The Food and Drug Administration (FDA) can authorize tobacco products containing hemp-derived cannabinoids, according to a new report from the Congressional Research Service (CRS). However, despite hemp being federally legalized under the 2018 Farm Bill, the FDA has yet to receive any applications for such products. Meanwhile, marijuana would remain banned as an additive in tobacco, even if it’s rescheduled under the Controlled Substances Act (CSA).
The CRS report provides an in-depth analysis of the potential impact of rescheduling marijuana from Schedule I to Schedule III under the CSA, as proposed by the Department of Justice. The report notes that rescheduling marijuana would not automatically legalize medical marijuana across the U.S. without FDA approval. The FDA has historically been reluctant to approve botanical drugs, meaning cannabis-derived medicines would likely still face significant regulatory hurdles.
Furthermore, although hemp is exempt from the CSA, the FDA has not approved any hemp-derived cannabinoids, like CBD, as food items or dietary supplements. Despite this, the market for these products has continued to grow, with the FDA opting to issue warning letters rather than removing them from shelves. The report also highlights that while hemp can be used in tobacco products, none of the 56 new tobacco products authorized by the FDA to date contain cannabinoids.
This legal and regulatory uncertainty presents both challenges and opportunities. On one hand, rescheduling marijuana could pave the way for more research and potential medicinal products. On the other hand, stringent FDA approvals and ongoing federal restrictions could stifle innovation and market growth. The report concludes with recommendations for Congress, suggesting they consider new legislation that could reshape cannabis regulations and enforcement, including the potential descheduling of marijuana entirely.
Meanwhile, the debate over hemp-derived cannabinoids continues, with some lawmakers proposing stricter regulations, such as Rep. Mary Miller’s amendment to the 2024 Farm Bill. This amendment seeks to close what some see as a loophole in the 2018 Farm Bill that legalized hemp but left certain synthetic cannabinoids, such as delta-8 THC, in legal limbo. As Congress weighs these proposals, the broader cannabis industry remains at a crossroads, navigating complex federal regulations while anticipating further changes.
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