Statement by John Bailey, Chief Scientist, Personal Care Products Council, Response to the 2010 EWG Sunscreen Report
For more than 30 years, consumers have trusted and relied on sunscreen products to protect them from the harmful effects of the sun, including skin cancer, sunburn, and premature aging of the skin. The safety and efficacy of sunscreen products have been thoroughly studied and tested by scientists and regulatory authorities throughout the world. Safety and efficacy of these products remains the highest priority for sunscreen manufacturers.
Despite the extensive body of credible scientific research that demonstrates the safety of sunscreen products, the Washington, DC-based activist group, the Environmental Working Group (EWG), has again questioned the safety of sunscreens in another unscientific and unsubstantiated report timed for release at the start of summer season. Although the American Academy of Dermatology, the Skin Cancer Foundation, the Centers for Disease Control, the U.S. Food & Drug Administration, physicians and other health care professionals have emphasized the safety of sunscreen use, EWG continues to make baseless assertions each year that many sunscreen products do not adequately protect skin from sun damage and that they contain dangerous ingredients.
It is widely recognized by sunscreen experts and dermatologists alike that “[a] single bad burn as a child will increase your skin’s susceptibility to damage and skin cancer throughout life.” We are deeply concerned that EWG’s baseless assertions will cause consumers to avoid using sunscreens on themselves and their children.
“EWG’s report lacks scientific credibility and represents a disservice to those working to decrease the incidents of skin cancer and other damage caused by the sun. Consumers can be confident that the sunscreen products they rely on for protection against the harmful effects of the sun are both safe and effective. Sunscreens in the U.S. are regulated as over-the-counter (OTC) drugs by the U.S. Food and Drug Administration (FDA) and must undergo pre-market approval that involves rigorous scientific assessment including safety and efficacy substantiation according to FDA standards.
“The FDA testing and regulatory process for sunscreen products is the most rigorous in the world. FDA scientists as well as independent scientific experts assess the safety of sunscreen products and the ingredients used in them. In addition to product evaluation and science-based regulation, FDA inspects manufacturing facilities and sets strict guidelines for good manufacturing practices.
“In its 2010 sunscreen report, EWG challenges the international scientific community’s consensus that sunscreen products are safe and effective for consumers. EWG’s allegations are in direct conflict with the established scientific and FDA safety assessments of sunscreen products and their ingredients, including those from scientific and regulatory bodies in the European Union, Canada, and several other countries.
“Ignoring the established scientific and regulatory safety assessment process for sunscreen products and ingredients, EWG invents its own sunscreen product rating system based on very questionable scientific methodology. EWG’s methodology for calculating SPF values has been proven to be inaccurate and unreliable by sunscreen experts around the world. It should be noted that those sunscreen products endorsed by EWG can be purchased on the group’s site via manufacturers’ links and that the ‘purchase will support EWG,’ which demonstrates a vested commercial interest. http://www.ewg.org/cosmetics/report/sunscreen09/Beach-Sunscreens
Vitamin A in Sunscreen
“Retinyl palmitate, commonly known as Vitamin A, has been used safely in various cosmetic preparations, including sunscreen products, for years. In its latest sunscreen report, EWG questions the safety of Vitamin A in sunscreens. Vitamin A, an important vitamin in humans, is made up of a family of compounds called retinoids. Retinoid esters, including retinyl palmitate, account for more than 70 percent of Vitamin A. Retinyl palmitate is approved by FDA as a food additive and as an over-the-counter (OTC) and prescription drug. To achieve premarket approval, FDA required extensive and rigorous testing. Retinol and retinyl palmitate have been reviewed by the Cosmetic Ingredient Review (CIR) expert panel and found to be safe for use in cosmetics.
“In 2000, the National Toxicology Program (NTP) published a notice stating that it would study the potential of retinyl palmitate to enhance UV radiation-induced photocarcinogenisity. While the study is listed as ‘in progress,’ the NTP recently released preliminary data on their Web site; scientific peer review of the entire study is now scheduled for late 2010 or early 2011. Peer review is essential before the results of a study can be accurately interpreted or used to support conclusions. It must be noted that this NTP study was not designed to study retinyl palmitate in the presence or absence of sunscreen formulations.
