The Federal Drug Administration is making headlines with the launch of their groundbreaking survey to review the safety practices and manufacturing standards of the cosmetics industry. The intention of the survey is to create a “systematic and detailed study” of current personal care manufacturing practices and processes.
A survey like this has never been conducted by the FDA before.
The FDA first announced plans for the survey in early July. The survey is voluntary, and according to the National Law Review, will collect a wide range of data about cosmetic companies including:
- Company production and volume, approximate revenue, company size.
- Data on written procedures and documentation relating to manufacturing, processing, maintenance, and training.
- Buildings and equipment management, including cleanliness, sanitation, pest control practices, and equipment maintenance.
- Materials and manufacturing, including inventory management and standard operating procedures; and quality control/product testing, including scope, quality testing.
- Rejected products or complaint response, and other corrective actions.
Currently, federal regulation for the cosmetics industry is limited to the 1938 Federal Food, Drug and Cosmetic Act. As of now, the FDA cannot recall cosmetic products with hazardous chemicals (recalls are voluntary) and does not need to approve any beauty product (with the exception of color additives) before the product hits the general market.
Acting in response to public concerns?
The FDA’s cosmetic industry survey announcement comes on the heels of the much publicized and bipartisan Personal Care Products Safety Act, introduced by California Democratic Senator Dianne Feinstein and Maine Republican Senator Susan Collins in May of 2017. The FDA Cosmetic Safety and Modernization Act, another regulatory bill, was proposed by Utah Republican Senator Orrin Hatch in October of 2017.
“There is no other class of products so widely used in the United States with so little regulation,” wrote Senator Feinstein and Senator Collins about the need for increased personal care industry regulation, in their article published in the Journal of the American Medical Association in February of 2018.
“Much of the change that we have seen is based on EU legislation, largely because Europe was the first region to have reasonably well thought-through, logical legislation for cosmetics.”
Dr. John Humphreys
Procter and Gamble
Both the Feinstein-Collins and Hatch proposed regulation bills would mandate registration of cosmetic facilities, enforce mandatory reporting, and create ingredient reviews by the FDA. However, only the Personal Care Products Safety Act has been endorsed by the American Cancer Society and personal care behemoths like L’Oréal, Johnson & Johnson, Procter and Gamble, Estée Lauder, The Honest Company, and Unilever.
Many link the launch of the FDA’s survey to growing public concerns about recent cosmetic product complaints and recalls. One of the top personal care product concerns? The 2016 FDA investigation of Guthy-Renker LLC, the company behind the WEN by Chaz Dean hair care line.
The company received more than 21,000 consumer complaints about hair loss, hair breakage, balding, itching, and rashes, which the FDA learned of after inspecting the company’s plant. However, despite the FDA investigation and a $26 million USD class action lawsuit, the WEN hair care line continues to be sold through QVC.
Influenced by the E.U.?
Increased industry regulation is also tied to the European Union’s example, which is currently leading the charge on cosmetovigilance, or the increasing regulatory standards for cosmetics. Currently, the E.U. has banned 1,328 chemicals from cosmetics and created required premarket safety assessments, mandatory registration, and government authorization for the use of materials in cosmetics.
“Much of the change that we have seen is based on EU legislation, largely because Europe was the first region to have reasonably well thought-through, logical legislation for cosmetics,” said Dr. John Humphreys of Procter and Gamble in an interview with Chemical Watch about potential new regulatory cosmetic measures and standards.
Cosmetic regulation has become a hot topic as of late, and as consumer demand for personal care, cosmetic, and beauty products grows, the increased focus of the federal government on industry regulation looms as becoming only more intense for manufacturers and formulators alike.
Public comment on the FDA’s cosmetic industry survey will be open until August 31, 2018.
