Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
FDA is renewing OMB approval for information collection under CGMP for dietary supplements, requiring manufacturers to maintain records and submit reports. No new requirements, but failure to comply with existing CGMP rules can lead to 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 on the information collection are due by August 17, 2026. Compliance with CGMP is ongoing.. 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 submitted a renewal request to OMB for continued approval of information collection under 21 CFR Part 111 (CGMP for dietary supplements). This is a routine renewal, not a new rule, but it reaffirms existing recordkeeping and reporting obligations.
Who it affects
Supplement brands, contract manufacturers, private-label sellers, ingredient suppliers
What you must do
Ensure your company maintains CGMP-compliant records (e.g., batch records, testing results, complaint files) and is prepared for FDA inspections. No new submissions required unless you are subject to a specific reporting requirement.
Deadline
Comments on the information collection are due by August 17, 2026. Compliance with CGMP is ongoing.
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