“Nevertheless, the EWG has inappropriately taken preliminary retinyl palmitate data from the NTP’s Web site to support their conclusions that products containing retinyl palmitate, including sunscreens, may not be safe. FDA, and other regulatory body scientists, cannot evaluate NTP study findings until the entire body of results, written in the standard NTP Technical Report format, is peer reviewed. Certainly, no credible scientific organization would ever evaluate such preliminary data and make recommendations based upon it.
“EWG’s report cites increasing skin cancer rates and questions sunscreen efficacy in fighting this dangerous disease. EWG fails to consider that skin cancer rates today are the result of excessive unprotected sun exposure from several decades prior and on our ability to better track, monitor and report occurrence of the disease. EWG’s assertions about sunscreen efficacy are contrary to the well-established scientific and medical consensus that sunscreen use helps to protect against skin cancer.
Safety of Oxybenzone
“In its latest sunscreen report, EWG questions the safety of an FDA-approved active ingredient in some sunscreens called oxybenzone. When used as a sunscreen ingredient, oxybenzone, also known as Benzophenone-3, protects the skin from harmful ultraviolet (UV) rays. Oxybenzone is also used to protect cosmetics and personal care products from degradation by absorbing UV rays.
“FDA and governing bodies in Canada and the EU have approved the use of Benzophenone-3 as a safe and effective OTC sunscreen ingredient. The safety of oxybenzone has also been reviewed and confirmed by the CIR expert panel (http://www.cir-safety.org/index.shtml). CIR, an independent panel of scientific and medical experts who assess the safety of cosmetic ingredients used in the U.S., has confirmed that oxybenzone is safe for use as a photostabilizer (to protect the formulation) in cosmetic products.
“In its sunscreen report, EWG also alleges a connection between UV filters found in sunscreens and hormone or endocrine disruption, but to date, available scientific data does not support a link between UV filter exposure to endocrine-disruptive effects in humans.
“EWG also questioned the safety of the inclusion of FDA-approved nanoparticles in sunscreen products, despite the fact that the general scientific consensus is that nanoparticles in personal care products pose no risk to human health. Sunscreens, some of which utilize sun-protecting nanoparticles to help prevent skin cancer, are required to go through an extensive FDA pre-market review process to prove they are safe and effective.
“The 2010 EWG report also claims that many sunscreen ingredients break down significantly when exposed to sunlight and quickly stop working. However, sunscreen formulators already take into account the physical and chemical properties of the active ingredients to ensure they perform effectively and meet all established FDA requirements, including chemical stability. FDA also requires that drugs, including sunscreens, meet strict stability testing requirements to ensure that they are effective when purchased by consumers. EWG’s assertions about the safety and efficacy of sunscreen products and ingredients lack the rigor and reliability of formal, expert evaluation, are not peer-reviewed, and could unnecessarily confuse or alarm consumers.
FDA Sunscreen Monograph
“Any accusations that the FDA has intentionally delayed issuing final sunscreen regulations are false and misguided. We support FDA’s commitment to making decisions based on sound science. Finalizing sunscreen safety standards is a complex regulatory undertaking that requires the careful application of scientific principles and consideration of the evolving science and thousands of data submissions.
“The Council has submitted extensive technical and scientific comments to assist FDA in making the best possible regulatory and scientific decision for consumers on sunscreen products. We understand that FDA is considering these comments, along with thousands of others that have been submitted, and will publish their conclusions after their review is complete. It is critical that FDA has a sound scientific basis for ensuring that sunscreens provide consumers with the protection they need.
“Consumers who have questions about sunscreen use and the safety and efficacy of sunscreens should visit FDA’s Web site at http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/Tanning/ucm116445.htm ,or the Personal Care Products Council’s safety Web site at http://www.cosmeticsinfo.org/product_details.php?product_id=47.
“The Personal Care Products Council joins with the American Academy of Dermatology, the Skin Cancer Foundation, the Centers for Disease Control, FDA and other health professionals in urging consumers to minimize their sun exposure as part of their personal safe sun strategy. This includes all of the following: limiting outdoor activities or seeking shade between 10:00 a.m. – 4 p.m. when exposure to UVA/UVB rays is the highest, wearing protective clothing, and using sunscreens.”