Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products
FDA is seeking public comment on proposed changes to Time and Extent Applications (TEAs) for nonprescription drugs. While not directly under MoCRA, this signals increased FDA scrutiny on OTC drug products, which may affect cosmetics marketed with drug claims (e.g., sunscreens, anti-acne).
Aforeworn detected this change in the Cosmetics & Personal-Care (MoCRA) space on July 6, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Low urgency. Indie beauty brands, contract manufacturers, private-label makers, importers/distributors that market cosmetics with OTC drug claims (e.g., SPF, anti-dandruff, antiperspirant). should confirm how it applies to their specific situation before acting. There is a time constraint attached: Comments due by August 25, 2026 (60 days from publication).. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Cosmetics & Personal-Care (MoCRA) 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 proposing changes to the TEA process, which could affect how nonprescription drug ingredients are reviewed and approved. This may lead to stricter requirements for OTC drug monographs.
Who it affects
Indie beauty brands, contract manufacturers, private-label makers, importers/distributors that market cosmetics with OTC drug claims (e.g., SPF, anti-dandruff, antiperspirant).
What you must do
Review current product claims to ensure compliance with OTC drug regulations. Submit public comments by the deadline if your business is affected.
Deadline
Comments due by August 25, 2026 (60 days from publication).
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