Sunscreen Safety Requirements

OUR CHALLENGE

A consortium of the leading cosmetic and personal care product companies relied on Integral to coordinate efforts to address updated U.S. Food and Drug Administration (FDA) requirements for sunscreen active ingredients. These new requirements, updated in 2019, created a need for data to support clinical and nonclinical safety endpoints for each of seven active ingredients in existing sunscreens and ultraviolet filters. Because these active ingredients are found in many sunscreen products produced by various companies, a single set of studies must be conducted which will impact the whole market.

OUR APPROACH

Over the course of several years, Integral provided project management support and technical and strategic input to the Sunscreen Consortium in meeting FDA regulatory requirements. Integral also managed the scientific program by advising on study design and providing oversight, as well as serving as communication lead. We worked on behalf of industry and science to ensure studies were conducted to meet FDA guidelines.

Specific tasks included: preparing for, or contributing to, comments regarding rulemaking or guidance from FDA or other relevant regulatory agencies for over the counter sunscreen drug products; drafting communications to FDA; preparing for and participating in FDA meetings; preparing FDA workplans and data packages for clinical and nonclinical safety testing; coordinating with commercial clinical and toxicological testing laboratories and a contract manufacturer to develop safety data for the sponsored active ingredients; overseeing and monitoring studies; developing novel test formulations in anticipation of clinical safety testing; developing study protocols in coordination with contract laboratories for conducting in vitro metabolism studies and other required testing; facilitating the sunscreen clinical and nonclinical work groups; conducting literature reviews on relevant toxicological topics related to sunscreen ingredients; and assisting with other needs of the consortium regarding sunscreen safety, as requested.

OUR IMPACT

This long-term project involved coordination across multiple industry companies and stakeholders with wide-ranging implications for a critical consumer product that is used by millions of people. Our work ensured that companies selling the seven sunscreen active ingredients continued to meet FDA regulatory requirements and that sunscreen products continued to be sold in the U.S. Integral also supported the development of 26 novel sunscreen formulations for use in anticipated clinical safety testing and drafted a formulations justification document that was submitted to FDA for review. Integral’s support ensured that member companies were aligned on various workstreams to meet regulatory deadlines.