The term, “cosmeceutical” has been used by some marketers in the cosmetics industry. It denotes a skin care formula or ingredient that provides therapeutic benefits to the skin above and beyond what would be seen with simple cosmetics.
 
It was coined by Dr. Albert Kligman, MD, in 1984, who defined cosmeceuticals as “a topical preparation that is sold as a cosmetic but has performance characteristics that suggest pharmaceutical action.” 

At the time, his laboratory was conducting clinical studies confirming the anti-aging effects of tretinoin and later retinol. Cosmetic benefits such as these had never been seen with any topical preparation before; thus, their discovery was groundbreaking at the time.
 
Kligman is most famous for his research on topical retinoid. Along with Dr. J.E. Fulton and Dr. G. Plewig, he developed the tretinoin treatment for acne that is still in use in current-day dermatological practice.
The study was truly considered groundbreaking, as prior to Kligman’s research, the benefits of these active ingredients for skin were unknown. It was following such research that Kligman started to call skin care products with therapeutic benefits as “cosmeceuticals.”
 
Some common skin care ingredients that have been considered “cosmeceuticals,” include: alpha hydroxy acids, beta hydroxy acids, ceramides, peptides and vitamins (A, B, C and E).
 
Kligman died February 9, 2010. He was 93. 
 
The cosmetics industry, wary of interference from the US Food and Drug Administration, never truly embraced the term. As recently as 2020, the FDA reminded the industry that term has no meaning under the law. 
 
According to the FD&C Act of 1938, FDA regulates cosmetics under the authority of these laws. The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce.
 
The FD&C Act defines cosmetics by their intended use, as “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.” Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. It does not include soap. But, if the product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug  (FD&C Act, 201(g)), or in some cases a medical device (FD&C Act, 201(h)), even if it affects the appearance. Other “personal care products” may be regulated as dietary supplements or as consumer products. 
 
Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives. However, FDA can pursue enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.
 
In general, except for color additives and those ingredients that are prohibited or restricted by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic, provided:

the ingredient and the finished cosmetic are safe under labeled or customary conditions of use,

the product is properly labeled, and

the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.

 
Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. The law also does not require cosmetic companies to share their safety information with FDA.
 
Recalls of cosmetics are voluntary actions taken by manufacturers or distributors to remove from the marketplace products that represent a hazard or gross deception, or that are somehow defective (21 CFR 7.40(a). FDA is not authorized to order recalls of cosmetics, but the agency does monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove dangerous products from the market without FDA's written request.