Statement by Farah Ahmed, Chair, Personal Care Products Council Sunscreen Committee In Response to the Environmental Working Group’s 2013 Sunscreen Report

“In a matter of days, Americans will begin the official start of the summer season by celebrating Memorial Day at beaches, pools and parks.  Before they walk outside, we want them to apply sunscreen to protect themselves and their families from the damaging effects of sun exposure.  Sunscreen products, when used as directed and as part of an overall safe sun regimen, are safe and help reduce the risk of skin cancer, premature skin aging, and other damaging effects of the sun.

“Despite the extensive and growing body of credible science demonstrating the safety, efficacy, and health benefits of sunscreens, the Environmental Working Group (EWG) continues to promote false and misleading assertions about sunscreen products and their ingredients.  Once again, the EWG report lacks the rigor and reliability of formal, expert scientific evaluation and is not peer-reviewed. Our concern is that confusing, unsubstantiated claims could actually serve to discourage consumers from using sunscreen on themselves and their children.

“The Centers for Disease Control, the American Academy of Dermatology (AAD), the Skin Cancer Foundation, and health care professionals around the world all emphasize the safety of sunscreens and the importance of their use as part of a safe sun regimen.  The dangers of sun exposure are clear and universally recognized by public health professionals and dermatologists. The National Institutes of Health ‘Report on Carcinogens’ identifies solar UV radiation as a ‘known human carcinogen.’ A single bad burn as a child is known to increase the skin’s susceptibility to damage and skin cancer throughout life.

“Unfortunately, the American public still has a long way to go before we treat sunscreens the way we treat seat belts. We want to get to a place where people are sun smart every time they step out of their door, automatically applying sunscreen – rain or shine, summer or winter – as well as wearing protective clothing and seeking shade when possible.

“Among the many allegations made in the EWG report that contradict scientific consensus is the claim that retinyl palmitate, or vitamin A, is unsafe for use in sunscreen.In fact, retinyl palmitate has been used safely in personal care products, including sunscreen, for many years and is also approved by the FDA for use as a food additive.

“The EWG report also questions the safety of oxybenzone.  Oxybenzone is an FDA approved over-the-counter sunscreen active ingredient.  It provides broad-spectrum protection from both UVA and UVB rays. In addition to the FDA, Health Canada and the European Union Cosmetic Ingredient Authority have approved the use of oxybenzone as a safe and effective sunscreen ingredient. Contrary to EWG’s claims, the global safety profile for oxybenzone is comprehensive and robust, and current scientific research shows no connection between oxybenzone and endocrine or hormone disruption.

“The EWG report raises a question about the safety of sunscreen sprays and powders.  In fact, in its proposed rule, FDA simply requested further information on the use of this unique dosage form and proposed a few labeling changes.  Until FDA makes its final decision, the agency is allowing these important dosage forms to remain on the market.

“EWG’s lack of understanding of SPF is demonstrated in their assertion that SPF refers only to UVB protection.  In fact, an SPF number can account for up to 20% UVA protection, especially in the higher SPF ranges.

“Our goal is to help consumers to make informed decisions, and use sunscreen as an important part of an overall safe sun regimen.  Sunscreen is a crucial step in the fight against skin cancer and premature skin aging. Our hope is that sun protection will become as much of a habit as putting on your seatbelt.”

References:

  • The Journal of Investigative Dermatology published a clinical study with whole body application of a commercial sunscreen product with 10% oxybenzone, no product-related changes to hormone levels were observed. Journal of Investigative Dermatology, 123:57–61, 2004.
  • U.S. Food and Drug Administration (FDA) – Reviewed and approved oxybenzone as a sunscreen ingredient since 1978 and continues to recognize it as safe and effective. http://www.fda.gov

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Second Episode In New Video Series Debunks Sunscreen Myths; Reinforces the Importance of Safe Sun Practices

Today, the Personal Care Products Council premiered the second episode in its new video series, Skin SmartTM.  In Episode Two, “Anti-aging and Skin Cancer Prevention,” Skin Smart takes an in-depth, science based look at the damage the sun can have on us and the important role sunscreens play as part of an overall safe sun regimen.  The Council and leading dermatologists discuss the effects of sun damage, debunk troubling myths about the safety of sunscreen ingredients, and explain the benefits of using sunscreen daily in the fight against skin cancer and premature skin aging.  

