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Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting

Detected July 5, 2026 · in Dietary-Supplement Labeling (FDA)

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 routine renewal, not a new requirement, but businesses must ensure compliance with existing reporting obligations.

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 Low 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. 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. No new requirements are introduced; the current reporting obligations remain unchanged.

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. Optionally, submit public comments by the deadline.

Deadline

Comments due by July 13, 2026

Source: https://www.federalregister.gov/documents/2026/05/13/2026-09543/agency-information-collection-activities-proposed-collection-comment-request-postmarketing-adverse

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