FDA Could Approve Hemp As A Tobacco Additive, But Marijuana Won’t Be Allowed Even If Rescheduled, Congressional Researchers Say

The Food and Drug Administration (FDA) can authorize tobacco products containing hemp-derived cannabinoids, congressional researchers say in a new report. But since the crop was federally legalized, the agency has yet to receive any applications for such a product. Marijuana, meanwhile, would still be banned as an additive for tobacco even if it’s rescheduled.

The Congressional Research Service (CRS) report released on Monday adds another layer of analysis about the potential impact of moving marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA), as the Justice Department has proposed. This new document focuses on the legal effects of rescheduling on FDA’s regulatory authority.

As CRS has pointed out in several recent reports, “marijuana would continue to be prohibited” even if it’s moved to Schedule III. In order for it to be legally dispensed following rescheduling, FDA would need to approve specific cannabis products as medicines, and the agency typically does not grant such approvals for botanical drugs.

“Rescheduling thus would not automatically legalize medical marijuana in the United States,” CRS said, adding without FDA approval, controlled substances “cannot legally be marketed in interstate commerce” under the Federal Food, Drug, and Cosmetic (FD&C) Act.

Also, while hemp was federally legalized under the 2018 Farm Bill, making it exempt from the CSA, FDA has so far declined to approve hemp-derived cannabinoids such as CBD as food items or dietary supplements. That hasn’t stopped the proliferation of such products, however. And while an FDA official told congressional lawmakers last month that the agency is authorized to remove cannabis edibles from the market for violating the FD&C Act, it typically sends warning letters to companies marketing unapproved products instead.

Interestingly, the CRS report includes another section that discusses FDA’s regulatory authority over tobacco and how that intersects with cannabis. Because marijuana would remain federally illegal even if its moved to Schedule III, the analysts said it would still be prohibited as an additive to tobacco.

“Hemp, however, may be incorporated into tobacco products without running afoul of the CSA,” it said. “These products would not receive marketing authorization if FDA determined that allowing the products to be marketed would not be appropriate for the protection of the public health. To date, none of the 56 new tobacco products FDA has authorized pursuant to a premarket tobacco product application (PMTA) contain a cannabinoid.”

The report concludes with policy considerations for Congress, noting for example that lawmakers could move to deschedule marijuana altogether, and they could further “consider whether to impose a new regulatory framework on marijuana and, if so, which agency should be tasked with such authority.”

“When crafting any such legislation, Congress might consider standards for safety, manufacturing, labeling, adverse event reporting, inspection, testing, premarket review, enforcement authority, and any other relevant considerations,” it said.

Last month, CRS separately released a report explaining how federal marijuana rescheduling is “unlikely” to improve banking access for state-legal cannabis businesses.

As President Joe Biden acknowledged in a speech over the weekend, however, marijuana rescheduling in not a done deal just yet.

The Justice Department formally proposed reclassifying cannabis as a Schedule III drug in March, in accordance with an earlier recommendation from the Department of Health and Human Services. The draft rule then went through a public comment period, and the DEA has since scheduled an administrative hearing in December—after the election—to gain additional input before potentially finalizing the rule.

Meanwhile, congressional lawmakers have been exploring legislative options to impose a general ban on hemp-derived cannabinoids such as delta-8 THC.

Rep. Mary Miller’s (R-IL) amendment to the 2024 Farm Bill, for example, was approved by a House committee in May and would remove cannabinoids that are “synthesized or manufactured outside of the plant” from the federal definition of legal hemp. The change is backed by prohibitionists as well as some marijuana companies, who’ve described the restriction as a fix to a “loophole” that was created under the 2018 Farm Bill that federally legalized hemp and its derivatives.

Anti-drug groups, law enforcement and some health organizations have called on Congress to embrace the ban, arguing that “trying to regulate semi-synthetic cannabinoids will not work.”

In addition to Miller’s amendment in the 2025 Farm Bill, the House Appropriations Committee in July approved a separate spending bill that contains a similar provision to prohibit cannabinoid products such as delta-8 THC and CBD containing any “quantifiable” amount of THC.

— Marijuana Moment is tracking more than 1,500 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they don’t miss any developments. Learn more about our marijuana bill tracker and become a supporter on Patreon to get access. —

Hemp-derived cannabinoids also came up in a recent federal appeals court decision in which judges ruled that cannabinoids derived from hemp, such as THC-O-acetate, indeed qualify as hemp and are legal under the 2018 Farm Bill. In making that ruling, the court rejected the Drug Enforcement Administration’s (DEA) more restrictive interpretation of the law.

How to address hemp-derived cannabinoids has caused some fractures within the cannabis community, and in some cases marijuana businesses have found themselves on the same side as prohibitionists in pushing a derivatives ban.

In California, meanwhile, Gov. Gavin Newsom (D) is also attempting to rein in the proliferation of products that contain intoxicating hemp-derived cannabinoids. While many support the aims of the proposal, some stakeholders contend it could ultimately limit access to federally legal CBD products.

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Photo courtesy of Martin Alonso.