On March 27, 2012, the House Energy and Commerce Committee held a hearing entitled “Examining the Current State of Cosmetics,” which considered existing FDA authority over cosmetics and calls to modernize that authority to address technological advances and globalization of the cosmetics industry. The hearing provided regulators and stakeholders an opportunity to voice their perspective on the future of the regulatory landscape governing cosmetics, with most expressing approval for adapting existing FDA authority to meet new industry needs while emphasizing extensive safeguards already put in place by industry. Witnesses further noted that maintaining FDA regulatory authority would help prevent individual state regulations which could deter innovation and disrupt interstate commerce.
Under the Federal Food, Drug and Cosmetic Act, companies are prohibited from introducing a misbranded or adulterated cosmetic product into the market. While cosmetics are not subject to pre-approval by FDA, companies are responsible for substantiating the safety of their products to ensure they are not adulterated or misbranded. Michael Landa, Director of the Center for Food Safety and Applied Nutrition (CFSAN) within FDA, noted that FDA regulations presently restrict the use of 10 types of ingredients in cosmetics due to safety concerns and also require specific labeling statements to appear on all products.
Landa explained in his written testimony to the Committee that the number of cosmetic imports has nearly doubled from FY 2004 to FY 2010 and suggested this trend necessitated an increasingly global effort to “better align practices for maintaining global consumer protection in the cosmetics arena without creating unnecessary obstacles to international trade.” President Obama’s FY 2013 Budget request would require domestic and foreign cosmetic manufacturers to register with FDA and pay an annual registration fee. Such fees would generate an additional $19 million in revenue, according to Administration estimates, which would be used to maintain the registration program and refine inspection and sampling of domestic and imported products, amongst other tasks.
Industry stakeholders were largely supportive of the Administration’s efforts to adapt existing FDA authority to meet new concerns, but also emphasized that cosmetics remain amongst the safest consumer products based on industry investment in product safety and development. Testifying on behalf of the Personal Care Products Council (PCPC), the trade association representing over 600 companies in the cosmetics industry, Dr. Halyna Breslawcek explained that the American cosmetics industry alone invests more than $3.6 billion on scientific research and development. Breslawcek encouraged FDA to incorporate findings of the Cosmetic Ingredient Review (CIR) into its regulatory process. The CIR is an independent non-profit body established in 1967 by industry that examines and assesses cosmetic ingredient safety issues raised by industry, FDA or any other domestic or foreign entity.
With regard to potential reform of FDA authority, industry stakeholders were largely receptive to modernization so long as it continues to provide for both safety and innovation within the cosmetics industry. Harvard Law Professor and Senior Counsel at Covington & Burling LLP Peter Hutt, also testifying on behalf of PCPC, indicated that PCPC supported enacting “into law the existing FDA programs for registration of manufacturing establishments and listing of cosmetic products.” Hutt explained in his written testimony that it was “extremely important” that “FDA establish national standards on safety that apply in every state” in order to avoid having FDA authority undermined by unique state regulatory regimes.
The hearing marked the first time in over 30 years that a Congressional hearing expressly and directly considered cosmetics safety. In November, FDA held a public meeting to consider whether new regulations were necessary to address microbial safety issues in cosmetics.
Any overhaul in FDA’s authority over cosmetics may be included in the reauthorization of the Prescription Drug User Fee Act, which expires in September. Two bills have already been proposed and a third industry-supported initiative is expected to be proposed in the coming weeks.