Whatcha Gonna Do?

Whatcha Gonna Do?

The marijuana legalization votes in Colorado and Washington have tongues wagging across the country.  And much of that tongue-wagging centers on one question: “Hey, Feds, whatcha gonna do now?  State legalization puts strong pressure on federal attempts to maintain the War on Drugs, and none of their possible responses would be effective.

The government’s choices narrow down to about six, although these can be combined or varied: 1) keep doing business as usual, 2) step in and try to enforce the federal marijuana laws vigorously, 3) bow out and ignore marijuana activity in these states, 4) treat the legalizing states like foreign drug producers and seal their borders with other states, 5) apply indirect pressures on bankers and landlords and stop federal funds to these states, or 6) ask congress to amend the federal laws.  None of these options provide the feds with a rosy outlook.

Business as usual looks like the best bet for the federal government.  Except for concerns with cross-border smuggling from Mexico (and to a lesser extent from Canada), marijuana is not on the federal radar anyway.  The dividing line for federal actions against marijuana is normally ninety-nine plants, that being the statutory threshold for applying the most severe sanctions.  States have been expected to pursue any cases involving smaller amounts.  This strategy has two major flaws.  First, a large and thriving commerce can develop operating under a hundred plant cap.  Second, it would create an impression either that the federal government is powerless to prevent marijuana commerce or that it condones that trade.

The feds can’t simply step in and close the gap by directly enforcing the federal marijuana laws.  They don’t have the resources.  The dirty little secret of the Drug War is that the federal government has always relied on the states to provide the manpower and resources to enforce the drug laws.  The numbers tell the story.  Each year about 1.5 million are arrested for drug offenses, over half of them for marijuana crimes.  Simple marijuana possession accounts for around 800,000 of those.  The federal court system handles just over 14,000 criminal cases each year – and that includes terrorism, bank robbery, kidnapping, and white collar crimes.  Even a relatively low-population state like Colorado will generate twice that number of cases each year.  Only 480 federal trial judges are available to handle these cases; and they have large civil dockets as well.  DEA agents will not lurk on street corners arresting teen agers holding a single joint.  The DEA has a total of around 5500 agents (including those stationed abroad and those acting bureaucratically in Washington).  This number is about the size of the Houston police force.  Teen-age stoners will become octogenarian couch potatoes before the DEA can get around to arresting them.

On the other hand, Colorado and Washington cannot just be ignored. Their experiments might be successful.  Rampant drug abuse and crime might not occur.  They might save large amounts and law enforcement and garner massive tax revenues.  And if that happens and the feds don’t slap them down, then the other forty-eight states will join the stampede (several bills have already been filed in state legislatures in less than a month.)

Surely the feds can force them to keep their weed at home and not let it leak out to the other states.  Can they be treated like drug-exporting countries like Colombia and Mexico?  Some states are already complaining about marijuana coming into their states from medical marijuana states like California, Oregon, Washington, and Colorado.  Legally grown marijuana from Colorado and Washington can severely undercut the price of Mexican imports and improve on the quality as well.  The 5500 DEA agents and 14,000 Border Patrol agents have been unable to even slow down the flow from Mexico, and they will have far fewer tools to prevent interstate traffic.  Washington’s two long borders with Oregon and Idaho and Colorado’s with Wyoming, Kansas, Nebraska, Oklahoma, New Mexico, and Utah are almost as long as the Mexican border.  The border patrol and ICE has no jurisdiction over interstate movement or commerce.  Interstate borders cannot be blocked with armored walls; and checkpoints and warrantless searches would be unconstitutional.  On the other hand, increased interstate commerce in legalized marijuana should greatly crimp the earnings and ability to do business of the Mexican cartels.

Indirect enforcement would also be ineffective.  In California, Colorado, and Montana the DEA has attempted to use the banking authorities to block marijuana businesses from using banks, tried oppressive income tax enforcement, and brought forfeitures against landlords.  But banking limitations are easily avoided and tax and forfeiture cases are so ponderous that, while they are destructive to a few individuals, they have little effect on the business overall and build public resentment.  While congress has pressured states into uniform drinking ages and speed limits by threatening to withhold highway funding, strong constitutional questions will arise if the feds try to withhold funds not related to the problem they are trying to regulate.

The feds could go to congress for help, but what could congress do?  The Controlled Substances Act already pushes the limits of congressional power under both the commerce and treaty clauses.  Under current circumstances congress is unlikely to increase spending on drug law enforcement to any great extent.  The courts have already been pushed to the limits on search and interrogation methods.  About the only doors open to congress at this point are those leading to a loosening of drug prohibition.

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Somewhere in Washington a conference room window glows in the midnight dark.  Fluorescent glare highlights a gleaming conference table littered with coffee cups, open law books, and laptops.   Tired men in wrinkled suits with tussled hair and ties askew talk quietly or stare blankly at the walls.  I wish I were there so I could ask: “Hey, Feds, whatcha gonna do now?”

