Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
FDA proposes to extend the information collection for postmarketing adverse event reporting for dietary supplements, requiring continued submission of serious adverse event reports to FDA within 15 business days. This is a renewal of existing requirements, not a new rule, but businesses must ensure compliance to avoid enforcement actions.
Aforeworn detected this change in the Dietary-Supplement Labeling (FDA) space on July 5, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Supplement brands, contract manufacturers, private-label sellers, ingredient suppliers should confirm how it applies to their specific situation before acting. There is a time constraint attached: Comments due by July 13, 2026 (60 days after publication on May 13, 2026).. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Dietary-Supplement Labeling (FDA) 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 seeking public comment on the proposed extension of the existing information collection for postmarketing adverse event reporting (OMB control number 0910-0609). The requirements themselves remain unchanged: mandatory reporting of serious adverse events within 15 business days, recordkeeping for 6 years, and submission of adverse event reports to FDA.
Who it affects
Supplement brands, contract manufacturers, private-label sellers, ingredient suppliers
What you must do
Review current adverse event reporting procedures to ensure compliance with existing requirements; submit comments to FDA by the deadline if desired.
Deadline
Comments due by July 13, 2026 (60 days after publication on May 13, 2026).
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