An Approach to Cosmeceuticals

The cosmeceutical industry is a vast, consumer-driven market that has demonstrated booming sales since the early 2000s, reaching $9.7 billion in 2011 and with predicted sales of $11.7 billion by 2016.¹ Cosmeceuticals promise highly desirable effects on the skin, including anti-aging, skin tightening, improved radiance, and more. Such assertions inevitably invite both excitement and suspicion.

The abundant cosmeceutical options and the validity of their claims can be challenging to navigate for both consumers and physicians. Consumers will pay a premium for products perceived as high-performance, and expect that the items will function as claimed. Moreover patients expect physicians, particularly dermatologists, to have expert insight into which products are worthwhile. As such, it behooves dermatologists to be aware of the available clinical and basic science evidence describing cosmeceuticals’ efficacy.

The level of scientific evidence for cosmeceuticals and the active ingredients they contain is extremely variable, with some ingredients offering more robust and convincing evidence than others.² This paper will introduce the broad categories of cosmeceuticals and provide discussion on the available literature, using two familiar ingredients as examples.

The term “cosmeceutical,” uniting the words cosmetic and pharmaceutical, was popularized by Dr. Albert Kligman in the 1980s.³ Cosmeceuticals are topical agents that offer properties of both cosmetics, which beautify or enhance appearance, and drugs, which therapeutically alter the skin’s physiology and/or reverse a disease process. Cosmeceuticals typically contain at least one distinguishing ingredient and purport beneficial effects beyond the abilities of purely cosmetic products, commonly claiming to improve skin function, texture, tone, radiance, or firmness.

The appeal of cosmeceuticals is partly due to their accessibility as over-the-counter (OTC) agents and owing to the commonly held notion that natural or organic ingredients are healthy, holistic, restorative, and safe. “Natural” products are colloquially defined as having botanical, mineral, or animal origins. While cosmeceuticals are often labeled as “natural” or “organic,” these terms are not recognized or regulated by the United States (US) Food and Drug Administration (FDA).⁴ In fact, the FDA does not recognize the cosmeceutical category as a whole, asserting that “a product can be a drug, a cosmetic, or a combination of both, but the term ‘cosmeceutical’ has no meaning under the law.”⁵ This is in contrast to products such as antidandruff shampoo, which is both cosmetic (a cleanser) and drug verified to treat dandruff. Cosmeceuticals undergo investigation by regulatory bodies only in the event of safety issues.

While the term “natural” is not supervised by regulatory bodies, use of the term “organic” is controlled by the US Department of Agriculture, which uses the same production, handling, processing, labeling, and certification standards set forth for other agricultural products labeled as organic.⁶

By definition, cosmeceuticals render less clinical change than the more regulated and prescribed pharmaceuticals. Any cosmeceutical claiming to significantly alter the function of the skin would be considered a drug, and therefore require the same rigorous testing, marketing, and regulatory standards as FDA-approved pharmaceuticals, which must demonstrate proof of efficacy from large, double-blind, and controlled clinical trials.

As such, it is often in the best interest of cosmeceutical manufacturers to maintain some degree of ambiguity to health claims. Marketing claims may differ between drugs and cosmeceuticals. For example, drugs claim to “decreases wrinkles” whereas a cosmetic may claim to “decrease the appearance of wrinkles.”⁷ The latter claim better protects cosmeceuticals from falling under the jurisdiction of regulatory bodies.