The word "cosmeceutical" appeared in a scientific journal in 1962. Twenty years later, a dermatologist gave it a precise meaning by listing three conditions it had to meet. Today, sixty years later, it appears in no legislation: neither the European Cosmetics Regulation nor U.S. law. In the meantime, it has become one of the words most often printed on packaging.
The point is that the word is not empty: whoever defined it attached precise criteria to it. The problem is that almost no product currently described as cosmeceutical meets all of them, and no authority checks. So the useful question to ask when standing in front of a shelf is not "is it a cosmeceutical?", but "does it meet the three conditions?" — and these are questions you can ask yourself.
[INDICE:h2]
Elisa Avalle · Founder and dermocosmetics specialist
Cosmeceutical is not a legal category, but neither is it merely a word invented by marketing. Knowing the original conditions is the quickest way to understand which products deserve the label.
What does cosmeceutical mean?
The term originated from the combination of "cosmetic" and "pharmaceutical" and refers to creams, serums, lotions, or cleansers that are not intended solely for aesthetic purposes but aim to perform a more targeted action thanks to a high concentration of active ingredients, some of which are also found in medicinal products.
They are not drugs. And precisely because they remain cosmetics, by law they may be applied only to healthy skin: if a product had the power to modify the structure or function of the body, it would be a drug and would follow an entirely different approval pathway.
Who invented the word: a contested origin
The version repeated everywhere is that the term was coined in 1984 by Albert Kligman, a dermatologist at the University of Pennsylvania and the same researcher who brought tretinoin into modern dermatology. This is the version reported in the dermatological literature, and it is the one I used for years, too.
Except that this is not where the story begins. Twenty years earlier, an American cosmetic chemist, Raymond E. Reed, one of the first members of the Society of Cosmetic Chemists, had already used the word and devoted a talk to it, published in the Journal of the Society of Cosmetic Chemists under the title "The Definition of Cosmeceutical".
On this point, the sources do not entirely agree, and it is right to say so. Most date the coinage to 1961, but Reed's text appears to have been published in 1962; some sources write that Reed "proposed" the term rather than coined it, and dermatological literature almost always credits Kligman with its creation. I found no single, definitive reconstruction, so I will not offer one: I will simply say that attributing it exclusively to Kligman is at the very least incomplete.
The difference between the two is not merely chronological, and this is where things become interesting. Reed focused on the product: for him, a cosmeceutical was a scientifically designed preparation for external use that produced a useful or desired result, was pleasant to use and complied with rigorous chemical, physical and medical standards. Kligman focused on the evidence: he was not interested in how the product was designed; he was interested in someone demonstrating that it works.
Twenty years separate the two definitions, and in between came the shift from an idea of industrial quality to an idea of clinical evidence. It is the same shift that the industry, for the most part, has not yet completed.
Kligman's three conditions
In Kligman's definition, a cosmeceutical is a topical preparation sold as a cosmetic but with performance suggesting pharmacological action. This is where the story almost always ends, and the most useful part gets lost: Kligman did not merely propose a label; he identified three conditions that a product must meet to deserve it.
- The active ingredient penetrates the stratum corneum and reaches its target in the skin at a sufficient concentration.
- It has a known biochemical mechanism of action in the target cell or tissue of human skin.
- There are published clinical studies, peer-reviewed, double-blind, placebo-controlled and statistically significant, supporting the efficacy claims.
The third is the one that separates the wheat from the chaff. It is relatively easy to demonstrate that a molecule does something in a test tube; it is much more challenging to demonstrate that the finished product, at that concentration and in that formulation, does something in real people compared with a placebo. This is the distinction between the efficacy of the active ingredient and the efficacy of the formulation, and it costs time and money: that is why most products stop at the first stage.
Why Europe never recognised it
Sixty years later, the category is not formally recognised by either the European Union or the US Food and Drug Administration. This is not an oversight: it is a consequence of how the regulations are written.
According to Article 2 of Regulation (EC) No 1223/2009, a cosmetic is a product intended to be applied to the external surfaces of the human body for the exclusive or main purpose of cleaning them, perfuming them, changing their appearance, correcting body odours, protecting them or keeping them in good condition. A medicine, by contrast, is intended to diagnose, cure, treat or prevent a disease, or to influence the structure or functions of the body.
