JAN-FEB 2016

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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14 JANUARY/FEBRUARY 2016 | Med Esthetics © GETTY IMAGES LEGAL ISSUES | THE U.S. SENATE is currently considering a bill to enhance the U.S. Food and Drug Administration (FDA) over- sight of cosmetics. This bill—the Personal Care Products Safety Act—is intended to bring the aging cosmetics laws in the U.S. 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 (FDCA), which was signed into law by Franklin Delano Roosevelt in 1938. The focus at the time the FDCA became law was removing ingredients known to cause harm. The FDA supported pas- sage of the 1938 law by pointing to Lash-Lure, an eyelash dye that caused eye damage and at least one case of blind- ness. Today, the focus has shifted from cracking down on unsafe products to identifying these ingredients before they are used in cosmetics products. It's too early at the time of this writing to predict if this bill, currently in the U.S. Senate, will be signed into law, but it Cosmetic Ingredients Face Scrutiny A detailed look at the Personal Care Products Safety Act, the proposed overhaul of cosmetics regulations now in the U.S. Senate. highlights the current areas of dissatisfaction with the 1938 law, and it illustrates possible legislative responses. Topics covered by the proposed bill include: • 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 HISTORY OF PROPOSED BILLS Lawmakers have failed repeatedly to pass new cosmetics laws. 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. In 2013 the FDA and several industry groups agreed on a By Jean Warshaw

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