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.
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