Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program
FDA is seeking OMB approval to continue collecting adverse event reports for cannabis and hemp products, including delta-8 THC. This affects reporting obligations for manufacturers and brands.
Aforeworn detected this change in the Cannabis & Hemp Operators space on July 5, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Processors/manufacturers and hemp-derived THC brands should confirm how it applies to their specific situation before acting. There is a time constraint attached: Comments due by August 25, 2025; reporting obligations continue as before.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Cannabis & Hemp Operators continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA is renewing its information collection for adverse event reporting, meaning existing reporting requirements remain in place and are being formalized for another OMB approval cycle.
Who it affects
Processors/manufacturers and hemp-derived THC brands
What you must do
Ensure your adverse event reporting procedures are compliant with FDA's current requirements; no new action needed unless you are not yet reporting.
Deadline
Comments due by August 25, 2025; reporting obligations continue as before.
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