Statement by Lezlee Westine, President and CEO Personal Care Products Council In Response to JAMA Opinion Piece, “Cosmetics, Regulations and the Public Health”


Washington, D.C.—“We appreciate Dr. Califf and his colleagues’ perspectives on the safety and regulation of personal care products by the U.S. Food and Drug Administration (FDA) and agree that regulation of cosmetics needs to be modernized.  We need to address some critical points about the safety of our products and the industry’s support for regulatory reform.

“Consumer safety is a top priority for cosmetic and personal care products companies, with careful and thorough scientific research and development serving as the foundation for everything we do.  Decades of consumer experience with our products demonstrate that they are one of the safest product categories regulated by the FDA. We take very seriously our responsibility for the safety of our products and those who trust and enjoy them.  

“Despite the very strong safety record of cosmetic products, the Council and its member companies believe more can be done to ensure that FDA has the appropriate authority and resources to regulate our products in the 21st century.  For nearly a decade, we have worked with a bipartisan group of leaders in Congress and a diverse group of interested parties to modernize federal regulatory oversight for cosmetics. For the past 25 years, the Council has advocated for increased FDA funding to ensure the Agency has the resources needed to regulate our industry.  That strong commitment has not waivered.

“As part of our ongoing commitment toward regulatory reform, our industry adopted a set of legislative principles to help guide bipartisan legislative action.  We have advocated for required reporting by manufacturers to FDA of serious and unexpected adverse health events. We also support mandatory registration with FDA of manufacturing facilities and ingredient statements; authorizing FDA to issue Good Manufacturing Practices for cosmetics; and creating a program for FDA to review the safety of cosmetic ingredients, among other things.

“Under the current regulatory system, companies conduct product safety evaluations using the same science-based approaches embedded in the research practices at FDA, the Environmental Protection Agency (EPA) and other regulatory agencies around the world.  Cosmetic safety assessments are thorough and address numerous health questions, including, but not limited to, the potential for cancer, reproductive harm, allergic reactions, and how an ingredient is cleared if it goes through the body.

“The industry employs nearly 6,000 scientific and technical professionals dedicated to ensuring product and ingredient safety.  Companies also work with a number of scientific and medical experts—chemists, toxicologists, microbiologists, dermatologists, epidemiologists, environmental scientists and other technical experts—to evaluate and ensure the safety of their products before they reach the consumer.  

“The Personal Care Products Council is steadfastly committed to public health and consumer safety.  It is time for Congress to step in and create a more modernized regulatory system for the personal care products sector – a system that advances safety, innovation and consumer confidence.”  

Testimony of Francine Lamoriello, Executive Vice President, Global Strategies, Personal Care Products Council at US Trade Representative Hearing – Negotiating Objectives Regarding Modernization of NAFTA


Good Afternoon. On behalf of the U.S. Personal Care Products Council, I am pleased to be here today to discuss our industry’s objectives for the renegotiation of NAFTA.

The Personal Care Products Council is the leading national trade association representing the global cosmetic and personal care products industry. Founded in 1894, our more than 600 member companies manufacture, distribute, and supply the vast majority of finished personal care products marketed in the United States. Our members continually strive to uphold and surpass the most stringent regulatory and product integrity standards worldwide.

Over the past two decades, NAFTA has contributed significantly to the ability of our member companies to expand manufacturing and employment here at home, and to achieve scientific and technological innovations that benefit consumers worldwide.

International trade is a critical component to the success of our industry. In 2016, the U.S. personal care products industry exported over $12 billion to the world. And, more relevant to today’s discussion, our exports to Mexico and Canada made up over 30% of our global exports, reaching $3.7 billion.

The strong export performance of the U.S. cosmetic and personal care industry reflects preference and loyalty to our brands by consumers in North America and, indeed, around the world. And, in developing the exciting, innovative products that consumers love, our member companies must think globally: searching worldwide for ingredients that offer unique quality and performance characteristics; special designs and packaging that support the brand’s image and fashions of the day; and services, such as marketing and advertising, that allow us to promote our products on the ground. Canada and Mexico are not only important markets for U.S. products, but are also important sources of our products’ components and services.

Thus, our industry firmly supports free trade in North America. Preserving and expanding the benefits that our industry has already experienced under NAFTA will be critical in any future negotiation. NAFTA must remain a trilateral agreement. Customs benefits and rules of origin criteria and zero tariff rates for our products and raw materials must be retained, and our companies must be able to move our products efficiently throughout the North American region.

Beyond retaining the commercial and economic benefits already achieved, the U.S. cosmetic and personal care products industry supports an ambitious agenda for “NAFTA 2.0” that eliminates remaining trade and regulatory barriers and also sets additional commitments to international best regulatory practices.

