FDAReview.org

Any marijuana-related policy garners considerable attention from medical professionals, lawyers, politicians, and, of course, the general public. President Trump’s recent executive order provides another example.

A quick Google reveals headlines and articles from Fox News, PBS News, ABC News, CNBC, and the New York Times declaring President Trump has “reclassified marijuana.” You can find similar headlines across the pond.

Many others question what this “historic policy shift” means for cannabis users, for marijuana policy in each state, for the Republican Party, and even for the entire US.

These are interesting questions—but a close reading of the executive order shows they might be overzealous. As featured on the White House website, the executive order is for “increasing medical marijuana and cannabidiol research.” It never mentions recreational marijuana use.

Trump’s order highlights a troublesome problem—a drug scheduling deeming marijuana “no currently accepted medical use” with medical research clearly indicating this is not true.

Noting marijuana’s classification serves as a roadblock to better research, the order reads, “decades of Federal drug control policy have neglected marijuana’s medical uses.  That oversight has limited the ability of scientists and manufacturers to complete the necessary research on safety and efficacy to inform doctors and patients.” It continues, “It is critical to close the gap between current medical marijuana and CBD use and medical knowledge of risks and benefits, including for specific populations and conditions.”

But what does the executive order do to help “close the gap?” Simply this:

The Attorney General shall take all necessary steps to complete the rulemaking process related to rescheduling marijuana to Schedule III of the CSA in the most expeditious manner in accordance with Federal law, including 21 U.S.C. 811.

The passage gives no direct order to reclassify—only to “complete the rulemaking process,” which might lead to rescheduling. Plenty of petitions in the past trying to reschedule marijuana were denied. It also gives no timeline for when rescheduling will happen. Even if marijuana becomes a Schedule III substance, the process can take 9 years.

This is the only command issued in the entire executive order. Headlines and interpretations that indicate anything more are speculative. Nonetheless, this underwhelming executive order could become the impetus for rescheduling marijuana, driven by grassroots efforts and state-level reform.

Scheduling aside, 47 states allow marijuana for medicinal use, with 38 of these states providing comprehensive medical marijuana programs. Over 6 million patients benefit from these treatments. Marijuana is legal for recreational use in 24 states, and several more states are likely to legalize it this year.

We have seen local and state-level efforts drive national policy before. In 2001, Arizona became the first state to allow terminally ill patients access to try potentially life-saving experimental medical treatments. This “right-to-try legislation” spread rapidly. By 2017, 37 states had enacted right-to-try laws. Over the same period, the FDA received more than 9,000 petitions from patients and physicians requesting access to experimental medications. In 2018, under President Trump’s first term, right-to-try became federal law.

Advocates of marijuana legalization still have reason for optimism because reform is possible with enough pressure. President Trump’s recent executive order could be a sign that a long-overdue rescheduling is on the horizon. But it is nowhere near sufficient itself.

National public health policy under the leadership of Department of Health and Human Services Secretary Robert F. Kennedy Jr. made no shortage of headlines in 2025. As a short list, RFK made controversial statements about vaccines, vowed (but failed) to find the root cause of autism, initiated efforts to ban some food dyes, cut funding, cut employment, misused AI, and tried to eliminate medical scientists from publishing in select academic journals based on their funding. Less importantly, he also wears jeans when he works out. 

In contrast, the Food and Drug Administration, easily the most powerful sub-agency overseen by the HHS and RFK, has had a quiet 2025. It began the process of banning red dye #3 in food products, reassessed some safety standards for cosmetics, and implemented a rule now requiring complete safety disclosures in drug advertisements.  

Most of the FDA’s planned major reforms are still underway. Currently, the agency is opening pathways to more quickly approve biosimilars, generic versions of complex drugs, and a new approval process for “gene-editing” treatments. Perhaps its most ambitious deregulatory effort is to approve new drugs in 1-2 months using a “plausible mechanism pathway” coupled with AI as part of a National Priority Voucher Program.

Slashing approval steps and bureaucratic oversights should bring drugs to the market and to patients faster. But these programs also require government employees to select drugs and their producers for swifter approval and special consideration. That’s grounds for rent-seeking. Record-breaking lobbying totals from the pharmaceutical industry in 2025 signal this is a genuine concern. 

Will the FDA’s recent actions lead to genuine deregulation, or will they succumb to regulatory capture? A recent petition might tell us. 

