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Smokable Forms of Marijuana Not Likely to Receive FDA Approval

smokable pot unlikely FDA approval Cannabis Now
Photo Gracie Malley for Cannabis Now


Smokable Forms of Marijuana Not Likely to Receive FDA Approval

The FDA’s commissioner Scott Gottlieb earlier this week said there’s very little chance the regulatory agency would ever approve smoking marijuana as medicine.

It’s becoming increasingly likely that marijuana could become a legitimate part of national commerce over the next few years. But whether or not herbaceous cannabis — consumed in smokable forms like joints and blunts — will ever receive FDA approval and federal legalization looks much less certain.

The Trump Administration, specifically the pot-hating man known as Attorney General Jeff Sessions, was once considered the worst thing to happen to cannabis reform since Nixon. However, the consensus now is that all of the anti-marijuana rhetoric that has come from these old-timey Republicans has given the marijuana movement the push it needs to go all the way.

But this doesn’t mean that the cannabis plant is any closer to being legitimized in terms of its medicinal value — at least not with respect to any form of the herb that requires the user to smoke it.

Earlier this week, Scott Gottlieb, who serves as Commissioner of the U.S. Food and Drug Administration, told Bloomberg News that the chances of the agency ever approving smokable pot products were slim to none.

Although a number of states have programs in place that allow qualified patients to smoke cannabis for its therapeutic benefits, Gottlieb says the FDA is apprehensive about awarding approval to a supposed medicine that must be consumed through a combustible means.

It’s not that the agency doesn’t believe that cannabis could have medicinal benefits in some cases. It is really more about having reservations about whether smoking could ever be considered an effective method of delivery, especially if the plant is being called medicine.

“I prescribed blood pressure pills and all kinds of other things to my patients when I was a practicing physician not too long ago,” Gottlieb said. “I never told a patient to go home, crush up a pill, roll it in a piece of paper and smoke it. Using a lung as a drug delivery vehicle isn’t optimal. That’s not to say that we wouldn’t evaluate it if it came in; it just wouldn’t be an optimal way to deliver an active ingredient.”

If the cannabis plant is to ever be considered safe and effective in the eyes of the federal government, the best chance, like it or not, is going to be through the pharmaceutical industry.

Right now, the FDA is on the verge of awarding Britain’s GW Pharmaceuticals the right to bring its cannabis-derived drug Epidiolex to the national market. The medication, which has been shown to reduce seizure frequency in epilepsy patients, is a strawberry-flavored cannabidiol (CBD) solution that is administered orally. If all goes according to plan, which is expected, the company would be the first-ever in the United States to win FDA approval for a medication derived entirely from the cannabis plant. By all accounts, Epidiolex is the federal government’s idea of what medical marijuana should look like. Not a joint or anything consumed using something called a dab rig.

This doesn’t mean that if marijuana finds itself legal nationwide in the next few years that smoking would be prohibited. But the FDA probably will not have anything to do with it. The regulations for smokable forms of cannabis would most likely fall under the jurisdiction of the Alcohol and Tobacco Tax and Trade Bureau (TTB). Of course, the name of this agency would be tweaked to reflect its authority over the newfound cannabis trade.

It is conceivable that both agencies would have a hand in the mix. Some pot products could be regulated by the FDA while others would be the responsibly of the TTB. The federal government already separates some forms of alcoholic beverages in this manner.

The end game really comes down to the most likely scenario for marijuana legalization at the national level. Will the federal government downgrade the Schedule I listing of the cannabis plant and allow it to be taken over by the pharmaceutical companies? Or will Congress do away with marijuana prohibition altogether and allow the herb to be taxed and regulated the same as alcohol and tobacco? If only for its medicinal function, then smokeable marijuana could still be illegal. However, as long as the nation moves towards a fully legal system, there will be a variety of pot products available for all, regardless of whether it is called pot or medicine.

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