amounts of THC incapable of producing an euphoric high, were illegal.  The DEA claimed all such products were bound to contain a minute amount of THC which placed them within Schedule I.

PharmaXtracts CBD products contain no THC because of our exclusive propriety process, but this process was not developed until 2017.

In Hemp Industries v. Drug Enforcement Admin., 333 F.3d 1082 (9th Cir. 2003)  (“Hemp I”), the preceding companion case to Hemp II, the Ninth Circuit held,

“On October 9, 2001, the DEA issued three rules.  The first is what the DEA denominates an ‘Interpretive Rule,’ purporting to interpret both the [Controlled Substances Act (“CSA”)] and the DEA regulations to ban all naturally-occurring THC, including that found in hemp seed and oil, on Schedule I.  66 Fed. Reg. 51,530 (October 9, 2001).

* * * *

“Notably, if naturally-occurring THC were covered under THC, there would be no need to have a separate category for marijuana, which obviously contains naturally-occurring THC.  Yet Congress maintained marijuana as a separate category.  P.L. 91-513, 84 Stat. 1236, 1242 (1970).

“The petitioners' products, hemp oil and sterilized seed, are explicitly exempted from this definition (as would be PharmaXracts’ CBD which is extracted from hemp or from mature hemp stalks).  This definition was carried over into the CSA from the Marijuana Tax Act of 1937 when the CSA was enacted and moved the plethora of drug laws into one comprehensive statute.”

* * * *

“Thereafter, Congress passed the Comprehensive Drug Abuse Prevention and Control Act of 1970 ("DAPCA") and added THC to Schedule I in the statute.  See 21 U.S.C. § 812(c), Schedule I (c)(17).  The DEA cites nothing in the legislative history of the act to show that the 1970 Congress consciously intended to cover naturally-occurring THC under THC as well as under marijuana.  Hemp I, 333 F.3d at 1085, 1088-1089.”

In Hemp II, the Ninth Circuit summarized its holding in Hemp I as follows:

“Appellants challenged the putative Interpretive Rule in [Hemp I].  During our consideration of that case, the DEA notified us that it would soon issue the Final Rules.  We set aside considering the merits of Hemp I to await them. . . .

Hemp I addressed whether the putative Interpretive Rule was an interpretive rule or a legislative rule under the Administrative Procedure Act.  That question turned primarily on whether the putative Interpretive Rule would ‘amend the DEA's own regulation on the coverage of naturally-occurring THC in Schedule I.’  Hemp I, 333 F.3d at 1088.  In that context, we held that the listing of ‘marijuana’ in Schedule I excludes the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.  Id. (quoting 21 U.S.C. § 802(16)).  We held further that the listing of THC in Schedule I, as part of the Comprehensive Drug Abuse Prevention and Control Act of 1970, applied only to synthetically-created THC.  We reasoned that ‘if naturally-occurring THC were covered under THC, there would be no need to have a separate category for marijuana, which obviously contains naturally-occurring THC.  Yet Congress maintained marijuana as a separate category.’  Hemp I, 333 F.3d at 1089.  We concluded that THC naturally-occurring within non-psychoactive hemp products did not fall under the DEA's regulation, which provided:

“‘The Director has investigated and designates all drugs, unless exempted by regulations in this part, containing any amount of the following substances as having a potential for abuse because of their:

 * * * *

“‘(3) Hallucinogenic effect”  Hemp I, 333 F.3d at 1015, citing 21 C.F.R. § 320.3(c) (1970)’

* * * *

“We held that the imposition of a ban on THC occurring naturally within non-psychoactive hemp products amended the DEA's own regulations, and that doing so could be accomplished, if at all, only by a legislative rule.  Hemp I, 333 F.3d at 1091.  We explicitly reserved the question of the validity of the DEA's proposed legislative rules, which have become the Final Rules, until the instant case was before us.  Id.

“. . . . The Final Rules amended 21 C.F.R. § 1308.11(d) (27) to insert the words ‘Meaning tetrahydrocannabinols naturally contained in a plant of the genus Cannabis (cannabis plant), as well as’ immediately before ‘[s]ynthetic equivalents of the substances contained in the cannabis plant’ in the section quoted above.  In considering the propriety of the Final Rules, we necessarily consider the propriety of this amendment to § 1308.11(d)(27).”  Hemp II, 357 F.3d at 1014-1015.