Pyruvate Dehydrogenase Complex Deficiency (PDCD) is a rare genetic condition that causes excessive lactic acid buildup because the body is unable to convert carbohydrates into energy, often resulting in extreme fatigue and neurological issues. Some PDCD develops in adulthood. The condition is considerably worse when it emerges in utero, leaving many infants and children with debilitating metabolic and neurological conditions.

Tragically, the condition is often fatal, and treatments only exist for the symptoms. But there may be an exception. 

Sodium Dichloroacetate (usually shortened to DCA) has unique properties that help absorb carbohydrates and reduce lactic acid buildup. As highlighted in peer-reviewed research, DCA can prevent fetal lactic acid buildup—which can literally save lives. Although relatively few studies have investigated DCA and PDCD, dozens of parent testimonies provide eye-opening evidence.

Research and testimonies aside, DCA is currently classified as an “investigational compound,” existing in a peculiar regulatory gray area within the FDA’s framework.

PCDC is rare enough (affecting about 1 in 40,000 births) that garnering enough participants for small-scale clinical trials is challenging and highly time-consuming. Without these clinical trials, it is nearly impossible to receive orphan drug status (which ironically exists to help drugs used to treat rare disorders receive approval). Unless PCDC passes its phase 1 trials, it is not eligible for right-to-try access. 

The FDA is no stranger to DCA, its situation, or the promise it provides. After receiving a new drug application in December 2024, the agency granted it priority consideration. In September 2025, DCA received a formal rejection and was asked to provide additional data and to conduct new clinical trials. DCA’s producer requested a meeting to discuss potential pathways forward. Their request was answered with a meeting. An accompanying petition signed by more than 80 established medical researchers and physicians surely helped. 

If new and/ or accelerated pathways to drug approval can’t find room for DCA and what it represents, what exactly are these pathways for? 

For the first time since the COVID-19 pandemic, the FDA finds itself under pressure from the medical field and the broader public to deregulate. It has taken several initial steps in this direction, but now faces its first real test of committing to genuine deregulation as a way to help patients. Let’s see if it passes. 

Over the last two decades, the drug overdose crisis—driven by opioids—has taken an unimaginable toll on American families and communities.

Yet the data suggest progress is being made in combating this epidemic. In 2024, opioid overdose deaths in the U.S. were nearly 27 percent lower than they had been in 2023—the first time that national opioid overdose deaths have decreased since 1999. In new research, we find that part of this decline can be explained by how states regulate the use of recreational marijuana.

Our failure to combat America’s deadly relationship with opioids is not from a lack of trying. Politicians and policymakers have tried seemingly every angle to save lives. Restricting opioid prescriptions, improving access to anti-overdose drugs, and tightening border security have not had a significant effect.

The opioid crisis has gotten so out of hand that many states will give people possessing heroin and engaged in other crimes complete legal immunity if they call 911 when witnessing an opioid overdose. While well-intended, these so-called Good Samaritan Laws have also done little to curb the opioid epidemic’s death toll.

[fusion_dropcap boxed=”no”]P[/fusion_dropcap]resident Trump stunned many when he nominated Robert F. Kennedy Jr. to serve as Secretary of the Department of Health and Human Services. Soon after, he appointed Dr. Marty Makary, another iconoclastic critic of the U.S.’s public health system. 

Less than three months later, the FDA laid off 3,500 (of about 19,700) employees. The rapid downsizing left some concerned that remaining employees would be overworked and overwhelmed. Others feared leaving the agency understaffed would lead to even more sluggish review times. 

These concerns aside, RFK Jr. remained steadfastly committed to reform, insisting that he only fired “corrupt” employees as he brought in his people. But a recent exit casts further doubt.

After serving for about two months, Dr. Vinay Prasad has stepped down from his position as Director of the Center for Biologics Evaluation and Research (a center within the FDA). Some media outlets cite Dr. Prasad, wanting to “spend more time with his family” and that he “did not want to be a distraction” to the Trump administration as reasons for his quick departure.

But these are not the only reasons.

Others point out that Dr. Prasad disagreed with his peers on fast-tracking several experimental treatments. First, he fought against granting access to accelerated approval for several multiple myeloma drugs. Then he also strongly disagreed with his peers on advancing a gene therapy to treat muscular dystrophy. According to a commentary published by Science, these points of difference made the recent appointee “not quite Trumpy enough.”

That is hard to believe. Dr. Prasad expressed many of the same concerns and criticisms of U.S. public health during the pandemic as RFJ Jr. and Dr. Makary. As an accomplished academic, he published many academic articles, gave lectures, and provided testimony questioning many FDA decisions.  Moreover, he was doing so before Trump’s first term.

