Federal Legislative Advocacy
The Personal Care Products Council (PCPC) advocates for legislation rooted in sound science at the federal, state, and local levels on policies that ensure the safety, quality, and innovation of cosmetics and personal care products.
PCPC has championed Congressional funding for FDA’s Office of Cosmetics and Colors and modernizing FDA’s authority to regulate cosmetics.
PCPC’s Principles for Federal Cosmetics Reform
Personal care products sold in the United States are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act of 1938. Cosmetics have an excellent safety record because FDA and the personal care products industry continuously strive to ensure safety. However, because the key statutory provisions authorizing FDA regulation of these products have not been updated since the law was first enacted, PCPC supports modernizing the FD&C Act to ensure that FDA has the appropriate authority and resources to regulate cosmetic products in the 21st Century.
Despite a very strong safety record, a comprehensive national program is needed to assure uniform regulation of cosmetics throughout the country, in order to prevent an unworkable patchwork of differing state requirements across the nation. It is critical that federal regulation gives consumers confidence in the safety of their cosmetics products wherever they are sold.
PCPC has been working for many years with leaders in Congress on a bipartisan basis. Several proposals have emerged and been filed as legislation. As part of our ongoing commitment toward modernization, PCPC and its member companies support the following principles to guide bipartisan legislative action, many of which mirror protections applied to other FDA-regulated products.
National Program Uniformity: Preempt state and local laws that would duplicate new authorities in FDA regulation of cosmetics; Preempt state and local laws for all cosmetic ingredients based on human health concerns if FDA has reviewed the ingredient’s safety or has been presented with a safety review of the ingredient by the Cosmetic Ingredient Review Expert Panel (CIR) and, after a period for FDA review, has not rejected the CIR safety finding.
Mandatory Registration: Establish mandatory foreign and domestic manufacturing establishment registration and ingredient reporting by manufacturers for all cosmetic products sold in the United States
Adverse Event Reporting: Require mandatory reporting by manufacturers to FDA of serious and unexpected adverse health events experienced by a consumer from a cosmetic product marketed and used in the United States.
Good Manufacturing Practices: Authorize FDA to issue Good Manufacturing Practices for cosmetic products.
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 in which FDA has a reasonable belief that the product is adulterated or otherwise is likely to cause serious adverse health consequences.
FDA Cosmetic Ingredient Review: Create an FDA program authorized to review the safety of individual cosmetic ingredients and nonfunctional constituents found in cosmetics, in a timely manner and utilizing widely accepted scientific principles such as those reflected in the scientific reviews by the Cosmetic Ingredient Review Expert Panel and other scientifically based organizations.
Cosmetic Records Inspection: Allow FDA to inspect a manufacturer’s records if FDA has a reasonable belief that a cosmetic product presents a threat of serious adverse health consequences to humans.
Safety Substantiation: Require manufacturers to substantiate the safety of cosmetic products and ingredients, utilizing widely accepted scientific principles and established scientific ingredient reviews such as the Cosmetic Ingredient Review. Manufacturers may choose which FDA-accepted data to use.
Special Provisions for Small Businesses: Allow flexibility for small businesses, as defined by the Small Business Administration, to comply with certain requirements, including additional time to submit ingredient statements to FDA, simplified ingredient statements, additional FDA guidance on safety substantiation, and extended effective date for GMP compliance. Very small cosmetic manufacturers (those making less than $2 million in gross receipts annually in the U.S.) would be entirely exempted from any new requirements.
OTC and Cosmetic Regulation: Clarify that when a product falls under FDA’s cosmetic and OTC drug authorities, and the requirements conflict, the OTC drug requirements will apply.
Alternatives to Animal Testing: Encourage FDA approval of alternatives to animal testing.
Importation: Bar importation of cosmetics produced outside the U.S. where the manufacturing facility or ingredient statement has not been registered with FDA.