Norman F. Estrin - Cosmetic regulation in a competitive environment

Cover

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edited by
Norman F. Estrin

Estrin Consulting Group, Inc.
Potomac, Maryland

James M. Akerson

Akerson Associates
Bethel, Connecticut

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ISBN: 0-8247-7516-3

This book is printed on acid-free paper.

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To James H. Merritt, a great leader and friend.
His drive and dedication helped prepare the cosmetic industry
for the new millennium.

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As with technological innovations, changes in the regulatory environment and our responses to its challenges tend to be incremental. Since publication of The Cosmetic Industry: Scientific and Regulatory Foundations (N. F. Estrin, ed.; Marcel Dekker, Inc.), there has been no new cosmetic legislation or massive changes in cosmetic regulation in the United States. For the most part, that book is still quite current and its breadth of coverage makes it useful to those with regulatory responsibilities or interests in the cosmetic industry.

Then what is the need for this new book? First, there have been important changes in cosmetic regulation. Thus, the chapters on regulation of labeling and advertising claims and the new sunscreen regulations will help bring the reader up-to-date on these topics. There have also been important changes in FDAs priorities and organization that will impact the cosmetic industry, which are summarized by John Bailey, FDAs Director of the Office of Cosmetics and Colors. Regulation by other government agencies also has implications for the cosmetic industry. For example, chapters on hazardous waste regulations, Proposition 65, and regulation of marketing claims by the Federal Trade Commission and States should be of interest. New cosmetic legislation in the international community, such as in the European Union, is also of great importance.

Knowledge of how the industry has responded to regulatory changes will provide the reader with expert advice in a host of areas, including substantiating the safety of cosmetics and toiletries, alternative methods for testing for eye irritation, clinical and stability testing, microbiology, total quality management (TQM), OSHA, and product liability. It is also

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useful for the reader to learn about other organizations that may impact their own organization.

Chapters on the role of the Cosmetic Ingredient Review (CIR), COLIPA, and the International Fragrance Association will add to the readers knowledge base. Finally, readers with an interest in history and its implications for the future should enjoy Peter Hutts chapter on the history of government regulation of adulteration and misbranding of cosmetics, along with the chapter on the development of CTFAs voluntary self-regulatory program.

In selecting the topics for this book, we were faced with the challenges of finding experts willing to devote the necessary time and effort to make a valuable contribution. Some gaps exist because of chapters that were not submitted or did not meet our standards. We look on these areas as opportunities to be covered in future books. We are grateful to all the contributors for being patient, providing updates when necessary, responding to constant badgering with grace, and giving us the best chapters they could produce. We think the reader will be grateful, too, when he or she has profited from reading them. In this competitive environment, no one can afford to fall behind in knowledge of current regulations or miss the opportunity to get expert advice. We hope this book proves to be a helpful guide.

Norman F. Estrin
James M. Akerson

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