Statement by Linda Loretz, PhD, Director, Safety and Regulatory Toxicology Personal Care Products Council on the Brigham and Women’s Hospital Study on Phthalates and Diabetes

A recent study conducted by researchers at Brigham and Women’s Hospital (BWH) found no causal link between the use of phthalates in personal care products and diabetes.  The study examined a possible association between diabetes and levels of certain phthalates in women.

“Diethyl Phthalate, also known as DEP, is the only phthalate with significant use in cosmetics. The BWH study found no association between DEP and diabetes in any of the four models used by the study’s authors.  The U.S. Food and Drug Administration (FDA) evaluated biomonitoring and toxicity data and concluded, “…FDA does not have compelling evidence that phthalates, as used in cosmetics, pose a safety risk.”   Moreover, DEP has been reviewed by other scientific authorities, including the Cosmetic Ingredient Review (CIR) Expert Panel in the U.S. and the Scientific Committee on Consumer Safety (SCCS) in the EU, and found to be safe for use in cosmetics.  DEP is allowed for use throughout the world.

“The lead researcher of the BWH study, Dr. Tamarra James-Todd, noted that “phthalates also exist in certain types of medical devices and medication that is used to treat diabetes and this could also explain the higher level of phthalates in diabetic women. So overall, more research is needed.”

“Personal care products remain one of the safest categories of products regulated by the FDA.  All cosmetic manufacturers are required by law to substantiate the safety of their products and the ingredients used in them before they are marketed.  The industry takes its responsibility for safety very seriously. Consumers can continue to use the personal care products that they have trusted and relied on for many years.”

Council Requests Public Comments On Draft Microbiological Guideline For Cosmetics

The Personal Care Products Council is requesting public comments on a revised Guideline, “M-2 Examination for and Identification of Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans” by August 17, 2012.  The guideline updates the version of this method that was published in 2007 and now includes methods for the identification of Candida albicans.       

The draft guideline outlines suitable methods for identifying the microorganisms listed in the title, and is intended to serve as a resource for manufacturers in their microbiological testing programs.

An electronic copy of the draft guideline is available online  Comments should be submitted by email to John Krowka,