Watching the Dominoes Fall - A Case Study in Preparedness for Increased Regulation in the Cosmetics Industry

Brian Foley, Vice President and General Counsel, NeoStrata Company, Inc., USA

Recent developments in the EU regulatory environment for consumer products illustrate the need for in-house regulatory and legal professionals to embed themselves in the product development and regulatory processes of their business organizations. Regulatory changes in one jurisdiction most often will have global supply chain implications which, if not managed optimally, can cost businesses unnecessary amounts of time and money. Particularly for smaller businesses with a global reach, compliance with multiple and seemingly inconsistent regulatory requirements present a financial burden and the distraction of resources from new business growth. Moreover, a new regulatory regime in one jurisdiction may signal similar impending changes in other jurisdictions that are prudent to consider even before enactment. Using as an example EU Regulation No. 1223/2009 on cosmetic products, which has a compliance deadline of July 2013, valuable lessons can be learned concerning the development and implementation of a compliance strategy that minimizes the financial and manpower burden on the business by anticipating differing regulatory requirements in multiple jurisdictions.

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USA Regulation Healthcare June 2012 Vol. 5, No. 19, Spring 2012

Brian Foley

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Brian Foley is currently Vice President, General Counsel and a member of the Board of Directors of NeoStrata Company, Inc. Mr. Foley is a 1984 honors graduate of New York Law School where he was a member of the law review, is currently a member of the bars of the states of New York, Connecticut, D.C. (inactive) and New Jersey (in-house counsel certification) and he has published scholarly articles in many legal papers and journals. Prior to joining NeoStrata, Mr. Foley was in private practice for 27 years, a partner in a New York based boutique law firm, a partner in New York based venture capital firms as well as an advisor to start-ups and emerging growth companies. The views expressed herein are those of Mr. Foley and not those of NeoStrata or any of its representatives.

NeoStrata Company , Inc.

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NeoStrata Company, Inc., located in Princeton NJ, is a world leading innovator that develops and markets a comprehensive range of clinically-proven, dermatologist developed skin care products featuring unsurpassed technologies which include alpha and poly hydroxyacids and new amino acid sugars which can significantly improve the health and beauty of every skin type. NeoStrata was founded as a start-up company in 1988 by entrepreneurs Dr. Eugene Van Scott and Dr. Ruey Yu, world renowned leaders in dermatology and dermatopharmacology. The company was built on a proud medical heritage that includes decades of clinical research, an unprecedented amount of U.S. and foreign patents in the industry, and articles in major journals of dermatology. These advanced therapeutic and cosmetic dermatological products are available worldwide through consumer outlets, physicians' offices and spas under the NeoStrata® and Exuviance® brand names.

USA Regulation Healthcare June 2012 Vol. 5, No. 19, Spring 2012