On March 27, the House Energy and Commerce Subcommittee on Health held a hearing, “Examining the Current State of Cosmetics.” The hearing focused on the regulatory authority of the Food and Drug Administration (FDA) over the cosmetics industry. As the industry faces new challenges with technology, globalization, and product safety, the hearing addressed implications of legislation that would increase FDA regulation.
In his opening statement, Chair Joe Pitts (R-PA), said, “Cosmetics are regulated by FDA under the Federal Food, Drug, and Cosmetic Act [(FFDCA) P.L. 75-717] of 1938. The FFDCA forbids the introduction of adulterated or misbranded cosmetics into interstate commerce and provides for seizure, criminal penalties, and other enforcement authorities for violations of the act. The Fair Packaging and Labeling Act [P.L. 89-755] also requires cosmetics to carry an ingredient declaration to help consumers make informed purchasing decisions. Unlike other products regulated by FDA, however, such as drugs, medical devices, and biologics, most cosmetic products and ingredients are not subject to FDA premarket approval. Instead, cosmetic manufacturers are largely responsible for substantiating the safety of their products and ingredients before they go to market. Currently, cosmetic facilities can register with FDA on a voluntary basis, but FDA cannot compel them to do so. While FDA has the authority under FFDCA to enter and inspect cosmetic manufacturing facilities, the industry does not pay user fees for this purpose…For the past several years, the industry and members of both parties have been reviewing FDA’s regulatory authority over these products. One issue under review is the need for a national uniform standard for cosmetic products and preemption of state legislation.”
Addressing concern over the safety of cosmetic products in her opening statement, Rep. Jan Schakowsky (D-IL), said, “The fact is this: cosmetics contain ingredients that can cause cancer, mutate cellular structure, and cause reproductive and developmental harm. Industry claims that these ingredients are present at such low doses that they aren’t a problem, but men, women, and children are exposed every day to dozens or hundreds of ingredients in their shampoos, cologne, makeup, lotions, and other products. We have to consider the cumulative effect of exposure. Any bill this committee considers must include – as the Schakowsky/Markey/Baldwin Safe Cosmetics Act [H.R. 2359] does – the following elements: 1) A strong safety standard that bans carcinogens, mutagens, and reproductive toxins; 2) Full ingredient disclosure and labeling. Consumers have a right to know what is in their products; and 3) Mandatory recall authority for the FDA. I think today’s testimony will underscore the need for these provisions, as well as the complexity of this industry and the need for thorough consideration of any legislation making changes to cosmetics regulations.”
Michael Landa, director of the Center for Food Safety and Applied Nutrition at the FDA, said, “The FFDCA defines a cosmetic as an ‘article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting effectiveness, or altering the appearance.’ The definition also includes articles intended for use as a component of any such articles. Cosmetics firms are responsible for substantiating the safety of their products and ingredients before marketing. However, they are not required to submit safety substantiation data to the agency, nor make it available to the agency. Under FFDCA, cosmetic products and ingredients (with the exception of color additives) are not subject to FDA premarket approval or premarket notification.” He continued, “[T]he FY2013 president’s budget request includes new legislative authority for FDA to require domestic and foreign cosmetics manufacturers to register with FDA and pay an annual registration fee. The user fees would support FDA’s cosmetics safety and other cosmetics-related responsibilities and are estimated to generate $19 million in new resources. The product, ingredient, and facility information submitted with registration would expand FDA’s information about the industry and better enable the agency to develop necessary guidance and safety standards. It would also enable the agency to identify and address research gaps, for example, about the safety of novel ingredients. With these additional funding resources, FDA would be able to conduct priority activities that meet public health and industry goals…Overall, the new authority for registration and user fees would strengthen FDA’s ability to protect American consumers from potentially unsafe cosmetic products or ingredients.”