Dr. Prasad is also not the only appointee to step down after disagreements surfaced. Less than a month ago, RFK Jr. fired two top HHS executives after losing confidence in them. Shortly afterwards, he fired 17 members of a CDC vaccine panel, citing the need to “restore public trust.”

The sad reality is that these hundreds of firings, appointments, and re-appointments have yet to lead to any FDA reforms. The closest the agency has come is a proposed revision of the accelerated approval process, which became a victim of regulatory capture during the pandemic. A lobbying boom from pharmaceutical producers and other healthcare providers since President Trump began his second term lends further pessimism.                                

Restoring trust in the FDA, HHS, and public health broadly requires more than removing people: it requires removing power. RFK Jr., Commissioner Makary, and others have yet to cut regulatory power, they have only replaced who has it. I certainly do not trust that.  

This January, the Food and Drug Administration announced Red Dye #3 (a synthetic food dye) must be removed from all food products by January 2027. It was a strange decision.

Red Dye #3 has been used to make food redder since 1907. To date, Red Dye #3 has only been clinically linked to lead to cancer in lab rats—never in humans. Notwithstanding, the use of Red Dye #3 has been in decline since the late 1980s due to health-related concerns.

This was just the beginning.

In April, the FDA announced a more ambitious plan to phase out eight additional food dyes, with some bans coming “within the coming months.” The press release also indicates that the FDA will fast-track the authorization of four new natural color additives and work with the National Institutes of Health to study the impact of food dyes on childhood behavior.

Banning a variety of food dyes has long been one of the top priorities for Secretary of the Department of Health and Human Services Robert F. Kennedy Jr., who is quoted in the same press release as saying:

These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development. That era is coming to an end. We’re restoring gold-standard science, applying common sense, and beginning to earn back the public’s trust. And we’re doing it by working with industry to get these toxic dyes out of the foods our families eat

RFK Jr.’s intentions are understandable. His approach of having the central government decide what products to ban and what to replace them with is anything but the “gold standard.” Instead, it’s an easy-to-replicate and repeatedly failed experiment.

Numerous state-initiated guidelines to recommend healthy diets and provide better nutrition labels have had little success. FDA and HHS financial support and revised approval guidelines to develop nicotine replacement therapies to help patients beat nicotine addiction have gone up in smoke.

Instead, food dye bans and regulations would be much better addressed at the state level, where many complex health decisions have been regulated without FDA involvement.

Several states and many cities began banning artificial trans-fats in 2010. The FDA did not issue a ban until 2015. Before it became federal law, 41 states enacted right-to-try laws, which grant terminally ill patients access to potentially life-saving experimental medication. Many states differ from the federally recommended vaccine schedules and provide their own. Well before RFK Jr.’s appointment, eleven states enacted legislation to remove food dyes from public school lunches and other products. California specifically banned Red Dye #3 two years ago.

State-led efforts to address and regulate complicated health policies are far from perfect. But they can vastly outperform federal efforts with the same goals.

Before 2016, states were tasked with regulating e-cigarette sales, including preventing retailers from selling to minors. After 2016, the FDA initiated a federal effort to prevent younger demographic vaping use from becoming an epidemic. Teenage and middle school-aged vaping rates increased afterward.

Whether and how food dyes impact our health is a complicated question and we could easily be decades away from reaching a scientific consensus. However, any complex question in health or public policy is better addressed with experimentation and varied approaches. A federal ban provides the opposite.

A new year often begins with new year’s resolutions (and hangovers). According to a survey performed by Statista, two of the most common resolutions Americans made this year are to lose weight and eat healthier. The two are usually related. Unfortunately, most resolutions don’t become new habits. But this year, the Food and Drug Administration is here to help. 

As President-elect Trump prepares to return to the White House this January, many continue to question his choices for key cabinet positions. Perhaps his most controversial appointment so far is Robert F. Kennedy Jr. (commonly referred to as RFK) as Secretary of the Department of Health and Human Services. And a recent vaccine-related controversy is not helping. 

Last November, the New York Times asked, “What is Ozempic, and why is it getting so much attention?” Five months later, it answered its own question with the headline, “This is what a miracle drug looks like.”

To the surprise of many, Donald Trump won the 2024 presidential election handedly. Even more are surprised by his rapid—and sometimes head-scratching—nominations ahead of taking office again.

Fall brings us pumpkin spice, college football, and seasonal illness. Although RSV and flu cases are increasing regionally, the Centers for Disease Control and Prevention and others believe the worst of “flu season” is behind us.