A multinational retailer has identified ToxStrategies as one of its preferred vendors for safety substantiation of cosmetic products manufactured by its private label suppliers. Under the Food, Drug and Cosmetics Act, the safety of all cosmetic products has always been a requirement. However, with the advent of the Modernization of Cosmetic Regulation Act (MoCRA), increased focus is anticipated, and companies are expected to have adequate safety substantiation for all cosmetic products (defined as: a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product). ToxStrategies is excited about this opportunity and is ready to assist clients looking for safety substantiation support to meet the U. S. Food and Drug Administration’s (FDA) requirements. The ToxStrategies team has unique qualifications to support a client’s safety substantiation needs including:
- Developed the U.S. Federal Drug Administration’s internal protocols on conducting cosmetic ingredient safety and aggregate exposure assessments
- Active membership in the Personal Care Product Council’s Safety and Regulatory Toxicology Committee and the MoCRA Safety Substantiation Workgroup
- Experience working in-house at global personal care and cosmetics companies supporting safety assessment for a multitude of product types
- Skilled in using a variety of software packages that can support safety assessment, including in silico/QSAR toxicology programs; OECD Toolbox, Benchmark Dose Software (BMDS), DEREK, and Toxtree.
- Experience creating safety substantiation templates, standard operating procedures, and associated Excel workbooks to streamline the assessment process
- Active monitoring of regulations pertaining to cosmetics and personal care products from the local to global level
- Experience in post-market surveillance
- U.S. board certified and European registered toxicologists
Additional details on ToxStrategies’ personal care and cosmetic qualifications can be found here: https://toxstrategies.com/services/cosmetics-personal-care-products/
If you have questions about how ToxStrategies can support your safety substantiation needs, reach out to Lauren Brown at LBrown@toxstrategies.com.