Cosmeceutical Regulations–A Global Overview

December 13, 2005 | Contact Author | By: David C. Steinberg, Steinberg & Associates
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Keywords: cosmeceutical

Abstract: Cosmeceuticals are not regulated as such in the Europeon Union, United States or Japan. In the EU, most are considered cosmetics; in the United States, most are seen as drugs that probably have not been approved by the U.S. Food and Drug Administration (FDA). In Japan, they are regulated as quasi-drugs. As you can see, we go from the extremes of limited regulated cosmetics in the EU to pre-approvals in Japan, and fi nally a lack of enforcement in the United States.

Cosmeceuticals are not regulated as such in the Europeon Union, United States or Japan. In the EU, most are considered cosmetics; in the United States, most are seen as drugs that probably have not been approved by the U.S. Food and Drug Administration (FDA). In Japan, they are regulated as quasi-drugs. As you can see, we go from the extremes of limited regulated cosmetics in the EU to pre-approvals in Japan, and finally a lack of enforcement in the United States. 

Before one can talk about the regulations of cosmeceutical products, you first have to define “cosmeceutical.” There is no recognized legal definition of a cosmeceutical, as compared to the legal definition of a cosmetic or a drug, anywhere in the world. The term was first used in 1946 by someone from the FDA but lay dormant until about 1981 when Albert M Kligman, M.D., Ph.D., popularized this word. He used it to describe a range of products between cosmetics (such as lipsticks and eye shadows) and “pure” drugs (such as antibiotics and corticosteroids). These products would have properties of both cosmetics (promoting attractiveness) and drugs (affecting the structure and function of the skin).