HHS Updated The Old Scientific Test For Scheduling, Lawyer Expert Shane Pennington Explains

SLAM DUNK. This points to the argument I’ve been making here on WeedPress since I first served a lawsuit in 2011 on a state, on the grounds that intrastate medical cannabis programs made Schedule one classification of cannabis null and void. Intrastate cannabis programs are literally evidence of “accepted medical use in the United States,” and, I have been proven right, 13 long years later, by HHS and FDA recently releasing a 252-page ruling that says yes, accepted medical use in the United States is now precedent as a matter of law. The intricacies, nuances, and complexities of international, federal, and state laws regarding how to remove schedule one classification has been fleshed out in full on the WeedPress platform in 1,400 articles over the past 13 years. And for those who have been learning this scheduling process, the following excerpt below is worth mentioning in legal briefs challenging cannabis as schedule one. Great work, Shane Pennington, cannabis attorney and Partner at Porter Wright Morris & Arthur LLP!

Critical explanation excerpted from https://www.cannabisbusinesstimes.com/news/dea-rescheduling-cannabis-accepted-medical-use-factor-test/:

“Your office has created a new two-factor test to determine currently accepted medical use,” Cornyn said during last week’s committee hearing. “What’s the reason for the change?”

Becerra pointed Cornyn to HHS’ 252-page explanation of its review, which states that HHS “updated” its analysis—not created a new one (the significance of this is detailed below).

….

Pennington said he believes the point Cornyn was trying to make is that the two-part test was made up out of thin air and therefore defective.

But Pennington said this is not the case.

“There’s a rule of law in administrative law that courts definitely apply,” he said. “If you’re going to create a new test for something like this, that’s fine. If you’re an agency, you can create a new standard—totally cool. But when you do, you have to say, we’re creating a new standard, and the reason we’re using this standard instead of the one that we used to use is X, Y, and Z. And explain it. As long as you do that, courts will be like, ‘good to go.’

Rescheduling opponents like Cornyn and U.S. House Rep. Andy Harris, R-Md., continue to argue that HHS wrongly leaned on a new, unreliable two-point standard and therefore the August recommendation to DEA was “misguided.”

But there is nothing in the 252-page document to suggest the two-point test is a newly created standard, Pennington said.

Instead, the HHS wrote in the report that it “has updated its analysis of a substance’s currently accepted medical use in treatment in the U.S.” for purposes of the CSA.

Importantly, Pennington said HHS officials did not make up the two-part test but rather fleshed out an already existing standard from 1982, one that predates DEA’s five-part test by a decade.  

According to an HHS notice on proposed recommendations to DEA regarding the scheduling status of “marihuana and its components” in the June 29, 1982, issue of the Federal Register, “a drug may also, theoretically, be legally marketed without violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) if it is manufactured, processed and used entirely within a single state without any connection at all with interstate commerce.”

In this instance, HHS officials were considering whether cannabis had obtained accepted medical use by virtue of “totally intrastate production” but found no basis at the time. (California didn’t become the first state to legalize medical cannabis until 14 years later.)

While cannabis did not satisfy the “intrastate production” standard when the HHS recognized this possibility in 1982, cannabis satisfies this standard today, Pennington said.

In addition, HHS cited the American Medical Association Council on Scientific Affairs in the 1982 Federal Register to back its view that cannabis did not have accepted medical use in therapy or treatment by physicians practicing medicine at the time in the U.S.

“Suffice to say that around 1982, HHS and DEA both recognized that currently accepted medical use basically meant—in the United States—meant that a substance had to be able to be legally used as medicine in the United States,” he said. “That was basically what they came to.”

And although the FD&C Act—a pharmaceutical pipeline for drugs to receive FDA approval through a process of clinical trials—provides one avenue for a drug to obtain accepted medical use status, it’s not the only avenue, HHS determined in 1982.

Thus, in 2023, when HHS/FDA officials conducted a scientific and medical analysis of cannabis and determined the plant does have currently accepted medical use in U.S., they did so by using an updated two-part test from four decades earlier, Pennington says.

“It’s literally being accepted and used in treatment in the United States all over the place,” he said. “So, if ever there was something that met the [intrastate production] standard that HHS talked about back in the day, it’s this.”

Full article: https://www.cannabisbusinesstimes.com/news/dea-rescheduling-cannabis-accepted-medical-use-factor-test/

Also quoted from the above article: “The reason ‘currently accepted medical use’ matters so much is because it’s kind of intuitive that if you can say that cannabis has a currently accepted medical use, then we know it doesn’t belong in Schedule I,” he [Pennington] said. “So then the question is, OK, well now what schedule does it belong in?”

Nail on the head. Read the full article, it’s mandatory. Keep digging. Schedule One is nearly done, but not quite yet. There’s works to be done first. We’re nearly there. Follow us on Facebook and subscribe to emails for more laser focusing on Schedule One — all other stories, and concerns, are petty trivialities by comparison to this developing and constantly updating story — I’ll keep only the best explanations of the ins and outs and how to’s as I understand them, regarding scheduling cannabis properly and respectably, and stick to timely relevant facts on this platform.

Truth, in the end, defeats the drug war failure.

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