Tag: Responsible person cosmetics
-
Form FDA 3500A and Cosmetic Adverse Event Reporting: Regulatory Reporting Under MoCRA
The Modernization of Cosmetics Regulation Act (MoCRA) fundamentally changed how cosmetic safety issues must be reported in the United States. Cosmetic companies are now legally required to report serious adverse events associated with their products to the US FDA within defined timelines. One of the primary tools used to fulfill this obligation is Form FDA…
-
Annual Cosmetic Product Listing Update: Keeping Product Data Current Under MoCRA
The Modernization of Cosmetics Regulation Act (MoCRA) established cosmetic product listing as a mandatory requirement for all cosmetic products marketed in the United States. Beyond initial listing, MoCRA also requires companies to perform an annual cosmetic product listing update with the US FDA. An annual update confirms that product information on file remains accurate and…
-
Serious Adverse Event Reporting for Cosmetics: US FDA MoCRA Compliance Explained
The Modernization of Cosmetics Regulation Act (MoCRA) has significantly strengthened post-market safety oversight for cosmetic products in the United States. One of the most critical obligations introduced under MoCRA is mandatory serious adverse event reporting to the US FDA. Cosmetic companies are now legally required to report serious adverse events associated with their products within…