To summarize, the DEA, for its own reasons and when left to its own devices, was trying to circumvent Congress by changing the definition of marijuana to include any plant containing any amount of THC, even trace amounts producing no euphoric effect, by an administrative rule rather than by a change in the statute which would require an act of Congress.  In so doing, the DEA was hoping to outlaw all products made from hemp for reasons known only to the Administrator of the DEA in October 2001, who was Asa Hutchinson, a Republican
Congressman from Arkansas until he was confirmed as DEA Administrator by the United States Senate on August 6, 2001, after being appointed to that position by President George W. Bush.

The Ninth Circuit then considered whether the DEA’s Final Rules were, in actuality, a scheduling action which placed non-psychoactive hemp in Schedule I for the first time without following the procedures required by the CSA.  Hemp II, 357 F.3d at 1015.  In this regard, the Ninth Circuit found the DEA Final Rules were, in fact, a scheduling action requiring the DEA follow CSA mandated procedures for such a classification change but, instead, the DEA tried to circumvent the law.  The Ninth Circuit found the DEA’s attempt to schedule non-psychoactive hemp within Schedule I was governed by 21 U.S.C. § 811(a) which first required a finding that the substance had “a potential for abuse.”  After 21 U.S.C. § 811(a) is first satisfied, 21 U.S.C. § 811 (a)(1)(B) requires a further findings be made pursuant to 21 U.S.C. § 812(b) before a scheduling change can be made.  

To reiterate, 21 U.S.C. § 812(b) states in pertinent part,

“. . . a drug or other substance may not be placed in any schedule unless the findings required for such schedule are made with respect to such drug or other substance.

“The findings required for each of the schedules are as follows:

“(1)  SCHEDULE I.

“(A)  The drug or other substance has a high potential for abuse.

 “(B)  The drug or other substance has no currently accepted medical use in treatment in the United States.

 “(C)  There is a lack of accepted safety for use of the drug or other substance under medical supervision.”

The Ninth Circuit found the DEA did not even “purport to have met the requirements for placement of non-psychoactive hemp on Schedule I.”  Hemp II, 357 F.3d at 1016.

In fact, the DEA keeping marijuana in Schedule I is in direct opposition to a 1988 finding made by DEA Administrative Law Judge Francis Young who wrote,

“The evidence in this record clearly shows that marijuana has been accepted as capable of relieving the distress of great numbers of very ill people and doing so with safety under medical supervision.  It would be unreasonable, arbitrary and capricious for the Drug Enforcement Administration to continue to stand between those sufferers and the benefits of this substance in light of the evidence.”

* * * *

“Marijuana, in its natural form, is one of the safest therapeutically active substances known.  In strict medical terms, marijuana is safer than many foods we commonly consume.”

Judge Young then recommended the DEA allow marijuana be prescribed as medicine.  See US Department of Justice, Drug Enforcement Administration, “In the Matter of Marijuana Rescheduling Petition,” [Docket #86-22], (September 6, 1988), p. 57.

The Drug Enforcement Administration cannot logically classify CBD a Schedule I drug because the United States Government Department of Health and Human Services has already admitted CBD is useful in treating various medical conditions, an assertion PharmaXtracts cannot presently claim without violating the Federal Food, Drug, and Cosmetic Act.

DEA agents raid a Cannabis field.  Photo credit ElaineThompson/Associated Press

The DEA failed to make any attempt to outlaw hemp by legal means because it would not have been able to show hemp has a “high potential for abuse.”  With respect to CBD, the DEA would never have been able to show CBD has “no currently accepted medical use in treatment in the United States” or that it lacks “accepted safety for use . . . under medical supervision.”  This is because on April 24, 1999, two years prior to the DEA publishing what it misleadingly referred to as its "Interpretive Rule," the United States Department of Health and Human Services patented CBD’s chemical composition (Patent Number US 6630507 B1) to treat specific medical conditions.   The patent abstract filed by scientists from the National Institutes of Health, National Institute of Mental Health states:

“Cannabinoids have been found to have antioxidant properties, unrelated to [N-Methry-D- aspartate (MNDA)] receptor antagonism.  This new found property makes cannabinoids useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases.  The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and HIV dementia.  Nonpsychoactive cannabinoids, such as cannabidiol, are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses useful in the method of the present invention.”

