The introduction of The Safe Cosmetics Act of 2010 (H.R. 5786) is renewing debate between activists and the personal care industry. According to industry experts, if passed, the bill would significantly change the regulatory structure of cosmetics in the U.S., by more closely aligning it with other FDA-regulated products, such as drugs, biologics and medical devices. For example, The Safe Cosmetics Act of 2010 would maintain current FDC Act §§ 601-603 concerning adulterated and misbranded cosmetics, but would amend the FDC Act to add a new subchapter on the regulations of cosmetics. Specifically, H.R. 5786 would, among other things:
• Require domestic and foreign establishments that manufacture, package or distribute cosmetics to register annually with FDA, including providing FDA with contact information, a description of the establishment’s 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. FDA would be required to make its registration list publicly available, but not the registration documents. Establishments would also be required to provide detailed product-specific information to FDA;
• Require FDA to establish a “schedule of fees . . . to provide for oversight and enforcement” of the new FDC Act subchapter on the regulation of cosmetics. Such fees would be prorated based on an establishment’s gross receipts or sales, and would only be assessed on companies with annual gross receipts or sales of more than $1 million;
• Require, within one year after the date of enactment of the Safe Cosmetics Act of 2010, “the label on each package of cosmetics, including cosmetics distributed for retail sale and professional use, to bear a declaration of the name of each ingredient in such cosmetic in descending order of predominance.” A similar requirement applies to internet vendors with respect to providing ingredient information;
• Require manufacturers and distributors of cosmetics and ingredients to submit (in an electronic format) to FDA, not later than one year after the date of enactment of the Safe Cosmetics Act of 2010, “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 information;
• Require FDA to issue regulations not later than two years after the date of enactment of the Safe Cosmetics Act of 2010 that includes lists of ingredients identified by the Agency as “prohibited ingredients,” “restricted ingredients,” or “safe without limits” for use in cosmetics. The FDA must also develop a “priority assessment list of not less than 300 ingredients” that cannot be included on the above-referenced lists “because of a lack of authoritative information on the safety of the ingredient.” FDA must make safety determinations for these ingredients.
• Prohibit companies from manufacturing, importing, distributing or marketing a cosmetic or cosmetic ingredient if the company failed to provide information to FDA as required under the bill or if the company’s products contain non-permitted ingredients;
• Require responsible parties to notify FDA if a marketed cosmetic “is adulterated or misbranded in a manner that presents a reasonable probability that the use or exposure to the cosmetic (or an ingredient or component used in any such cosmetic) will cause a threat of serious adverse health consequences or death to humans.” FDA may request a voluntary recall of the affected products, issue an order for the company to cease distribution, and, under certain circumstances, require a recall or issue an emergency recall order;
• Give FDA the authority to require that cosmetics containing “nano-scale” materials be labeled as such;
• Mandate the reporting of adverse health effects associated with the use of a cosmetic; and
• Require FDA to publish a list of “alternative testing methods” that do not involve the use of animals to testa chemical substance and that must be used in product testing where practicable.
But according to Lezlee Westine, president and chief executive officer of the Personal Care Product Council, 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.
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,” said Westine in a statement. “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.”
For its part, The Personal Care Products Council has offered its own five-point plan to ensure the safety of cosmetics.
• Enhanced FDA Registration. It requires that personal care products manufacturers that market their products in the U.S. 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.
• 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;
• 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;
• 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;
• 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,” noted Westine. “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."
