Dr. Albert Kligman of the University of Pennsylvania is described as the father of cosmeceuticals, a term he popularized. Cosmeceuticals are hybrid products which provide beyond simple cosmetic enhancement but fell short in qualifying as a pharmaceutical. Since mid-1980s, the term has already existed, but it first appeared in the world market in 1996.
Cosmetics, first recorded to be used by Egyptians in 4000 B.C., are products which cleanse and beautify the skin. While, pharmaceuticals are drug products which prevent, mitigate, treat or cure disease and/or affect the body’s structure or function.
Although the term ‘cosmeceuticals’ has been used in many reputable journal articles, it remains unrecognized by the U.S. food and drug administration (FDA) and other regulatory bodies hence, there is prevalent confusion in its definition and scope. Currently, it is being classified as either a subclass of a cosmetic or drug. In Europe and Japan, cosmeceuticals are categorized under cosmetics; however, in the US, cosmeceuticals are considered to be a subclass of drugs.
The scope of cosmeceuticals has exponentially been expanding and this encompasses products for both veterinary and human use. Examples of veterinary cosmeceuticals include shampoos and anti-ectoparasites, while cosmeceuticals for humans include alpha-hydroxy acids for exfoliation and skin rejuvenation and topical vitamin C. Commonly, human cosmeceuticals are used for, but not limited to, the following:
- skin lightening or depigmentation
- sun protection
- anti-wrinkle/ anti-aging effects
- scar reduction
- antioxidant effects
- hair strengthening/ hair fall arrest/ hair growth stimulation/ textural hair improvement
- treatment of specific disorders (e.g., acne, rosacea, melisma)
- miscellaneous uses
Deficiency in regulatory nomenclature of cosmeceuticals holds an impact which can cause far-reaching consequences concerning the essentials of product labeling, the stringency of testing protocol, and approval for sale and distribution.
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a cosmeceutical is identified as a drug, a cosmetic, or a combination of both, but its term has no meaning under the law. Distinctively, the FD&C Act defines drugs and cosmetics as the following, respectively:
“Drugs, in part, are defined by their intended use, as ‘articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease’ and ‘articles (other than food) intended to affect the structure or any function of the body of man or other animals’ [FD&C Act, sec. 201(g)(1)].”
“Cosmetic are defined by their intended use, and are ‘articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance’ [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.”
In contrast to drug products requiring premarket approval from FDA prior to it being made available to the consumers, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market.
Even when regulations and processes relating to cosmetics are less complex, as per Good Clinical Practices (GCP), clinical studies with adequate power should be essential to demonstrate the intended activity of the cosmeceutical for treatment of the particular minor skin disorder or 'condition', and there must be an assurance that safety requirements are optimal and that there are no expected side effects.
Also, Good Manufacturing Practice (GMP) for cosmetics are guidelines provided, but not regulated, by the FDA which play a significant factor in ensuring that the cosmetic products are neither adulterated nor misbranded. This is in contrast to drugs which by law requires strict adherence to GMP requirements, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a drug to be adulterated [FD&C Act, sec. 501(a)(2)(B)].
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- Oricha, B. (2010). Cosmeceuticals: A Review. African Journal of Pharmacy and Pharmacology, 4(4), 127-129. Retrieved from: https://www.researchgate.net/publication/268293743_Cosmeceuticals_A_review
- Pandey, A., Jatana, G., & Sonthalia, S. (2020). Cosmeceuticals. Retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK544223/
- U.S. Food and Drug Administration. (2020). Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics. Retrieved from: https://www.fda.gov/cosmetics/cosmetics-guidance-documents/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics
- U.S. Food and Drug Administration. (2020). Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?). Retrieved from: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap
- U.S. Food and Drug Administration. (2020). Title 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals. Electronic Code of Federal Regulations. Retrieved from: ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=58749a5c0e679e98398bf80ec3d738de&rgn=div5&view=text&node=21:184.108.40.206.11&idno=21#se21.4.211_142