The Tenth Amendment: What does it really say?

Almost twenty years have passed since the revolution in state medical marijuana laws first erupted.  With eighteen jurisdictions joining that revolution, questions about the relationship between state and federal laws have come to the fore.  Central to the debates has been the role and force of the Tenth Amendment to the Constitution.  Unfortunately, most of what has been said about that amendment has ranged between the mistaken and the ridiculous.  The time is ripe to examine that amendment and find out its actual meaning.  The place to start is with the text itself.

Amendment X

The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.

The most straight-forward reading of this amendment is that it provides a series of tests to determine whether a government (federal or state) may constitutionally exercise a power that it claims.  These tests apply to both federal and state governments.

In order to be constitutional, a power asserted by the federal government (normally through a statute, executive order, or administrative regulation), must be delegated to it by the Constitution.  In many cases that power will be one of those expressly delegated in Article I.  For instance, the Controlled Substances Act has been upheld as a valid exercise of the power to regulate Interstate Commerce.

The express powers listed in Article I are not the only ones that the Constitution delegates to the Federal government.  Other sources of powers for the Federal Government include:
-- the “necessary and proper” clause of Article I – source of the power to create a Federal bank exercised by the first Congress,
 --the foreign affairs and commander in chief powers of Article II,
 --the judicial clause of Article III,
--the “republican form of government” clause
--the “full faith and credit” clause. 

The XIV and XV Amendments added additional powers for the Federal Government to insure equal protection of the laws and voting rights.

Unfortunately, most of those arguing for increased state powers under the Tenth Amendment read it as if it limited the Federal Government to only those powers expressly enumerated in Article I.  Many of them actually misquote the text to read: “The powers not expressly [sic] delegated to the United States…”.  That interpretation would completely enervate the government and is supported neither by text nor by history.

The Founders assumed that the states would continue to be responsible for the regulation of most day-to-day activities.  But they also put constraints on those state activities.  In order to comply with the Tenth Amendment, state action must meet three tests: is the activity prohibited to the states by the Constitution; is the power exercised one that has been delegated to the Federal Government; and have the people themselves exercised that power?

The Constitution imposes several strong prohibitions on the states.  These include bans on monetizing anything but gold or silver, interfering with contracts, refusing to give full faith and credit to the laws of other states, and requiring the states to grant free right of passage and residence of the inhabitants of other states.  The XIV and XV Amendments additionally forbade states from denying equal protection of the law to persons and from interfering with the right to vote.

In some states the people have directly taken powers from the state by exercise of ballot initiative or referendum powers.  The most noted example of this direct application of popular power identified in the Tenth Amendment is Proposition 13, through which Californians limited the state’s power to impose property taxes. Many states, including Oregon, Washington, Montana, California, Colorado, and Michigan, have used this power to restrict the state’s power to punish the medical use of marijuana.

Most state federalism[1] problems arise when a state tries to act concerning a power delegated to the federal government.  These problems may be divided into four categories:
1. A power has been delegated to the federal government, the federal government has not acted to implement that power, but a state attempts to do so;
2. The federal government has exercised a delegated power and a state has also exercised that power in a way  not inconsistent with the federal power;

3. The federal government has acted and a state elects to do nothing in this area; and

4. The federal government has acted and a state attempts to act in a way that is inconsistent with, or that would interfere with, the federal activity.

The first of these cases – no federal action in an area delegated to the federal government – presents few, if any, problems for state drug laws because federal regulation in this area is all encompassing.  This whole area can be relegated to the arcana of the Dormant Commerce Clause, now used primarily to befuddle and terrorize law students.

The second situation – the federal government has acted in a delegated area and a state government also acts within that area – is common and causes few problems so long as the state action is consistent with the federal action.  Robbing a nationally chartered bank and a federal crime and also is the state crime of bank robbery.  Both or either of those governments may prosecute and punish.  Likewise, a federal hate crime violating the civil rights of the victim, may also be punished by a state as an assault or battery.

Most current state drug laws fall within this category.  Possession or distribution of marijuana is a violation of both federal and state statutes, and each may enforce its own law.  Often cooperative task forces, mixing federal and state agents, join together to investigate possible drug crimes and make arrests.   Either or both of the governments may then prosecute those arrested.  The state law does not have to exactly mirror the federal statute so long as it does not interfere with federal enforcement of its own law.

