FDA Plan To Include Hemp-Derived Cannabinoids In Federal Adverse Health Event Reporting System Goes To White House For Approval

The U.S. Food and Drug Administration (FDA) is moving forward with a
proposal that aims to better track the health impacts of hemp-derived
cannabinoid products by adding CBD and other hemp-derived cannabinoids as
selectable options on federal documents used by healthcare professionals,
patients and consumers to report adverse events.

Initially unveiled in January, the proposal would revise the “Product Type”
field of FDA safety reporting documents to include a selection for
“Cannabinoid Hemp Products (such as products containing CBD).” An initial
round of comments was open until mid-March.

In a post published in the Federal Register this week, FDA announced that
the “proposed collection of information” has now been submitted to the
White House Office of Management and Budget (OMB) “for review and
clearance.”

The new filing says that two comments were received in the initial round of
public feedback supporting 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.” A third called for changes to make entries easier by
respondents.

“FDA appreciates each comment and although we continue to modify applicable
forms to increase the utility of the information collection as our limited
resources allow,” the agency said, “we are proposing no other modifications
at this time.”

An additional round of feedback is now being accepted on the submission of
the information, with comments due by July 25.

The move—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.

Earlier this week, for example, a powerful House committee approved a
spending bill containing provisions that hemp stakeholders say would
devastate the industry, prohibiting most consumable cannabinoid products
that were federally legalized during the first Trump administration.

The House Appropriations Committee passed the agriculture appropriations
legislation in a 35-27 vote on Monday. It now heads to the Rules Committee
to be prepared for floor consideration.

While the panel adopted a manager’s amendment to a report attached to the
bill earlier this month that provided clarifying language stating that
members did not intend to prohibit non-intoxicating cannabinoid products
with “trace or insignificant amounts of THC,” the underlying bill went
unchanged, despite the industry’s concerns about the proposal.

The large-scale measure covers a wide range of issues, but for hemp
advocates and stakeholders, there’s one section of particular concern that
would redefine the crop under federal statute in a way that would prohibit
cannabis products containing any “quantifiable” amount of THC or “any other
cannabinoids that have similar effects (or are marketed to have similar
effects) on humans or animals” as THC.

The Congressional Research Service (CRS) released a report last week
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.

An Appropriations Committee press release on Monday said the bill “supports
the Trump Administration and mandate of the American people by…closing the
hemp loophole that has resulted in the proliferation of unregulated
intoxicating hemp products, including Delta-8 and hemp flower, being sold
online and in gas stations across the country.”

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.

There are some differences between the prior spending bill and this latest
version for 2026, including a redefining of what constitutes a
“quantifiable” amount of THC that’d be prohibited for hemp products.

It now says that a quantifiable amount is “based on substance, form,
manufacture, or article (as determined by the Secretary of Health and Human
Services in consultation with the Secretary of Agriculture),” whereas it
was previously defined as an amount simply “determined by the Secretary in
consultation with the Secretary of Health and Human Services.”

The proposed legislation also now specifies that the term hemp does not
include “a drug that is the subject of an application approved under
subsection (c) or (j) of section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355),” which seems to carve out an exception for
Food and Drug Administration- (FDA) approved drugs such Epidiolex, which is
synthesized from CBD.

A leading alcohol industry association, meanwhile, has called on Congress
to dial back language in the House spending bill that would ban most
consumable hemp products, instead proposing to maintain the legalization of
naturally derived cannabinoids from the crop and only prohibit synthetic
items.

Key GOP congressional lawmakers—including one member who supports marijuana
legalization—don’t seem especially concerned about provisions in the bill
despite concern from stakeholders that it would put much of the hemp
industry in jeopardy by banning most consumable products derived from the
plant.

Jonathan Miller, general counsel of the U.S. Hemp Roundtable, told
congressional lawmakers in April that the market is “begging” for federal
regulations around cannabis products.

At the hearing, Rep. James Comer (R-KY) also inquired about FDA inaction
around regulations, sarcastically asking if it’d require “a gazillion
bureaucrats that work from home” to regulate cannabinoids such as CBD.

A report from Bloomberg Intelligence (BI) last year called cannabis a
“significant threat” to the alcohol industry, citing survey data that
suggests more people are using cannabis as a substitute for alcoholic
beverages such a beer and wine.

Last November, meanwhile, a beer industry trade group put out a statement
of guiding principles to address what it called “the proliferation of
largely unregulated intoxicating hemp and cannabis products,” warning of
risks to consumers and communities resulting from THC consumption.

Separately at FDA, the head of the federal agency recently called exploring
the therapeutic potential of psychedelics such as psilocybin and ibogaine a
“top priority” for the Trump administration, especially when it comes to
helping military veterans grapple with trauma from being sent to fight
“unnecessary wars.”

And in Texas, Gov. Greg Abbott (R) earlier this month signed into law a
bill to create a state-backed research consortium to conduct clinical
trials on ibogaine as a possible treatment for substance use disorders and
other mental health conditions, with an ultimate goal of developing the
psychedelic into a prescription drug with FDA approval, with the state
retaining a portion of the profit.

As for hemp-derived cannabinoids in Texas, Abbott also recently vetoed a
controversial bill that would have banned consumable hemp products with any
traces of THC, which advocates and stakeholders say would have devastated a
growing industry in the state.

CBD From Cannabis Could Help Reduce Alcohol Binge Drinking, Study Shows

The post FDA Plan To Include Hemp-Derived Cannabinoids In Federal Adverse
Health Event Reporting System Goes To White House For Approval appeared
first on Marijuana Moment.