The World Health Organization and the Centers for Disease Control agree that skin cancer is the leading preventable cancer.  The FDA has stated that proper sunscreen use is a crucial step in the fight against skin cancer and premature skin aging.

Episode two includes appearances by leading dermatologist and Vice President of the Skin Cancer Foundation, Elizabeth Hale, MD and well recognized dermatologist Howard Brooks, MD.

“There are too many incidences of skin cancer around the world,” said Farah Ahmed, Chair of the Sunscreen Committee at the Personal Care Products Council.  “This disease is largely preventable through a proper safe sun regimen that includes the daily application of sunscreen,” said Ahmed.

“People of all skin colors and types are susceptible to harmful ultraviolet rays that damage the skin and create early aging in young people,” said Dr. Brooks.  Dr. Hale added, “Regardless of the weather, everyone – people of all ages – should apply sunscreen each day. UV rays still reach the earth and can harm you even on the cloudiest days.”

“Through Skin Smart, we are striving to empower viewers with real science and expert advice to achieve their most healthy and beautiful skin,” said Ahmed.

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New Video Series Encourages Safe Sun Practices; Highlights Importance of Sunscreen As Part of a Daily Skin Care Regimen

The Personal Care Products Council announced today the launch of a new video series, Skin Smart.TM Skin Smart takes an in-depth look at the role sunscreens play as part of an overall safe sun routine. The Council, along with leading dermatologists, alleviates confusion and corrects misinformation about sunscreen use and its safety and explains the new sunscreen labeling regulations recently passed by the U.S. Food and Drug Administration (FDA), which go into effect on December 17, 2012.

The World Health Organization and the Centers for Disease Control agree that skin cancer is the leading preventable cancer.  The FDA has stated that proper sunscreen use is a crucial step in the fight against skin cancer and premature skin aging.

The first episode in the series includes appearances by dermatologists Doris Day, MD and Diane Berson, MD who are working to help patients understand sun damage and the importance of caring for their skin.  

“Our mission here is critical – to raise awareness and educate women and men about the harmful effects the sun has on our skin,” said Farah Ahmed, Chair of the Sunscreen Committee at the Personal Care Products Council.  “Our message is clear – sunscreens are not just for the summer or the beach. They should be used by people of all ages and skin tones, every day, rain or shine and year round,” said Ahmed.

“Everyday sun exposure damages skin.  We can find a wide variety of products that meet the needs of all skin types, from dry and sensitive, to oily and acne prone,” said Dr. Berson.  “Establishing a habit of applying sunscreen daily is a significant preventative measure that everyone can take to reduce their risk of skin cancer and premature skin aging,” Dr. Day added.

“Skin Smart is about sharing real science and expert advice, to empower people to make smart and informed choices when it comes to their skin beauty and health,” said Ahmed.

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Statement by Farah Ahmed, Chair Personal Care Products Council Sunscreen Task Force Response to the 2012 EWG False Allegations Regarding Sunscreen

“Consumers can be confident that sunscreen products in stores today – regardless of whether they bear the pre or post FDA sunscreen final rule compliant label – when used as part of an overall safe sun regimen, are safe and help protect against skin cancer, premature skin aging, and other damaging effects of the sun.

“The Environmental Working Group’s (EWG) latest effort to pressure retailers to remove sunscreens from store shelves will create a shortage of products, which would clearly result in putting consumers at risk and undermining public health.  The dangers of the sun and the importance of daily sunscreen use is strongly supported by the American Academy of Dermatology (AAD), the Skin Cancer Foundation, and other recognized health advocates. In fact, even EWG acknowledges that consumers should use sunscreen.   Furthermore, removing safe and effective sunscreens currently on the market would create significant and unnecessary economic and environmental waste.

