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.[1]”   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.   

Skin Cancer

“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.

Nanotechnology

“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.”

More from PCPC

Statement By John Bailey, Chief Scientist, The Personal Care Products Council on Campaign for Safe Cosmetics report, “Not So Sexy: The Health Risks of Secret Chemicals in Fragrance”

“A new report alleging that a number of popular, brand-name perfumes contain “secret” ingredients that could cause harm to consumers grossly misrepresents the science on fragrance ingredients and presents a distorted picture of how they are regulated and labeled. The report titled, “Not So Sexy: The Health Risks of Secret Chemicals in Fragrance,” and released by the U.S.-based Campaign for Safe Cosmetics and the Environmental Working Group, and the Canadian-based Environmental Defence, does a disservice to consumers looking for full and accurate information and trustworthy advice about the products they purchase.

“The validity of the report is seriously undermined by its failure to include quantitative measurements of the “secret” ingredients it purported to find. Such measurements are a fundamental element of toxicological risk assessments. Without them, it is impossible to make valid judgments about potential risks.

“The report also erroneously alleges that many of the materials ‘revealed’ in their testing have not been assessed for safety. In fact, most of the ingredients have been the subject of a safety assessment by one or more authoritative bodies.

“Usage standards for fragrance are set based on the recommendations of a scientific panel of toxicologists, dermatologists, pathologists and environmental scientists that is overseen by the Research Institute for Fragrance Materials (RIFM), an independent research center. The RIFM database contains a significant volume of information on fragrance materials.  

“With respect to allegations in the report of sensitization from fragrance ingredients, it has long been known that a certain percentage of individuals in the population are sensitive to some natural or manmade materials in the environment. In fact, some of the strongest sensitizers are derived from natural sources such as peanuts.

“Fragrance materials and other cosmetic ingredients are tested for their potential to cause sensitization and allergic reactions. When these tests identify substances that may be sensitizing agents, manufacturers take the appropriate steps to formulate in a manner that minimizes the chances of sensitization and allergic reaction. Many of these substances have been used for decades, and much is known about them. The actual occurrence of sensitization in the marketplace is quite low.

“For individuals who are extremely sensitive, products are labeled either with the individual ingredients in them or under the general heading of “fragrance.”  This information helps consumers to select products that are safe and appropriate for them to use. Individuals who experience allergic reactions should consult their physician.

“The assertions in the report that some fragrance ingredients could be hormone disruptors are based on incomplete assessments of available scientific data about potential hormone affects and do not take into account actual exposure in cosmetic products. The studies relied upon in the allegations are not directly relevant to human exposure, and many of the laboratory tests that have been done were completed under conditions that are not directly applicable to the use of these ingredients in cosmetic products. In some substances the hormone effects measured are tens of thousands of times less than what would be expected to cause effects in humans.  The weight of evidence in hormone disruption science today does not support the conclusions presented in this report.

“Although the report alleges deficiencies in U.S. labeling laws for fragrances, virtually all countries, including the European Union, allow fragrance ingredients to be declared on product labels under the general term of “fragrance.”  This is because fragrance components are made up of many substances, and it’s simply impossible to list them all on a product label. In addition, the listing of all fragrance materials would be meaningless to all but expert chemists. The practical approach chosen by regulatory authorities has been to require specific declarations or restrictions only when there is a clearly defined need.

“This action was taken by Europe for a small number of materials that are known sensitizers. In fact, these restrictions had already been identified by industry-sponsored safety review programs and are an integral part of Code of Conduct developed by the International Fragrance Association (IFRA).

“Cosmetic and personal care product manufacturers take their safety responsibilities very seriously. Cosmetic ingredients are carefully selected for safety and suitability for their specific applications, and consumers can be confident in the safety of their products.”

More from PCPC

Personal Care Products Council Update on SB484

Nearly five years have elapsed since Senate Bill 484 (authored by former state senator Carole Migden) established the California Safe Cosmetics Act.  This new program was announced with much initial fanfare and proclamations about how it would protect the health of the millions of Californians who use cosmetics and other already safe personal care products by requiring manufacturers of those products to report to a state agency the ingredients in their products that are already listed on the product label.

Yet, a half-decade and millions of taxpayer dollars later, this California Department of Public Health (CDPH) program remains mired in bureaucracy. It has failed to effectively implement the program or achieve its goals. Consequently, it is little surprise there has been an absence of communication to the public.

Given these and related issues, as well as a concern about the ongoing information vacuum, the Personal Care Products Council has decided to provide an update to its members, the media and California consumers – all of whom deserve to be apprised of the status of this program.

First, we believe that our industry and CDPH have a responsibility to provide important information to consumers.  But the credibility of CDPH or any other government entity depends on its commitment to accuracy, responsibility, unassailable data and accountability to the public it serves.

It is disconcerting that the State of California – despite repeated warnings and expressed concerns from industry – would nonetheless choose to make information public that it knew to be inaccurate, incomplete and completely devoid of context.

This is precisely what occurred when CDPH released flawed information about ingredients in our products to activist groups with a political and public relations agenda.  

Let’s be clear: Our products are safe and are already regulated by the U.S. Food and Drug Administration (FDA). This industry’s commitment to compliance has been exemplary, as is evident from the following chronology:

  • While we do not believe the California Safe Cosmetics Act offers any significant public health benefit and is a waste of precious taxpayer dollars, our member companies have maintained an earnest respect for the law and worked in good faith to comply with the terms of the Act.
  • Since the program’s inception several years ago, our diligence has included numerous requests to CDPH to develop legally binding regulations to assist the manufacturers of these products in submitting data required under the law and assure the public that the information is accurate and complete. Specifically, we raised a number of questions about listing ingredients, addressing technological problems with the computer database and establishing a methodology for reviewing and listing new ingredients in the future.
  • When the state failed to respond to our numerous requests to provide necessary legally binding regulations that would provide clear instructions on what information to file with the Department, some companies filed data that was not required by the statute. Many companies were rushing to provide the data in a timely manner – and now belatedly realize that some of the data submitted was irrelevant, unnecessary and misreported.
  • Upon realizing this, we notified CDPH officials only to be told that the department had no mechanism for our companies to correct, clarify or remove the wrong data.  In fact, CDPH officials assured us the issues would be resolved prior to making our industry data public.
  • Yet in February – and again in March – CDPH released the entire flawed database to two environmental activist groups that had filed public records act requests. In April, we learned the information had been made public.
  • As of today, CDPH has spent several million dollars on this program and is still unable to address our concerns, provide customary guidance in the form of regulations or create a way for our companies to ensure their submitted data is correct and in compliance with the law. As a result, the information now in the public domain is inaccurate. As a result, we fear the public will be misled and confused by this information rather than be benefited by it as proposed by the legislation’s sponsors and the Department.

Unfortunately, it is hard to take the California Safe Cosmetics Act seriously when CDPH officials ignore such fundamental lawmaking principles. Our industry stands committed to following the law and ensuring the continued safety of our products. We cannot remain silent while CDPH allows distorted facts and misinformation to circulate in the public domain.

For additional information about cosmetic and personal care products and their ingredients, visit www.CosmeticsInfo.org.

More from PCPC