Council Responds to FDA Actions on Sunscreens

Council Responds to FDA Actions on Sunscreens

• With the Food and Drug Administration’s release of the Final Sunscreen Monograph this summer, Farah Ahmed, chair, Sunscreen Task Force, Personal Care Product Council, issued the following statement:

“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 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 US. This ruling will help further educate consumers about the importance of using sunscreens as part of an overall sun protection regimen.

“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.”

More info: www.CosmeticsInfo.org

Safe Cosmetic Act Re-Introduced in Congress

• It’s back! Lawmakers are calling for new regulations for the U.S. cosmetics industry. Recently, Reps. Jan Schakowsky, D-IL, Ed Markey, D-MA, and Tammy Baldwin, D-WI introduced the Safe Cosmetics Act to the House, which would give the FDA the power to regulate chemicals in cosmetics. The act would require that these companies phase out chemicals linked to cancer and birth defects, require complete ingredients lists and create health and safety standards for cosmetics.

“The growing number of reports of serious health problems arising from the use of dangerous chemicals in personal care products shows a need to update our laws and protect men, women, and children from harmful exposure,” said Rep. Schakowsky. “Currently, manufacturers are not required to disclose all their ingredients on labels, and the FDA has no power to supervise the use of toxic chemicals in cosmetics. Americans are left in the dark about harmful mystery ingredients in personal care products; consumers deserve confidence that the products that they use will not hurt them.”

Last year, the industry came together to successfully defeat the same bill.