Most state attempts to reform marijuana laws fall into the third category.  If the federal government has acted in an area, a state may choose to do nothing regarding that subject.  Even though the federal government has made all possession or distribution of marijuana illegal, a state government may elect not to take state action against marijuana users or growers itself.  If a state purports to legalize marijuana for medical use, it is in fact merely stating that the state will not use its enforcement powers to prevent distribution or use of marijuana for medical uses.  It cannot set aside the federal prohibition nor may it prevent the federal government from enforcing its laws within the state’s border.  On the other hand, the federal government may not require a state to use its resources to enforce the federal law.  To date, seventeen states have removed state penalties (“legalized”) medical marijuana, and fourteen have replaced state criminal penalties for possession of some amount of marijuana, imposing a small fine for a civil infraction instead (“decriminalization”).  The Tenth Amendment allows a state to refrain from taking action against all or some marijuana users.  It does not allow a state to set aside or interfere with the enforcement of a federal law.

Most problems for a state arise when it attempts to act in an area in which the federal government has acted and the state’s act conflicts or interferes with the federal law.

Although, as noted above, a state may act if that action is roughly parallel to or supportive of federal action, three activities are constitutionally forbidden to the states.  A state may not nullify a federal law, direct or compel its agents or citizens to violate a federal law, or take any action that interferes with the enforcement of a federal law or makes its enforcement more difficult.

Nullification, or the theory that a state could set aside a federal law, preventing its enforcement within that state, gained some support very soon after the ratification of the Constitution.  It was proposed, even though no state attempted it, until the 1830s when South Carolina announced that it intended to prevent imposition of the new tariff in its state.  When President Jackson threatened to use federal troops to enforce the law, South Carolina backed down, and no state has seriously claimed the power to nullify since then. 

The inability to nullify federal law has greatly hampered state attempts to implement medical marijuana laws.  A marijuana distributor, legal under state law, is still just an illegal drug dealer to the DEA and may be convicted and sent to federal prison.  If a bank accepts deposits from that distributor, it has probably violated federal money-laundering laws; and that distributor’s landlord may find his property forfeited under the Continuing Criminal Enterprise Act.  Many early attempts at medical marijuana laws ran afoul of the nullification ban by trying to require doctors’ prescriptions or distribution by pharmacies, either of which would be an attempt to nullify federal laws regulating prescription drugs.

A state may not require one of its agents or employees to violate the federal law.  At least two states that originally proposed state-run dispensaries and growing operations had to drop those provisions.  The New Jersey statute has been delayed for about two years because the governor tried to require that a state university grow all of the marijuana to be distributed.

The requirement that a state not hamper or interfere with federal enforcement of federal law is proving problematic.  A California Appeals Court has ruled that a city may not require marijuana dispensaries to obtain a business permit because that could make federal law enforcement more difficult[2].  Likewise, a local ordinance requiring all outdoor marijuana growing be screened by fences so that it could not be seen from the street is probably unconstitutional.  A DEA agent’s job would be hampered because he would be unable to see the illegal activity from the street.

The Tenth Amendment is not a sword the states can use to cut down or limit the federal law.  At most it is a shield, allowing states to refrain from being co-opted into joining the federal enforcement.  Constitutional state reform of marijuana law is limited to the extent that, at most, a state may elect to be an onlooker of the War on Drugs instead of a participant.

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[1][1]  Federalism deals with the allocation of powers between federal and state governments.

[2] Now under review by the California Supreme Court

Wash My Mouth with Soap

          For some time now – at least a decade – I have been dissatisfied with the language used to describe the use and regulation of controlled substances.  So it’s time to wash my mouth out with soap (at least figuratively) and clean up my vocabulary.

What is wrong with our current vocabulary, based on the concepts of addiction, drug abuse, and controlled substances?  It has four fundamental flaws that prevent rational discussions of the issues involved.  It turns inanimate, morally neutral chemicals into immoral destructive agents; it creates a dichotomy between abstinence and addiction, overlooking all other behavior patterns; it also dichotomizes medical applications and abuse, ignoring a universe of other motivations for consumption, turning all users not following strict medical instruction into criminal Others; and it improperly reifies “dangerous drugs” from a legal category into an actual substance. 

Demon Rum invaded political thinking during the 1830s.  Alcohol was personified as an active agent of evil, lurking to pounce on – and destroy – any innocent soul who fell into his trap.  This personification carried over into the concept of drugs as an aggressive enemy in a War on Drugs.  The problem is that drugs are neutral chemicals and may be used for either good or evil.  Just as Nobel’s dynamite could be used both to build railroad tunnels and to raze cities through bombardment, morphine could be used both to enable life-saving surgery and to satisfy an addict’s compulsion.  Methamphetamine is both a bane on the street corner and a path to a normal life for a child with an attention disorder.

The reaction to harmful alcohol consumption began as a temperance movement, memorialized by the still-used name of the Women’s Christian Temperance Union.  Dr. Benjamin Rush, the Founding Father from Philadelphia, was one of the first to recognize that harm could result from excessive consumption of distilled spirits; but he also recommended beer, wine, and cider as healthy beverages.  By the end of the Civil War the idea of temperance had been replaced by that of total abstinence forcibly insured by the absolute prohibition of alcoholic beverages.  This goal of forced abstinence through legally mandated prohibition was then made the mechanism for controlling all drugs.  This limited view of intoxicating behaviors has led to common acceptance of myths like the claim that a single taste of crack cocaine can create a lifelong addict.

