Sunday, December 11, 2011

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.

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


  1. Buford:

    1. Why does this reclassification proposal not run into the same basic argument that no other drug (i.e. therapeutic intervention) is ingested as smoke and ingesting hot smoke is dangerous?

    2. The CSA definition includes "drug or other substance."

    I assume, to be complete, that the statutory change would also require removing cannabis entirely from the CSA Schedules. I assume that this reclassification would obviate the "currently accepted medical use in treatment" objection. Why would the "drug or other substance has a high potential for abuse" and "lack of accepted safety for use of the drug or other substance under medical supervision" prongs not prevent cannabis from being sold in interstate commerce (i.e. anywhere)? Are there are any other dietary supplements that are deemed to have a high potential for abuse and a lack of accepted safety for use"?

  2. That was the intent of the suggested amendment: to remove mj from the CSA and eliminate all DEA jurisdiction over it.

    The nice thing is that, by treating mj as an herb, the FDA would still have a "watching" jurisdiction and could intervene if it were improperly marketed.

    Dietary supplements have a horrible safety record. A few years back a popular weight-loss supplement caused several deaths and St. John's Wort has a lot of problematic drug interactions, just to list a couple of the problems. Nutmeg, a psychedelic, has caused several deaths.

    Supplements with psychoactive effects that should put them under CSA (probably Sch. V) include, St. John's Wort, kava, and ginko

  3. Doesn't the CSA still catch cannabis, psilocybin, etc. since it refers to "drug or other substance"? I.e. even if you except cannabis from the "drug" category it is still a "substance"?