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76 August 2015 | beautystorebusiness.com Beauty & The Law THE U.S. SENATE IS CURRENTLY CONSIDERING A bill to enhance the U.S. Food and Drug Administration's oversight of cosmetics. This bill is intended to bring the aging cosmetics laws in the United States in line with consumer demand for more rigorous guarantees of safety. The law that currently governs cosmetics is the Federal Food, Drug and Cosmetic Act, which was signed into law by Franklin Delano Roosevelt in 1938. Since then, U.S. consumers have become much more vocal in demanding safe products and safe cosmetics, in particular. The focus at the time the FDCA became law was removing ingredients known to cause harm. The FDA supported passage of the 1938 law by pointing to Lash- Lure, an eyelash dye that caused eye damage and at least one case of blindness. The FDA wanted the power to regulate such dangerous cosmetics, and now the focus has shifted to understanding chemicals before they are used in cosmetics products. Slowly, and behind many other countries, U.S. consumers are coming to the view that regulators must be satisfied chemicals are safe before they can be used, instead of only removing them from products after they have been proven unsafe. It's too early at the time of this writing to predict if this bill in the U.S. Senate will be signed into law, but it highlights the current areas of dissatisfaction with the 1938 law, and it illustrates possible legislative responses. Major areas are: • How to ensure ingredient safety • Whether cosmetics facilities should register with the FDA • Mandatory "good manufacturing practices" • Instituting a requirement to report injuries • Whether states can regulate cosmetics, also called federal preemption of state laws • Giving the FDA authority to order recalls of unsafe products This column will explore this current proposal for modernizing the law in these areas. HISTORY OF PROPOSED BILLS Lawmakers have failed repeatedly to pass new cosmetics laws. As early as 1997, Senator Ted Kennedy said, "the Food and Drug Administration does not today have the authority, power, or personnel to protect the American consumer on the issue of these cosmetics." Proposed laws have been considered every year since 2010. The Safe Cosmetics Act of 2011, the Cosmetics Safety Enhancement Act, and the Cosmetic Safety Amendments Act of 2012 all failed to gain enough traction to become law. More recently, in 2013 the FDA and several industry groups agreed on a framework for a modernized law, but those discussions broke down in 2014. California Senator Dianne Feinstein and Maine Senator Susan Collins introduced a bill in the U.S. Senate in April called the Personal Care Products Safety Act. Senator Feinstein noted that there are "very few protections in place" to ensure cosmetics' safety. Their bill has the support of the Personal Care Products Council and the International Fragrance Association; and several large manufacturers, including Revlon, Estée Lauder, L'Oréal and Johnson & Johnson; and consumer groups, including the Environmental Working Group, the National Alliance for Hispanic Health and the National Psoriasis Foundation. The Independent Cosmetic Manufacturers and Distributors and the Hand- made Cosmetic Alliance as well as others oppose it. An alternative bill based on the failed Cosmetic Safety Amendments Act of 2012 with new additions will likely have been introduced in the U.S. House of Representatives by the time you read this. The Rose Sheet reported on the possibility of this alternative bill in early June. The alternative bill is championed by ICMAD and is supported by Mary Kay—which issued a press release on it in early June—as well as others (including Merle Norman Cosmetics). SAFETY Under the existing law, unlike drugs, most ingredients in cosmetics are not approved by the FDA before they are marketed—although some particularly toxic cosmetics ingredients are banned. The only ingredients that must be reviewed by the FDA before they are incorporated into cosmetics—called a premarket review—are color additives. Other than premarket review for color addi- tives, FDA's primary opportunity to review the safety of a cosmetic is after a product is marketed, and then the FDCA allows the FDA to sue to prohibit adulterated and misbranded cosmetics from being marketed in interstate commerce. Cosmetics are adulterated if they or their packaging have ingredients that could cause any injury, are contaminated, contain a prohibited color additive, or are manufactured or stored in an unsanitary manner. Cosmetics are misbranded if they have labels that are incorrect, misleading, incomplete, lack mandated information, or are packaged misleadingly. Cosmetics manufacturers are not required to perform any specific test for product safety, although they are responsible for the safety of cosmetics and ingredients. In 1960, Congress revised the FDCA and then the FDA argued that it had the authority to conduct premarket reviews of all finished cosmetics that are intended to impart color, such as lipsticks and blushers. A federal circuit court disagreed, ruling that the 1960 amendments did not require premarket review of cosmetics products, just color additives used in them. As a result, the FDA cannot require review of finished products before they are brought to market. If it becomes law, the Personal Care Products Safety Act will require that at least five ingredients and byproducts be tested each year to evaluate their safe use. The bill requires the FDA to review and determine the safety of the substances. The FDA must find one of three things: (i) the substance is safe under specified conditions; (ii) it is safe under all conditions; or (iii) it is not safe for use in cosmetics under any conditions. The FDA will then issue orders mandating conditions of use for ingredients, regulating any byproducts, and specifying any required consumer warnings. All Internet retailers must include the warnings and product-label information on their websites. Any product that is not A Modern Look for Cosmetics Law? Here's a detailed look at the Personal Care Products Safety Act—the proposed overhaul of cosmetics—in the U.S. Senate. by Jean Warshaw Image courtesy of Barry Burns