• The University of Mississippi, recipient of a contract from the National Institute on Drug Abuse (NIDA) to produce marijuana for research, is currently the only legal producer of marijuana in the U.S. The DEA has declared that federal law and international treaty obligations prohibit approval of a second producer of marijuana.
• In order to obtain FDA approval of a new drug, applicants must provide detailed information about the manufacturing process used to produce the drug. Any entity using the NIDA marijuana for research would not have the ability to provide this information to the FDA.
• Under FDA guidelines and the DEA's interpretation of the law, the only entity that could carry out research on the therapeutic benefits of marijuana and present a complete and acceptable New Drug Application to the FDA is the University of Mississippi. The university has never and will never submit a research protocol to the DEA.
• FDA approval, therefore, is impossible.

Ten states have enacted laws to protect seriously ill patients from arrest for using medical marijuana, and many state legislatures have or will be considering legislation that would do the same. While these bills have overwhelming popular support in their states, some legislators feel uneasy about them -- often citing a concern that U.S. Food and Drug Administration (FDA) is needed.

Unfortunately, on December 10, 2004, the Drug Enforcement Administration (DEA) slammed the door on this approval process, when it denied an application to establish a facility to produce marijuana for FDA-approved research aimed at developing marijuana as a prescription medicine.

Currently, there is only one source for research-level marijuana in the U.S. -- a National Institute on Drug Abuse (NIDA)-contracted farm in Mississippi. But NIDA's marijuana has been only inconsistently available to researchers and cannot be used for prescription sale. Because testing would need to be done on the same product that is sold to patients, FDA approval of marijuana is effectively impossible ... unless an alternative source is made available. The DEA's rejection of an application by Dr. Lyle Craker (director of the Medicinal Plant Program at the University of Massachusetts Amherst) to do exactly this effectively blocked this option.

As FDA approval is impossible and the U.S. Congress has been slow to act, thousands of seriously ill people in 40 states will continue to face the threat of state-level arrest and imprisonment for the simple act of using their medicine. The only humane option during this time is for the states to pass laws to protect medical marijuana patients -- thus leaving medical decisions to patients and their doctors.