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2024 MoCRA Update: Delays, Enforcement and More

Jan 24, 2024 | Featured, Life Sciences, Pharmaceutical and Cosmetics

As the first US cosmetic regulation in over 80 years is finally being implemented, Reed Tech is keep a close eye on all evolving mandates, requirements and deadlines to communicate all relevant information to our customers. As such, Reed Tech subject-matter experts, Gary Saner and Julia Frasch, recorded this video after the latest updates from the FDA in December 2023. Please watch the video below to ensure you are up to speed. Additionally, sign up for our newsletter to receive thought leadership and guidance from our Reed Tech subject-matter experts.

Need help understanding what MoCRA means for your company? Contact us at [email protected] for a consultation.

Here are some key takeaways:

  • Facility Registration & Product Listing Enforcement Delays: The statutory deadline of December 29, 2023 remained intact and FDA encourages companies to comply as soon as possible. However, enforcement is delayed for a period of six months until July 1, 2024. This gives companies more time to register their facilities and list their products.
  • Serious Adverse Event Reporting Now Required: This requirement went into effect December 29, 2023, as planned. Companies must report serious adverse events associated with their cosmetic products within 15 days of first receiving notice.
  • The FDA may issue further updates or guidance in the coming months. It’s recommended to stay informed by checking the FDA website or subscribing to relevant industry publications.

To learn more about the Modernization of Cosmetics Regulation Act (MoCRA), read our full blog post here and contact us at [email protected].