In 2023, Congress passed the Modernization of Cosmetics Regulation Act (MoCRA) which updated Chapter VI of the Food, Drug, and Cosmetic Act.

As part of this revision, any manufacturer of a cosmetic product, regardless of size, must notify the FDA when they become aware of a serious adverse event related to any of their products.

To assist in following the activities required in MoCRA, a downloadable Word procedure and required forms and instructions are available below.