Are you prepared for FDA’s new Modernization of Cosmetics Regulation Act (MoCRA)?
If you have a cosmetic product, MoCRA requires that your product is safe. AIBMR can provide inexpensive and timely non-animal tox studies to meet MoCRA requirements.
In August of 2023, FDA released draft guidance for the cosmetics industry following the new provision of the FD&C Act, section 607, which was signed into law in 2022, called the Modernization of Cosmetics Regulation Act (MoCRA). The MoCRA is “the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938” as noted by FDA. This new section, in part, requires manufacturers of cosmetics to register their facilities with the FDA, list each marketed cosmetic product with FDA, and maintain records supporting adequate safety substantiation of their products.
While FDA does not have the legal authority to approve cosmetic products, it can take action against a manufacturer or distributor if there is reliable information showing a cosmetic does not meet the legal requirement for safety.
AIBMR can help you compile the required tox data for your cosmetic products. Initially a thorough literature review can be conducted of publicly available and internal data. When additional tox data is necessary, AIBMR can recommend a non-animal in vitro testing strategy with their partner lab, Toxi-Coop in the EU with very competitive pricing and timing.