Regulations Sponsored by
The Personal Care Product's Council and the Safe Cosmetics Alliance have both announced their support for H.R. 4395, a bill introduced by Representative Leonard Lance (R-NJ) known as the Cosmetic Safety Amendments Act of 2012. This bill calls for the U.S. Food and Drug Administration (FDA) to have greater regulatory oversight over cosmetic regulation.
H.R. 4395, which builds upon portions of The FDA Globalization Act of 2008 as introduced by Congressman John Dingell (D-MI), calls for increased reporting and transparency by the industry and enhanced regulatory oversight without further straining taxpayer resources and damaging small and medium-sized businesses’ ability to compete globally and create new manufacturing jobs in the United States. The legislation aims to create formal processes for the FDA to review ingredients for safety, set safety levels for trace impurities, create national uniformity for cosmetics regulations, review all safety determinations made by the Cosmetic Ingredient Review (CIR) Expert Panel and establish industry-wide “Good Manufacturing Practices.” In addition, under the new legislation, the voluntary registration programs for facilities and products would become mandatory, as would the reporting of any serious and unexpected adverse events.
The FDA's Federal Food, Drug, and Cosmetic Act (FD&C Act) that currently regulates cosmetics in the United States requires that all cosmetics be substantiated for safety before they are marketed, contain no prohibited ingredients, and that all labeling and packaging be in compliance with US regulations. Under the FD&C Act, it is a crime to market an unsafe cosmetic product.
“Everyone agrees that we need to update the regulation of personal care products,” said Lance. “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 regulation requires cosmetics manufacturers who market their products in the United States to: 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. When requested or on its own initiative, FDA would be required to establish safe levels for trace constituents in cosmetic ingredients and products. 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. FDA would be required to review current and future findings on the safety of cosmetic ingredients by the CIR Expert Panel and determine if these findings are correct. If there are instances in which 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 would establish industry-wide “Good Manufacturing Practices” requirements. Finally, FDA’s new regulatory authority would preempt similar state legislation for cosmetics and personal care products.