Op-Ed by Lezlee Westine, President and CEO Personal Care Products Council, on Modernizing the FDA to Protect Cosmetics Users
This op-ed, authored by Lezlee Westine, President and CEO, Personal Care Products Council, originally appeared in RealClearPolicy on March 4, 2019.
Millions of American families use cosmetics and personal care products every day. From toothpaste, sunscreen and lipstick to deodorant, shampoo and moisturizer, these products are used to promote the beauty, health and well-being of consumers. We hold sacred the trust that families put in the safety and effectiveness of our products. That is why cosmetics and personal care product companies are committed to product safety and scientific innovation. We want families to have continued confidence in our products.
Decades of consumer experience with our products demonstrate they are among the safest product categories regulated by the U.S. Food & Drug Administration (FDA). FDA has clear authority — today — to regulate the safety of these products under the federal Food, Drug & Cosmetic Act, which requires companies to substantiate that every product and each individual ingredient is safe and that the label on the product is not misleading before the product is made available to consumers. It’s a company’s clear, legal responsibility to ensure that its products comply with the law and the current law provides penalties for manufacturers that do not meet these standards.
Nevertheless, we are working under a 20th century regulatory system for 21st century products. That doesn’t make sense.
The Personal Care Products Council (PCPC) and its member companies support modernizing the Food, Drug & Cosmetics Act to ensure FDA has the appropriate authority and resources to regulate cosmetic products in the 21st century. We believe well-crafted 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 sector. Our commitment to reform has not wavered, and we believe regulations should be based on the best available science and applied on a consistent basis nationwide to enhance our ability to innovate and further strengthen consumer confidence in the products they trust and enjoy every day.
Our member companies support a set of principles that guide our support of bipartisan legislation. These principles include:
- A science-based national regulatory system for cosmetics ensures safe products in the marketplace, eliminates consumer confusion, gives entrepreneurs greater certainty and makes it possible to innovate and create jobs.
- Legislation to modernize the FDA should create a program that authorizes FDA to review the safety of individual cosmetic ingredients. This will further strengthen consumer confidence.
- Manufacturers should be required to report to the FDA serious and unexpected adverse health events experienced by a consumer of cosmetic products.
- The FDA should have the authority to order a mandatory recall of a product if it is adulterated or causes serious adverse health consequences.
- Finally, small businesses must be given flexibility to meet the new reforms. These should 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.) should be entirely exempted from any new requirements. Small businesses are the backbone of our nation’s economy and a primary source for innovation. They should not be put under undue pressure that could jeopardize their business.
Regulators, legislators, nongovernmental organizations and industry are all on the same side when it comes to modernizing the FDA. We urge Congress to pass bipartisan legislation that meets our mutual goal — creating a regulatory system that advances safety, innovation and consumer confidence.