Assessment of Alopecia Potentially Due to the Use of Hair Care Products

In response to a U.S. Food and Drug Administration (FDA) investigation, as well as several subsequent lawsuits, our client reached out to our ChemRisk team to evaluate the safety of a hair care product and its potential to cause hair loss in users under the intended condition of use.

Our scientists developed a comprehensive safety evaluation and worked with academic institutions and dermatologists to develop a tier-based testing strategy that we then applied to a variety of endpoints of interest. We evaluated the claims and safety of the hair products, presented our research findings to FDA representatives, and also used the findings to support expert witness evaluations.

Following our investigation, the safety evaluation—preclinical and clinical—of the product has appeared in numerous peer-reviewed publications. Additionally, we have presented our studies at multiple national scientific conferences. Our work has also fostered discussions between our scientists and regulators regarding cosmetic reform.