The order outlines a broad research agenda and calls for clearer standards for products that fall under FDA oversight, including those that may contain THC above new statutory limits.
Rescheduling process to proceed “in the most expeditious manner”
Marijuana is currently classified by the US Drug Enforcement Agency (DEA) as Schedule I, which is defined as “as drugs with no currently accepted medical use and a high potential for abuse” and currently includes heroin and lysergic acid diethylamide (LSD).
This classification has remained in place despite the Department of Health and Human Services recommending in 2023 that it should be moved to Schedule III. As noted in today’s executive order, Schedule III substances have “a currently accepted medical use in treatment in the United States, and a potential for moderate or low physical dependence or high psychological dependence,” and currently include anabolic steroids and testosterone.
The order also notes that the National Institute on Drug Abuse concurred with FDA’s recommendation to reschedule and that the Department of Justice’s proposed rule in 2024 “received nearly 43,000 public comments.”
“It is hereby ordered that 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,” the order said.
For manufacturers and suppliers in the dietary supplement and functional ingredient sectors, the shift to Schedule III may ease barriers to academic and clinical research, particularly on cannabinoids that appear in both marijuana and hemp-derived products.
Order highlights widespread CBD use and calls for improved safeguards
The order cites increasing consumer use of hemp-derived cannabinoid products. It states that “one in 5 United States adults and nearly 15 percent of seniors reported using CBD in the past year,” adding that “chronic pain patients have reported improvements with CBD use in clinical studies.”
At the same time, the Administration notes gaps in product quality and consistency. “A recent study found that some commercially available CBD products evaluated were inaccurately labeled regarding CBD isolate, broad-spectrum, or full-spectrum composition, posing safety risks for consumers,” the order reported.
The document also points to regulatory complexity created by Public Law 119-37, stating that “some full-spectrum CBD products will once again be controlled as marijuana under the CSA… because they contain THC levels above the per-container threshold.” NutraIngredients previously covered Public Law 119-37, which passed as H.R.5371 earlier this month.
The upcoming change may affect formulators and suppliers handling products marketed as full-spectrum or containing naturally occurring THC.
“It is the policy of my Administration to increase medical marijuana and CBD research to better inform patients and doctors,” the order said, referencing the need to “close the gap between current medical marijuana and CBD use and medical knowledge of risks and benefits.”
Federal agencies directed to help shape a new CBD regulatory framework
Beyond scheduling, the executive order directs a cross-agency effort to update the statutory definition of final hemp-derived cannabinoid products. This includes work with Congress on rules that would “allow Americans to benefit from access to appropriate full-spectrum CBD products while preserving the Congress’s intent to restrict the sale of products that pose serious health risks.”
The order states that this work “will include consultation with appropriate executive departments and agencies and authorities to develop a regulatory framework for hemp-derived cannabinoid products, including development of guidance on an upper limit on milligrams of THC per serving with considerations on per container limits and CBD to THC ratio requirements.”
The Secretary of Health and Human Services, the FDA Commissioner, and other federal health leaders are instructed to “develop research methods and models utilizing real-world evidence to improve access to hemp-derived cannabinoid products in accordance with Federal law and to inform standards of care.”
Industry reaction
The executive order aligns with long-standing priorities for medical marijuana and hemp, according to the American Herbal Products Association. “AHPA welcomes today’s Executive Order from the White House ‘Increasing Medical Marijuana and Cannabidiol Research,’” Graham Rigby, the association’s president and CEO, told NutraIngredients.
AHPA views the current lack of clinical guidance as a significant gap for patients and manufacturers, said Rigby, and noted that the order “rightly prioritizes closing that knowledge gap with modern research methods”.
Two provisions are especially relevant for supplement and botanical product companies, he added. “The directive to move the federal process forward on Schedule III rescheduling will reduce barriers that have impeded rigorous medical research,” and that the call for clearer statutory and regulatory boundaries for hemp-derived cannabinoids signals commitment to “access and consumer protection.”
CBD American Shaman founder and president Vince Sanders told NI that companies are weighing the operational uncertainties that could follow rescheduling. “Rescheduling marijuana to Schedule III could mean many different things, and right now there’s still significant uncertainty,” he said.
Sanders noted that new prescription or pharmacy pathways could influence how cannabis products reach consumers and how businesses structure compliance. “We don’t yet know what the final regulatory framework will look like,” Sanders said. “What is clear is that Schedule III has the potential to be one of the biggest shifts in cannabis history.”
