Marijuana Moment: FDA Is Now Tracking Adverse Health Events Related To Hemp Cannabinoids Like CBD Following White House Approval

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The Food and Drug Administration (FDA) has updated its adverse drug event reporting forms to begin tracking incidents related to hemp-derived cannabinoid products such as CBD.

The change to the federal documents—which are used by healthcare professionals, consumers and companies to report adverse experiences with drugs, cosmetics and other products—received sign-off from the White House Office of Management and Budget (OMB) earlier this month.

This comes about three months after FDA posted a notice in the Federal Register advising that it would be requesting the approval for the cannabis-related change to the forms, which was first unveiled in January.

The FDA change revises the “Product Type” field of safety reporting documents that are part of the agency’s MedWatch program to include a selection for “Cannabinoid Hemp Products (such as products containing CBD).” It was finalized following an initial public comment period that ended in May and a second round that closed in July.

Two comments FDA received expressed support for the addition of a “cannabinoid hemp product” category “but encouraged FDA to include additional categories as well that would allow for specific data as it pertained to a wider variety of individual products,” the agency said at the time. A third called for changes to make entries easier by respondents.

Also, asked in July about the widespread availability of intoxicating cannabinoid products, such as delta-8 THC, the head of FDA warned that the use of cannabinoids can lead to cardiac problems and psychosis.

Meanwhile, the move to revise FDA forms 3500, 3500A and 3500B—designed to more actively gather information about adverse health effects that might be linked to hemp-derived products—comes amid a number of other CBD-focused actions at the federal level and state levels.

For example, President Donald Trump on Sunday posted a video on his Truth Social platform promoting the health benefits of cannabis—suggesting that covering hemp-derived CBD under Medicare would be “the most important senior health initiative of the century.”

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On Friday, bipartisan House lawmakers pushed back against attempts to ban hemp THC products, arguing that it would “deal a fatal blow” to the industry and, as currently included in a spending bill, violates congressional rules. To that end, the members said there are plans in the works to introduce an alternative measure to regulate the market.

While the Senate ultimately stripped similar language from its version of the agriculture spending measure following a procedural protest from Sen. Rand Paul (R-KY), there’s still concern among stakeholders that it could wind up in the final package delivered to the president following bicameral negotiations.

Democratic senators also sent a letter to leadership earlier this month that warned of the major upheaval that would happen in the hemp market if products containing any amount of THC were banned.

Dozens of hemp farmers from Kentucky also recently urged their state’s senior U.S. senator, McConnell, to back off from his push to recriminalize some products that are derived from their crops.

Paul, for his part, recently cautioned that the cannabis policy movement has “swung hard on the prohibitionist side” amid the ongoing debate over intoxicating hemp products. And he worries that, if things go awry, the hemp market could be decimated “within the next two weeks.”

Asked about recent conversations with McConnell and Harris, Paul said “we’ve been working diligently” with the staff “trying to reach a compromise.”

“A lot of the conversations have been constructive. They say, at least on the surface, they’re not trying to eliminate it—but I think we are, in some ways, talking past each other,” he said.

Meanwhile, Paul recently filed a standalone bill that would go in the opposite direction of the hemp ban, proposing to triple the concentration of THC that the crop could legally contain, while addressing multiple other concerns the industry has expressed about federal regulations.

The senator introduced the legislation, titled the Hemp Economic Mobilization Plan (HEMP) Act, in June. It mirrors versions he’s sponsored over the last several sessions.

Harris, who championed the hemp THC ban in his chamber version of the agriculture spending legislation, told Marijuana Moment that he wasn’t concerned about any potential opposition to the hemp ban in the Senate—and he also disputed reports about the scope of what his legislation would do to the industry.

The Congressional Research Service (CRS) released a report in June stating that the legislation would “effectively” prohibit hemp-derived cannabinoid products. Initially it said that such a ban would prevent the sale of CBD as well, but the CRS report was updated to exclude that language for reasons that are unclear.

The hemp language is largely consistent with appropriations and agriculture legislation that was introduced, but not ultimately enacted, under the last Congress.

Hemp industry stakeholders rallied against that proposal, an earlier version of which was also included in the base bill from the subcommittee last year. It’s virtually identical to a provision of the 2024 Farm Bill that was attached by a separate committee last May via an amendment from Rep. Mary Miller (R-IL), which was also not enacted into law.

Photo courtesy of Kimzy Nanney.

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