Department of Health and Human Services, Washington, D.C.  File photo.

The Government did not publicize its patent but, instead, kept it under wraps.  The Government’s patent was widely exposed 14 years after the Government submitted its application by John Crudele on September 11, 2013, in a New York Post article entitled “Feds patented medical pot . . . while fighting it.”  A pro-marijuana legalization website, StoptheDrugWar.org, had exposed the Government’s patent more than three years earlier with the comment, “The lynch pin in the War on Drugs is cannabis.  Without the suppression and interdiction of this popular and widely used substance, there simply would not be enough ‘illegal drug use’ going on to justify the huge amount of money and resources spent on ‘fighting drugs.’"  See https://stopthedrugwar.org/speakeasy/2008/jul/23/significance_us_govt_cannabinoid

PharmaXtracts needs not worry about infringing on the Government’s patent because PharmaXtracts’ products use CBD extracted from hemp rather than CBD synthesized from precursor chemical compounds.  CBD is a naturally occurring substance and, therefore, cannot be patented.  What the Government patented was the ability to market synthetic CBD to treat a “wide variety of oxidation associated diseases,” and as a “neuroprotectant” and for the treatment of “neurodegenerative diseases.”  The Government did not patent the ability to market CBD for the treatment of other disorders or for no specific disorder.        

PharmaXtracts does not market its CBD products for the treatment of any particular medical condition.  In fact, PharmaXtracts specifically states its CBD products are not intended to diagnose, treat, cure, or prevent any disease in conformance with the Federal Food, Drug, and Cosmetic Act which does not allow PharmaXtracts to market CBD as a “drug.”  See 21 U.S.C. §321(g)(1)(B) (“The term ‘drug’ means . . . articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals . . .”) and 21 U.S.C. §355(a) (“No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.”)

Portion of the Department of Health and Human Services United States Patent Application for Cannabiniol.  Source United States Patent and Trademark Office.

The Government’s CBD patent application was filed on April 21, 1999, granted on October 7, 2003, and its patent will end on April 21, 2019.  The only reasonable explanation for the Government patenting the use of CBD to treat oxidation associated diseases, as a neuroprotectant, and to treat neurodegenerative diseases, and then keeping its patent under wraps and not releasing it into the public domain (as NASA has done with so many of its patents) while at the same time refusing to conduct clinical trials to prove CBD’s effectiveness as a medical remedy, is that the Government has sought to stifle research into the benefits of CBD as an excuse to keep marijuana a Schedule I drug.   According to an August 22, 2016 article by Alicia Wallace published in The Cannabist, a pro-marijuana website, the National Institute of Health only granted one firm, Kannalife Sciences Inc., “an exclusive license to utilize part of the technology outlined in the patent to develop cannabinoid-and cannabidiol-based drugs for the treatment of hepatic encephalopathy – brain damage that could result from conditions such as cirrhosis.”   That license was granted in 2011, but it was not until 2016 that Kannalife “began raising $15 million in private investments” to “start clinical trials related to hepatic encephalopathy as soon as the first quarter of 2018.”  See http://www.thecannabist.co/2016/08/22/marijuana-patents-6630507-research-dea-nih-fda-kannalife/61255/.  In other words, the license was given for one restrictive purpose to a small, underfunded firm, that didn’t begin moving on its license until close to the expiration of the patent date, which can only be described as a total sham.

The Ninth Circuit also found the Attorney General would have been unable to make a rule classifying non-psychoactive hemp products as Schedule I without the proposed rule change being made on the record after an opportunity for “a hearing pursuant to the rulemaking procedures prescribed by subchapter II of chapter 5 of Title 5 [ 5 U.S.C. § 551 et seq.].”  Hemp II, 357 F.3d at 1016.

As stated by the Ninth Circuit,

 “Formal rulemaking requires hearings on the record, and section 557(c) invites parties to submit proposed findings and oppose the stated bases of tentative agency decisions, and requires the agency to issue formal rulings on each finding, conclusion, or exception on the record.  . . . it suffices to say that the DEA did not and does not claim to have followed formal rulemaking procedures.”  Hemp II, 357 F.3d at 1016.

The 2014 Farm Bill allows hemp to be grown in the United States when licensed by a state’s department of agriculture.

