Cannabis as GRASE?

I'm thinking outside the box here [WARNING: I'm way ouside my expertise here, maybe even outside my area of competence; FDA law is not for the beginner]. This may be of more interest to those on the West Coast who are more actively engaged in med mj litigation.

I have long thought that the FDA (at least until its recent politicazation), with its scientific basis and lack of law enforcement bias, would be a good way around the DEA to firmly establish the medical basis of marijuana in an unassailable way. But the FDA itself has biases, including some against botanicals and other than single-molecular drugs, and a New Drug Application costs, literally, hundreds of millions and takes years. without a patentable compound or process to entice a big Pharma to undertake it, there was no way to overcome this hurdle.

But in 2004, the FDA changed its regulations concerning the GRASE (Generally Recognized As Safe and Effective) process so that botanicals could be included in the established monographs (including the analgesics) with an abbreviated process using sales and use outside the US to prove safety and effectiveness.

The GRASE list contains those drugs that may be included in OTC drug preparations without an NDA: things like aspirin. These are drug components that have been used for so long and so widely that their safety and effectiveness is readily accepted.

Until 2004, US prohibition prevented cannabis from being considered from GRASE, since it was not marketed within the time limits allowed.

However, now that foreign proof is allowed for botanicals, the door may be opened. After all, cannabis has been marketed as a drug for about 150 years now, and its effectiveness is widely documented.

While a GRASE petition is still expensive and time-consuming, it is orders of magnitude less than an NDA, and might be within the reach of a grant-based academic or a deep-pocketed reform group.

With a GRASE listing, the DEA would completely loose the medical use and safety prongs of Schedule 1, and with an FDA finding, might be forced to reschedule as a matter of law -- no factual findings for DEA to "interprete". Even if the FDA refused to amend the GRASE monograph, the findings of their scientific panel should still prove conclusive on the DEA.

I have done only the sketchiest research so far, but it would pay to have an FDA expert look at the issue. If cannabis could be established as GRASE, the highest possible schedule would be 4, and 5 would be more likely. In addition, it would solve the problem of how to market it without approved FDA labeling after an NDA.