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The Council Calls for Greater FDA Role

July 16, 2010

Supports legislation to strengthen and modernize regulatory oversight.

In a groundbreaking initiative intended to enhance existing protections for millions of American consumers, the nation's cosmetics industry has announced plans to support legislation that would strengthen and modernize regulatory oversight of the industry and create a greater role for the U.S. Food and Drug Administration (FDA) in assessing ingredient safety for personal care products.

The proposal represents the culmination of more than three years of planning and research by the Personal Care Products Council (the Council), which has consistently advocated for more FDA funding to support additional regulatory oversight. The Council detailed its proposal in a letter to key health policy leaders in Congress. The proposal would enhance current FDA and industry safety initiatives.

The Council is seeking to create formal processes for 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 FDA under the Federal Food, Drug, and Cosmetic Act. Our products remain among the safest in the marketplace," said Lezlee Westine, the Council's president and chief executive officer. "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."

Westine emphasized the proactive nature of today's announcement, which is being made in the absence of any specific public health risk or legislative mandate involving personal care products, which remain safe to use. Rather, the industry is responding to American consumers who are requesting and deserving more transparency from government and industry while ensuring their ability to keep pace with continued demand for innovative products.

"From Wall Street to the Gulf of Mexico, we have seen what can happen when there is a breakdown in the relationship between government and the private sector," said Westine. "Our initiative recognizes the need to establish a more collaborative and constructive relationship with federal regulators."
Toward that end, the Council's five-point plan includes mandatory industry reporting and mandatory Good Manufacturing Practices, two provisions currently in HR 759, the Food and Drug Administration Globalization Act of 2009, introduced by Congressman John Dingell (D-MI), and three additional provisions that industry is seeking.

The Council plan includes:

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 aremanufactured.
• File with FDA product ingredient reports disclosing all of theingredients used in those products; and
• Report to FDA any serious unexpected adverse event with a personalcare product experienced by consumers.

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;

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;

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; and

FDA-Issued Good Manufacturing Practices. FDA would establish industry-wide "Good Manufacturing Practices" requirements.

"The current process has served the public well for decades, but the time has come for us to advocate for additional safeguards as science and technology evolve. Today's consumers have even higher expectations for the products they choose for themselves and the companies that provide them," said Westine. "Our companies commend Rep. Dingell for his ongoing work to better protect consumers and increase transparency. We look forward to working with the current and next Congress to ensure these changes are meaningful and attain the full force of federal law."