Testimony for FDA meeting on sunscreen active ingredient safety testing

Delivered by Dr. Anna Mazzucco
September 4, 2014

Thank you for the opportunity to speak today on behalf of the Cancer Prevention and Treatment Fund. My name is Dr. Anna Mazzucco, and after completing my Ph.D. in Cell and Developmental Biology from Harvard Medical School I conducted research at the National Cancer Institute. I bring those perspectives today.

Our nonprofit research center conducts research and scrutinizes data to provide objective and reliable information to patients and providers.  Our president is on the Board of Directors of the Alliance for a Stronger FDA, which is a nonprofit dedicated to increasing the resources that the FDA needs to do its job.  Our organization does not accept funding from pharmaceutical companies, and therefore I have no conflict of interest.

In 2014 almost 10,000 Americans died from melanoma skin cancer, and 76,000 new cases were diagnosed.¹  Despite warnings to avoid sun exposure, adults and children are spending a great deal of time in the sun, thus making safe and effective sunscreens essential to prevent skin cancer.  At the same time, Americans are using sunscreens more frequently and on a more long-term basis than ever before, as the FDA’s report noted.

Therefore, our safety and efficacy standards must reflect that Americans of all ages rely on these products regularly.  In its prepared questions, FDA scientists point out the lack of safety testing in pediatric populations.  I hope you’ll agree that we need conclusive evidence that these products are safe for children, and also for prenatal exposures when pregnant women use them.  Clinical studies must include separate analyses of these and other vulnerable populations before products can be marketed for widespread use.

Studies of several active ingredients currently on the market have raised concerns about photostability—how long the protections last under real-world conditions.²

Testing for photostability should be required as part of the pre-market testing of sunscreen active ingredients.  Consumers need to know how long products so that they can avoid increased skin cancer risk.

Several active ingredients currently on the market have also shown potential endocrine-disrupting or carcinogenic activity.^{3 4}   We support the FDA scientists’ proposal to require that active ingredients be tested for carcinogenic and developmental and reproductive toxicity prior to marketing.  Research shows that endocrine-disrupting agents often have greater risks at low doses,⁵ so dose-response testing is not appropriate for these studies.  Without well-designed studies, children and others who are particularly susceptible could be harmed by these hormone-altering ingredients.

There is also research evidence that certain active ingredients demonstrate potentially carcinogenic activity when exposed to UV light, such as generating free radicals that damage DNA and can cause harmful mutations.  Testing for carcinogenic activity should be done under conditions that reflect real-world use as closely as possible, i.e. during UV light exposure.  Such carefully designed testing is needed to ensure that safety data is reliable and meaningful.  Without such information, products intended to help prevent cancer may do just the opposite.

As you consider FDA’s questions, please pay special attention to the issue of combining active ingredients with different vehicles, to make sure that does NOT result in final product formulations which are marketed over-the-counter without any additional testing.  We agree with FDA scientists that different vehicles could change the properties or absorption of active ingredients in ways that could affect safety or efficacy of the final product.  As medical professionals, please urge the FDA to directly confront this problem through additional testing requirements that can ensure products that will be safe and effective for all consumers.