The word "cosmeceutical" appears in a scientific journal in 1962. Twenty years later, a dermatologist gave it a precise meaning, listing three conditions to be met. Today, sixty years later, it appears in no legislation: neither the European Cosmetics Regulation nor US legislation. In the meantime, it has become one of the words most frequently printed on packaging.
The point is that the word is not empty: whoever defined it attached specific criteria to it. The problem is that few products now described as cosmeceuticals meet all of them, and no authority verifies this. So the useful question to ask 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.
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Elisa Avalle · Founder and dermocosmetics specialist
Cosmeceutical is not a legal category, but it is not simply a word invented by marketing either. Knowing the original conditions is the quickest way to understand which products deserve the label.
What cosmeceutical means
The term comes 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 authorization process.
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 early members of the Society of Cosmetic Chemists, had already used the word and devoted a presentation 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 origin. 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 much of the sector 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 activity. However, this is almost always where the account 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 on 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 contenders. It is relatively easy to demonstrate that a molecule does something in vitro; it is much more challenging to demonstrate that the finished product, at that concentration and in that formula, 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 many products stop at the first stage.
Why Europe never recognized it
Sixty years later, the category is not formally recognized 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 primary purpose of cleaning them, perfuming them, changing their appearance, correcting body odors, protecting them, or keeping them in good condition. A drug, by contrast, is intended to diagnose, cure, treat, or prevent a disease, or to affect the structure or functions of the body.
In the United States, the reasoning is identical and older: the Food, Drug and Cosmetic Act of 1938 classifies as a drug any substance intended for the diagnosis, cure, treatment or prevention of a disease. 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 may describe something real.
No authority verifies whether a product deserves that name. The only possible verification is the one you carry out yourself, and there are three questions.
Cosmeceutical, dermocosmetic and functional skincare
These are three terms that are used as synonyms, but they are not. None of them is a regulatory category (legally, there are only "cosmetic" and "drug"), but each describes a different approach to formulation.
| Term | What it indicates | Where it is found |
|---|---|---|
| Cosmeceutical | High concentration of actives, 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 parapharmacy channel |
| Functional skincare | Shorter INCI lists and higher percentages of actives that truly make a difference | The approach we have chosen at LeLang |
In functional skincare, 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 actives 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 the label.
Where research is heading, and where it has not yet arrived
A 2025 review dedicated to anti-ageing cosmeceuticals examines an interesting family of molecules: next-generation retinoids, such as hydroxypinacolone retinoate and retinyl retinoate, show efficacy comparable to tretinoin with better tolerability.
However, the same review adds the part that marketing rarely 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 destroys the trust of those who buy.
There is also a downside. A review published in 2024 in Skin Health and Disease notes that many ingredients sold as cosmeceuticals do not have sufficient clinical evidence of either efficacy 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.
LeLang’s choice
When it comes to skincare, I care about ensuring that information is presented clearly, so 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 would be the first to benefit from the ambiguity, and that is precisely why I prefer to eliminate it.
At LeLang, we prioritize active ingredients whose efficacy is documented by clinical studies in humans, and we never use animal testing, which has been banned for cosmetics in Europe under Article 18 of Regulation 1223/2009: preliminary ingredient tests are 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, 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 an active ingredient working - in other words, the premise of the first of Kligman’s three conditions.
FERULIC + HA SERUM Vitamin C and ferulic acid face serum Antioxidant and tone-evening, with dual hyaluronic acid. Helps prevent dark sp... Discover FERULIC + HA SERUM
And if you prefer to see the products before choosing them and get guidance from someone with technical training, you can find LeLang at partner pharmacies throughout Italy. At the counter, the right question is about concentration, not the category name.
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 invented the term cosmeceutical?
The most common answer is Albert Kligman, in 1984. However, this account is incomplete: cosmetic chemist Raymond E. Reed had already used and defined the word twenty years earlier, in a presentation 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 term's originator; what can be said with certainty is that Reed got there first and Kligman gave the term the operational meaning still used today.
How can I tell whether a product is really 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 there, the product may still be excellent, but the word on the packaging adds nothing.
Are studies by the active ingredient's manufacturer valid?
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. When we cite a manufacturer's study, we try to say so and indicate how many people took part in the test: the number of subjects is information that changes 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 regulatory 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 this 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 body's structure, 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 complement a dermatological treatment plan, but when it comes to a disease, the point of reference remains the doctor.
Is cosmeceuticals recognized outside Europe?
It does not exist as a legal category even in the United States. In Japan and Korea, however, regulated intermediate categories do exist, which is one of the reasons 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; the 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 body of available studies.
Where to continue
The guide to cosmetic ingredients, to learn how to read an INCI · Why buy cosmetics from a pharmacy · Peptides in cosmetics · Retinol: what it does and doesn't do.
