A new scheduling category could bring in a host of challenges for a poorly understood area of drug policy, especially after legislative processes. The legislative process would undoubtedly alter the proposed language. It unlikely a new scheduling category would be created that doesn’t follow the same logic as the existing schedules. For example, would all drugs and substances that are not scheduled, then have to then undergo an assessment or be automatically included under the definition of a schedule VI drug (i.e., products related to alcohol, tobacco, OTC, and even prescription drugs like epidiolex)? This could open the door to scheduling unscheduled products. Advocates are making the argument that this approach would mean the DEA, FDA, NIDA, and federal agencies would not be involved...
Yep, it could be written better, like saying DEA has no authority to remove anything Congress places in Schedule VI and that it clearly supersedes anything in the international treaties. It could have further clarity, but that would fix most of your objections to it. My main problem with it is it does not include an application under 21 C.F.R. 1307.03 (21 U.S.C. 822(d)) for an immediate federal exemption. Why wait for Congress to act?
Hey Carl, I think I just realized your point about 1307.03 and 822(d). You're saying Congress/DEA have already created the tools DEA needs to create an exemption that would accomplish most of this. Is that right? Whether those tools are sufficiently broad to do all the work the Foundation has in mind, I'm not sure. But they're certainly broad enough to do a whole bunch of it. And anyway, I wholeheartedly agree with your underlying point, i.e., that we should be trying to use administrative and statutory flexibilities that Congress built into the Act decades ago to solve many problems rather than waiting on Congress to fix these problems through legislation. I often push the use of 21 usc 872(e), for example, to solve research problems. And I've encouraged states to use the law enforcement exemptions in DEA's regs to facilitate important research of the products people use everyday in state-legal markets. Alas, it appears nobody's listening. Sorry it took me so long to see your point here. And, as always, thanks for reading!
Yes, think of temporary injunction and a permanent injunction. An exemption would just be a temporary placeholder for permanent de-scheduling. It would be far more limited, but it would eliminate the tax penalty under 26 USC 280E for state registered manufacturers and distributors. It would be based on public health and risk of diversion. My attorney got our state department of health to answer both of those questions a couple months ago during my administrative hearing. Our program has been up and running since December of 2018 and there has been zero diversion and zero adverse health issues. The department agreed to file under 1307.03 two years ago, but says it's complicated and they haven't been able to move forward with it. So, I'm asking them to recommend the legislature create a task force to study the issue so they understand it and can explain it to the governor.
It's always been understood that state law creates an exception to federal drug law. Take 14 CFR 91.19(b) for example, which has been a federal regulation since 1973. And 21 USC 863(f)(1) added in 1986.
The only caveat for 21 CFR 1307.03 is that you cannot have another remedy. 21 CFR 1307.03 has to be your only option.
And this from 2006:
Gonzales v. O Centro Espírita Beneficente União do Vegetal, 546 U.S. 418, 432 (2006):
The Act contains a provision authorizing the Attorney General to “waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.” 21 U.S.C. § 822(d).
Gonzales v. O Centro Espírita Beneficente União do Vegetal, 546 U.S. 418, 433 (2006):
And in fact an exception has been made to the Schedule I ban for religious use. For the past 35 years, there has been a regulatory exemption for use of peyote — a Schedule I substance — by the Native American Church. See 21 C.F.R. § 1307.31 (2005).
A new scheduling category could bring in a host of challenges for a poorly understood area of drug policy, especially after legislative processes. The legislative process would undoubtedly alter the proposed language. It unlikely a new scheduling category would be created that doesn’t follow the same logic as the existing schedules. For example, would all drugs and substances that are not scheduled, then have to then undergo an assessment or be automatically included under the definition of a schedule VI drug (i.e., products related to alcohol, tobacco, OTC, and even prescription drugs like epidiolex)? This could open the door to scheduling unscheduled products. Advocates are making the argument that this approach would mean the DEA, FDA, NIDA, and federal agencies would not be involved...
Yep, it could be written better, like saying DEA has no authority to remove anything Congress places in Schedule VI and that it clearly supersedes anything in the international treaties. It could have further clarity, but that would fix most of your objections to it. My main problem with it is it does not include an application under 21 C.F.R. 1307.03 (21 U.S.C. 822(d)) for an immediate federal exemption. Why wait for Congress to act?
Hey Carl, I think I just realized your point about 1307.03 and 822(d). You're saying Congress/DEA have already created the tools DEA needs to create an exemption that would accomplish most of this. Is that right? Whether those tools are sufficiently broad to do all the work the Foundation has in mind, I'm not sure. But they're certainly broad enough to do a whole bunch of it. And anyway, I wholeheartedly agree with your underlying point, i.e., that we should be trying to use administrative and statutory flexibilities that Congress built into the Act decades ago to solve many problems rather than waiting on Congress to fix these problems through legislation. I often push the use of 21 usc 872(e), for example, to solve research problems. And I've encouraged states to use the law enforcement exemptions in DEA's regs to facilitate important research of the products people use everyday in state-legal markets. Alas, it appears nobody's listening. Sorry it took me so long to see your point here. And, as always, thanks for reading!
Yes, think of temporary injunction and a permanent injunction. An exemption would just be a temporary placeholder for permanent de-scheduling. It would be far more limited, but it would eliminate the tax penalty under 26 USC 280E for state registered manufacturers and distributors. It would be based on public health and risk of diversion. My attorney got our state department of health to answer both of those questions a couple months ago during my administrative hearing. Our program has been up and running since December of 2018 and there has been zero diversion and zero adverse health issues. The department agreed to file under 1307.03 two years ago, but says it's complicated and they haven't been able to move forward with it. So, I'm asking them to recommend the legislature create a task force to study the issue so they understand it and can explain it to the governor.
It's always been understood that state law creates an exception to federal drug law. Take 14 CFR 91.19(b) for example, which has been a federal regulation since 1973. And 21 USC 863(f)(1) added in 1986.
The only caveat for 21 CFR 1307.03 is that you cannot have another remedy. 21 CFR 1307.03 has to be your only option.
And this from 2006:
Gonzales v. O Centro Espírita Beneficente União do Vegetal, 546 U.S. 418, 432 (2006):
The Act contains a provision authorizing the Attorney General to “waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.” 21 U.S.C. § 822(d).
Gonzales v. O Centro Espírita Beneficente União do Vegetal, 546 U.S. 418, 433 (2006):
And in fact an exception has been made to the Schedule I ban for religious use. For the past 35 years, there has been a regulatory exemption for use of peyote — a Schedule I substance — by the Native American Church. See 21 C.F.R. § 1307.31 (2005).