Statement By Lezlee Westine President And CEO Of The Personal Care Products Council In Response To The Safe Cosmetics Act of 2011 Introduced Today In Congress By Representatives Jan Schakowsky (D-IL), Edward Markey (D-MA) And Tammy Baldwin (D-WI)

“We agree with Reps. Schakowsky, Markey and Baldwin about the need for certain provisions of the U.S. Food, Drug and Cosmetic Act to be modernized in order to keep pace with evolving science and the growth of our industry.  To that end, we are working with the House Energy & Commerce Committee leadership to propose reasonable, science-based changes to the law that will meaningfully enhance cosmetics regulation without over burdening FDA or imposing costly and unnecessary restrictions on business.  

“We are committed to working with the Committee leadership to enhance FDA oversight and give the agency the information and flexibility it needs to continue to ensure consumer safety and safeguard public health.  Last July, our industry was the first to propose such legislation, which would also provide the business certainty companies need to continue to innovate, grow and create new manufacturing jobs in the U.S.

“We are still reviewing the provisions of Rep. Schakowsky’s new bill, but we are very concerned that, as written, it contains provisions that will place unnecessary burdens on FDA and businesses of all sizes and may compromise jobs without providing meaningful benefits to consumers.

“Strong federal safety requirements already govern cosmetics and personal care products sold in the U.S. The safety of cosmetic and personal care products in the U.S. is overseen by the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which requires that all cosmetics be substantiated for safety before they are marketed, contain no prohibited ingredients, and that all labeling and packaging be in compliance with U.S. regulations. Under the FD&C Act it is a crime to market an unsafe cosmetic product.”

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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.

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“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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Council Appoints Halyna Breslawec New Chief Scientist

The Personal Care Products Council (the Council) announced today that Halyna Breslawec, Ph.D., will become the organization’s chief scientist, replacing John Bailey, Ph.D., who officially retires on July 29 after nine years of service.  In her new role, Breslawec will oversee the Council’s scientific programs, technical committees and publications and will serve as the industry’s scientific liaison for several domestic and international organizations.

“Halyna’s scientific credentials and background are impressive, and we are so pleased that she will soon be managing our scientific programs,” said Lezlee Westine, Council President & CEO.  “She brings a great scientific foundation and proven leadership skills to the Council and will be a wonderful asset in her work on behalf of an industry that is committed to product safety, quality, and innovation.”

Breslawec worked at the U.S. Food and Drug Administration (FDA) for more than 14 years in numerous leadership roles directing the review and approval of medical devices at both the office and division levels.  She assessed clinical trials as well as the organization and structure of operational units at the Center for Devices and Radiological Health. While working in the FDA Commissioner’s office Breslawec also developed a program to implement FDA’s human subject protection regulations for the clinical and academic communities.

Breslawec currently serves as Deputy Director for the Cosmetic Ingredient Review (CIR), an independent, non-profit panel of scientific and medical experts that assesses the safety of cosmetic ingredients used in the U.S.  She is responsible for planning and executing CIR activities while serving as liaison between the expert panel and the CIR professional staff.

Prior to joining CIR, Breslawec worked as a consultant where she was a recognized expert in FDA regulation.  She helped medical device companies develop regulatory policies, evaluated clinical trials and prepared medical device applications for FDA submission.    

She earned a Ph.D. in pharmacognosy (medicinal chemistry) and a B.S. in biochemistry from the University of Minnesota.

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