FDA explains mandatory adverse‑event reporting for industry and launches cosmetics dashboard with caveats

Janavi Srinivasan, Director of the Division of Cosmetics at FDA, reviewed postmarket surveillance tools and the agency’s expectations for adverse‑event reporting under MOCRA.

Srinivasan said MOCRA defines what constitutes a "serious adverse event" and makes industry reporting of serious adverse events mandatory. She told listeners industry (the responsible person) "must report to the FDA within 15 business days of receiving the serious adverse event report" and include a copy of the product label or retail packaging with the submission. Srinivasan emphasized that nonserious adverse‑event reporting by industry remains voluntary.

On follow‑up reporting, she said industry must report any new and material medical information within one year and within 15 business days of receipt. She also stated that industry is required to retain adverse‑event reports for six years, with exclusions for small businesses as defined in MOCRA.

Srinivasan outlined submission options: consumers and health professionals can use MedWatch (Forms 3500/3500B); industry can use the Electronic Submission Gateway (for bulk XML submissions) or the Safety Reporting Portal (SRP) after registering an account. She urged industry to populate key form fields correctly (for example, check the 15‑day box in section G6 on Form 3500A for expedited reports and use clear adverse‑event terms in section G7) to avoid incomplete submissions.

She also described a public FDA cosmetics dashboard launched in September 2025 that presents releasable FAERS adverse‑event reports from 2001 to the present and is updated daily. Srinivasan warned users that "the existence of the adverse event reports for cosmetic product in FAERS does not mean that the cosmetic product caused the adverse event" and urged readers to consult the dashboard’s disclaimers and FAQs.