This kind of binary, all-or-nothing, thinking about the effects of drug use led naturally to another binary concept.  The accepted wisdom became that all use of drugs that was not medically mandated and under a doctor’s supervision was abusive or addictive use.  This belief has persisted even in the face of centuries of social and personal use of drugs like alcohol, nicotine (tobacco), and caffeine (tea and coffee).  One consequence is that a person experimenting with a single marijuana joint is viewed as a criminal other and treated as a dangerous stranger to be punished and expelled from common society.

Dangerous drugs do not exist although the use of many, if not all, drugs may have dangerous consequences.  Aspirin may cause gastric bleeding and prevent blood clotting while many have used heroin or marijuana for decades with no adverse consequences (except for those imposed by the criminal laws).  On the other hand, the human body does not distinguish between heroin and morphine.  These two drugs can be used almost interchangeably as medicine, but the law interposes an unbridgeable chasm between them.  Heroin, marijuana, and LSD have nothing in common, but “Just Say No” thinking treats them as if they were a single substance.

The concepts and ideas behind this traditional vocabulary limit thinking about management of drug taking behavior to a few worn-out concepts.  It also prevents considering alternatives outside of the Prohibitionistic all-or-nothing, heaven-or-hell sloganeering.  It is time for developing new ways of talking so that new ideas can enter the discussion.

Having thoroughly cleaned my mouth (and hopefully my brain as well), I resolve to change my way of talking.  No longer will I talk about addiction, addicts, or drug abuse.  No longer will I refer to “dangerous drugs”.  

“Dangerous Drugs” do not exist.  The problems (and benefits) accompanying opioids are different from those around stimulants, anti-anxiety drugs, hallucinogens, or marijuana; and they should be dealt with separately.  If they must be discussed as a group, “controlled substances” may be the best way to aggregate them.

Drug addiction and drug abuse refer to two different concepts and need to be replaced with a different organization of ideas.  Instead of the all-encompassing “addiction” I hope to present a more analytic range of drug-using behaviors ranging from experimental use through casual to social use.  Most users would fit into one of these categories.  Those into heavier or more routine use would be either habitual or compulsive users, the last category including many of those now counted as addicts.

I have never seen anyone abuse a drug (the image that phrase calls to mind is that of a poor, innocent pill strapped to a post while some meanie lashes it with a big whip).  Some drug users do use them in ways that are damaging either to themselves or to those around them.  The paradigmatic examples are tobacco users whose compulsion leads about 400,000 of them to death each year and those who drink alcohol in ways that facilitate their killing others in car wrecks and indulging in domestic violence.  This distinction also provides for a way to analyze the differences between heavy and repeated use and binge use that frequently leads to harmful conduct.

Simply cleaning up the way people talk not only removes harmful and false myths from our discourse; it also opens the door to explore new solutions for long-standing problems.

I hope my newly-cleansed mouth will lead others to follow my example.

Marijuana: Drug or Herb? (Part II)

Marijuana: Drug or Herb? (Part II)

While I was writing “Marijuana: Drug or Herb?” (posted 12/11/11), a small idea started nibbling at the far corners of my mind.  That nibbling has grown into a constant gnawing, so with a large measure of diffidence, I am sharing that idea with you.  I warn you that this idea goes far beyond my areas of competence, but my hope is that someone with greater knowledge than mine (a very low standard) of the production, distribution, and prescription regulations of the Drug Abuse Control and Prevention Act, FDA practice, and regulation of dietary Supplements will either shoot it down completely or flesh it out into a viable theory.

Rescheduling marijuana out of the totally prohibited drugs of Schedule I has been a major effort of drug law reformers for more than forty years – longer than the professional lives of most of those concerned.  In the last few years many of those reformers have become concerned about what will happen if marijuana is rescheduled.  The consensus has been that, if it is to be legally distributed, marijuana will have to pursue a New Drug Application through the FDA – an arduous and costly procedure.  But is that consensus necessarily correct?  Answering this question requires looking at the total federal scheme for regulating drugs.

Speaking broadly (and ignoring literally dozens of amendments), federal drug regulation rests on four statutes: the Food, Drug and Cosmetics Act (FDCA), the Drug Abuse Control and Prevention Act, Part I (DACP), the Controlled Substances Act (CSA, which is Part II of the DACP), and the Dietary Supplement Health and Education Act (DSHE).  These acts were passed over a sixty-year period and contain many overlaps while allowing gaps to remain in their coverage.

