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What’s Important?

  1. “Cosmeceuticals” remains a popular but unofficial category for personal care product status despite its introduction nearly 40 years ago.

  2. Current regulations discourage manufacturers from publishing supportive scientific clinical trials to evaluate the efficacy of their products.

  3. There is no standard organic certification for skincare products used by all companies. Rather, there are several certification bodies, which is confusing for consumers.

  4. The “dermatologist tested” term is used when one dermatologist has tried the formula but use of this expression does not require any official clinical research by that dermatologist.

What’s New?

  1. The ISO 16128 standard describes a nomenclature and process that should be used to define the presence and amount of natural ingredients in skincare products. It is being adopted by many reputable companies.

  2. Medical grade skincare and professional grade skincare are descriptive terms but not legal categories.

What’s Coming?

  1. The Cosmetic Ingredient Review is constantly publishing new safety reports on ingredients.

  2. New sunscreen claim rules are expected in the future but have been in a holding pattern for over a decade.


According to the US Food and Drug Administration (USFDA), a personal care product can be classified as a drug, an over-the-counter (OTC) drug, or a cosmetic, or in some cases more than one of these groups (see Box 32-1). The term “cosmeceutical” was introduced in 1984 by Albert Kligman, MD, at a meeting of the Society of Cosmetic Chemists because he felt that a new regulatory category should exist.1,2 Although this topic has been debated for decades, the classification “cosmeceuticals” has still not been officially recognized. In other words, it has no legal meaning. The term, however, is increasingly a part of the mainstream vernacular and frequently used to describe products that are known to exert a biologic action but are regulated as cosmetics (e.g., products containing retinol). Although it is well known that retinol stimulates retinoic acid receptors resulting in biologic activity, retinol is a popular ingredient contained in numerous cosmetic skincare products. Companies often list retinol as an inactive ingredient on product labels to avoid regulatory action by the FDA.

Which category a product fits in depends on its ingredients, how much of the ingredient is present, and what claim will be made (e.g., acne lotion vs. moisturizer).

BOX 32-1 The Three Legal Categories for Skincare Products

  • Drug: Must be FDA approved, extensive data show efficacy and safety

  • OTC: Must follow monograph guidelines, has ingredients that have shown efficacy and safety to treat a certain condition

  • Cosmetic: Voluntary registration

The stage for the unforeseen regulatory loophole in which cosmeceuticals reside was set in 1938 when the US Congress passed a statute known as the Federal Food, Drug, and Cosmetic Act (FD&C Act), which outlined formal criteria for classification of drugs and cosmetics. In this document, cosmetics were defined ...

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