In the United States, the reasoning is identical and dates back further: the Food, Drug and Cosmetic Act of 1938 classifies any substance intended for the diagnosis, cure, treatment, or prevention of a disease as a drug. The term found no place in that framework, and it has not found one since.
There is no room for a third category between the two definitions. A product is either on one side or the other—and “cosmeceutical” remains a commercial description, even if it can describe something real.
No authority verifies whether a product deserves that name. The only possible verification is the one you carry out yourself, and it involves three questions.
Cosmeceutical, dermocosmetic, and functional cosmetics
These are three terms that are often used as synonyms, but they are not. None of the three is a regulatory category—for the law, only “cosmetic” and “drug” exist—but each describes a different approach to formulation.
| Term | What it indicates | Where it is found |
|---|---|---|
| Cosmeceutical | High concentration of active ingredients, some also used in pharmaceuticals | Term of American origin, widely used in marketing |
| Dermocosmetic | Formulation designed for skin with specific needs, often dermatologically tested | Pharmacy and para-pharmacy channel |
| Functional cosmetics | Shorter INCI lists and higher percentages of the active ingredients that truly make a difference | The approach we have chosen at LeLang |
In functional cosmetics, the focus shifts to functionality: higher percentages of bioactive ingredients and shorter INCI lists, because the number of ingredients is reduced while the concentrations of those that truly make a difference are increased. Fewer ingredients, chosen better.
Among the active ingredients that follow this approach are peptides, niacinamide, hyaluronic acid, and topical vitamin C: molecules with a documented mechanism of action, not ingredients chosen for how they sound on a label.
Where research is headed—and where it has not yet arrived
A 2025 review dedicated to anti-aging cosmeceuticals takes stock of an interesting family of molecules: next-generation retinoids, such as hydroxypinacolone retinoate and retinyl retinoate, show efficacy comparable to tretinoin with better tolerability.
The same review, however, adds the part that marketing never mentions: the available studies are still few and based on small samples. It is a credible promise, not established evidence — and the difference between the two is exactly what builds or loses the trust of those who buy.
The reverse is also true. A 2024 overview published in Skin Health and Disease notes that many ingredients sold as cosmeceuticals do not have sufficient clinical evidence for either effectiveness or safety, precisely because no authority verifies their claims before they are placed on the market. Not all active ingredients are equal, and the word on the cover does not make them so.
The LeLang choice
When it comes to skincare, I care about making sure information is presented clearly, so that everyone can make their own decision freely. That is why I distinguish between cosmetics, cosmeceuticals, and functional cosmetics instead of using the three terms as synonyms: I am the first person who would benefit from the ambiguity, and that is precisely why I prefer to eliminate it.
At LeLang, we use active ingredients whose effectiveness is documented by clinical studies in humans, and we never resort to animal testing, which has been banned for cosmetics in Europe under Article 18 of Regulation 1223/2009: preliminary testing of ingredients is based on in vitro models.
A concrete example of what “a short INCI list and high percentages” means: in the FeruliC + HA serum, vitamin C is stabilized with ferulic acid instead of being added on its own. It is not an extra ingredient added to lengthen the list: without that stabilization, the ascorbic acid oxidizes, and the percentage stated on the label no longer corresponds to what reaches the skin. It is the difference between an active ingredient being present and being functional — that is, the first of Kligman’s three conditions.
FERULIC + HA SERUM Brightening antioxidant serum for the face based on Vitamin C & Ferulic AcidEFFECTS: Lightens blemishes Stimulates c... Discover FERULIC + HA SERUM
And if you prefer to see the products before choosing them and be guided by someone with technical training, you can find LeLang in partner pharmacies throughout Italy. At the counter, the right question is about concentration, not the name of the category.
Frequently asked questions about cosmeceuticals
Are cosmeceuticals more effective than regular cosmetics?
They can be, but not because of the name. Since there is no legal definition, anyone can use the term: what makes the difference is the concentration of active ingredients and the studies supporting them, not the label.
Who coined the term “cosmeceutical”?
