Former FDA official, who believes that it is most likely marijuana will be placed in Schedule III under the Controlled Substances Act after an ongoing administrative review requested by President Biden last. The FDA official stated that it is aware of political factors, such as the upcoming 2024 elections, and a change in policy may be made sooner than later.
Howard Sklamberg spoke on a Mindset Capital Podcast released on Thursday about the potential outcomes of the review and the impact of rescheduling. He also discussed the timeline of the agency.
Sklamberg said that FDA’s review of cannabis’ scheduling will “certainly not” result in either a recommendation for it to remain on Schedule I, or a guidance to remove it from the schedule.
He said that the agency is more flexible since it last examined marijuana’s scheduling in 2016. Maintaining the status quo, therefore, is unlikely. The FDA would find it difficult to de-schedule marijuana due to regulatory constraints.
Sklamberg is now an attorney with Arnold & Porter. Schedule II, he said, is still possible but would not have the same impact in terms of allowing cannabis companies to claim federal tax deductions. He said that FDA doesn’t have to be “results oriented,” but context is important.
The former official discussed also the government’s new schedule, arguing against the idea that the review will take many years like it did in the past.
This is not on a normal schedule. “They are aware of its importance, its interest, and the White House’s concern for the issue. They’re also aware that the election cycle is ending at the end 2024, as well as the term of this administration. “I believe all of those things come together.”
The FDA is not a part of the administration’s review deadline, but HHS Secretary Xavier Becerra told Marijuana Moment that agencies aimed to complete their work by the end the year.
The FDA is only one half of the process. After completing its scientific review of marijuana, the FDA will share its findings with the Drug Enforcement Administration. The DEA then conducts their own eight-step evaluation before making a final decision.
Sklamberg said in his Podcast that while a schedule change would be “a huge” step, regulations will continue to evolve for years. As younger voters who are more in favor of legalization become more represented in politics, it is likely that new policies reflect this.
He said: “I believe this will be an essential step in a long process.”
Sklamberg dismissed the concern that putting marijuana on Schedule III could lead to a crackdown of state markets. He acknowledged that industry stakeholders and advocates prefer to see a complete descheduling. However, he noted that the FDA and Justice Department have been largely hands-off in the legalization campaign while cannabis remains a Schedule 1 drug. He argued that it “defies logic”, to believe the agencies will suddenly enforce criminalization when cannabis is moved to a more restrictive category.
Sklamberg was a contributor to a report on scheduling considerations , which was published by the Coalition for Cannabis Scheduling Reform (a newly formed group) in June. In February, Sklamberg wrote a memo on behalf of Columbia Care that discussed the topic.
He said that FDA is unlikely to change its approach towards marijuana, even if it were rescheduled. This is because increased enforcement would put a strain on the agency’s limited resources and force them to compromise their other food safety duties, such as monitoring interstate dairy trade or preventing E. Coli.
He continued that if FDA tried to single out marijuana or hemp companies as violating their rules in relation to the introduction of unapproved additives to food or as dietary supplement, they would be violating a mandate against arbitrary action and could end up in legal trouble.
Conversations ended on another federal marijuana issue: the possibility that the U.S. Attorney General reissue a memo with explicit guidance to federal prosecutors on cannabis enforcement priorities. The Trump administration revoked a memo from the Obama era on this issue known as the Cole Memo. Some advocates are pushing for an updated version of the memo to provide clarity and assurance to industry and consumers.
Sklamberg downplayed the practical effect of such a memorandum, noting that Justice Department policy on marijuana hasn’t changed in more than two years after the last version under the Trump Administration in 2018 was rescinded.
He said, “I believe its effect would more be reassuring than real.” “I do not think that a Garland memorandum is needed for the administration’s current posture. We’d need to read the memo before we can make any changes, but it doesn’t seem like it’ll be a major change.
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Last week, Rep. Matt Gaetz, R-FL, pressed DEA Administrator Anne Milgram for more information on her recent comments about the origins and timeline of President Joe Biden’s marijuana scheduling review. He wants a copy of the letter Milgram says the president sent last year to the HHS secretary and attorney general directing the review. He wants to know if the administrator has asked HHS for an update about their timetable , as she promised during a recent House Judiciary Subcommittee Hearing.
A lawyer filed a Freedom of Information Act request to HHS, in order to obtain a copy of Biden’s alleged letter rescheduling. said earlier in the month that it did not have any records of such a letter.
Marijuana Moment asked for clarifications on the letter separately from the Justice Department, but the spokesperson referred this question to the White House. The White House responded by pointing to the president’s statement on the directive, but declined to comment on the actual letter.
In separate testimony before Congress, the White House Drug Czar stated that the President’s marijuana pardons as well as his scheduling directive are part of a coordinated cannabis policy in a patchwork state legalization model.
Some legislators are becoming frustrated by the administration’s strategy. In March, Congressional Cannabis Caucus Co-chair Rep. Earl Blumenauer, (D-OR), along with 15 other members of Congress from both parties, demanded transparency in the cannabis schedule review.
Bahamas Government Unveils Proposal To Legalize Marijuana For Medical, Religious And Scientific Use
Photo by Mike Latimer.
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