Over 26,000 Cosmetics Serious Adverse Events Reported to FDA in 2024
HAMPTON, Va., Sept. 24, 2025 /PRNewswire/ — Registrar Corp, the global leader in compliance and regulations, and Denver Health today announced the launch of the Adverse Events Protection Program, a fully integrated solution to help cosmetics brands around the globe track and investigate adverse events related to the use of their products.
According to the FDA Adverse Event Reporting System (FAERS) Public Dashboard, cosmetics companies filed 26,262 Serious Adverse Event reports in 2024, a five-fold increase over 2023. The FDA now requires cosmetics brands to investigate and report serious incidents resulting in severe health outcomes like death, life-threatening experiences, or significant disfigurement to the FDA within 15-days.
Cosmetics brands struggle to intake, track, investigate, and report on Adverse Events due to the extensive amount of information, including personal identifiable and medical information, needed from affected consumers. Registrar Corp’s new Adverse Event Protection Program provides both the technology and medical expertise to protect cosmetics companies and their consumers.
The Adverse Event Protection Program includes:
- Registrar Corp’s Adverse Event Management software for consumer intake via mobile devices, investigation tracking, FDA reporting, digital recordkeeping, and audit-readiness
- Denver Health’s in-house clinical team of physicians to review and determine the severity of the Adverse Event and delivering a complete reporting package within five business days
“We are thrilled to partner with Denver Health to provide cosmetics brands with a seamless Adverse Events compliance solution from consumer intake to FDA reporting,” said Raj Shah, CEO of Registrar Corp.
Cosmetics companies rarely have in-house medical expertise as certain credentials, licensing, and a deep understanding of recent codes is needed to conduct Adverse Event investigations. The new Adverse Event Protection Program allows companies to have the expert resources and systems in place when an Adverse Event occurs.
Denver Health, founded in 1856, has a long-standing reputation for medical excellence and public health innovation. As part of this system, Denver Health’s Rocky Mountain Poison and Drug Safety (RMPDS) has provided research services to consumer products companies and governments for over 65 years.
“Combined with Registrar Corp’s AEM software, cosmetics brands now have a complete Adverse Events program from consumer intake to FDA submission,” said Dr. Kevin Nork, Associate Director of Pharmacovigilance.
To learn more, visit Adverse Events Protection Program at RegistrarCorp.com.
About Registrar Corp
Registrar Corp’s mission is to keep consumers safe and healthy by helping food, beverage, cosmetics, medical devices, and drug companies meet compliance requirements. We are the world’s largest compliance company with over 30,000 clients in more than 180 countries. Headquartered in Hampton, Virginia, our dedicated team in 20 offices worldwide makes compliance quick and easy. To learn more, visit www.registrarcorp.com.
About Denver Health
Denver Health is a non-profit healthcare provider founded in 1856 and based in Colorado, USA. Denver Health’s Rocky Mountain Poison & Drug Safety (RMPDS) unit provides clinical case review, toxicology expertise, and medical guidance for cosmetics and drug products.
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SOURCE Registrar Corp