PCPC Supports FDA Modernization
Lezlee Westine
President & CEO
Personal Care Products Council
The Personal Care Products Council (PCPC) and its member companies support modernizing the Food, Drug & Cosmetics Act to ensure the U.S. Food and Drug Administration (FDA) has the appropriate authority and resources to regulate cosmetic products in the 21st century.
Decades of consumer experience with our products demonstrate they are among the safest product categories regulated by the FDA. Nevertheless, we believe well-crafted, science-based reforms will support the industry’s ability to innovate and further strengthen consumer confidence in our products.
For more than a decade, PCPC and its member companies have worked with a bipartisan group of leaders in Congress and a diverse group of interested parties to create a more contemporary regulatory system for the cosmetics and personal care sectors.
We believe a comprehensive national program, based on the best available science, is needed to ensure uniform regulation of cosmetics throughout the country, in order to prevent an unworkable patchwork of differing state requirements across the nation.
Our member companies endorse a set of reform principles, including:
Mandatory Registration: Establish mandatory foreign and domestic manufacturing registration and ingredient reporting by manufacturers for all cosmetic products sold in the U.S.;
Adverse Event Reporting: Require mandatory reporting by manufacturers to FDA of serious and unexpected adverse health events from a cosmetic product marketed and used in the U.S.;
Mandatory Recall: Provide FDA authority to order a mandatory recall of a product if a manufacturer refuses to comply with an FDA request for a voluntary recall;
FDA Cosmetic Ingredient Review: Create an FDA program authorized to review the safety of individual cosmetic ingredients and nonfunctional constituents;
Cosmetic Records Inspection: Allow FDA to inspect a manufacturer’s records if FDA has a reasonable belief that a cosmetic product presents a health threat;
Safety Substantiation: Require manufacturers to substantiate the safety of cosmetic products and ingredients;
Alternatives to Animal Testing: Encourage FDA approval of alternatives to animal testing;
National Program Uniformity: Preempt state and local laws that would duplicate new authorities in FDA regulation of cosmetics; and
Importation: Bar importation of cosmetics produced outside the U.S. where the manufacturing facility or ingredient statement has not been registered with FDA.
Regulators, legislators, nongovernmental organizations, and industry are all on the same side when it comes to modernizing the FDA.
As different approaches are considered, we look forward to continuing to work with partners in the NGO community and leaders in Congress, including Senators Feinstein and Collins, Chairman Alexander, Ranking Member Murray, Chairman Pallone, and Rep. Shimkus, to create a more contemporary regulatory system for the personal care products sector—one that supports FDA’s public health mission, advances safety, innovation, and consumer confidence.