Short answer: “Cosmeceutical” is a marketing word, not a regulatory one. The U.S. Food and Drug Administration says so in plain language: “The FD&C Act does not recognize any such category as ‘cosmeceuticals.’ A product can be a drug, a cosmetic, or a combination of both, but the term ‘cosmeceutical’ has no meaning under the law.” There is no third shelf. That does not make every product using the word dishonest — some are very good — it means the word carries no information, and you are back to judging the formula.

The word is free. The formulation is not.

Where the word came from

The credit here is worth getting right, because it is repeated carelessly almost everywhere. The dermatologist Albert Kligman — the University of Pennsylvania researcher behind topical tretinoin’s use in dermatology — introduced the term to the industry in 1984, at a national scientific meeting of the Society of Cosmetic Chemists, and gave it the definition that stuck: a topical preparation sold as a cosmetic but with performance characteristics that suggest pharmaceutical action. That is the version most review articles cite.

It may not be the first use. Several accounts in the cosmetic science literature trace the word further back, to Raymond Reed, a founding member of the U.S. Society of Cosmetic Chemists, around 1961. We could not verify an original Reed document, so treat that earlier date as contested. What is not contested is that Kligman is why the word entered wide circulation, as shorthand for products doing more than a conventional cosmetic while not being prescription drugs.

Whatever it meant among scientists, the marketing departments found it, and it stopped describing anything in particular. Today “cosmeceutical” appears on products ranging from serious, well-evidenced formulas to scented lotion in a heavy jar. Both uses are equally legal, because there is no rule to break.

What the law actually recognizes

Two categories, and they are defined by what the maker intends the product to do.

A cosmetic, in the statute’s words, is an article “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” — section 201(i) of the FD&C Act. A drug is an article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body of man or other animals” — section 201(g)(1).

That second half of the drug definition is where skincare gets caught. A product does not have to claim to cure anything; a claim to change how the body works can be enough. To illustrate rather than to state a legal test: saying a cream makes skin look firmer sits comfortably in cosmetic territory, while saying a cream rebuilds the skin’s structural proteins points toward a drug claim. Classification turns on intended use and the overall context of what a company says about its product, not on any single phrase in isolation.

Cosmetics do not go through FDA approval before sale. Color additives are the exception. Everything else reaches the shelf on the manufacturer’s own judgment, and regulators act afterwards if something goes wrong. That is the system. Knowing it changes how you read a label.

Intent decides, not ingredients

The same substance can land in either category depending on what the label says about it.

Toothpaste that cleans teeth is a cosmetic. Add fluoride and a cavity-prevention claim and it becomes a cosmetic and a drug at once. A shampoo that washes hair is a cosmetic. An anti-dandruff shampoo is both. Sunscreens marketed in the United States with sun-protection claims are regulated as over-the-counter drugs, governed by a monograph that dictates the wording permitted on the tube — and the same product may also perform cosmetic functions.

So there is no such thing as a “cosmeceutical ingredient.” There are ingredients, and there are the claims a company makes about them, and it is the claims and the intended use that determine how a product is regulated. This is why two products containing the same active at the same percentage can be treated differently. One brand wrote carefully. The other did not.

It also explains the strange, hedged phrasing on products that genuinely work. “Helps reduce the appearance of fine lines” reads as a cosmetic claim. Drop “appearance of” and the sentence starts pointing at what the product does to the body rather than to how it looks. That is why so much careful copy reads like legal throat-clearing.

What MoCRA changed, and what it left alone

The Modernization of Cosmetics Regulation Act was signed on December 29, 2022, as part of the Consolidated Appropriations Act, 2023. The FDA describes it as the most significant expansion of its authority to regulate cosmetics since the FD&C Act was passed in 1938. It matters, and it is routinely misreported.

In broad terms, it introduced facility registration and product listing with the FDA, a requirement to keep records supporting adequate safety substantiation, reporting of serious adverse events within 15 business days, expanded records access, mandatory recall authority for the FDA for the first time, and rulemaking on fragrance allergen labeling and good manufacturing practice.

The detail matters, and this is where most write-ups go wrong. MoCRA exempts certain small businesses from the GMP, registration and listing requirements — though not for products that regularly contact the mucous membrane of the eye, products that are injected, products intended for internal use, or products intended to alter appearance for more than 24 hours where the consumer does not remove them. Implementation has been phased: enforcement of registration and listing began on July 1, 2024. Several rulemakings are still outstanding. As of August 2026 the FDA has published draft guidance on cosmetic GMP but has not issued a final GMP regulation, and the fragrance allergen labeling rule has not been finalized either; the proposed rule on asbestos testing methods for talc-containing products was withdrawn in November 2025. Regulatory status in this area moves. Anyone relying on it for compliance should check current FDA guidance rather than a blog post.

What it did not do: create pre-market approval for cosmetics. Create a “cosmeceutical” category. Define “medical grade,” “clinical grade,” “pharmaceutical grade” or “physician dispensed.” Require anyone to prove a product works before selling it.

Read that list twice. MoCRA raised the floor on safety and traceability, which is genuinely good. It left efficacy exactly where it was — unverified before sale, and challengeable only afterwards.

The middle category exists — just not here

Here is the part that makes the word feel almost reasonable. The intermediate category people imagine when they hear “cosmeceutical” is real in other markets.

