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

OG Article  Written By Anthony Martinelli in News, Studies Watch Today's LIVE Episode on YouTube, X, and Rumble

June 27, 2025

The U.S. Food and Drug Administration (FDA) is advancing a proposal designed to enhance the tracking of health impacts from hemp-derived cannabinoid products. This initiative involves adding CBD and other hemp-derived cannabinoids as selectable options on federal documents utilized by healthcare professionals, patients, and consumers for reporting adverse events.

Initially presented in January, the proposal seeks to modify the “Product Type” field of FDA safety reporting forms to include a selection for “Cannabinoid Hemp Products (such as products containing CBD).” The initial public comment period concluded in mid-March.

This week, the FDA announced in a Federal Register post 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 indicates that two comments received during the initial feedback round supported the inclusion of a “cannabinoid hemp product” category. However, these comments also "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 comment advocated for changes to streamline entries for 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 stated, “we are proposing no other modifications at this time.”

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

This action—aimed at more actively gathering data on potential adverse health effects linked to hemp-derived products—coincides with several other CBD-focused initiatives at both federal and state levels.

For instance, earlier this week, a powerful House committee approved a spending bill containing provisions that hemp stakeholders contend would severely harm the industry. These provisions would prohibit most consumable cannabinoid products that were federally legalized during the first Trump administration.

The House Appropriations Committee passed the agriculture appropriations legislation with a 35-27 vote on Monday. It now proceeds to the Rules Committee for preparation for floor consideration.

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

The extensive measure encompasses a broad spectrum of issues, yet for hemp advocates and stakeholders, one section is particularly worrisome. It 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.

Last week, the Congressional Research Service (CRS) issued a report stating that the legislation would “effectively” outlaw hemp-derived cannabinoid products. Initially, it suggested such a ban would also prevent the sale of CBD, but the CRS report was later updated to omit that language for unclear reasons.

A press release from the Appropriations Committee on Monday stated 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 largely aligns with appropriations and agriculture legislation introduced, but not ultimately enacted, under the previous Congress.

Hemp industry stakeholders strongly opposed that proposal, an earlier version of which was also included in the base bill from the subcommittee last year. It is virtually identical to a provision of the 2024 Farm Bill that was appended by a separate committee last May via an amendment from Rep. Mary Miller (R-IL), which also did not become law.

Some differences exist between the prior spending bill and this latest 2026 version, including a redefinition of what constitutes a “quantifiable” amount of THC that would be prohibited for hemp products.

It now specifies 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 states 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 appears to create an exception for Food and Drug Administration- (FDA) approved drugs such as Epidiolex, which is synthesized from CBD.

Meanwhile, a leading alcohol industry association has urged Congress to scale back language in the House spending bill that would ban most consumable hemp products. Instead, they propose maintaining the legalization of naturally derived cannabinoids from the crop and only prohibiting synthetic items.

Key GOP congressional lawmakers—including one member who supports cannabis legalization—do not seem overly concerned about provisions in the bill, despite stakeholder apprehension that it would jeopardize much of the hemp industry by banning most consumable products derived from the plant.

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

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

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

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

Separately at the 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 assisting military veterans grappling with trauma from serving in “unnecessary wars.”

And in Texas, Gov. Greg Abbott (R) earlier this month signed into law a bill to establish 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 the ultimate goal of developing the psychedelic into a prescription drug with FDA approval, and the state retaining a portion of the profit.

As for hemp-derived cannabinoids in Texas, Abbott also recently vetoed a contentious 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.