Los Angeles Times: “Marijuana has been approved by California, many other states and the nation’s capital to treat a range of illnesses, but in a decision announced Friday the federal government ruled that it has no accepted medical use and should remain classified as a dangerous drug like heroin.”
The following is Drug Enforcement Administrator Michele M. Leonhart’s the June 21, 2011, letter:
June 21, 2011.
On October 9, 2002, you petitioned the Drug Enforcement Administration (DEA) to initiate rulemaking proceedings under the rescheduling provisions of the Controlled Substances Act (CSA). Specifically, you petitioned DEA to have marijuana removed from schedule I of the CSA and rescheduled as cannabis in schedule III, IV or V.
You requested that DEA remove marijuana from schedule I based on your assertion that:
(1) Cannabis has an accepted medical use in the United States;
(2) Cannabis is safe for use under medical supervision;
(3) Cannabis has an abuse potential lower than schedule I or II drugs; and
(4) Cannabis has a dependence liability that is lower than schedule I or II drugs.
In accordance with the CSA rescheduling provisions, after gathering the necessary data, DEA requested a scientific and medical evaluation and scheduling recommendation from the Department of Health and Human Services (DHHS). DHHS concluded that marijuana has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision. Therefore, DHHS recommended that marijuana remain in schedule I. The scientific and medical evaluation and scheduling recommendation that DHHS submitted to DEA is attached hereto.
Based on the DHHS evaluation and all other relevant data, DEA has concluded that there is no substantial evidence that marijuana should be removed from schedule I. A document prepared by DEA addressing these materials in detail also is attached hereto. In short, marijuana continues to meet the criteria for schedule I control under the CSA because:
(1) Marijuana has a high potential for abuse. The DHHS evaluation and the additional data gathered by DEA show that marijuana has a high potential for abuse.
(2) Marijuana has no currently accepted medical use in treatment in the United States. According to established case law, marijuana has no “currently accepted medical use” because: The drug’s chemistry is not known and reproducible; there are no adequate safety studies; there are no adequate and well-controlled studies proving efficacy; the drug is not accepted by qualified experts; and the scientific evidence is not widely available.
(3) Marijuana lacks accepted safety for use under medical supervision. At present, there are no U.S. Food and Drug Administration (FDA)-approved marijuana products, nor is marijuana under a New Drug Application (NDA) evaluation at the FDA for any indication. Marijuana does not have a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. At this time, the known risks of marijuana use have not been shown to be outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy.
You also argued that cannabis has a dependence liability that is lower than schedule I or II drugs. Findings as to the physical or psychological dependence of a drug are only one of eight factors to be considered. As discussed further in the attached documents, DHHS states that long-term, regular use of marijuana can lead to physical dependence and withdrawal following discontinuation as well as psychic addiction or dependence.
The statutory mandate of 21 U.S.C. 812(b) is dispositive. Congress established only one schedule, schedule I, for drugs of abuse with “no currently accepted medical use in treatment in the United States” and “lack of accepted safety for use under medical supervision.” 21 U.S.C. 812(b).
Accordingly, and as set forth in detail in the accompanying DHHS and DEA documents, there is no statutory basis under the CSA for DEA to grant your petition to initiate rulemaking proceedings to reschedule marijuana. Your petition is, therefore, hereby denied.
Michele M. Leonhart,
Read the entire Denial of Petition To Initiate Proceedings To Reschedule Marijuana that follows the above letter.