“In August 2011, the Council requested FDA to extend the compliance date for its final sunscreen rule out of a serious concern for a potential shortage of sunscreens on the market because industry was unable to complete transitioning their product labeling before the deadline.  Echoing the same concern, FDA provided an additional six months for industry to implement the new rule. The final sunscreen rule requires that any product labeled on or after the compliance date meet the requirements of the rule. In other words, older products can remain on the market and when sold-out be replaced by products with the new label.   This further validates that sunscreens with both new and old labels are safe and effective.

“Consumers should know that we are not aware of any companies that are reformulating to meet the new final sunscreen rule.  For example, a product labeled as “SPF 30” and “protects against UVA rays” would be labeled “SPF 30” and “Broad Spectrum” according to the new final rule.

“Regarding claims such as “sunblock” (vs. sunscreen), “sweatproof” (vs. “sweat resistant”), and “waterproof” (vs. “water resistant”), EWG has provided no reliable data or information to support that consumers have been misled by these terms in any way, and they falsely assert that FDA has considered these terms false and misleading since 1990.  In fact, these terms were created by FDA and were part of FDA’s original sunscreen rulemaking. FDA has been reconsidering these terms, allowing companies flexibility and choice regarding use of these terms in the interim. With the final sunscreen rule, we now know which terms the agency has chosen, but the performance of the products remain the same whether they are “sunscreens” or “sunblocks”, or “waterproof” vs. “water resistant 80 minutes”.

“The dangers of the sun are clear and widely recognized by scientists and dermatologists. The World Health Organization and the National Institutes of Health identify solar UV radiation as a carcinogen.  A single bad burn as a child increases the skin’s susceptibility to damage and skin cancer throughout life. Consumers can be confident that sunscreen products when used as part of an overall safe sun regimen are safe and will help protect them from skin cancer, premature skin aging, and other damaging effects of the sun.

“For more information about the safety and efficacy of sunscreens, please visit www.cosmeticsinfo.org or the U.S. Food and Drug Administration’s website at: www.fda.gov.”

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Statement by Farah Ahmed, Chair Personal Care Products Council Sunscreen Task Force Response to the 2012 EWG Suncreen Report May 15, 2012

“Consumers can be confident that sunscreen products, as part of an overall safe sun regimen, are safe and will help protect them from skin cancer, premature skin aging, and other damaging effects of the sun.

“Allegations contained in the Environmental Working Group’s 2012 sunscreen report disregard or distort an extensive body of scientific research on the safety, efficacy and health benefits of sunscreen and could confuse consumers and discourage them from using sunscreen. With skin cancer rates on the rise, this does a great disservice to consumers and undermines the efforts of public health advocates to educate people about the importance of using sunscreen as part of their sun protection regimen.

“By challenging the medical and scientific consensus that sunscreen products are safe and effective, the EWG report defies the scientific assessments of sunscreen products and ingredients by regulatory authorities in the U.S., E.U., and Canada.  In the U.S. sunscreens are regulated as over-the-counter drugs by the FDA and are subject to rigorous safety and efficacy substantiation.

“Experts at the Centers for Disease Control, the American Academy of Dermatology, the Skin Cancer Foundation, and health care professionals throughout the world also emphasize the safety of sunscreens and the importance of their use as part of a safe sun regimen.

“Among the numerous allegations made in the report is the assertion that retinyl palmitate, an ingredient used in some sunscreens to condition and moisturize the skin, is unsafe. Retinyl palmitate, more commonly known as Vitamin A, has been used safely for many years in various personal care products, including sunscreen. It is approved by the FDA for use as a food additive and has been reviewed twice by the Cosmetic Ingredient Review and found to be safe. A large body of evidence suggests that retinoids have anti-cancer effects in humans.

“EWG also questions the safety of an FDA-approved active ingredient in some sunscreens called oxybenzone.  Oxybenzone, also known as Benzophenone-3, protects the skin from harmful UV rays. FDA and regulatory authorities in Canada and the European Union have approved the use of oxybenzone as a safe and effective sunscreen ingredient. While EWG alleges a connection between oxybenzone and hormone or endocrine disruption, current scientific research does not support such a link in humans.

“The 2012 EWG report also claims that many sunscreen ingredients break down significantly when exposed to sunlight and quickly stop working. This is simply not true. Sunscreen formulators take into account the physical and chemical properties of the active ingredients to ensure they perform effectively and meet all established FDA requirements, to ensure they are effective when purchased by consumers.

“Unprotected sun exposure increases cancer risk, and sunscreen has been scientifically proven to reduce that risk.  Nevertheless, EWG’s report cites increasing skin cancer rates and questions sunscreen efficacy in fighting this dangerous disease.  The report fails to consider that higher skin cancer rates are the result of excessive unprotected sun exposure from several previous decades as well as the ability today to better track, monitor, and report the occurrence of the disease.

“The dangers of the sun are clear and widely recognized by scientists and dermatologists. The World Health Organization and the National Institutes of Health identify solar UV radiation as a carcinogen.  A single bad burn as a child increases the skin’s susceptibility to damage and skin cancer throughout life. Consumers can be confident that sunscreen products, when used as directed and as part of an overall safe sun regimen, are safe and will help protect them from skin cancer, premature skin aging, and other damaging effects of the sun.

“For more information about the safety and efficacy of sunscreens please visit http://www.personalcarecouncil.org/sites/default/files/FactsAboutSunscreen.pdf the Personal Care Product Council’s safety website: www.CosmeticsInfo.org or the U.S. Food and Drug Administration’s website at: www.FDA.gov.”

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Council Response To Release Of Final FDA Sunscreen Rules

The U.S. Food and Drug Administration (FDA) today issued its final rulemaking addressing the way in which the agency will require sunscreen products to be tested and labeled.  The agency also published three other documents, including a Draft Enforcement Guidance for Industry document, further explaining the final rule, a Proposed Rule on sunscreens with SPFs greater than 50, and an Advance Notice of Proposed Rulemaking (ANPR) recognizing and requesting information about alternative dosage forms of sunscreen products such as sprays, powders, wipes, and shampoos. These documents may be found at: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm239463.htm

For more than 30 years, consumers have benefited from the use of sunscreen products to protect themselves from the harmful effects of the sun, including sun burn, premature skin aging, and certain types of skin cancer.   The safety and efficacy of sunscreen products have been thoroughly studied and tested by scientists and regulatory bodies throughout the world, and there is an extensive body of credible scientific research that demonstrates the safety and efficacy of sunscreens.

________________________________________

“FDA’s recognition today of the important role sunscreens play in protecting the public not only from sunburn but also from skin cancer and premature aging due to the sun is a very significant victory for public health.  The role of UV rays in causing skin damage and the role of sunscreens in protecting against this sun damage are widely acknowledged within the medical and scientific communities, and we’re very pleased the agency has taken this critical step.

“Sun exposure is cumulative and the greater the exposure, the higher the risk to all skin types of developing signs of premature skin and/or certain types of skin cancer.  Skin cancer is the most common of all cancers in humans, and skin cancer rates in all races are rising in the U.S. This ruling will help further educate consumers about the importance of using sunscreens as part of an overall sun protection regimen that includes avoiding the sun during peak hours and wearing protective clothing.

FDA SUNSCREEN MONOGRAPH

“We are also pleased that FDA reaffirmed there are no safety issues with any of the sunscreen active ingredients, including nanoscale titanium dioxide and zinc oxide.  The agency confirmed that it evaluated available scientific literature, tested sunscreen nanoscale ingredients and concluded they do not penetrate the skin.

“We urge the agency to keep this rulemaking current and evolving to accommodate new scientific research that becomes available and enable companies to continue to innovate by producing products with higher SPFs, new effective ingredients, new dosage forms and even additional public health benefits.

“In its Proposed Rule, FDA acknowledged that SPFs higher than 50 have been substantiated by independent clinical testing labs, and the results are validated and repeatable.  We look forward to working further with the agency on this issue. Individual companies may also provide their own additional data supporting SPFs higher than 50.

“We are evaluating FDA’s specified implementation period, but we are concerned about manufacturers’ ability to make the required testing and labeling changes in only 12 months given the thousands of products on the market, the limited number of testing facilities, and the time needed to redesign product labeling.  It is unusual for FDA to require such a short implementation period for a rule making of this scope. Manufacturers typically require at least two years to design and implement broad-scale, product-wide labeling changes.

“The industry and the FDA share a mutual goal of ensuring that consumers are protecting themselves against the sun and are aware of the benefits sunscreen products provide. The labeling clarity the Final Rule provides will help achieve this goal.”

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Statement by Farah Ahmed, Chair Personal Care Products Council Sunscreen Task Force, Response to the 2011 EWG Sunscreen Report

“Despite the extensive body of credible scientific research that demonstrates the safety, efficacy, and public health benefits of sunscreen products, the Washington, DC-based activist group, the Environmental Working Group (EWG), has again questioned the safety and efficacy of sunscreens in another unscientific and unsubstantiated report released just in time for Memorial Day.  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 confuse and alarm consumers.

“In its 2011 sunscreen report, EWG once again challenges the scientific community’s consensus that sunscreen products are safe and effective.  The group’s allegations are in direct conflict with established scientific safety assessments of sunscreen products and their ingredients and the assessments of regulatory authorities in the U.S., 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 not based on credible scientific methodology. In fact, EWG’s methodology for calculating SPF values has been proven to be inaccurate and unreliable by sunscreen experts, both in the U.S. and abroad.

“Compounding this lack of scientific objectivity is the fact that sunscreen products ranked highly by EWG are promoted for sale on the group’s Web site via their partnership with Amazon.com, generating revenue for EWG and demonstrating a clear and inappropriate commercial interest.

“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.  Sunscreen products have been thoroughly studied and tested by qualified scientists and regulatory authorities throughout the world. In the U.S., sunscreens are regulated as over-the-counter (OTC) drugs by the U.S. Food & Drug Administration (FDA) and are subject to rigorous scientific assessment, including safety and efficacy substantiation according to FDA standards that are among the most rigorous in the world.

“In addition to FDA, the Centers for Disease Control (CDC), the American Academy of Dermatology (AAD), the Skin Cancer Foundation, physicians and other health care professionals also emphasize the safety of sunscreens and the importance of their use as part of a safe sun regimen.

The dangers of the sun are clear and widely recognized by sunscreen experts and dermatologists.  A National Institutes of Health “Report on Carcinogens” identifies solar UV radiation as a “known human carcinogen.” Further, a single bad burn as a child is known to increase the skin’s susceptibility to damage and skin cancer throughout life.  In light of this scientifically sound and somber evidence of the dangers of the sun, it is alarming that EWG’s “annual report” could cause some consumers to avoid using sunscreens on themselves and their children.

“EWG’s report is fraught with unsubstantiated assertions, contradictions, and distorted facts.  Some examples include:

Skin Cancer

“EWG’s report cites increasing skin cancer rates and questions sunscreen efficacy in fighting this dangerous disease.  EWG fails to consider that the higher skin cancer rates of today are the result of excessive unprotected sun exposure from several previous decades as well as the ability to better track, monitor, and report occurrence of the disease.

“It is important to understand that approximately 90 percent of nonmelanoma skin cancers are associated with exposure to ultraviolet (UV) rays from the sun.1 Each year there are more new cases of skin cancer than the combined incidence of cancers of the breast, prostate, lung and colon.2 Further, up to 90 percent of the visible changes commonly attributed to aging are caused by the sun.3

“EWG’s assertions are contrary to the body of scientific and medical data that recognizes the use of sunscreens as part of an overall program of sun safety to help protect against skin cancer and other forms of damage caused by the sun.

Vitamin A in Sunscreen

“Retinyl palmitate, commonly known as Vitamin A, has been used safely in various cosmetic and cosmetic/OTC drug preparations, including sunscreen products, for many years.  In its latest sunscreen report, EWG once again 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. Retinyl palmitate has been reviewed by the Cosmetic Ingredient Review (CIR) twice and found to be safe for use in cosmetics. CIR is an independent panel of renowned scientific and medical experts that assesses the safety of cosmetic ingredients used in the U.S.

“There is no compelling evidence that retinyl palmitate in sunscreen products presents any human health risk to consumers.  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 photocarcinogenicity.  The NTP issued a report for this study in 2011, conducting a peer review in January 2011. The Personal Care Products Council filed extensive and detailed comments highlighting the serious methodological flaws associated with this study.  In spite of these flaws, the NTP Peer Review Panel nevertheless concluded there was an effect above the control cream (cream without retinyl palmitate) used in the test. Unfortunately, the control cream, which in all toxicological tests should not cause any effect on the test animals, was improperly formulated for this test and caused a significant response that all but obscured the ability to detect any affect arising from retinyl palmitate.  In fact, the flaws are so significant that the results of the study cannot be used for a science-based assessment of risk. It should be noted that there is a large body of evidence that in humans, retinoids have anti-cancer effects, in contrast to the effects sometimes seen in mouse models.

“Unfortunately, EWG has inappropriately used these findings to alarm consumers by telling them that products containing retinyl palmitate, including sunscreens, may not be safe.  Their position is simply not supported by the available scientific data.

Safety of Oxybenzone

“In its latest sunscreen report, EWG again 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 UV rays.

“FDA and regulatory authorities in Canada and the European Union have approved the use of oxybenzone 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 has confirmed that oxybenzone is safe for use as a photo stabilizer (to protect the formulation) in cosmetic products.

“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 and endocrine-disruptive effects in humans.

Sunscreen and Free Radicals

“It is well known that UV light can produce free radicals in the surface of the skin and that this leads to the damage associated with excessive exposure to sunlight, most often observed as redness or sunburn.4  The skin produces natural barriers that absorb the UV light to protect against damage.  The interaction of solar UV with these natural barriers can produce free radicals.

“The application of a sunscreen supplements the natural UV absorbers and protects against free radical formation and the associated damage that can occur.  Even if sunscreens were to form free radicals, this would occur on the surface of the skin and would not affect the underlying structures.

“Every sunscreen is tested in an SPF test to establish the level of protection provided by the product.  These tests confirm that the level of damage in sunscreen-protected skin is well below what occurs in the absence of sunscreen application since there is no ‘redness’ produced.  Moreover, even with doses of UV light, which do produce free radicals and redness, the presence of sunscreens blocks such reactions.

“By virtue of their ability to absorb UV radiation before it can interact with skin, sunscreens provide significant protection against UV-induced free radical formation within skin compared with unprotected skin. Studies have documented the protective effects of individual sunscreen actives as well as commercial sunscreen products for their ability to protect against UV-induced free radical formation within skin compared with untreated or bare skin.5

Vitamin D

“EWG outlines the benefits of vitamin D, but then creates confusion and mischaracterizes the role of sunscreens in cases of alleged Vitamin D deficiency.  AAD notes that getting Vitamin D primarily from sun exposure is not advisable.6   While UV radiation is one source of Vitamin D, it is not the best source because the benefits of obtaining Vitamin D through UV exposure cannot be separated from an increased risk of skin cancer.  Instead, the AAD recommends that ‘…an adequate amount of vitamin D be obtained from a healthy diet that includes foods naturally rich in Vitamin D (e.g., dairy products and fish), foods/beverages fortified with Vitamin D (e.g., fortified milk and fortified cereals), and/or Vitamin D supplements.’7

Nanotechnology

“EWG also questioned the safety of the inclusion of nanoparticles in sunscreen products, despite the fact that the general scientific consensus is that nano-sized titanium dioxide and zinc oxide in personal care products pose no risk to human health.  Sunscreen active ingredients, some of which utilize sun-protecting nanoparticles, go through an extensive FDA review process to demonstrate they are safe and effective.

Stability

“The 2011 EWG report also claims that many sunscreen ingredients break down significantly when exposed to sunlight and quickly stop working.  This is simply not true. Sunscreen formulators 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 sunscreens meet strict stability testing requirements to ensure they are effective when purchased by consumers.

FDA Sunscreen Monograph

“EWG asserts that FDA has intentionally delayed issuing the final sunscreen regulations.  We are not aware of any evidence to support this assertion. We support FDA’s commitment to making decisions based on sound science.  Finalizing sunscreen safety standards is a highly complex regulatory undertaking that requires the careful application of scientific principles and consideration of the evolving science and thousands of data submissions received by FDA. The Council has submitted extensive technical and scientific comments as part of FDA’s public and transparent OTC rulemaking process.  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, Centers for Disease Control, FDA and other health professionals in urging consumers to minimize their sun exposure as part of an overall safe sun strategy.  This includes all of the following: limiting outdoor activities or seeking shade between 10:00 a.m. – 4:00 p.m. when exposure to UVA/UVB rays is the highest, wearing protective clothing, and using sunscreen.”

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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.

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“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.”

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Statement By John Bailey, Chief Scientist Personal Care Products Council, Response To EWG’s 2009 Sunscreen Report

For more than 30 years, consumers have benefited from the use of sunscreen products to protect themselves from the harmful effects of the sun, including sun burn, premature skin aging, and certain types of skin cancer.   The safety and efficacy of sunscreen products have been thoroughly studied and tested by scientists and regulatory bodies throughout the world, and there is an extensive body of credible scientific research that demonstrates the safety and efficacy of sunscreens.

The Personal Care Products Council has joined with the American Academy of Dermatology, the Skin Cancer Foundation, the Centers for Disease Control, the FDA, physicians and other health professionals and organizations 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 between 10:00 a.m. – 4 p.m. when exposure to UVA/UVB rays is the highest, wearing protective clothing, and using sunscreens.

Nevertheless, each year at the start of summer vacation season, the Environmental Working Group (EWG), a Washington-based activist group, issues an unscientific and unsubstantiated report questioning the safety of sunscreens and sunscreen ingredients. Like its 2007 and 2008 predecessors, the 2009 report alleges that many sunscreens do not adequately protect skin from sun damage and/or contain dangerous chemicals.

“Sunscreen manufacturers understand that sunscreens are a critically important tool for consumers and health professionals in the fight against skin cancer, premature aging, and other harmful effects of the sun, and they have made the safety and efficacy of their products their very highest priority.

“Consumers can be confident in the safety of the sunscreens they buy for themselves and their families because all sunscreens sold in the U.S. are regulated as over-the-counter (OTC) drugs by the U.S. Food and Drug Administration (FDA), which requires them to go through a rigorous scientific assessment and approval process that includes safety and performance testing before marketing.  The OTC review program, through which FDA requires significant safety and efficacy data on every active ingredient that is used in a sunscreen product, is the most rigorous in the world for ensuring the safety and efficacy of sunscreen products and is conducted in an open, transparent manner. The law gives the agency broad authority to inspect manufacturing facilities, to require adherence to strict good manufacturing practices, and to enforce the stringent, science-based regulations that ensure sunscreen products are safe and effective for consumers.  FDA also relies on independent experts in the science of sun protection to help advise them in their assessment of safety and efficacy.

“Allegations made in the EWG report about the safety and efficacy of sunscreens conflict with FDA assessments of sunscreen products and their ingredients as well as with the safety assessments and approvals of regulatory and scientific experts in the European Union, Canada and numerous other countries.

“For example, EWG has specifically questioned the safety of the common active ingredient in sunscreens called oxybenzone.  However, oxybenzone is approved by the FDA (http://frwebgate1.access.gpo.gov/cgi-bin/PDFgate.cgi?WAISdocID=537756507619+1+2+0&WAISaction=retrieve), the European Union (http://ec.europa.eu/enterprise/cosmetics/cosing/index.cfm?fuseaction=search.results&annex=VII&search ) and Canada (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_sunprotect_ecransolaire-eng.php) as a safe and effective sunscreen ingredient.  It has also been reviewed by the Cosmetic Ingredient Review (CIR) program (http://www.cir-safety.org/index.shtml), an independent panel of leading scientific and medical experts who assess the safety of cosmetic ingredients used in the U.S., and determined it to be safe for use as a photostabilizer (to protect the formulation) in cosmetic products.

“These reviews, based on the most current science available and conducted in a public forum, provide clear support for the safety of this important ingredient.  In contrast, EWG’s assertions about the safety of oxybenzone lack the rigor and reliability of formal, expert evaluation, are not peer-reviewed, and could unnecessarily confuse or alarm consumers and even cause them to alter their safe sun habits.

“Although the report tries to credit activist pressure on manufacturers for changes in product formulations, it is well known that the personal care products industry is dynamic and innovative and constantly employs cutting-edge science to introduce new, better and more effective products for consumers.

“The 2009 EWG report also alleges that many sunscreens contain ingredients that break down significantly when they are exposed to sunlight, stop working effectively in a short period of time, and do not contain stabilizing ingredients.  However, sunscreen formulators carefully formulate their products to take into account all of the physical and chemical properties of the active ingredients to make sure they perform as required and meet all of the requirements established by FDA, which include chemical stability in the formulation.

“EWG purports to give consumers expert recommendations and guidelines about the safest, most effective sunscreens to buy through its own rating system it has invented. However, the group has used a method to calculate SPF and UVA values that is recognized to not accurately or reliably predict these values.

“Further, EWG does not possess expertise in the complex and evolving science of sunscreen formulation and testing and has ignored the weight of evidence in the international scientific community on the safety of sunscreens. Consumers who have questions about sunscreen use and the safety and efficacy of sunscreens should visit the FDA’s Web site at http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/Tanning/ucm116445.htm ,or the Personal Care Products Council’s consumer information Web site at http://www.cosmeticsinfo.org/product_details.php?product_id=47.

“As the FDA works to finalize its revised sunscreen regulations, the Council has submitted technical and scientific comments supported by sound science that we believe would improve the final monograph. FDA is considering these comments, along with thousands of others that have been submitted to the agency and will publish their conclusions after that review is complete.  We encourage FDA to take these comments into account and to allocate the resources necessary to enable the agency to issue the final regulations as soon as possible.”

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Statement by John Bailey, Chief Scientist The Personal Care Products Council The Importance of Sunscreens

A report by the Environmental Working Group (EWG) targets sunscreens as the summer season begins. This unfortunate attack on sunscreen products is an unjustified attempt to discredit an extensive, long-standing body of scientific data. Sunscreen products have been thoroughly studied and tested, and used safely for more than 30 years. Sunscreens safely and effectively protect consumers against the harmful effects of UV radiation contained in sunlight, including skin cancer.

Sunscreens are over-the-counter (OTC) drugs subject to rigorous scientific and regulatory oversight by the U.S. Food and Drug Administration (FDA). The safety and effectiveness of sunscreens is also ensured by FDA’s drug advisory panel, a committee of independent scientific and medical experts that advises the agency, the dermatological community, and the companies that invest significant time and resources to provide consumers with safe and effective products. We question EWG’s methodology and their data sources.

“Sunscreens are an important tool for consumers and health professionals in the fight against skin cancer and other harmful effects of the sun. Consumers can have a high level of confidence that sunscreen products are safe and effective when used as directed.

There are currently strong FDA safety and effectiveness regulations that govern the manufacture and marketing of all sunscreen products. Sunscreens are classified as drugs by FDA and the agency requires significant safety and efficacy data on every active ingredient before it is approved for use in a sunscreen product. The agency also has broad authority to inspect manufacturers, require adherence to strict manufacturing practices, and enforce rigorous, science-based regulations to ensure that sunscreen products are safe and effective for consumers. Any suggestion that FDA has purposely delayed finalizing the sunscreen monograph is wrong. FDA is committed to making decisions based on sound science. The finalization of the sunscreen safety standards is a large and complicated regulatory undertaking addressing complex scientific principles involving countless submissions of data. FDA must thoroughly evaluate all of this information in making the best possible regulatory and scientific decision for consumers.

EWG has specifically questioned the safety of oxybenzone. Oxybenzone is approved by FDA, the European Union and Canada as a safe and effective sunscreen ingredient. It has also been reviewed by the Cosmetic Ingredient Review (CIR) Expert Panel and determined to be safe for uses other than as a UV filter. These reviews have been based on the most current science available, conducted in a public forum and provide clear support for the safety of this important ingredient. EWG’s questions about the safety of oxybenzone lack the same level of rigor and reliability and unnecessarily alarm consumers.

The Personal Care Products Council has worked closely with FDA to ensure science-based regulations that protect consumers and ensure sunscreens are safe and effective. We have also joined with the American Academy of Dermatology, the Skin Cancer Foundation, 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 between 10:00 a.m. – 4 p.m. when exposure to UVA/UVB rays is the highest, wearing protective clothing, and using sunscreens.”

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