Thursday, April 26, 2007

Thinking about Legalization

Thinking about Legalization
Either this Congress or the next -- within the next three and a half years -- may create an exception to the Controlled Substances Act, allowing for the medical use of marijuana, either nationwide or in those states with state statutes allowing it. Religious and even recreational legality are not totally out of the picture.
But unless planning and preparation are done now, the result could be as dysfunctional as the present situation.
First, if medical use is allowed only as an exception to the CSA, then marijuana -- even medical marijuana -- will still be subject to the (even more?) vindictive jurisdiction and regulation of the D.E.A. Non-medical marijuana will still be a controlled substance under D.E.A. enforcement; and I am sure that they will insist on stringent controls to "prevent leakage" from the medical situation to recreational use. Since the plants themselves are fungible and the use cannot be determined until the plant is in the hands of the ultimate consumer, I am sure the D.E.A. will impose strict cradle-to-grave (clone-to-exhalation?) registration and tracking on medicinal plants and probably create (with court approval) strong presumptions against medical use. In short, people will still get busted and have to spend thousands to defend themselves and producers will be buried in paperwork and inspectors.
Even if the enabling statute keeps the D.E.A. at arm's length, some kind of regulation is inevitable. Nothing ingestable today is sold in an unregulated market. The four choices seem to be 1) treat marijuana was a drug, 2) treat it as a dietary supplement; 3) treat it as a food stuff; or 4) consider it sui generis and create a market regulatory scheme just for marijuana.
Since we are considering medical use, treating marijuana as a drug would seem the most reasonable, but it is probably the most impractical solution. If it were a drug, it would have to be approved by the FDA for marketing (I think any idea of a strictly intrastate, non-FDA plan is unrealistic). Currently, New Drug Applications take between 5 and 10 years to process and cost in the neighborhood of $500 Million and up. I see no one on the horizon willing to undertake this effort, and the additional time is too long.
The dietary supplement category is where marijuana seems to fit best, but the law prevents classification of any drug as a supplement. Since either a medical exemption statute or the current claims and uses for marijuana clear make a drug for supplement classification purposes, this approach seems unlikely unless the enabling statute specifically so categorized it.
Classification as a food would provide health and safety regulation of the growing and processing, but would not provide any way to separate medicinal and non-medicinal products or to limit marketing to adults. This also seems unlikely.
The best, and politically most available, method would be for the enabling statute to classify marijuana as sui generis and not subject to the Food, Drug, and Cosmetics Act. The enabling act should decide whether it would be marketing outside the FDA or whether the FDA's jurisdiction should be extended to include it. Either way would be acceptable.
Precedents for sui generis treatment exist in the marketing of both alcohol and tobacco, the other major personal intoxicants. Tobacco was marketed before the creation of the FDA and, according to the Supreme Court, was omitted from The FDCA scheme. The Repeal Amendment for alcohol let regulation to the states.
Among the choices to be made are issues of jurisdiction. Should regulation be left totally to the states, taken totally by the Federal government preemptively, or shared between the two, as controlled substances are now handled? Should remedies and sanctions be administrative or strictly judicial?

Other issues to be decided include:

-Authorized vendors
--Pharmacies only?
--Direct producer to consumer sales?
--All normal retail outlets?

-Authorization for purchase
--Prescription only?
--Doctor recommendation required?
--Behind-the-counter with signed register?
--Medical marijuana buyer's ID card?
--OTC with buyer at risk of proving medical need on arrest?

-Sales to minors
--Not allowed?
--On doctor's prescription or recommendation?
--Only on prescription with parental consent?
--Sales to parent or guardian only?

-Frequency or quantity limitations?

-Labeling
--THC content?
--Producer's identification?
--Strain or hybrid type identification?
---Mandatory or voluntary?
---Need for variety standards?
---Recommendations for specific medical uses?

-Use restrictions
--Consumption in public?
--Protections against employment discrimination?
--Driving and other use restrictions?

I'm sure that the rest of you can come up with several issues that have skipped my mind, and the time to bring them up is now. I can practically guarantee that the ones I have listed will rather quickly lead to litigation (criminal and civil) and political fights. The current situation in California, and to a lesser extent in Colorado and Oregon, shows what can happen if these issues are not decided early.
I have presented questions, not answers. Many alternatives, including sometimes the alternative of doing nothing, are viable. But all of us together can start building a reasonable framework. Let's share ideas and solutions. Perhaps one of the reform groups could set up a web site to host discussions of these issues.

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