In U.S. v. White Plume, 447 F.3d 1067 (8th Cir. 2006) (“White Plume”), the Eighth Circuit allowed the DEA to prosecute a member of the Oglala Sioux Tribe on the Pine Ridge Indian Reservation for growing hemp.  In so finding, the Eighth Circuit distinguished Hemp II by finding,

“[T]he appellants in Hemp II did not grow marijuana, but manufactured products using imported hemp which, though containing natural THC, was not, at the time they possessed it, part of a marijuana plant.  Indeed, in Hemp I, the court acknowledged that ‘[t]he industrial hemp plant itself, which falls under the definition of marijuana, may not be grown in the United States. Therefore, the seeds and oil must be imported.’”  White Plume, 447 F.3d at 1073, citing  Hemp II, 333 F.3d at 1085 n. 2.

President Obama signs the 2014 Farm Bill.  White House photo.

However, White Plume was decided before passage of the 2014 Farm Bill, which President Barack Obama signed into law on February 7, 2014, the applicable portion of which is codified in 7 U.S.C. §5940 entitled “Legitimacy of Industrial Hemp Research,” which states in pertinent part,

“(a)  . . . a State department of agriculture may grow or cultivate industrial hemp if–

“(1)  the industrial hemp is grown or cultivated for purposes of research conducted under an agricultural pilot program or other agricultural or academic research; and

“(2)  the growing or cultivating of industrial hemp is allowed under the laws of the State in which such institution of higher education or State department of agriculture is located and such research occurs,”

* * * *

“(b)  . . . In this section:

“(1)  . . . The term “agricultural pilot program” means a pilot program to study the growth, cultivation, or marketing of industrial hemp—

“(A)  in States that permit the growth or cultivation of industrial hemp under the laws of the State; and

“(B)  in a manner that—

“(i)  ensures that only institutions of higher education and State departments of agriculture are used to grow or cultivate industrial hemp;

“(ii)  requires that sites used for growing or cultivating industrial hemp in a State be certified by, and registered with, the State department of agriculture; and

“(iii)  authorizes State departments of agriculture to promulgate regulations to carry out the pilot program in the States in accordance with the purposes of this section.

“(2)  . . . 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.

“(3)  . . . The term “State department of agriculture” means the agency, commission, or department of a State government responsible for agriculture within the State.”

Pursuant to the power granted the state departments of agriculture to “promote regulations to carry out the pilot program[s],” California and Nevada established a number of pilot programs. 

PharmaXtracts CBD is extracted from Cannabis which by inherited traits and applied horticultural techniques is “industrial hemp” as defined, grown, and marketed in conformance with the Legitimacy of Industrial Hemp Research section of the Agriculture Act of 2014, 7 U.S.C. §5940.  PharmaXtracts' hemp is grown in pilot programs lawfully established under 7 U.S.C. §5940 in conformance with California Food and Agricultural Code, Division 24, §81001, et seq., and Nevada Revised Statutes §557.010, et seq.  California’s and Nevada’s respective Departments of Agriculture have certified, registered, and regulated the growing of our industrial hemp in conformance with federal and state laws, rules, and regulations.

Federal law, in particular, 7 U.S.C. §5940(b)(1), encourages the study of marketing industrial hemp products pursuant to these pilot programs, and by the rights and protections established by the Legitimacy of Industrial Hemp Research, 7 U.S.C. §5940, and pursuant to the guarantees of those rights and protections by the Full Faith and Credit Clause, Article VI, Section 1 of the Constitution, the Supremacy Clause, Article VI, Section 2 of the Constitution, and the Equal Protection Clause, Section 1 of the Fourteenth Amendment, PharmaXtracts markets its CBD Products to all 50 States, the District of Columbia, and all United States Territories.

Now that hemp is defined as Cannabis with a THC level not exceeding 0.3 percent on a dry weight basis, the question becomes whether that definition of hemp takes hemp out of the Controlled Substances Act’s definition of marijuana, whether a hemp plant’s leaves and flowering parts now fall not just within the exception to the federal definition of marijuana but outside the federal definition of marijuana altogether.  Given its prejudicial record against marijuana, the Drug Enforcement Administration would inevitably argue it does not.