The FDCA controls the marketing of all drugs affecting interstate commerce.  Any drug without an FDA approved label will be presumed misbranded, and therefore its sale would be deceptive and misleading.  That label must include information about at least one medical use for which the drug has been proved, to the satisfaction of the FDA, to be both effective and safe.  Because it is constitutionally barred from regulating the practice of medicine, the FDA cannot require doctors to use those drugs for their proven uses nor can it bar doctors from prescribing those drugs for other, non-labeled uses.  This latter practice of off-label prescribing is wide-spread.  Hair restoration was originally an off-label use of Rogaine.

Two exemptions to FDA jurisdiction are recognized.  The Supreme Court has held that Congress intentionally exempted alcohol and tobacco (two truly dangerous drugs) from regulation by the FDA (and by implication, from the DEA).  The DSHE conditionally exempts dietary supplements, including herbs, from FDA regulation.  The FDA only retains what may be called “watching jurisdiction”.  If sufficient evidence exists that the supplement is misbranded or marketed in a deceptive or misleading fashion (normally by making health claims), the FDA may remove the product from the market until the distributor has obtained an NDA.

The DEA has the authority under the CSA to find that a drug has a potential for abuse.  If it so finds, the DEA may bar its manufacture, distribution, or possession (by placing the drug in Schedule I) or regulate the method by which it is distributed (by placing it in Schedules II – V).

Once a drug is in Schedules II –V, the DACP controls the way in which the DEA (originally the BNDD) regulates the manufacture, inventory, and distribution of that drug.  If the FDA has ruled the drug to be available only on prescription, the DEA also regulates the manner in which that prescription is processed and filled.  Neither the FDA nor the DEA may require or forbid a doctor to employ a drug other than those in Schedule I; and only the FDA – not the DEA – may determine that a prescription is required for the dispensing of a drug.  But the DSHE exempts dietary supplements, including herbs, from pre-sale FDA jurisdiction.  The FDA can intervene in the distribution of supplements only if the distributor has violated the statutory restrictions imposed by that act.

What if marijuana were rescheduled – either by agency action or by court order (see “The Cornerstone of American Drug Policy”, posted 12/1/11)?  The most logical placement of marijuana would be in Sched. V, but placement in Sched. II, in the uncomfortable company of morphine, fentanyl, methadone, cocaine, amphetamine, methamphetamine, and Ritalin, is more likely.

As a scheduled controlled substance, marijuana producers and distributors would be subject to more (if Sched. II) or less (if Sched. V) stringent requirements for security, storage, inventory, transportation, and reporting.  But purchasers and end-users would only have to deal with state requirements.  In the sixteen jurisdictions with medical marijuana laws, those meeting the medical needs requirements could purchase freely without the necessity of a prescription.  No prescription could be required (unless imposed by state law) because the DEA is without power to require prescriptions (it can only regulate the methods by which prescriptions are handled) and the FDA would have to recognize that, marijuana being an herb, it could only act after distributors violated the limits imposed by the DSHE.  No NDA or proof of efficacy and safety could be required.

So far, all that has been demonstrated is that I still possess the Law Professor’s uncanny ability to construct complex and implausible hypothetical cases with which to confuse – and possibly enlighten – the class.  Now it’s your turn.  Can the real lawyers out there either point out the fatal flaws in the hypothetical or build it into a useable theory?  Let’s see what you can do!

   

Marijuana: Drug or Herb?

Marijuana: Drug or Herb?

The main focus of the drug law reform movement for over forty years has been to force the DEA to move marijuana from Schedule I, making unlawful any production, distribution, or possession, to one of the less stringent schedules (II-V), in which it could be made available for medical use.  However, many have lately realized that merely rescheduling marijuana would not make it available to patients in need; its sale or distribution would still be totally blocked by lack of FDA approval for movement in commerce as a drug.

Students of classical logic or rhetoric will recognize this situation as placing marijuana on the horns of a dilemma.  One of those horns impales marijuana on DEA prohibition, while the other gores it with the lack of FDA approval.  In either case, the medical use of marijuana is impossible.

But that same student knows that the resolution of a dilemma is to go between the horns – to find a third solution, avoiding the bad outcomes threatened by the two choices presented.  Congress has already set up a third solution that would allow marijuana to avoid both DEA prohibition and FDA regulation.  Congress should recognize that, according to its own regulatory scheme, marijuana is not a drug: it is an herb.

Federal law provides three systems for regulating physiologically active substances.  The most comprehensive is the regulation of the marketing of drugs in or affecting interstate commerce by the FDA.  The sale of any drug not bearing an approved FDA label is deceptive and misleading, and therefore forbidden.

Those drugs with some potential for abuse (not defined in the statute) are regulated by the CSA.  Those with no medical use (Schedule I drugs) may not be lawfully produced, sold, or possessed.  Drugs in the less restricted schedules (II-V) have some demonstrated medical use and may be sold, but only under the regulation of both DEA and FDA.  The many drugs legally sold under dual regulation by DEA and FDA include morphine, OxyCotin, cocaine, methamphetamine, and Ritalin.

