Personal Care Products Council supports expanded FDA role in industry oversight

WASHINGTON The Personal Care Products Council announced on July 15 that it is calling for a greater role by the Food and Drug Administration in regulatory oversight of personal care products and assessing ingredient safety.

The announcement came less than a week before the introduction of the Safe Cosmetics Act of 2010 in Congress by Reps. Jan Schakowsky, D-Ill., Ed Markey, D-Mass., and Tammy Baldwin, D-Wis.

The proposal by the Council represents the culmination of more than three years of planning and research by the cosmetics industry trade group. The Council detailed its proposal in a letter to health policy leaders in Congress.

The Council is seeking to create formal processes for the FDA to review ingredients for safety at the request of the public and stakeholder groups and to review all safety determinations made by the Cosmetic Ingredient Review (CIR) Expert Panel. No such FDA processes currently exist.

"For decades, the industry has had an impeccable safety record under the existing requirements implemented by the FDA under the Federal Food, Drug, and Cosmetic Act. Our products remain among the safest in the marketplace," stated Lezlee Westine, the Council's president and CEO. "Nonetheless, we believe it is time to develop a more contemporary approach that includes a greater federal regulatory role. In fact, for the last 30 years, we have aggressively implemented numerous safety initiatives and processes to strengthen industry safety practices. Our consumers deserve multiple layers of protection and transparency."

The Council's five-point plan includes mandatory industry reporting and mandatory Good Manufacturing Practices, two provisions currently in HR 759, the FDA Globalization Act of 2009, introduced by Congressman John Dingell, D-Mich., and three additional provisions that industry is seeking.  The Council plan includes:

(1) Enhanced FDA Registration. It requires that personal care products manufacturers who market their products in the United States comply with the following:

• Register with FDA all facilities where those products are manufactured.


• File with FDA product ingredient reports disclosing all of the ingredients used in those products; and


• Report to FDA any serious unexpected adverse event with a personal care product experienced by consumers.

(2) New Process to Set Safety Levels for Trace Constituents. When requested or on its own initiative, FDA would be required to establish safe levels for trace constituents in cosmetic ingredients and products;   (3) New FDA Ingredient Review Process.  Once a request has been made, or FDA unilaterally determines action is warranted, the agency would be required to review the safety of any ingredient intended for use in a personal care product and set safety use levels for such ingredient on a specified timetable;   (4) New FDA Oversight of CIR Findings.  FDA would be required to review current and future findings on the safety of cosmetic ingredients by the Cosmetic Ingredient Review (CIR) Expert Panel and determine if these findings are correct.  If there are instances in which it determines a CIR finding is not correct, FDA would determine by guidance or regulations if, or under what conditions, the ingredient can be used safely in personal care products;   (5) FDA-Issued Good Manufacturing Practices.  FDA would establish industry-wide "Good Manufacturing Practices" requirements.

As mentioned earlier, the move came days prior to the July 21 introduction of the Safe Cosmetics Act of 2010 (HR 5786) in Congress, which, in a similar vein, aims to give the FDA authority to ensure that personal care products are free of harmful ingredients.

According to the Campaign for Safe Cosmetics, major provisions of this proposed legislation would:

• Phase out ingredients linked to cancer, birth defects and developmental harm


• Create a health-based safety standard that includes protections for children, the elderly, workers and other vulnerable populations


• Requiring full ingredient disclosure, including the constituent ingredients of fragrance and salon products, on product labels and company websites


• Give workers access to information about unsafe chemicals in personal care products


• Require data sharing to avoid duplicative testing and encourage the development of alternatives to animal testing


• Provide adequate funding the FDA Office of Cosmetics and Colors so it has the resources to provide effective oversight


• Level the playing field for small businesses.