Figure 1 A continuum between cosmetics and pharmaceutical products. (From Ref. 1.)

2. The European Union has established different European Court (EC) directives that separately discuss cosmetics and drugs [2]. There is no provision for the term "cosmeceutical." Most of the national regulations for cosmetics and drugs agree with the definitions set forth in the EC directives.

3. The term "cosmeceutical" was introduced in 1961 by Raymond E. Reed and popularized in years to follow by Albert M. Kligman, MD, Ph.D. [1,3]. As of the year 2001, no official consensus for a definition of cosmeceutical existed within the cosmetic, toiletry, or pharmaceutical industry, nor was one close to being established [1,2,4,5].

"Cosmeceutical" has been used to describe products that yield benefits traditionally thought to be cosmetic in nature, such as moisturization, as well as products that make marketing claims approaching those of drug products, such as reducing (the appearance of) wrinkles. It has been suggested that the term be used to classify cosmetics of different types [2]. Japan was progressive in attempting to make such a new product classification, referred to as "quasi-drugs" [1,2]. The new classification included substances causing "a mild action on the body" and demonstrated to be safe. There remains much controversy over how to classify and register products into this new classification, without a major advantage for doing so.

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