On January 8, 2015, Senator Ron Wyden (D-OR) introduced the Industrial Hemp Farming Act of 2015 which would exclude hemp from the Controlled Substances Act’s definition of marijuana if its THC content is not greater than 0.3 percent which would allow anyone to grow hemp without state department of agricultural oversight (unless specifically outlawed by the individual state) and which would more clearly allow flowering parts containing no greater than 0.3 percent THC but with a high CBD content to be marketed nationwide without violating federal law.  Although the Industrial Hemp Farm Act of 2015 has 11 Democrat, 4 Republican, and 1 Independent Senate cosponsors, it has been stuck in the Republican controlled Senate Judiciary Committee for over two years while it waits to come to a vote before being presented to the full Senate.

On January 26, 2015, the Industrial Hemp Farming Act of 2015 was also introduced in the House of Representatives by Congressman Thomas Massie (R-KY), where it has 48 Democratic and 27 Republican cosponsors, but it has been stuck in the Republican controlled House Judiciary Committee and the House Energy and Commerce Subcommittee on Health.

On March 25, 2015, Representative Scott Perry (R-PA) introduced the Charlotte’s Web Medical Access Act of 2015 (“CWMSA”) which also excludes CBD and CBD rich plants from the Controlled Substances Act, defines a CBD-rich plant as having not more than 0.3 percent THC and, further, exempts CBD or CBD-rich plants from the Federal Food, Drug, and Cosmetic Act meaning it could be advertised as having drug-like properties.  The CWMSA also provides that nothing in the Federal Food, Drug, and Cosmetic Act shall restrict any activities related to the use, production, or distribution of marijuana in a state in which such activities are legal under state law.  Although the CWMAA has 33 Republican and 30 Democrat cosponsors, it has been stuck in the Republican controlled House Energy and Commerce Subcommittee on Health and in the House Judiciary Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.  Perry’s bill is named after Charlotte Figi, a young girl whose parents and physicians claim she experienced a reduction of epileptic seizures brought on by Dravet syndrome after she began being treated with CBD.
            
On May 13, 2015, Senator Cory Gardner (R-CO) introduced the Therapeutic Hemp Medical Access Act of 2015 which would exclude cannabidiol-rich plants from the definition of marijuana if their THC content does not exceed 0.3 percent.  How high the CBD content need be is not specified in Gardner’s bill.  Although the Therapeutic Hemp Medical Access Act of 2015 has 8 Republican and 5 Democrat co-sponsors, it too has been stuck in the Senate Judiciary Committee.

Republican Colorado Senator Cory Gardner.  Photo credit Redvote

Why the Senate and House Republican leadership has pigeonholed all four bills remains a mystery.  Some anti-marijuana crusaders have argued the introduction of these pieces of legislation prove CBD is a Schedule I drug ignoring the fact that CBD entirely produced from mature Cannabis stems is exempt from the federal definition of marijuana regardless of its THC level and that under the 2014 Farm Bill, even the leaves and flowering parts of the Cannabis plant are hemp, not marijuana, so long as the THC level is less than or equal to 0.3 percent.

What passage of these bills would actually do is (1) in Wyden’s bill, allow for the growing of hemp without the needed approval of a state department of agriculture, (2) in Perry’s bill, allow for the growing of hemp without the needed approval of a state department of agriculture and allow CBD to be advertised as being able to treat medical ailments without violating FDA regulations and, (3) in Gardner’s bill, allow CBD to be extracted from hemp flowers in addition to hemp stalks while still being exempt from the federal definition of marijuana.

Go to CBD 102.

PharmaXtracts sells the finest, purest CBD products at the lowest prices you will find anywhere.  With over three decades of combined experience in the industry, PharmaXtracts is a band of brothers who decided the CBD market needed a serious intervention.  No longer could we stand by and let false information be perpetuated and insignificant dosages be taken by people who suffer from serious ailments.  It was time to bring clarity to a once very shady world.*

Note:   PharmaXtracts claims no copyright for the pictures and photographs used in this post but considers them within the public domain.  PharmaXtracts claims a copyright for the text used herein.  © 2017 PharmaXtracts

*These statements have not been evaluated by the United States Food and Drug Administration.  PharmaXtracts CBD products are not intended to diagnose, treat, cure, or prevent any disease.  A doctor’s advise should be sought before using PharmaXtracts CBD products or any other Cannabis extract especially if you have a serious medical condition, use prescription medications, are pregnant, or are nursing a child.  Not for sale to those under the age of 18 years.  Keep PharmaXtracts CBD products out of the reach of children.