{"id":81915,"date":"2025-06-26T05:22:21","date_gmt":"2025-06-26T13:22:21","guid":{"rendered":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/2025\/06\/26\/fda-plan-to-include-hemp-derived-cannabinoids-in-federal-adverse-health-event-reporting-system-goes-to-white-house-for-approval\/"},"modified":"2025-06-26T06:46:22","modified_gmt":"2025-06-26T14:46:22","slug":"fda-plan-to-include-hemp-derived-cannabinoids-in-federal-adverse-health-event-reporting-system-goes-to-white-house-for-approval","status":"publish","type":"post","link":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/2025\/06\/26\/fda-plan-to-include-hemp-derived-cannabinoids-in-federal-adverse-health-event-reporting-system-goes-to-white-house-for-approval\/","title":{"rendered":"FDA Plan To Include Hemp-Derived Cannabinoids In Federal Adverse Health Event Reporting System Goes To White House For Approval"},"content":{"rendered":"<\/p>\n

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<\/a>.<\/p>\n

Initially unveiled in January, the proposal would revise the \u201cProduct Type\u201d field of FDA safety reporting documents to include a selection for \u201cCannabinoid Hemp Products (such as products containing CBD).\u201d An initial round of comments was open until mid-March.<\/p>\n

In a post published in the Federal Register this week, FDA announced that the \u201cproposed collection of information\u201d has now been submitted to the White House Office of Management and Budget (OMB) \u201cfor review and clearance.\u201d<\/p>\n

The new filing says that two comments were received in the initial round of public feedback supporting the addition of a \u201ccannabinoid hemp product\u201d category \u201cbut encouraged FDA to include additional categories as well that would allow for specific data as it pertained to a wider variety of individual products.\u201d A third called for changes to make entries easier by respondents.<\/p>\n

\u201cFDA appreciates each comment and although we continue to modify applicable forms to increase the utility of the information collection as our limited resources allow,\u201d the agency said<\/a>, \u201cwe are proposing no other modifications at this time.\u201d<\/p>\n

An additional round of feedback is now being accepted on the submission of the information, with comments<\/a> due by July 25.<\/p>\n

The move\u2014designed to more actively gather information about adverse health effects that might be linked to hemp-derived products\u2014comes amid a number of other CBD-focused actions at the federal level and state levels.<\/p>\n

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

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.<\/p>\n

While the panel adopted a manager\u2019s amendment to a report attached to the bill earlier this month<\/a> that provided clarifying language stating that members did not intend to prohibit non-intoxicating cannabinoid products with \u201ctrace or insignificant amounts of THC,\u201d the underlying bill went unchanged, despite the industry\u2019s concerns about the proposal.<\/p>\n

The large-scale measure covers a wide range of issues, but for hemp advocates and stakeholders, there\u2019s one section of particular concern that would redefine the crop under federal statute in a way that would prohibit cannabis products containing any \u201cquantifiable\u201d amount of THC or \u201cany other cannabinoids that have similar effects (or are marketed to have similar effects) on humans or animals\u201d as THC.<\/p>\n

The Congressional Research Service (CRS) released a report last week stating that the legislation would \u201ceffectively\u201d prohibit hemp-derived cannabinoid products<\/a>. 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.<\/p>\n

An Appropriations Committee press release on Monday said the bill \u201csupports the Trump Administration and mandate of the American people by\u2026closing 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.\u201d<\/p>\n

The hemp\u00a0language\u00a0is largely consistent with appropriations and agriculture legislation that was introduced, but not ultimately enacted, under the last Congress.<\/p>\n

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\u2019s\u00a0virtually identical to a provision of the 2024 Farm Bill that was attached by a separate committee<\/a>\u00a0last May via an amendment from Rep. Mary Miller (R-IL), which was also not enacted into law.<\/p>\n

There are some differences between the prior spending bill and this latest version for 2026, including a redefining of what constitutes a \u201cquantifiable\u201d amount of THC that\u2019d be prohibited for hemp products.<\/p>\n

It now says that a quantifiable amount is \u201cbased on substance, form, manufacture, or article (as determined by the Secretary of Health and Human Services in consultation with the Secretary of Agriculture),\u201d whereas it was previously defined as an amount simply \u201cdetermined by the Secretary in consultation with the Secretary of Health and Human Services.\u201d<\/p>\n

The proposed legislation also now specifies that the term hemp does not include \u201ca 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),\u201d which seems to carve out an exception for Food and Drug Administration- (FDA) approved drugs such Epidiolex, which is synthesized from CBD.<\/p>\n

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\u00a0proposing to maintain the legalization of naturally derived cannabinoids<\/a>\u00a0from the crop and only prohibit synthetic items.<\/p>\n

Key GOP congressional lawmakers\u2014including one member who supports marijuana legalization\u2014don\u2019t seem especially concerned about provisions in the bill<\/a> despite concern from stakeholders that it would put much of the hemp industry in jeopardy by banning most consumable products<\/a>\u00a0derived from the plant.<\/p>\n

Jonathan Miller, general counsel of the U.S. Hemp Roundtable,\u00a0told congressional lawmakers in April that the market is \u201cbegging\u201d for federal regulations<\/a>\u00a0around cannabis products.<\/p>\n

At the hearing, Rep. James Comer (R-KY) also inquired about FDA inaction around regulations, sarcastically asking if it\u2019d require \u201ca gazillion bureaucrats that work from home\u201d to regulate cannabinoids such as CBD.<\/p>\n

A report from Bloomberg Intelligence (BI) last year\u00a0called cannabis a \u201csignificant threat\u201d to the alcohol industry<\/a>, citing survey data that suggests more people are using cannabis as a substitute for alcoholic beverages such a beer and wine.<\/p>\n

Last November, meanwhile, a beer industry trade group\u00a0put out a statement of guiding principles to address what it called \u201cthe proliferation of largely unregulated intoxicating hemp and cannabis products,\u201d<\/a>\u00a0warning of risks to consumers and communities resulting from THC consumption.<\/p>\n

Separately at FDA, the head of the federal agency recently called exploring the therapeutic potential of psychedelics such as psilocybin and ibogaine a \u201ctop priority\u201d for the Trump administration<\/a>, especially when it comes to helping military veterans grapple with trauma from being sent to fight \u201cunnecessary wars.\u201d<\/p>\n

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<\/a> 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.<\/p>\n

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<\/a>, which advocates and stakeholders say would have devastated a growing industry in the state.<\/p>\n

\n

CBD From Cannabis Could Help Reduce Alcohol Binge Drinking, Study Shows<\/a><\/p>\n<\/blockquote>\n

\n

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


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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. InitiallyContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":24,"featured_media":0,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[18,81],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/81915"}],"collection":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/users\/24"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=81915"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/81915\/revisions"}],"predecessor-version":[{"id":81916,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/81915\/revisions\/81916"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=81915"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=81915"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=81915"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}