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Statement on the Safe Cosmetics and Personal Care Products Act of 2013 (H.R.1385) Introduced in Congress by Representatives Jan Schakowsky (D-IL) and Edward Markey (D-MA)
Submitted by Jennifer on April 9, 2013
For Immediate Release:
April 9, 2013
PAMELA BUSIEK STEVE SLEEPER LEZLEE WESTINE
President & CEO Executive Director President & CEO
Independent Cosmetic Manufacturers Professional Beauty Association Personal Care Products Council
“While we agree with Representatives Schakowsky and Markey that certain provisions of the Food, Drug and Cosmetic (FD&C) Act should be modernized to keep pace with evolving science and the growth of the personal care industry, we believe our industry’s approach as outlined below is practical and science-based. We are working with Members of Congress and the Food and Drug Administration (FDA) to propose changes to the law that will make meaningful enhancements to cosmetics regulation without overburdening FDA or imposing costly and unnecessary restrictions on American businesses.
“The safety of cosmetic and personal care products in the U.S. is overseen by FDA under the FD&C Act. The law requires that all cosmetics be substantiated for safety before they are marketed, contain no prohibited ingredients, and that all labeling and packaging must be in compliance with U.S. regulations. Under the FD&C Act, it is a federal crime to market an unsafe cosmetic product.
“Our goal is that an agreement on cosmetics legislation will be reached quickly with FDA and that legislation that enhances FDA’s regulatory authority can be passed on a bipartisan basis. We will continue to support Congress and FDA in their efforts. Consumers deserve a strong and sensible regulatory climate for the products that they and their families use and trust every day. We believe it is time to modernize the statute, passed more than 70 years ago, so the regulatory functions over cosmetics and personal care products keep pace with the changes in science and technology while providing the industry the ability to innovate and improve products and meet consumer demand.
“We believe the following measures would enhance FDA oversight and give the agency the information and flexibility it needs to continue to ensure consumer safety and safeguard public health:
(1) Enhanced FDA Registration. Require that personal care products manufacturers that 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.
• 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 by a consumer or other stakeholder, 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 FDA agrees with these findings. If there are instances in which it does not agree with a CIR ingredient review, 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.
“We believe our proposed measures would further enhance the effectiveness of the FDA cosmetic regulatory structure, and we look forward to continuing to work with Congress toward that goal.”
Personal Care Products Council
Professional Beauty Association (PBA)
Manufacturers and Distributors (ICMAD)