However, not all products meeting the definition of drugs under the CSA and FDCA (briefly, a substance ingested for the purpose of affecting bodily or mental function) are subject to these two agencies.  In 1996 congress enacted the Dietary Supplement Health and Education Act.  That act allowed the marketing of dietary supplements, herbal preparations, and vitamins without FDA prior approval so long as no health claims were made on the packaging or in the advertising of the product.  The preparations covered by this act include St. John’s wort and kavakava, both taken for their supposed psychoactive effects.  These effects should otherwise bring them under the CSA and DEA control.

(Congress has apparently created a fourth category of drug regulation as well.  In ruling against the FDA’s proposed attempt to regulate cigarette marketing, the Supreme Court held that the failure of congress to expressly include tobacco and alcohol in either the FDCA or the CSA established a clear congressional intent not to regulate these drugs.  This fourth category containing of drugs that are not regulated consists of two of the most dangerous and addicting substances people have ever ingested.)

The question then becomes whether marijuana is a drug, a controlled substance, or a dietary supplement.  Of those three categories, marijuana (and possibly psilocybin mushrooms and mescaline cacti) seems to best fit as a dietary supplement.  Supplements are statutorily defined  as:

`(gg) The term `dietary supplement' means a food for special dietary use, as defined in section 411(c)(3), that--

`(1) includes--

`(A) a vitamin;

`(B) a mineral;

`(C) an herb;

`(D) an amino acid;

`(E) another ingredient for use by man to supplement the diet by increasing the total dietary intake; or

`(F) a concentrate or extract of any ingredient described in clause (A), (B), (C), (D), or (E); and

`(2)(A) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or

`(B) complies with section 411(c)(1)(B)(ii).'.21 U.S.C. 411.

These naturally occurring substances are significantly different from the single-molecule drugs normally covered by the stricter FDCA and CSA.  Congress, in the Dietary Supplement Health and Education Act has already provided a model of this kind of restructuring:

(b) EXCLUSION FROM DEFINITION OF DRUG- Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is amended by adding at the end the following new sentence: `The term `drug' does not include a dietary supplement or an ingredient described in clause (A), (B), (C), (D), (E), or (F) of paragraph (gg)(1) in, or intended for use in, a dietary supplement.'.

That section could be amended to read: “…Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) and Drug Abuse Control and Prevention Act of 1970[1] are amended by adding at the end the following new sentence: `The term `drug' does not include a dietary supplement, including any plant or parts of plants of the genus Cannabis,…”

This reform might be more feasible than either decriminalization or legalization.  A member of congress would be merely streamlining regulation to make it more reasonable.  He would not have to face voters in defending his “soft on crime” vote to legalize dope and free hordes of fiends on the highways and around the school yards.

Marijuana is only an herb like St. John’s wort and kava, not a drug like heroin or methamphetamine.  It is time to treat it like one.  Please pass the cannabis brownies.

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[1] Which included the Controlled Substances Act as Part II

The Cornerstone of American Drug Policy

The Cornerstone of American Drug Policy

The cornerstone of American drug policy is the Controlled Substances Act of 1970, and the cornerstone of that act is the scheduling scheme.  That act divides controlled substances into five categories, or schedules.  Drugs in Schedule I, which include marijuana, heroin, LSD, peyote, and MDMA among others, may not be manufactured, distributed, or possessed by anyone. The definition of Schedule I drugs is therefore the cornerstone of the scheduling process.

To be classified in Schedule I, a drug must have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and cannot be used safely under medical supervision.  None of these three primitives are defined in the act and have not been clarified by the courts.  But the problematic element is the second.  What is “currently accepted medical use in treatment in the United States”?

Two meanings of this phrase are possible.  The first is to treat the language as requiring the DEA to look into the actual medical efficacy of the drug as shown by medical science.  This meaning has been followed by the Drug Enforcement Agency in proceedings to reschedule marijuana and MDMA since 1972. The courts have never examined this definition, all but one of the appeals on marijuana having been decided on procedural grounds.  Even in original NORML case, the court never reached the substantive issues.

The second possible meaning is that the issue is strictly one of demographics.  Under this theory, the DEA has no competency to examine the scientific and medical questions, but must limit itself to determining what, in fact, doctors do in the course of treating patients.  In other words, the question becomes one of whether a substantial number of doctors treat marijuana or MDMA is a therapeutic agent when dealing with their patients and whether other doctors approve or disapprove of that use.

An examination of the development of the regulation of both legal and illegal drugs indicates that the second reading, limiting the DEA to the question of what doctors do in practice, is more consistent with current constitutional law.  That story began soon after the enactment of the Harrison Narcotic Tax Act in 1914.

That act criminalized a doctor’s dispensing or prescribing an opiate to a patient outside of the normal course of medical practice.  The government began prosecuting doctors who furnished morphine or heroin   for the purpose of maintaining their habits (much like methadone is used today), claiming that maintaining addicts in a stable, functioning life was not part of the normal practice of medicine.

The Supreme Court considered that question three times before deciding that Congress had no constitutional authority to say what was “the practice of medicine”.  In Linder (1925) the Court held that medical practice was not part of interstate commerce and, consequentially, the power to regulate medicine, including determination of what is or is not medicine, is reserved solely to the states.

While the Supreme Court has discussed medical marijuana in over twenty opinions, it has not directly dealt with this problem of interpretation of the CSA.  However, in Conant v. Walters (2002), the Ninth Circuit applied this reasoning in holding that the federal government, acting under the CSA, could not prevent a state-licensed doctor from recommending the use of marijuana to a patient.  So far the DEA has not presented the issue to another circuit.

Congress was faced with this exclusion of the federal government from the regulation of medicine when it created the Food and Drug Administration through the Food, Drug, and Cosmetics Act in the1930s.  The purpose of the act was to insure food and drug safety, but since Congress could not regulate drugs directly, indirect action was called for.

Consequently, the FDA was not given power to approve drugs, but instead, it was empowered to prevent drugs from being sold in a deceptive or misleading manner.  A drug sale would be misleading and deceptive unless that drug bore a label approved by the FDA. That label would be approved only if it were substantiated by valid scientific tests that the drug was safe for the intended use.

That method of regulating drugs by controlling their marketing was continued as the FDCA was amended, first in the1950s to separate prescription and over-the-counter drugs and then in the 1960s to require scientific proof of efficacy for at least one medical use before a label could be approved.  The Supreme Court has approved this distinction in cases involving the rights of doctors to prescribe drugs for “off label” uses, treatment of conditions not included on the label, although manufacturers have been punished for publicizing or advertising those uses.  Doctors distributing drugs which they themselves had produced and furnished to their own patients as part of a broader therapy and not using the instrumentalities of interstate commerce have also been held to be outside the jurisdiction of the FDA.  The most recent case, Gonzales v. Oregon (2005), prevented the DEA from taking action against doctors acting under Oregon’s assisted suicide law.

A determination of "efficacy" seems very close to determining medical utility - since efficacy seems to imply "effective in treating a disease" "relieving symptoms" "boosting health functions" etc. What is the difference?

This constitutional derivation strongly favors the interpretation that the DEA is limited to asking only what doctors are, in fact, doing and is barred from inquiring into the medical or scientific value of the drug.  The statutory language itself reinforces this interpretation.  The statute specifies “currently accepted medical use”; Congress could have easily used “medically effective” or “substantial medical value” if the intent had been to empower the DEA to conduct independent scientific investigations.  Congress did, in fact, empower the FAA, FCC, and NTSB with those kinds of direct powers in regulating airplanes, broadcast stations, and trucks and buses: all direct instrumentalities of interstate commerce.

The DEA’s own Administrative Law Judge applied a “medical use” standard in the first two contested scheduling proceedings under the CSA: the first marijuana petition and the proceeding for the emergency scheduling of MDMA. The politically appointed Administrator reversed his recommendations in both cases.  In the MDMA proceeding, the Administrator rejected the ALJ’s findings, equating “medical use” with “approved by the FDA”.  The Court of Appeals (Grinspoon, First Circuit,1987)  rejected this interpretation and remanded the case for further consideration.

If the courts were to require the DEA to use a medical use standard instead of a medical value standard, rescheduling of marijuana and MDMA would necessarily follow, allowing them to be sold through normal medical channels; and the rescheduling of psilocybin, LSD, mescaline, and possibly heroin and ibogaine would be likely. These drugs, while having no, or little, current medical use, could be covered by a “but for…” argument.  Each of them had thriving medical use and widespread favorable medical reporting before they were classified as Schedule I drugs.  But for that classification, their medical use would probably be common today.  Heroin, for instance, is routinely used in many countries with developed, sophisticated medical systems.  This information would be probative in a rescheduling action.  If coupled with expert opinions about the scope of its use by American physicians and pharmacologists, it should be persuasive.

Since the passage of the CSA medical use of marijuana has blossomed even while forbidden.  Thousands of refereed medical papers have been published,  its effectiveness. Sixteen jurisdictions have enacted medical marijuana laws, and well over a million patients now regularly use medical marijuana under those laws.  The undercover illegal use by patients in other states could easily double that total.

Marijuana has now met the statutory requirements that necessitate its removal from the absolute prohibition of Schedule I.  It has been shown to be qualified as a drug available for a doctor’s prescription just like OxyCotin, cocaine, and methamphetamine. All that is necessary is for the DEA to apply the law as written.

