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government-trade

Debate Over Cosmetics Regulation in House

House lawmakers and industry officials aired competing views over the need to modernize the FDA and strengthen federal regulations.

WASHINGTON — House lawmakers and cosmetics industry officials aired competing views over the need to modernize the Food and Drug Administration and strengthen federal cosmetics regulations at a House hearing Tuesday.

An FDA official argued the case for new authority and industry user fees while cosmetics executives defended the industry’s dedication to scientific safety testing and warned against overly burdensome state and federal regulations. The House Committee on Energy and Commerce’s subcommittee on health hearing focused on several proposals to modernize the FDA, including whether it should be given authority to require mandatory registration of companies and ingredients, charge user fees, issue mandatory recalls and require companies to report adverse impacts. It also focused on the need for a national standard for the regulation of cosmetics and ingredients to replace a patchwork of state laws that businesses say make it difficult to sell their products across state lines.

“Unlike other products regulated by the FDA, such as drugs and medical devices…most cosmetic product ingredients are not subject to FDA premarket approval,” said Rep. Joe Pitts (R., Pa.), chairman of the subcommittee. “Instead, cosmetics manufacturers are largely responsible for substantiating the safety of their product ingredients before they go to market. Currently, cosmetics facilities can register with FDA on a voluntary basis but FDA cannot compel them to do so.”

Michael M. Landa, director of the FDA’s Center for Food Safety and Applied Nutrition, said the agency faces challenges from an increasingly global marketplace and from rapid changes in the cosmetics industry relating to the use of more sophisticated technologies that has lead to more complex ingredients. More than eight billion personal care products, which include primarily cosmetics but also some over the counter drugs, are sold annually in the U.S., Landa said. Estimates of annual U.S. sales of the products range from $54 billion to more than $60 billion.

President Obama’s fiscal year 2013 budget proposal requested new legislative authority for the FDA to require domestic and foreign cosmetics manufacturers to register with the agency and pay an annual registration fee estimated to generate $19 million in new resources. Congress would have to approve such a provision in its budget. Nearly 1,600 domestic and foreign cosmetics companies have voluntarily registered with the FDA and more than 39,000 cosmetics product ingredient statements have been filed, but it only covers a fraction of the manufacturers, he said.

“We estimate that only one-third of cosmetics manufacturers voluntarily file cosmetic product ingredient statements for their products with FDA,” Landa said. “Overall, the new authority for registration and user fees would strengthen FDA’s ability to protect American consumers from potentially unsafe cosmetic products or ingredients.”

Halyna Breslawec, chief scientist and executive vice president for science for the Personal Care Products Council, told lawmakers that a modernized regulatory structure for cosmetics should be “comprehensive and robust, but should not be so overly burdensome that it stifles or prevents companies from delivering innovative products to the marketplace.”

She said the cosmetics industry in the U.S. invests more than $3.6 billion each year on scientific research and development.

“As a result of this research, 2,000 new products are launched each year, and numerous scientific studies are published on enhancing or developing new safety methods,” she said.