Why FDA Will Have Difficulty Regulating Marijuana
June 18th, 2024 // 5:08 pm @ jmpickett
The FDA does an admirable job overall of protecting the public from defective foods, drugs and devices. But the recent federal rescheduling of marijuana, which was confirmed by the president recently, will pose challenges to the FDA. The idea is to move cannabis from Schedule I, which features drugs without an accepted medical use, such as LSD, to Schedule III. This less dangerous category has drugs on it that have a moderate to low potential for dependence physically and psychologically.
We frequently hear that FDA will regulate marijuana soon because it has been rescheduled. But that isn’t quite true, because states are regulating non-FDA-approved marijuana products. This shows the difficulties the FDA will have in exercising its consumer protection mandate after the rescheduling is over.
What FDA will be grappling with after the shift to Schedule III is complete isn’t marijuana per se, but the marijuana-derived drug products that consumers do not generally request or like. A recent poll of cannabis users found that 3/4 preferred regular botanical cannabis products over pharmaceuticals that contain cannabis.
The politics of marijuana also make it harder for FDA to exercise its regulatory muscles. Another poll of likely voters showed that the Democrats could enjoy political benefits by talking up the rescheduling with voters. But doing so would confuse voters with rescheduling marijuana with legalizing all marijuana products. Keep in mind that cannabis flower, which is the part of the plant that is usually smoked, will still be illegal under federal law when the rescheduling is complete. That is the case even though it has been legalized in many states. Cannabis flower legalization at the federal level will not even be discussed. Nor will the pre-rolls or vape pens that are sold nationwide.
The point we make here is there is a big difference between rescheduling cannabis and making it legal federally. Politics makes this area rather muddy. Overall, FDA isn’t well equipped to regulate marijuana products; FDA usually deals with absolutes, such as single-compound pharmaceuticals with standard doses and uniform effects that can be recommended to millions of people with approximately the same results. But marijuana dosages vary greatly depending on the individual’s physiology. Some users can get extremely high from a 5 mg edible, while others may feel fine at 50 mg or more.
