FDA Announces Registration and Listing Updates: The Release of New Discontinuation/Relisting Features in Cosmetics Direct
Cosmetics Constituent Update Today the U.S. Food and Drug Administration (FDA) announced the release of the following enhancements to help industry keep their registration and listing submissions up to date: the availability of two new features in Cosmetics Direct,...
Product Claim Substantiation
Product Claim Substantiation By Jay Ansell, EAS Independent Consultant Substantiating a product claim is required by U.S. law and can help brands avoid regulatory action or provide an effective defense in litigation. For example, in April 2023, the US Federal Trade...
Cosmetic Safety Substantiation
MoCRA, effective December 2023, requires safety substantiation. It amends the FD&C Act. MoCRA mandates maintaining safety records, facility registration, product ingredient registration, and reporting serious adverse events. This seminar, with insights from experts, will overview cosmetic safety assessment.
FDA Issues Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products
Today, the U.S. FDA has provided an update on its ongoing activities related to serious adverse event reporting mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which are enforceable starting December 29, 2023. A responsible person is...