More than a decade after it was filed, the Food and Drug Administration (FDA) has finally rejected a petition to exempt bulk marijuana and cannabis tinctures from regulated control under a long-standing federal statute.
In September 2011, FDA received the request from a doctor and an attorney from California, seeking an exemption under the federal Food, Drug, and Cosmetic Act (FDAC) that would allow bulk marijuana and tinctures to be marketed without requiring an approved “new drug” application.
The petitioners specifically asked for an administrative hearing to consider their assertion that a “grandfather clause” in FDAC that provides exemptions for drugs produced before 1938 would apply to cannabis, which they said was actively marketed and sold in the U.S. in the early 20th century.
FDA responded to the petition last week by denying it—a decition that took more than 11 years. That’s a fairly significant time-lapse for a nine-page response that essentially provided a statutory explanation to justify the denial.
The agency said in its response letter that the petitioners have “not demonstrated that you have a right to an opportunity for a hearing,” nor have they demonstrated “that a formal evidential hearing is in the public’s interest.”
A main part of the agency’s statutory interpretation is that the exemption cited by petitioners requires a given substance to have been classified as “specific finished drug products.”
They therefore would have needed to prove that there is a current cannabis product that was marketed between 1907-1938 in order to “serve as a companion” that would make it eligible for an exemption. Generic bulk marijuana and tinctures don’t fit the bill, FDA said.
Asked by Marijuana Moment why the review and response took over a decade, an FDA spokesperson said that the agency “has many pressing priorities, and we do our best to resolve them in a timely manner.”
“The referenced petition raised significant issues requiring extensive review and analysis by Agency officials,” the spokesperson said. “We responded publicly to the petition when we reached a decision on petitioners’ requests.”
William McPike, the lawyer who co-submitted the petition with Dr. Beverly Mikuriya, told Marijuana Moment that he’s “shocked” it took the agency so long to reply.
“I thought they forgot about us,” he said.
While McPike said he thought that he and Mikuriya presented a “good case” with the petition, he doesn’t plan to appeal the denial because he is hopeful the federal government will resechedule or deschedule marijuana soon anyway.
To that end, FDA’s decision on the petition comes as the agency works to conduct a scientific review of cannabis as part of a multi-agency process looking into its Schedule I classification under the Controlled Substances Act, which was directed by President Joe Biden last month.
Janet Woodcock, FDA’s principal deputy commissioner who formerly served as acting commissioner, said recently that the agency is exploring “what flexibilities we might have” when it comes the federal review, which she described as a “very high priority.”
But she said that while FDA will lead the scientific and medical evaluation of cannabis, it is the the Drug Enforcement Administration (DEA) that “has the final word” on any potential scheduling decision. And she pointed out that even doing scientific research into marijuana is “very, very difficult” because of it current restrictive Schedule I status.
Both FDA and DEA have separately received and rejected multiple petitioners to take action to carve out exemptions or start the process of rescheduling marijuana under the CSA.
Woodcock emphasized last month that FDA conducts “the scientific and medical assessment,” with input from the National Institute on Drug Abuse (NIDA), to develop a scheduling recommendation. And DEA is “not supposed to” second-guess its findings.
That being said, because federal drug scheduling is dictated by DEA statute in the Controlled Substances Act (CSA), it’s the law enforcement agency that gets the final say on whether marijuana is removed from Schedule I.
The Justice Department and U.S. Department of Health and Human Services (HHS) have committed to quickly carrying out the president’s scheduling review, which could result in a recommendation to place cannabis in a lower schedule or remove it altogether, effectively legalizing the plant under federal law.
HHS Secretary Xavier Becerra has said officials will “work as quickly as we can” to complete the analysis of cannabis scheduling per the president’s directive.
The Department of Justice, for its part, “will expeditiously administer the President’s proclamation, which pardons individuals who engaged in simple possession of marijuana, restoring political, civil, and other rights to those convicted of that offense,” a department spokesperson said.
Last year, meanwhile, a federal appeals court dismissed a petition to require DEA to reevaluate marijuana’s scheduling under CSA—but one judge said in a concurring opinion that the agency may soon be forced to consider a policy change anyway based on a misinterpretation of the medical value of cannabis.
And outside of marijuana, DEA recently rejected a petition to reschedule psilocybin and a doctor’s request for a federal waiver to obtain and administer the psychedelic to terminally ill patients, prompting a new set of legal challenges in federal court.
Read the 2011 marijuana exemption petition and FDA’s new response letter below: