Statement by Iain Davies, PhD, Senior Environmental Scientist The Personal Care Products Council, In Response to Study on Sunscreens and Coral Reefs

“Benzophenone-3 (BP-3; oxybenzone) is an important sunscreen ingredient found in many personal care products and is designed to protect people against the damaging effects of ultraviolet (UV) light. In fact, according to the American Academy of Dermatology (AAD), oxybenzone is one of the few available sunscreen ingredients that effectively protect skin from both UVA and UVB rays that can contribute to skin cancer and premature skin aging.

“A study published recently in Archives of Environmental Contamination and Toxicology suggests that this common sunscreen ingredient could be harmful to coral and contributing to the decline of reefs around the world. This conclusion is based upon research conducted under laboratory conditions, which do not accurately reflect the complexity of the natural marine environment.

“Degradation of the world’s coral reefs is a serious concern. According to the U.S. National Oceanic and Atmospheric Administration’s (NOAA) Coral Reef Conservation Program, coral reefs are threatened by an increasing array of impacts – primarily from global climate change, unsustainable fishing and other factors. There is no scientific evidence that under naturally-occurring conditions, sunscreen ingredients, which have been safely used around the world for decades, are contributing to this issue.

“Our greatest concern is that this report may result in fewer people wearing sunscreens. In fact, a recent survey by the Centers for Disease Control and Prevention (CDC) published in the Journal of the American Academy of Dermatology found that approximately 43% of men and 27% of women never use sunscreen on their faces or other exposed skin. This is particularly concerning when we consider:

  • Every year, there are more than 63,000 new cases of melanoma, the deadliest form of skin cancer, resulting in nearly 9,000 deaths;
  • Skin cancer is the most commonly diagnosed cancer in the United States, with 5 million people treated each year;
  • More than 1 out of every 3 Americans reports getting sunburned each year. Sunburn is a clear sign of overexposure to the sun’s UV rays, a major cause of skin cancer – a single bad burn in childhood doubles the risk of developing melanoma later in life.

“We all can play an important role in the fight against skin cancer. In addition to FDA, the Centers for Disease Control and Prevention (CDC), the U.S. Surgeon General, AAD, the Skin Cancer Foundation and health care professionals worldwide all emphasize that using sunscreens is a critical part of a safe sun regimen. The dangers of unprotected sun exposure are clear and universally recognized by public health professionals and dermatologists.

“As sunscreen manufacturers, our goal is to provide Americans with access to a wide variety of safe, effective and innovative sunscreens to use as an important part of an overall sun safe regimen.”

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Statement by Farah K. Ahmed, Chair, Sunscreen Task Force, Personal Care Products Council in Response to the Environmental Working Group (EWG) 2015 Sunscreen Shopping Guide

“While the Environmental Working Group (EWG) 2015 Sunscreen Shopping Guide helps raise awareness of the dangers of sun exposure and the importance of using sunscreen to prevent skin cancer, it also contains false information, inaccuracies, and methodology flaws that ultimately render it misleading and potentially harmful to public health.  

“This year’s shopping guide contains little new information and is virtually identical to its 2014 and 2013 predecessors.  As in previous years, this year’s guide is not a scientific document, nor has it been peer reviewed or reviewed for accuracy by recognized sunscreen experts.  At best, it is an inaccurate document that should not be used to assess sunscreens or make shopping decisions.

“Our greatest concern is that the report is falsely alarming and may result in even more people avoiding the use of sunscreen on themselves or their children.  People are already not adequately protecting themselves from the sun. In fact, a recent Centers for Disease Control and Prevention (CDC) survey published in the Journal of the American Academy of Dermatology found that approximately 43% of men and 27% of women never use sunscreen on their faces or other exposed skin.  This is particularly concerning when we consider:

  • Every year, there are more than 63,000 new cases of melanoma, the deadliest form of skin cancer, resulting in nearly 9,000 deaths;
  • Skin cancer is the most commonly diagnosed cancer in the United States, with 5 MILLION PEOPLE treated each year;
  • More than 1 out of every 3 Americans reports getting sunburned each year. Sunburn is a clear sign of overexposure to the sun’s UV (ultraviolet) rays, a major cause of skin cancer – a single bad burn in childhood doubles the risk of developing melanoma later in life.

“In addition to FDA, the Centers for Disease Control and Prevention (CDC), the U.S. Surgeon General, the American Academy of Dermatology (AAD), the Skin Cancer Foundation and health care professionals worldwide all emphasize that using sunscreens is a critical part of a safe sun regimen.  The dangers of sun exposure are clear and universally recognized by public health professionals and dermatologists.

“As sunscreen manufactures, our goal is to provide Americans with access to a wide variety of safe, effective and innovative sunscreens to use as an important part of an overall sun safe regimen.”

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Statement by Farah K. Ahmed, Chair Sunscreen Task Force, Personal Care Products Council On Consumer Reports’ “5 Things You Must Know About Sunscreen”

“It is important to note that the U.S. Food & Drug Administration (FDA) regulates sunscreens as over-the-counter (OTC) drugs and requires rigorous testing for sunscreen effectiveness (both SPF and “Broad Spectrum”). Consumers can rest assured that this reliable and credible testing method results in sunscreens that are safe and effective in protecting them from harmful UV rays.  FDA’s sunscreen testing requirements are well recognized by experts and regulatory authorities in the U.S. as well as globally. It appears that Consumer Reports did not use FDA’s official sunscreen test method but rather used a different test not recognized by scientific experts.

“FDA requires a specific test for ‘Broad Spectrum’ that is very similar to the European standard.  However, the vast majority of sunscreens on the U.S. market that meet FDA’s “Broad Spectrum” test also meet Europe’s UVA test.

“It is inaccurate to suggest that natural sunscreens do not work as effectively as others.  The SPF and Broad Spectrum tests measure the level of sunscreen protection provided to consumers, regardless of whether that sunscreen is “natural,” “organic,” “green,” etc.  

“The Centers for Disease Control and Prevention (CDC), 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.

“Our goal is to help consumers make informed decisions and use sunscreen as an important part of an overall safe sun program.  Sunscreen is a crucial step in the fight against skin cancer and premature skin aging. It is our hope that using sunscreen becomes as much of a habit as putting on your seatbelt.  

“For more information on the importance of safe sun practices, please watch our Skin Smart educational video series.”

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Industry Veteran Elizabeth Anderson to Leave Position as General Counsel; Trade Association Promotes Thomas Myers to Top Legal Position

Elizabeth (Betsy) Anderson will be leaving her position as general counsel from the Personal Care Products Council, effective May 29. Anderson joined the association’s legal team in 1996, holding both assistant and associate general counsel positions before being promoted to general counsel in 2006.  

Throughout her tenure, Anderson has served as a trusted advisor to several CEOs and served as an important member of the executive leadership team, advocating on behalf of the cosmetics and personal care industry before federal and state regulators in the areas of OTC labeling, combination colors, sunscreens and antimicrobials. Her accomplishments include receiving the 2014 Distinguished Service & Leadership Award from the Food & Drug Law Institute (FDLI) as well as serving as Chair of FDLI’s Board of Directors.

“We very much appreciate Betsy’s leadership and commitment to the Council over the last 19 years,” said Lezlee Westine, President and CEO. “She has been an invaluable member of our executive leadership team and has helped the Council become one of the most effective trade associations in Washington. We will miss her greatly,” said Westine.

Succeeding Anderson as general counsel will be Thomas Myers, currently the organization’s associate general counsel.

Myers is currently responsible for handling legal and regulatory issues facing the cosmetics industry, particularly in the area of environmental law. Before joining the Council, Myers was Counsel at the U.S. Chamber of Commerce, and he has more than a decade of experience in private law practice, where he worked for the international law firms Jones Day and Greenberg Traurig.   

“I am confident that Tom will be an excellent addition to our executive leadership team,” said Westine. “He is a strong and experienced professional with sound judgement and an unwavering commitment to our industry.”

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Statement by Farah Ahmed, Chair, Sunscreen Committee Personal Care Products Council In Response to FDA Announcement on New Sunscreen Ingredient Applications

“We are very disappointed with the U.S. Food and Drug Administration’s (FDA) preliminary decision on the last two pending sunscreen ingredients, ecamsule and enzacamene.  On February 24, 2015, the Agency announced that it needed additional data before it could approve these ingredients – ingredients that have been approved and used safely by millions of consumers worldwide.

“Reducing the rate of skin cancer is a priority for personal care products companies.  Every day our industry’s research and development scientists strive to advance sunscreen formulation technology to create sunscreens that families enjoy and trust to help protect them against the harmful effects of the sun.  FDA must keep up with technology in order for us to offer Americans new and innovative sunscreens.

“The goal of the Sunscreen Innovation Act, passed in late 2014, is to modernize and streamline FDA’s process for reviewing sunscreen ingredients that have already been on the market in other countries for at least five years.  However, the manner in which FDA reviews sunscreen ingredient safety needs updating. FDA should use a state-of-the-art framework that is science-based, flexible to advances in toxicological and medical science, and used by regulators and authoritative scientific bodies around the world.

“Having a wide range of FDA approved sunscreen ingredients allows our industry to provide American families with a greater variety of safe and effective sunscreens.  We believe that this greater choice will encourage sunscreen use and further protect the public from the damaging effects of the sun, including premature skin aging and skin cancer.

“The Centers for Disease Control and Prevention (CDC), the American Academy of Dermatology (AAD), the Skin Cancer Foundation and health care professionals worldwide all emphasize that using sunscreens is a critical 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 in childhood doubles the risk of developing skin cancer later in life.

“Our goal is to provide Americans with access to a wide variety of safe and innovative sunscreens to use as an important part of an overall safe sun program.”  

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Statement by the Personal Care Products Council and the Consumer Healthcare Products Association on FDA Meeting to Discuss Science and Safety of Sunscreen Ingredients

“Today’s sunscreen ingredients have a wealth of data to support their safety.  The totality of this data includes pre-clinical and clinical results, and decades of post-marketing information.  Each of these pre-established and well recognized scientific principles help assure that sunscreens have a wide margin of safety.  This week’s meeting of the Food and Drug Administration Nonprescription Drugs Advisory Committee (NDAC) is an important extension of our ongoing work in sunscreen safety and draws attention to the fact that sunscreens play an essential role in the prevention of skin cancer for millions of American families.

“Having an array of safe and effective sunscreen ingredients allows sunscreen makers to formulate safe products that meet the differing needs of individuals and their families; while providing necessary protection against the damaging effects of the sun, including premature skin aging and skin cancer.  Ensuring that consumers continue to have access to a broad variety of approved sunscreen active ingredients is critical. If any of the currently available ingredients were taken away from the marketplace, the protection afforded by those available products would be adversely impacted.

“American families can be confident that sunscreen products, when used as part of an overall safe sun regimen, are safe and effective.  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.”

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Statement by Farah Ahmed, Chair, Sunscreen Committee Personal Care Products Council in Response to the Environmental Working Group (EWG) 2014 Sunscreen Report

“This year the Environmental Working Group (EWG) released its annual sunscreen report along with a sun safety campaign.  While there are several points in the campaign that we agree with – mainly, “[o]ur hope is that sun protection will become as much of a habit as putting on your seatbelt,”  we are disappointed that, despite the extensive and growing body of credible science demonstrating the safety, efficacy and health benefits of sunscreens, EWG continues to make false and misleading statements about sunscreen products and their ingredients.  Once again, EWG does not use formal, expert scientific evaluation in its report, and the report is not peer-reviewed. These confusing, unsubstantiated claims could actually discourage people from using sunscreen, putting themselves and their children at risk.

Sunscreen Sprays and Powders Are Safe

“The EWG campaign raises false concerns about the safety of sunscreen sprays and powders.  In its proposed rule, the Food & Drug Administration (FDA) simply requested further information on the unique spray dosage form and proposed a few labeling changes.  The Council and its member companies submitted significant data to address the Agency’s request. Scientists and dermatologists have expressed their support of sprays and powders and their desire to allow consumers access to these products.  Until FDA makes its final decision, these sprays and powders can remain on the market and provide consumers with additional sunscreen choices.

Daily Moisturizer with SPF is Effective

“Any product labeled with an SPF – whether a beach sunscreen, daily moisturizer, foundation, lip gloss, etc. – must meet the same rigorous SPF and “Broad Spectrum” testing and labeling requirements required by FDA.  EWG states that moisturizers (and other makeup) with sun protection factor (SPF) are somehow less effective. This is untrue and makes no sense. Providing a wide variety of sunscreen options is an effective way to encourage its daily use.

Super-High SPFs

“EWG’s super-high SPF discussion is completely inaccurate.  In fact, their lack of basic understanding of SPF is demonstrated in their assertion that SPF refers only to UVB protection.  These are the facts:

1)  An SPF number can account for up to 20 percent of UVA protection, especially in the higher SPF ranges.  FDA stated that the SPF test is accurate for high SPFs, specifically for SPFs through 50. The Agency was unclear about whether higher SPFs provide additional meaningful benefit.  This is reflected in the scientific community as experts are currently divided. We understand that FDA has received comments in support of, and opposed to, allowing for ultra high SPFs.  It is now up to FDA to make a determination, and once they do, the industry will certainly comply. Until then, ultra high SPFs will remain on the market for consumers who wish to use them.

2)  EWG states that European consumers can get “better” sunscreens, which is not true. U.S. sunscreen ingredients allow the formulation of products that meet all global standards for SPF and UVA, including European and Canadian criteria.  Europe allows for a greater variety of sunscreen ingredients, but this does not mean that they have “better” ingredients or product formulations, but rather, there are a greater variety of sunscreen ingredients and sunscreen formulations.  It is important to keep in mind that sunscreens in the U.S. are regulated as over-the-counter drugs and must pass the rigors of all applicable drug regulatory requirements. In Europe, sunscreens are regulated as cosmetics.

Oxybenzone, Vitamin A Safe, Used Globally

“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.  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.

“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.   EWG’s report claims that retinyl palmitate, or vitamin A, is unsafe for use in sunscreens, which contradicts scientific consensus.

Sunscreen Important Part of an Overall Safe Sun Routine

“The Centers for Disease Control and Prevention (CDC), 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.

“Our goal is to help consumers 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. Echoing the statement we made in 2013, our hope is that sun protection will become as much of a habit as putting on your seatbelt.  

“For more information on the importance of safe sun practices, please watch our Skin Smart educational video series.”

References:

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The Skin Cancer Foundation Honors Industry’s Commitment to Skin Cancer Education and Prevention–Personal Care Products Council Sunscreen Committee Receives Skin Sense Award for its Long Standing Work in the Fight against Skin Cancer

At its annual gala in New York City last night, The Skin Cancer Foundation honored the Personal Care Products Council’s Sunscreen Committee for its extensive work in educating the public on the importance of practicing a safe sun regimen, including daily use of sunscreens.  The World Health Organization and the Centers for Disease Control agree that skin cancer is the leading preventable cancer, and the Food and Drug Administration (FDA) has stated that proper sunscreen use is a crucial step in the fight against skin cancer and premature skin aging.

The PCPC Sunscreen Committee was recognized for its work on the Skin Smart TM educational video series that offers an in-depth look at the role sunscreens play as part of an overall safe sun routine, and specifically for their interpretation of FDA’s new sunscreen labeling guidelines that were announced in December 2012.

“Tonight we recognize members of the Personal Care Products Council’s Sunscreen Committee for supporting The Skin Cancer Foundation’s mission of decreasing the incidence of skin cancer through public awareness and education,” said Perry Robins, MD, President of The Skin Cancer Foundation, to an audience of approximately 400.

“It is a profound honor to accept this prestigious award on behalf of the Personal Care Products Council Sunscreen Committee.  The Committee’s goal is to ensure that sunscreen is treated in the same manner as seatbelts — put on automatically,” said Committee Chair Farah Ahmed, who accepted the award for the group.  “Our work, along with the Skin Cancer Foundation’s, is critical and we know it has already opened the eyes of many to the dangers of the sun,” said Ahmed.

“The Centers for Disease Control, 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.

“We look forward to building on the Foundation’s advocacy efforts to help make sun safety a daily priority for all,” said Ahmed.

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Personal Care Products Council Submits Public Comments on Reducing UV Exposure to the Centers for Disease Control and Prevention– Industry Remains Committed in its Fight Against Skin Cancer

On September 4, the Personal Care Products Council (the Council) submitted public comments to the Centers for Disease Control and Prevention (CDC) in response to the Agency’s request for information about reducing exposure to UV radiation in order to reduce skin cancer rates.

The Council’s efforts in providing scientific data to the U.S. Food and Drug Administration (FDA) on the safety and efficacy of sunscreens as well as educating Americans on a comprehensive safe sun regimen have been significant for more than 25 years.

“Individuals of all ages and skin tones should use sunscreen daily as part of an overall safe sun regimen to reduce the risk of UV damage, including premature skin aging and skin cancer,” said Farah Ahmed, Chair, Personal Care Products Council Sunscreen Committee.  “As we continue advocating for sound science, our industry looks forward to working with the CDC and the Surgeon General in the commitment to preventing skin cancer,” Ahmed said.

The Council’s activities on educating the public about the health benefits from daily sunscreen use include:

  • Provided volumes of scientific and technical data supporting sunscreen’s ability to reduce the risk of skin aging and skin cancer when used as part of an overall safe sun program.  For the first time in 2011, the U.S. Food and Drug Administration (FDA) permitted companies to communicate the skin cancer prevention benefits that these products provide.
  • Created a video series titled, Skin SmartTM to help educate the public about skin health and wellness.  The first episode of Skin Smart is meant to help consumers understand the new sunscreen labeling regulations that FDA released in 2011, as well as highlight the many forms that sunscreens take in every day personal care products.
  • Created a second Skin SmartTM episode to demonstrate how the sun’s rays can damage skin, 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.
  • Hosted a number of educational workshops with key opinion leaders from the dermatology community as well as sunscreen experts from industry to discuss and exchange important information regarding proper skin care, including regular use of sunscreens.  The workshops provide a forum for understanding sunscreens and sun protection from many different perspectives – photobiology, regulatory, cosmetic chemistry, clinical experience, etc.

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

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New Online Survey Conducted by Harris Interactive Shows Many Americans Uninformed About Anti-Aging and Year-Round Sun Protection Nearly 40 percent say sunscreen is used mainly on sunny days

As children return to school and memories of summer vacations fade, a new nationwide online survey conducted by Harris Interactive, Inc.1 shows that many Americans around the country are uninformed about sun protection, regardless of the season.  They also are unaware of the risks of sun exposure and who is at risk for sun damage. In fact, 90 percent of skin aging is caused by everyday sun exposure that occurs throughout the year, not just at the beach.

“The American public is still not in a place where they are sun smart every time they step out of their door,” said Farah K. Ahmed, Chair, Personal Care Products Council Sunscreen Committee.

Wear Sunscreen Every Day – Even When Cloudy

Nearly 2/5 (38 percent) of Americans say sunscreen is mainly for use on a sunny day.  However, according to the American Academy of Dermatology (AAD), even on cloudy days, up to 80 percent of the sun’s harmful UV rays can penetrate your skin and cause damage.  Since UV rays can be reflected off of water, sand, snow and concrete, the risk of sunburn can be high even if you are in the shade or when skiing on a cold, winter day.

Cloudy with a Chance of Wrinkles

Americans are unaware of the damage everyday sun exposure causes.  Two in five (40 percent) say the main risk of sun exposure is sunburn, and 45 percent think skin aging is mostly related to a person’s genetics.  However, extensive research demonstrates that it’s everyday sun exposure that contributes heavily towards:

  • Wrinkles
  • Fine lines
  • Sagging skin
  • Dull skin
  • Dehydrated skin
  • Age spots

In addition, sun exposure also contributes to:

  • Pre-cancerous (actinic keratosis) and cancerous (basal cell carcinoma, squamous cell carcinoma and melanoma) skin lesions – caused by loss of the skin’s immune function
  • Benign tumors
  • Telangiectasias — the dilation of small blood vessels under the skin

Everyone Is At Risk

One-third (33 percent) of Americans believe the darker a person’s skin, the less susceptible they are to sun damage.  According to the Centers for Disease Control and Prevention (CDC), everyone’s skin is damaged by UV exposure, but those with lighter skin types are more at risk for developing skin cancer.

“Unfortunately, the American public still has a long way to go before we treat sunscreen the way we treat seatbelts,” said Ahmed.  “Every time you step out of your door, you should automatically apply sunscreen – rain or shine, summer or winter – as well as wear protective clothing and seek shade whenever possible.”

According to the AAD and the Skin Cancer Foundation, some of the best ways to protect yourself from UV damage are to:

  • Seek shade when appropriate.  The sun’s rays are strongest between 10 a.m. and 2 p.m. If your shadow appears to be shorter than you are, seek shade.
  • Wear protective clothing, such as a long-sleeved shirt, pants, a wide-brimmed hat, and sunglasses.
  • Generously apply a broad-spectrum, water-resistant sunscreen with a Sun Protection Factor (SPF) of 30 or more to all exposed skin. “Broad-spectrum” provides protection from both ultraviolet A (UVA) and ultraviolet B (UVB) rays.
  • Use extra caution near water, snow, and sand because they reflect and intensify the damaging rays of the sun, which can increase your chances of sunburn.
  • Avoid tanning beds. Ultraviolet light from the sun and tanning beds can cause skin cancer and wrinkling. If you want to look tan, consider using a self-tanning product or spray, but continue to use sunscreen with it.

“Our goal is to help consumers make informed decisions, and use sunscreen as part of a daily safe sun regimen.  Sunscreen is a crucial step in the fight against premature skin aging, sunburn, and skin cancer,” said Ahmed. “Today, consumers can find sunscreen protection in a variety of products labeled with SPF, such as daily facial moisturizers, foundations, lipsticks, powders, etc.  Our hope is that sun protection will become as much of a habit as putting on your seatbelt,” said Ahmed.

[1]Nationwide online survey conducted among 2,010 U.S. adults ages 18 or older by Harris Interactive, Inc. on behalf of the Personal Care Products Council from August 14-16, 2013. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated.  For complete survey methodology, including weighting variables, please contact Lisa Powers (202-466-0489) or Hayley McConnell (202-454-0302).

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