Japan regulates a class of quasi-drugs, sitting between cosmetics and pharmaceuticals, with approved active ingredients and permitted claims — whitening and anti-dandruff products are examples. South Korea has a functional cosmetics designation administered by its Ministry of Food and Drug Safety, covering skin whitening, wrinkle improvement and UV protection among other statutory headings, with a review process attached. In both systems a brand has to apply, submit data and be granted the status.

The European Union, meanwhile, works much as the United States does on this specific point. Regulation (EC) No 1223/2009 recognizes “cosmetic products”; the word “cosmeceutical” appears nowhere in it. The EU does require a safety assessment and a designated responsible person for every product placed on the market, which the United States does not, but that is a safety mechanism rather than an intermediate category.

So the category is not a fantasy. It just does not exist where you are shopping. A brand telling a U.S. customer that its product is “a cosmeceutical” is not describing an approval it obtained. It is describing an aspiration.

So what should you do with the word?

Ignore it, and look at the things the word is standing in for. Every one of these is something you can assess before you buy.

• Which actives are in it, and what does the ingredient list tell you? Under 21 CFR 701.3, a brand may group its declaration: ingredients above 1% in descending order of predominance, then ingredients at 1% or below in any order, then color additives in any order. That is useful context, but it does not let you locate an exact 1% line by eye, and a low position is a question rather than a verdict — several genuinely effective ingredients belong below 1%.
• Does the brand publish anything about concentration? Brands that publish their concentrations are telling you something useful. A brand that treats its formulation detail as confidential is not thereby confessing to a weak formula — proprietary formulation information is a normal commercial reality — but published detail is easier for you to evaluate than an unpublished claim.
• Is the packaging appropriate to the formula? Light, air and heat can affect the stability of some ingredients, and thoughtful packaging is designed with that in mind. Whether a given container suits a given formula depends on the formulation, the material and the stability work behind it.
• What does the brand say about how the product was developed? The useful question is who is responsible for the product’s development and formulation, and what relevant expertise supports that process. Good products come out of collaboration between brand product developers, cosmetic chemists, manufacturing laboratories and skincare professionals — no single named individual has to have done all of it.
• Is there any evidence on the finished product? Look at what the brand publishes about how the finished formula was tested, and by whom. Testing on a raw material is not testing on the product you are buying.

This is the same test that applies to “medical grade”, and for the same reason: both phrases are unregulated, and both are sometimes attached to excellent formulas. The phrase is never the evidence. The next article in this series takes apart three more of them — “dermatologist tested,” “dermatologist recommended” and “clinically proven” — which sound even more official and are governed just as loosely.

What we say about our own products

Esenté uses the phrase “clinical grade.” It is positioning rather than a regulatory category, and we would rather say so than let the phrase do work it has not earned — pretending otherwise would be the exact behavior this article is criticizing.

What we will stand behind are the checkable attributes: botanically based formulations, packed in Miron violet glass rather than clear plastic, and developed collaboratively by Victoria Nash with Esenté’s professional formulation and manufacturing partners. Victoria is a licensed aesthetician with long professional experience, and that experience informs the product direction, ingredient research and performance requirements she brings to that collaboration.

Apply the questions above to us. Apply them to every brand you buy from.

Frequently asked questions

What is a cosmeceutical?

It is an informal marketing term for a cosmetic product positioned as having drug-like benefits. The FDA states that the FD&C Act “does not recognize any such category as ‘cosmeceuticals’” and that the term “has no meaning under the law.” Legally, the product is a cosmetic, a drug, or both.

Are cosmeceuticals FDA approved?

No. The FDA does not approve cosmetics before they go on sale, and it does not recognize “cosmeceutical” as a category to approve. Color additives require approval, and over-the-counter drug products such as sunscreens are subject to their own regulatory framework.

Is there any difference between a cosmeceutical and a cosmetic?

Not in law. Brands may use the term to suggest a more performance-oriented or active-focused formulation, but the term itself provides no assurance of concentration, efficacy or formulation quality. Sometimes there is a serious formula behind it. The word will not tell you which case you are in.

Did the 2022 cosmetics law change any of this?

MoCRA, signed December 29, 2022, introduced facility registration, product listing, safety substantiation records, serious adverse event reporting and FDA recall authority, with exemptions for certain small businesses and phased implementation. Registration and listing enforcement began July 1, 2024, and some rulemaking, including the good manufacturing practice regulation, remained outstanding as of August 2026. It did not introduce pre-market approval and it did not create any category between cosmetics and drugs.

Do other countries recognize cosmeceuticals?

Not under that name, but Japan regulates quasi-drugs and South Korea regulates functional cosmetics, both of which are genuine intermediate categories with an application and review process. The EU and the U.S. have no equivalent — Regulation (EC) No 1223/2009 does not use the word at all.

If the word means nothing, why do good brands still use it?

Because customers search for it, and because the alternative — explaining active concentration, raw material grade and packaging stability on a box — does not fit on a box. The honest version is to use the shorthand and then publish the detail behind it.

What should I look at before buying?

Ingredient selection, formulation quality, packaging suited to the formula, credible product-development expertise behind it, and whatever the brand publishes about how the finished product was tested. Keeping an exact formulation confidential is normal commercial practice and tells you nothing about quality either way — so judge what is published.

About the author. Victoria Nash, founder of Esenté Skincare and Younger You Clinique, has been a licensed aesthetician since 2004 and is an experienced skincare educator.

Reviewed by Victoria Nash, licensed aesthetician and founder of Esenté Skincare & Younger You Clinique. This article is educational and is not medical advice. Ask your dermatologist or licensed skincare professional about your own skin.