FDA’s Scientific Review Backs Reclassification of Marijuana as Lower-Risk Drug

Rahul Gupta
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In a groundbreaking move, the U.S. Food and Drug Administration (FDA) has recommended reclassifying marijuana from Schedule I to Schedule III, signaling a potential shift in federal cannabis policy.

The FDA’s recent scientific review highlights marijuana’s lower potential for abuse, accepted medical use, and a low or moderate risk of physical dependence.

This development comes amid decades of debate over marijuana legalization, with significant implications for the cannabis industry, medical research, and criminal justice policies.

Marijuana has been classified as a Schedule I drug since 1970, alongside substances like heroin and LSD. 

However, the FDA’s recent recommendation challenges this classification, emphasizing marijuana’s distinct characteristics compared to more dangerous controlled substances.

The call for rescheduling aligns with the Department of Health and Human Services’ evaluation of scientific and medical evidence, challenging the perception of marijuana as one of the most hazardous substances.

The FDA’s review, encompassing 252 pages, provides credible evidence supporting marijuana’s legitimate medical uses. 

The National Institute on Drug Abuse supports the FDA’s findings, acknowledging that while marijuana sees high nonmedical use in the U.S., it doesn’t lead to severe outcomes comparable to substances like heroin and cocaine.

This recognition underscores the potential medical benefits of marijuana, challenging its current restrictive classification.

Former FDA Deputy Commissioner Howard Sklamberg stated that the analysis was unsurprising but acknowledged its reflection of the substantial research and information since the last agency’s scientific assessment.

The FDA’s recommendation is seen as a significant step towards acknowledging marijuana’s medical potential and easing restrictions on its use and research.

MARIJUANASource: Joshua Resnick
Woman smoking Marijuana

This move follows years of legal challenges and debates surrounding marijuana’s classification. 

While the recommendation is not binding, it sets the stage for potential changes in federal regulation, pending the response of the Drug Enforcement Administration (DEA).

The DEA holds the final authority for any changes to marijuana’s scheduling. The process will involve a rulemaking period, allowing public input before finalizing any scheduling action.

The attention drawn by the FDA’s review underscores its potential impact on marijuana regulation, affecting the cannabis industry, medical research, and criminal justice policies.

National Organization for the reform of Marijuana Laws (NORML) Deputy Director Paul Armentano recognizes the recommendation to reschedule Marijuana reflects public sentiment. He acknowledges the widespread belief among patients and advocates that cannabis is a safe and effective therapeutic option for millions of Americans, expressing this in a statement from the advocacy group.

Reclassifying marijuana as a Schedule III drug carries numerous potential benefits.

MARIJUANA Source: Pfüderi_from_pixabay
Marijuana Plant

It could enhance access to medical marijuana for patients in need and provide expanded opportunities for research into its medical benefits.

The shift would also alleviate restrictions on banking services for the cannabis industry, and the IRS rule denying tax deductions for most marijuana businesses would no longer be applicable.

Reclassification could also prompt changes in criminal justice policies, potentially reducing the incarceration of individuals for nonviolent drug offenses.

Despite the momentum towards reclassification, opponents of cannabis legalization argue that the drug remains dangerous, leading to addiction and negative health outcomes. 

The gateway drug theory, suggesting a link to more dangerous substances, continues to be a point of contention. 

However, the FDA’s review challenges these concerns, providing robust evidence that marijuana is less risky than previously thought and possesses legitimate medical uses.

In 2022, President Joe Biden initiated a review of marijuana’s federal scheduling, requesting the administrative process from US Health and Human Services Secretary Xavier Becerra and the attorney general. 

The recent release of FDA documents officially confirms the recommendation for rescheduling, specifically to Schedule III, aligning with substances like Ketamine and Tylenol with Codeine.

The documents emphasize the scientific support for marijuana’s therapeutic benefits, particularly in treating pain, anorexia, and nausea and vomiting from chemotherapy.

While the FDA doesn’t claim marijuana is universally safe and effective, its findings pave the way for acknowledging its medical legitimacy.

The final decision on marijuana’s scheduling rests with the DEA, which will consider various statutory and regulatory criteria.

Industry experts anticipate potential positive changes, including improved research opportunities, eased operational constraints, and tax-related benefits for cannabis businesses.

The FDA’s recommendation to reschedule marijuana to Schedule III marks a significant milestone in the ongoing debate over its legalization. 

While the decision is not binding, it opens avenues for potential shifts in federal regulation, impacting the cannabis industry, medical research, and criminal justice policies.

The next steps involve the DEA’s response and a rulemaking process with public input.

As the landscape evolves, the potential benefits of recognizing its medical uses and reducing its regulatory constraints could reshape the future of marijuana in the United States.

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