On Tuesday, Rep. Jan Schakowsky (D-IL), along with Reps. Ed Markey (D-MA) and Tammy Baldwin (D-WI), introduced H.R. 5786, the Safe Cosmetics Act of 2010. (Full language accessible here.) This bill was introduced only days after the Personal Care Products Council (PCPC) petitioned Congress for greater oversight from the US Food and Drug Association (FDA) on cosmetics regulation, making this month truly the month of cosmetics regulation in the United States.
Although H.R. 5786 is not related to the regulatory oversight proposed by the PCPC, the two have some similarities in that both call for more FDA oversight on cosmetics regulation. However, it seems that H.R. 5786 calls for much more oversight. In addition, the bill reportedly is based on findings by the Campaign for Safe Cosmetics, which supports the bill. The group's site points out the following: "[The bill] also requires suppliers of cosmetic ingredients to make available to manufacturers information regarding the toxicological properties and the safety – including any safety tests they’ve conducted – of those ingredients, including the chemicals in fragrance and preservatives."
H.R. 5786 seeks to amend Chapter VI of the Food, Drug and Cosmetic Act, which concerns adulterated and misbranded cosmetics, by adding a subchapter on the regulation of cosmetics. Highlights of this subchapter include the FDA requiring: the registration of all manufacturers, distributors and packaging houses of cosmetics; the declaration of
Annual registration of domestic and foreign establishments that manufacture, package or distribute cosmetics in the United States would be required under H.R. 5786. These companies would have to provide contact information, a description of their activities, gross receipts, the number of employees and the name and address of any company that supplies a cosmetic manufacturing establishment with ingredients for its products. This list, then would be made publicly available by the FDA. According to David Steinberg, C&T magazine columnist, "This bill is positioned to be very costly for both the FDA and the industry."
Within one year of enactment, manufacturers and distributors of cosmetics and ingredients must submit all reasonably available information in the possession or control of the manufacturer or distributor that has not previously been submitted to [FDA] regarding the physical, chemical, and toxicological properties of single or multiple chemicals listed on the cosmetic labels,” including function and uses, tests of cosmetics, and exposure and fate information. Within that year, H.R. 5786 also requires cosmetic labels to include a declaration of the name of each ingredient in such cosmetic in descending order of predominance.
Meanwhile, PCPC president and CEO Lezlee Westine has released a statement regarding the Act. The full text follows:
We appreciate the interest of Representatives Schakowsky, Markey and Baldwin in cosmetic regulation, and we share their desire to ensure that existing FDA regulatory oversight is enhanced to take into account evolving science, the continued growth of our industry, and the need to modernize the regulatory structure. Toward that end, our industry has lobbied for the last several years to obtain additional funding for FDA's Office of Cosmetics and Colors. We also just last week proposed a number of new measures, including FDA ingredient reviews, that we believe would enhance FDA oversight and give the agency the information and flexibility it needs to continue to ensure consumer safety and safeguard public health.
We are concerned that the Safe Cosmetics Act of 2010 as written is not based on credible and established scientific principles, would put an enormous if not impossible burden on FDA, and would create a mammoth new regulatory structure for cosmetics, parts of which would far exceed that of any other FDA-regulated product category including food or drugs. The measures the bill would mandate are likely unachievable even with the addition of hundreds of additional FDA scientists and millions more in funding and would not make a meaningful contribution to product safety.
We urge Congress to carefully consider our recently announced proposals to strengthen FDA cosmetics oversight, including FDA ingredient reviews, and encourage the passage of the FDA Globalization Act of 2009, sponsored by Rep. John Dingell, which also includes enhanced FDA regulations of cosmetics manufacturers. Our proposals and Rep. Dingell's legislation constitute the strongest, most efficient, and viable approach to modernizing the FDA regulation of cosmetics, increasing transparency, and enhancing existing consumer safeguards as science and technology evolve.
Our plan includes the following five elements:
(1) Enhanced FDA Registration. It requires that personal care products manufacturers that market their products in the United States comply with the following:
- Register with FDA all facilities where those products are manufactured.
- File with FDA product ingredient reports disclosing all of the ingredients used in those products; and
- Report to FDA any serious unexpected adverse event with a personal care product experienced by consumers.
(2) New Process to Set Safety Levels for Trace Constituents. When requested or on its own initiative, FDA would be required to establish safe levels for trace constituents in cosmetic ingredients and products;
(3) New FDA Ingredient Review Process. Once a request has been made, or FDA unilaterally determines action is warranted, the agency would be required to review the safety of any ingredient intended for use in a personal care product and set safety use levels for such ingredient on a specified timetable;
(4) New FDA Oversight of CIR Findings. FDA would be required to review current and future findings on the safety of cosmetic ingredients by the Cosmetic Ingredient Review (CIR) Expert Panel and determine if these findings are correct. If there are instances in which it determines a CIR finding is not correct, FDA would determine by guidance or regulations if, or under what conditions, the ingredient can be used safely in personal care products;
(5) FDA-Issued Good Manufacturing Practices. FDA would establish industry-wide "Good Manufacturing Practices" requirements.
Strong federal safety requirements already govern cosmetics and personal care products sold in the U.S. The safety of cosmetic and personal care products in the U.S. is overseen by the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which requires that all cosmetics be substantiated for safety before they are marketed, contain no prohibited ingredients, and that all labeling and packaging must be in compliance with U.S. regulations. Under the FD&C Act it is a crime to market an unsafe cosmetic product. Our proposed measures would further enhance the effectiveness of the FDA cosmetic regulatory structure.