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

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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Cannabinoids Like CBD Following White House Approval appeared first on Marijuana
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