Regulatory Overview of Cosmeceuticals

Cosmeceuticals are an intriguing and burgeoning ‘eld within dermatology and the skin care market. This industry was estimated to have generated approximately $8.2 billion in sales in 2012 (1). Furthermore, researchers focusing on cosmeceutical products highlight strong growth perspectives in the coming years with a rapid compound annual growth rate of 7.7% and the global cosmeceutical market reaching $42.4 billion by 2018 (2). While consumers in the United States spend more on cosmeceutical products than all of Europe combined, consumers in France and Germany spend the most within Europe (3). Although there is no strict de‘nition for cosmeceuticals within the skin care industry or dermatology realm (4), they are typically considered cosmetic products with components that have “drug-like” bene‘ts and properties. Examples of cosmeceuticals include moisturizers, serums, topical antioxidants, retinoids, peptides, and botanicals. As a category, they are believed to contain either one or a mix of ingredients that improve skin condition and appearance without making an explicit assertion on skin health. In addition to their aesthetic properties which make them desirable for both consumers and patients, development of cosmeceutical products has several economical advantages, as the process of marketing them is simpler and they require less monetary investment than a drug, which may require from $800 million to upward of $1 billion (5).