The most common answer is Albert Kligman, in 1984. However, that account is incomplete: cosmetic chemist Raymond E. Reed had already used and defined the word twenty years earlier, in a talk published in the Journal of the Society of Cosmetic Chemists in 1962. Sources differ on the exact year and on who should be considered the person who coined the term: what can be said with certainty is that Reed got there first, while Kligman gave the term the operational meaning still used today.
How can I tell whether a product is truly a cosmeceutical?
By applying Kligman's three conditions. Can the active ingredient penetrate, and at what concentration is it present? Is its mechanism of action known? Are there clinical studies in humans, and are they independent studies or studies by the active ingredient's manufacturer? A serious company answers these questions directly. If the answers are not available, the product may still be excellent—but the word on the cover adds nothing.
Do studies by the active ingredient's manufacturer carry weight?
They have value, but not the same value as an independent study, and the two should not be conflated. The problem is not citing them; it is citing them without saying that they come from the manufacturer. We always disclose this, and we also state how many people took part in the test: the number of subjects is information that affects the weight of the data.
Do they require a prescription or medical advice?
No, they are cosmetics and can be purchased freely. A pharmacist can recommend them, and a dermatologist can include them in a treatment plan, but they are not prescribed.
What distinguishes a cosmeceutical from a topical drug?
The stated purpose and the authorization framework. A topical drug has an approved therapeutic indication and a registration process; a cosmetic, even the most advanced one, can only improve the appearance of healthy skin.
Are cosmetic retinol and tretinoin the same thing?
No, and it is the clearest example of the difference. Tretinoin is retinoic acid, a prescription drug. Cosmetic retinol is a precursor that the skin must convert, with lower efficacy and better tolerability.
How can I recognize a claim that promises too much?
If a cosmetic claims to cure, heal, or treat a disease, or to act on the structure of the body, it is going beyond what regulations allow. A responsible company talks about appearance, comfort, and prevention. No cosmetic can claim to treat acne, rosacea, psoriasis, or dermatitis: it can support a dermatological treatment plan, but for a medical condition, the doctor remains the point of reference.
Is cosmeceuticals recognized outside Europe?
It does not exist as a legal category even in the United States. Japan and Korea, on the other hand, have regulated intermediate categories, which is one reason why certain Asian products have no direct equivalent here.
15-Minute Free Consultation with the Founder
Have a product in your hands and don't know whether its claims hold up? Bring it to me: we'll read it together. Book a free virtual skincare consultation with me.
Elisa Avalle is the founder of LeLang Skin Care, specializing in dermocosmetics at the University of Barcelona.
Sources for this article
01 Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products — Article 2 (definition of a cosmetic product) and Article 18 (ban on animal testing).
02 Commission Regulation (EU) No. 655/2013 — common criteria for the justification of claims relating to cosmetic products.
03 Federal Food, Drug, and Cosmetic Act, United States, 1938 — definition of a drug and a cosmetic.
04 Reed R. E. — The Definition of "Cosmeceutical", Journal of the Society of Cosmetic Chemists, vol. 13, no. 2, 1962 — the first documented definition of the term. Several sources date the coinage to 1961 and the published text to 1962; attribution is not unanimous.
05 Cosmeceuticals, StatPearls, National Library of Medicine — Kligman's definition and its three qualifying conditions.
06 Cosmeceuticals: A Proposal for Rational Definition, Evaluation, and Regulation, Archives of Dermatology (now JAMA Dermatology), 1996 — on the category's lack of recognition by regulatory authorities.
07 Crous C., Pretorius J., Petzer A. — Overview of popular cosmeceuticals in dermatology, Skin Health and Disease, 2024 — on the lack of clinical evidence of efficacy and safety for many cosmeceutical ingredients.
08 Cosmeceuticals for Anti-Aging: Mechanisms, Clinical Evidence, and Regulatory Insights — A Comprehensive Review, Cosmetics, 2025 — on next-generation retinoids and the still limited scope of the available studies.
Where to continue
The guide to cosmetic ingredients, to learn how to read an INCI · Why buy cosmetics at a pharmacy · Peptides in cosmetics · Retinol: what it does and doesn't do.