In particular, the re-negotiation of NAFTA offers an opportunity to deepen the commitment of NAFTA partners to comprehensive regulatory convergence in the cosmetics sector.

The goal of comprehensive cosmetic regulatory convergence with Canada and Mexico would significantly reduce industry costs related to product formulation, marketing, labeling, and supply chain management; would avoid unnecessary duplication, and would facilitate market access and trade, especially for small and medium-sized companies. Consumers would enjoy access to a wider array of safe and effective products at more competitive prices, and regulators would be positioned to conserve resources for product categories that may pose greater risks to public health and safety.

We believe the goal of comprehensive cosmetics regulatory convergence throughout the NAFTA region can best be achieved by including in NAFTA 2.0 a sector-specific Annex that would confirm regulatory good practice for cosmetics products, allow for deeper regulatory convergence for the cosmetics sector in North America, and encourage the wider goal of global regulatory convergence.

A NAFTA Cosmetic Annex should include commitments to a risk-based regulatory approach that recognizes that cosmetic products pose minimal potential risk to human health and safety; Should eliminate burdensome registration and testing requirements that are not in keeping with international best practices; and, should align labeling requirements wherever possible, in particular with respect to ingredient labeling, which should be fully harmonized based on the International Nomenclature of Cosmetic Ingredients (INCI).

We have detailed these and other aspects of a NAFTA Cosmetics Annex in our written submission. I would like to point out that our objectives for a NAFTA Cosmetics Annex go beyond what was achieved in the TPP Agreement. In our view, the modern and robust regulatory systems already in place in the United States, Canada and Mexico should provide the basis for trust and confidence that will allow regulators to pursue broader and deeper alignment.

This will be particularly important in considering ways in which Canada and the United States can better align their regulatory practices for over- the-Counter (OTC)-type cosmetics (Mexico does not recognize this category of products).

U.S.-Canada trade in OTC products, such as sunscreens, antiperspirants, antiseptic cleansers and others, is very significant.

We believe that NAFTA should include commitments by the U.S. and Canada to take steps such as aligning requirements for good manufacturing practices; allowing for mutual acceptance of products compliance with either system’s requirements; eliminating redundant inspection procedures; and harmonizing recognized test methods.

Measures such as these would recognize the fundamentally similar regulatory approach already being followed for these products by the U.S. FDA and Health Canada, and would reduce administrative burdens and costs for the two regulators as well as for industry.

The U.S. Personal Care Products Council is working closely with our sister associations in Canada and Mexico to support the renegotiation of NAFTA, and we are in agreement on all of the objectives I’ve described.

In short, we believe strongly that an updated NAFTA can advance our goals of providing global consumers with safe, innovative products and expanding international trade and economic growth.

Once again, we appreciate this opportunity to present the views of our industry and would be pleased to respond to any questions.

Thank you.

Global Cosmetics and Personal Care Industry Addresses Plastic Pollution in Oceans


“The global cosmetics and personal care products industry has a strong and longstanding commitment to protecting the environment and we actively support the ongoing, concerted efforts by industry, governments, multinational entities and NGOs to identify and target sources of plastic ocean debris.

“We believe that efforts towards protecting the environment matter.  Our industry led the way by taking action to phase out plastic microbeads from cleansing and exfoliating wash-off products despite scientific research having shown that these ingredients in our products are not a significant contributor to marine pollution.

“We are disappointed that the U.N. Environment Programme’s (UNEP) Clean Seas campaign inaccurately overstates the contribution of cosmetics and personal care products to microplastic marine litter.  Further, we are disappointed that the UNEP initiative does not recognize the significant efforts already taken by our industry.

“A number of studies by independent researchers from around the world have pointed to the leading sources of plastic pollution at both the “macro” and “micro” levels – discarded bags and other plastic packaging, particles from vehicle tires washed off roads, and synthetic fibers from textiles, among other sources.  These studies, including UNEP’s research, have concluded that ingredients in cosmetics and personal care products, such as plastic microbeads, make up only the tiniest fraction of plastic pollution in aquatic environments. For example, UNEP’s 2016 report, Marine Plastics Debris and Microplastics, concluded that, ‘Although the use of microplastics in [personal care products] may appear to represent a significant source, it is relatively small compared with other sources…’

“In addition, recent studies have found that wastewater treatment facilities remove up to 99 percent of all solid plastic particles, whatever their source1.

“We sincerely hope the Clean Seas initiative will follow the science to the true sources and impacts of plastic debris, and find real solutions that will benefit our environment and all those who depend on it.  We look forward to serving as a resource for UNEP’s continued work.”