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FDA Head Says There’s ‘No Reason For DEA To Delay’ Rescheduling Marijuana

The head of the Food and Drug Administration (FDA) says there’s “no reason” for the Drug Enforcement Administration (DEA) to “delay” making a marijuana scheduling decision.


FDA Commissioner Robert Califf also said that, “as a child of the sixties,” it would “be nice if in my lifetime we came up with a regulatory scheme” for cannabis.



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At a hearing before the House Oversight and Accountability Committee on Thursday, Rep.


Nancy Mace (R-SC) pressed Califf on the timeline for the scheduling review after his agency under the U.S. Department of Health and Human Services (HHS) recommended that DEA move cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA).



 

The “timing of a regulatory decision is something that would be up to the DEA, not up to me,” Califf said. “There’s no reason for DEA to delay. They have to take into account all the regulations that are in play.”


Asked whether he expects FDA would assume additional regulatory responsibilities if cannabis is rescheduled, the commissioner said that’s a “very complicated topic,” especially given that this “falls in this area where state regulation has been dominant.”


“This is an area where I believe we would be better off if we had guidance from Congress about how to proceed,” Califf said. “Medical marijuana is one thing where there’s a medical purpose and it’s proven through traditional medical pathways, but when it’s used for recreational purposes, there is no medical benefit in that case, it doesn’t fall under our typical regulation.”


Mace, who also recently discussed scheduling issues and the need for the GOP-controlled House to advance cannabis reform legislation, also raised concerns about the prevalence of hemp-derived intoxicating cannabinoids and the lack of regulations around those products.


“Without revealing too much about my age, I’m a child of the sixties so it’d be nice if, in my lifetime, we came up with a regulatory scheme where—whatever your belief is about use of the product—where the safety issues that you refer to are written into law so that we have a scheme whereby we can regulate it.”


Prohibitionist Rep. Pete Sessions (R-TX) also addressed the cannabis scheduling issue, stating he believes that “FDA did not base its assessment in scientific facts or realities of how marijuana has been abused and used in our country today.”


FDA’s recommendation to reschedule cannabis “completely ignores the realities of a drug that is causing enormous consequences of children and adults in our country, high schools, middle schools and communities.”


He then repeated talking points that he and other GOP lawmakers forwarded to DEA Administrator Anne Milgram urging the agency to keep marijuana in Schedule I of the CSA, including criticism of the revised review process FDA used that involved a new a two-pronged analysis instead of a five-factor review that has been used in the past. Opponents of cannabis reform argue this policy shift is evidence of FDA intentionally exercising more discretion to justify its rescheduling recommendation for political, rather than scientific, reasons.


“Let me remind you that a Schedule III does not put marijuana on the market in the United States,” Califf responded. “With all due respect, I think [cannabis] is differentiable from heroin and, I think, cigarettes.”


He added that “your colleague just gave exactly the opposite point of view” on marijuana policy, referencing Mace’s comments.


Meanwhile, Oversight Committee Chairman James Comer (R-KY) said at Thursday’s hearing that FDA is “putting its own bureaucratic priorities over the American people” by refusing to regulate hemp products such as CBD unless it received additional authorization from Congress.


“Instead of using its existing authority, the FDA is requesting new authorities and money that it does not need,” the chairman said. “This is the FDA putting its own bureaucratic priorities over the American people who can benefit from these products.”


“The FDA’s refusal to regulate hemp products is creating significant confusion in the market and resulting in products with intoxicants that can be dangerous to Americans who use these products,” he said. “It has also halted business trying in good faith to enter the market while bad actors continue to thrive.”


Later in the hearing, Comer again criticized FDA for its failure to regulate CBD and the commissioner responded that, under the current system, it’s true that “good players [in the industry] are penalized because of things bad players do.”


In his concluding remarks, Comer asked what Califf expects to happen with CBD regulations over the next year in light of his concerns.


“It’s Congress’s decision to make, so we would really look forward to work with you all as quickly as possible to come up with a regulatory pathway that you think is reasonable and enables us to take action,” the commissioner said.


Califf said in written testimony submitted to lawmakers that while FDA has concluded it lacks proper authority to implement regulations allowing hemp-derived CBD, “we recognize that consumers want access to these products.”


“That is why FDA announced that the Agency is prepared to work with Congress on a new regulatory pathway that would provide access, safeguards, and oversight over products containing CBD in ways that existing pathways cannot,” he said.


“FDA has concluded that a new regulatory regime is needed, which could encourage better information to inform consumers about their choices,” Califf added. “In the meantime, FDA continues to assess the evolving information base and build awareness for Americans.”


Rep. Gary Palmer (R-AL) asked Califf whether FDA is actively monitoring CBD use among Americans. The commissioner responded that “this is a similar area where harm reduction through a regulatory strategy is probably our best approach and we need more research on exactly what the facts are.”


“We’d like to see a regulatory pathway, but as we talked earlier, the FDA is a referee and we need a rulebook—and you guys write the rulebook.”


The hearing comes nearly a year after a House subcommittee held an earlier first-of-its kind meeting where members examined the impacts of FDA inaction on developing the CBD regulations.


Last year, Comer said that his panel would be launching an investigation into the matter, and he requested that FDA turn over documents related to its decision not to regulated the cannabinoid. Even before the agency made that decision, the congressman expressed his intent to address the lack of rules.


On marijuana, the commissioner’s comments on Thursday come as the Biden administration continues to tout its role in issuing cannabis pardons and directing the marijuana scheduling review, including in a presidential proclamation declaring April “Second Chance Month.”

President Joe Biden also discussed the marijuana actions in a historic context last month, during his State of the Union address.


Vice President Kamala Harris also urged DEA to finish its review and reschedule marijuana “as quickly as possible” while meeting pardon recipients for a roundtable event at the White House last month. Behind closed doors, she also said “we need to legalize marijuana.”


A DEA official recently said it sometimes takes up to six months for DEA to complete its analysis of health officials’ scheduling recommendations—which is just about how long it has now been since the agency began its current cannabis assessment.


Meanwhile, last month, HHS Secretary Xavier Becerra defended his agency’s rescheduling recommendation during a Senate committee hearing and also told cannabis lobbyist Don Murphy that he should pay DEA a visit and “knock on their door” for answers about the timing of their decision.


Certain DEA officials are reportedly resisting the Biden administration’s rescheduling push, disputing the HHS findings on marijuana’s safety profile and medical potential, according to unnamed sources who spoke with The Wall Street Journal.


In January, meanwhile, a coalition of hemp industry organizations called on the House Energy and Commerce Committee to hold a hearing addressing the ongoing lack of FDA regulations for products made with constituents of the crop such as CBD.

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