Tuesday, December 20, 2011

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!



  1. I don't understand the second-to-last paragraph. How could cannabis be in Schedule II and also be an herb? Because it is a "substance"?
    When you say the FDA must recognize cannabis as an herb, are you going back to the position in your prior post to the effect that Congress should amend the FDCA, or are you talking about some kind of administrative action by the FDA or something else?

  2. The point I am trying to make is that the definition of "drug" in the CSA is different from that in the FDCA as amended by the DSHE, and contains both drugs and supplements as defined by the combination of those two acts.

    The CSA, which pre-dates the DSHE, does not preclude the latter from exempting psychoactive herbs, including mj, from primary FDA jurisdiction.

    The second step is that, once mj is rescheduled so that sales or possession is not per se illegal, the DSHE precludes the FDA from requirig either an NDA or sale by prescription.

    Rescheduling, as a matter of law, would make mj available for OTC purchase.

  3. What I am arguing is that the CSA operates within the overall context of the FDCA. When the CSA declares something to be a controlled substance in Scheds. II - V, that substance then comes under the DEA's controll as to the methods by which it can be sold or by which it may be prescribed IF the FDA has designated it as a prescription drug. Remember, many controlled substances -- those in Sched. V including DXM and some codeine preparations, for instance -- are now marketed OTC.

    If my reading of the DSHE is correct, then mj, even as a controlled substance, could be sold without FDA approval and, as a matter of law, couls not be listed as a prescription drug or required to get an NDA unless and until the FDA meets the statutory requirements for intervention into the marketing of an herb.

    To simplify, any rescheduling of mj would, in effect, put it in a category as if it were Sched. V as a matter of law.