It is becoming increasingly obvious that Medical Cannabis (aka Medical Marijuana) is catalyzing a raging debate across the nation and stimulating a flood of interest within the international medical community. With stakeholders polarizing on both sides of the issue, and legitimate patients left in the balance, it can be difficult to discern how we arrived at this unfortunate juncture. To better understand Hawai`i’s position within this political quagmire, let’s try to simplify the perspective and focus on the facts.

When the State of Hawaii decriminalized the medical use of Cannabis in 2000, it created an accepted medical use for a Schedule I controlled botanical drug substance. The State was well within its authority by doing so, as illustrated by the ruling in a contemporary Supreme Court case that affirmed the right of states to decide the medical use of controlled substances 1. This is also illustrated by the Hawai`i Senate and House of Representative committee hearings in 1971 and 1972, during which the State version of the Federal Controlled Substances Act (CSA) was significantly modified to protect the State’s authority over controlled substances 2.

The decriminalization of the medical use of Cannabis, provided by Hawai`i’s Medical Marijuana Program, allows registered patients with approved medical conditions to self-produce and self-administer Cannabis under medical supervision with certain limitations on the number of plants and amount of material that can be possessed3. This state-level medical use of Cannabis stands in stark contrast to the Federal CSA, which places Cannabis, along with LSD and Heroin, in Schedule I, meaning that it has no accepted medical use 4. However, it must be remembered that being placed in Schedule I is not a life sentence. The Federal CSA is specifically designed to provide non-federal entities with an administrative mechanism by which to apply for a reclassification of a controlled substance once a change in use has occurred5.

It should also be pointed out that there are actually two pathways for a Schedule I controlled substance to be moved to a less restrictive category. The first way involves the formal FDA-approved Phase I-III randomized clinical trials drug approval process that was designed to facilitate the development and marketing of single-agent pharmaceutical drug products. The second way, as exemplified by the Medical Cannabis Programs that sixteen states plus the District of Columbia have already created, is for a state to invoke its authority over the medical use of controlled substances and give a controlled substance a new medical use.

However, this is only the first step that a state must take along this path. Once Hawai`i created a medical use for a controlled substance, the state also obligated itself to comply with the Federal CSA and file a formal application with the Drug Enforcement Administration (DEA) in order to eliminate the current inconsistency between state and federal law. Once the State does its part by filing the application, the DEA is obligated to follow the guidelines of the Federal CSA and reclassify the controlled substance in question based on the new medical use that the State is reporting. It’s that simple, or at least it should be.

The problem is that the State of Hawai`i, with its eleven year-old Medical Cannabis Program operating in direct conflict with federal law, has yet to fulfill its legal obligation to the Federal CSA by initiating the reclassification process. By not doing so, the State is not only violating the Federal CSA and failing to protect the State’s right to decide the medical use of a controlled substance, but it is also putting its registered patients at undue risk of federal persecution and preventing the state from developing a properly regulated program.

The solution to this dilemma is rather straight forward, and involves a two-pronged approach. The first action required is for the State to file a formal application with the DEA, in accordance with 21 CFR 1308.43, to have Cannabis reclassified based on the “currently accepted medical use in treatment in the United States” that exists by the very fact that Hawaii has a Medical Marijuana Program. Secondly, the State will also need to file a temporary and permanent injunction in U.S. District Court for the District of Hawai`i, on the same day that the DEA application is faxed and mailed overnight, enjoining any further enforcement of Cannabis as a Schedule I controlled substance while the application with the DEA is pending.

Under better circumstances, the DEA would have already recognized that Cannabis no longer meets Schedule I criteria, and would have initiated reclassification proceedings on its own in order to honor its responsibility for keeping the Federal CSA up to date. However, given the current federal stance on Cannabis, such motivation needs to be supplied by the State.

It should also be remembered that this is a legal issue, not a scientific one. The State has created an accepted medical use for a Schedule I controlled substance. This substance must therefore be rescheduled. End of discussion. It’s the State’s responsibility to alert the DEA to the change that has taken place, and then it’s the DEA’s obligation to invoke its rulemaking authority and decide, based on a review of all existing current scientific evidence, what would be the best classification for Cannabis. Regardless of how the DEA decides to reclassify, one thing is for certain: Cannabis can no longer be in Schedule I.

About the author: Clifton Otto is a retina specialist here on Oahu, at the Retina Institute of Hawaii, where he supervises several ongoing national studies dealing with macular degeneration and diabetic retinopathy. He also worked as a natural products chemist at the University of Hawaii, and as a reference standard chemist at Wyeth-Ayerst Pharmaceuticals before attending medical school in New York.

1.Gonzales v. Oregon, 546 U.S. 243, 258 (2006): “The Attorney General has rulemaking power to fulfill his duties under the CSA. The specific respects in which he is authorized to make rules, however, instruct us that he is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.”

2.SSCR 527, Senate Journal – Standing Committee Reports, 1971, p. 1038, and HSCR 81-72, House Journal – Standing Committee Reports, 1972, p. 664. The Hawai`i State Uniform Controlled Substances Act became non-uniform with the Federal CSA when the legislature removed the Schedule I criteria “no currently accepted medical use in treatment in the United States”, thereby preserving the State’s right to decide on the medical use of controlled substances.

3.Hawai`i’s Medical Marijuana Program, administered by the Narcotics Enforcement Division of the Department of Public Safety, currently allows registered patients with certain qualifying conditions to cultivate no more than three flowering plants and four vegetating plants, and to possess no more than three ounces of “usable” material at any one time.

4.The Federal Controlled Substances Act, Article 2, Section 203, lists the following criteria for Schedule I inclusion: “(1) has high potential for abuse; (2) has no currently accepted medical use in treatment in the United States; and (3) lacks accepted safety for use under medical supervision.”

5.21 CFR 1308.43,