Speaking on behalf of the Personal Care Products Council,Halyna Breslawec, chief scientist and executive vice president for science at the council, said, “Cosmetics are among the safest category of products regulated by the FDA. The safety of our consumers and their families is always the number one priority for our industry. Careful and thorough scientific research and development are the most important aspects of cosmetic formulation and the foundation for everything that we do. The American cosmetics industry invests more than $3.6 billion each year on scientific research and development. As a result of this research, 2,000 new products are launched each year, and numerous scientific studies are published on enhancing or developing new safety methods. A regulatory structure should be comprehensive and robust, but should not be so overly burdensome that it stifles or prevents companies from delivering innovative products to the marketplace. Product safety is a priority for each of our member companies and for our trade association. The companies we represent invest substantial resources each year to ensure the safety and efficacy of their products. Companies work diligently with chemists, toxicologists, microbiologists, dermatologists, environmental scientists and other scientific experts to evaluate and ensure the safety of cosmetic products before they reach the marketplace.” She added, “The cosmetic industry plays a unique role in the lives of American women, and not just as women consumers. Our industry is committed to enhancing their lives in a number of ways. We are dedicated to ensuring women have advantages and opportunities for both their professional and personal success. Women comprise 66 percent of our industry’s workforce, compared to 48 percent of the overall workforce. Women now hold more than half of all management positions in our industry, compared with 36 percent of industry in general. Moreover, women of color represent 22 percent of our total workforce, and 11 percent of management, compared to 17 percent of employment and seven percent of management industries throughout the entire economy.”
Curran Dandurand, chief executive officer of Jack Black Skincare, said, “Currently within the United States there has been a movement to create separate state requirements. These regulations would be separate and apart from, and inconsistent with, the federal standards established by the FDA. Compliance with separate state laws that are inconsistent with federal standards would necessitate labeling changes, reformulation, excess packaging, and extensive registration requirements, which are simply not feasible for small companies like ours, even successful ones. Smaller companies cannot afford to carry separate inventories to meet the different state requirements and cannot afford the regulatory staff needed to meet the registration requirements contained in some of the proposed state legislative initiatives.” She added, “For the benefit of all stakeholders, consumers, personal care marketers, as well as regulators, there needs to be one consistent national standard that protects consumer health and safety and provides clear direction and certainty for the regulated companies and the regulators. This would mean transparency in all health and safety decisions and a single forum where all can participate. We support the modernization of the FDA laws that creates a national standard for cosmetics. I believe this will best protect the health and safety of our consumers and provide a strong foundation for growth and success of our small entrepreneurial companies that create jobs here in the U.S.”
Michael J. DiBartolomeis, chief occupational lead of the California Safe Cosmetics Program at the California Department of Public Health, said, “The cosmetics provision within the FFDCA was written in 1938 and has not been significantly amended in over 70 years. Since that time, the cosmetics industry has grown to be a multibillion dollar industry with products being marketed world wide and sold not only in retail stores but by individuals working out of their homes and over the Internet. While the industry has changed, the provisions in the federal law for regulating cosmetics have not.” He continued, explaining how the state of California has addressed this issue, “The California Safe Cosmetics Act [S.B. 484] was signed into law in 2005, and is based on the principle of ‘right to know.’ The act requires manufacturers with aggregate sales of greater than one million dollars and whose products are sold in California to disclose to the state all intentionally added chemical ingredients in their products that are known or suspected to cause cancer or reproductive and or developmental toxicity, regardless of the concentration of the chemical…Although the Safe Cosmetics Act does not set product safety standards or ban any products, it responds to public concerns about the safety of cosmetics by empowering them to avoid the most toxic chemicals, and it thereby also promotes product reformulation. The act grants authority to the state’s Safe Cosmetics Program to conduct audits, investigations, and health-based studies, and requires manufacturers to submit any additional information on their products as deemed necessary by the program for conducting these assessments. Note that FDA does not have comparable authority.”
Debbie May, president and chief executive officer of Wholesale Supplies Plus, and Peter Barton Hutt, senior counsel at Covington and Burling, LLP, also testified.
