WASHINGTON—New proposed legislation introduced by Rep. Leonard Lance (R-NJ)—the Cosmetic Safety Amendments Act of 2012, H.R. 4395, a move to modernize federal oversight of cosmetics and personal care products—is receiving major support from the cosmetic industry, including the Personal Care Products Council (PCPC) and the Safe Cosmetics Alliance.
“FDA regulation of cosmetics has protected the public for decades, and this landmark legislation will enhance protections for millions of American consumers," said Lezlee Westine, president and CEO, PCPC. “Cosmetics companies recognize the need for a modern regulatory process that keeps pace with product innovation, as well as the demand for transparency. The Council applauds Congressman Lance for introducing this bill and will work to help gain bipartisan support for its passage."
The cosmetic and personal care industry employs 8.2 million people, directly or indirectly, in the United States. The industry has an estimated $60 billion in annual American retail sales and is a net exporter. Small businesses with 50 or fewer employees make up 92 percent of the industry and women represent 66 percent of its workforce.
“Everyone agrees we need to update the regulation of personal care products," Rep. Lance said. “This bill will continue to advance consumer safety and provide a regulatory framework that furthers growth and innovation for American cosmetics manufacturers and small businesses."
The new legislation proposes the following changes to the current law:
- Enhanced FDA Registration. It requires personal care products manufacturers who market their products in the United States comply with the following: Register all facilities where those products are manufactured; file product ingredient reports disclosing ingredients used, consistent with current guidelines; and report any serious unexpected adverse event with a product experienced by a consumer.
- 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 determines review is warranted, the agency would be required to make a determination about the safety of any ingredient intended for use in a personal care product and set safe 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 Cosmetic Ingredient Review (CIR) Expert Panel and determine if these findings are correct. If there are instances it determines a CIR finding is unsupported, FDA would determine by guidance or regulations if, or under what conditions, the ingredient can be used safely in cosmetic products.
- FDA-Issued Good Manufacturing Practices. FDA would establish industry-wide GMP (good manufacturing practices) requirements.
- National Uniformity. FDA’s new regulatory authority would preempt similar state legislation for cosmetics and personal care products.
To read more about the discussion of furthered FDA oversight and modernized regulations, click here.
