Cosmeceuticals: undefined, unclassified, and unregulated.

The cosmeceutical category is an undefined, unclassified, and unregulated area of dermatology that is yet in its infancy. Traditional cosmeceuticals involve the topical application of biologically active ingredients that affect the skin barrier and overall skin health. The ability of these ingredients to enhance skin functioning depends on how they are formulated into products that can maintain the integrity of the active ingredient, deliver it in a biologically active form to the skin, reach the target site in sufficient quantity to exert an effect, and properly release from the carrier vehicle. In the United States, cosmeceuticals are sold as cosmetics, making marketing, packaging, and aesthetic appeal important considerations. Ideally, the cosmeceutical should be clinically tested for efficacy to ensure a proven skin benefit and also to substantiate marketing claims. Governmental limitations of efficacy claims restrict cosmeceutical development because products can only be assessed in terms of their ability to improve skin appearance but not function. Improving function would remove the cosmeceutical from the cosmetic category and place it in the drug category. Herein lies the challenge of defining the cosmeceutical category.