Gun Prohibition Won't Work either

Gun Prohibition Won’t Work Either

Violence in the Mexican drug war is soaring to unprecedented highs. Latest estimates claim that at least half of the guns used in that conflict were purchased in Texas and smuggled into Mexico, which has outlawed personal ownership of firearms. The United States government has announced that it will step up its efforts to interdict those weapons at the border and prevent their movement into Mexico.

However, this gun prohibition will not work. It suffers from the same flaws that prevented prohibitions against alcohol, drugs, gambling, prostitution, or even against counterfeit Gucci bags or pirated movies from working. The harder interdiction is imposed, the higher the price for the contraband soars, and the more ruthless the dealers attracted to the trade become. The result is not suppression of the prohibited trade; it just becomes more expensive, corrupt, and violent.

The only effective means to suppress or moderate a functioning market are those that operate on the demand side of that market. The market for tobacco provides a good example. The number of tobacco users has decreased by about 60 per cent (from over half of the adult population to about twenty per cent) through the use of three techniques: research into the psychology and physiology of tobacco use, education of users and potential users, and limitations on advertising.

While those tools against tobacco use have taken about fifty years to work, in Mexico, the United States has a much stronger tool than any of these to use against the demand for guns. The United States government has total control over the more than $30 Billion that, each year, is spent by American users and fuels the Mexican drug wars. That sum is a conservative estimate of the amount that the U.S. drug laws pump into the Mexican economy annually: an amount that is one of the top four sources of foreign money in the Mexican economy.

This money generated by the American drug laws has two effects on the demand for guns in Mexico. The most important is that control of that money is what the cartels are fighting over and what allows them to fend off the Mexican government. The second is that the money is necessary for the purchase of the guns themselves.

While Mexican society has always had a machismo strain of violence dating back to at least the time of the Spanish conquest, the current cartel wars have multiplied that violence into a different phenomenon. The best comparison, although on a smaller scale, is the way civil unrest exploded in Colombia with the growth of the cocaine market in the 1980s. Mexico’s violence is similar to – but much larger than – the gang violence that erupted in Chicago when millions of illegal alcohol dollars flooded the city. Greedy, ruthless men fought and killed to get their share of the loot. Without the money, violence in Mexico would quickly fade to the much lower historical levels, just as it did in Chicago with the repeal of prohibition.

If large amounts of money were removed from the equation, the demand for guns would decrease for a second reason: guns cost money. And the military-grade arms now in demand cost a lot of money. A single rifle like a Kalashnikov can cost up to a thousand dollars. Machine guns and rocket launchers go for much more. Without the illegal drug money, the cartels would be limited to guns more typical of a street criminal than the Pentagon quality arms they now use.

However, this proposal rests on two other questions: can the United States afford to purge its laws of drug prohibition and how much would those changes affect the Mexican cartels?

The U. S. not only can, but should, change its drug laws from ones based on prohibition to a new approach based on regulating and lowering demand. Almost no one doubts that the current prohibition approach – now ninety-five years old – has been an abject failure. More people are addicted to opiates today than were addicted in 1914; and marijuana, used by fewer than 100,000 people in 1937 when it was outlawed, has been used by over 40% of today’s adults. The latest FBI data shows over 1.6 million drug arrests in 2009, but anyone in America can easily buy any drug in any community in the country. The War on Drugs has cost over $1 trillion, and the only results are increased drug use, the highest imprisonment rate in the world, and high levels of violence and corruption. When one finds himself in the bottom of a deep hole, he should stop digging and look for a way out.

Would changing American drug laws put the Mexican cartels out of business? Replacing prohibition with regulation would hurt the cartels in two ways.

First, illegal drug prices are at least ten times as high as the equivalent legal prices would be. The risk premiums associated with prohibition are the lure that attracts violent gangsters to the business in the first place. Legal heroin was sold for the same price as aspirin. Legal cocaine was cheap enough to be used as an ingredient in Coca-Cola and tooth powder. Marijuana is no harder to grow and process than broccoli. If ninety per cent or more of the money were withheld from the cartels, they would probably get out of the business. But even if they continued as dealers, they could not afford to buy black market military-grade arms.

More important, the very market supporting the cartels would probably disappear. Local American farmers can out produce and undersell Mexican competition. This displacement is already happening in California. Walgreens could buy legal cocaine directly from Colombia, bypassing the Mexican middlemen entirely – or they could grow and process it themselves in Hawai’i. Pharmacists already sell methamphetamine under the trade name Desoxyn. Mexican sources are just not needed.

The way to stop the arms traffic into Mexico is not to erect another form of prohibition scheme guaranteed to fail like all prohibitions must fail. The wise approach, instead, is to replace the current destructive prohibitions that fuel that traffic with a system of demand-oriented regulation controlling the demand side of the market.