Explainer

Where a Cosmetic Stops and a Drug Begins

The claim

“If a cream is on the shelf saying it does that, somebody approved the claim.”

The short answer

Intended use decides the category, and the marketing is the evidence. The same molecule in the same jar is a cosmetic or a drug depending on the sentence on the pack. Nobody pre-approves a cosmetic; MoCRA registration is not approval.

Evidence status

Settled

The Cosmetic Record · Published 2026-08-06 · Last checked 2026-08-06 · 26 sources · Corrections: none

1. Two definitions, one jar: intended use decides, and the marketing is the evidence

The United States defines both categories in a single section of one statute, and it defines them by purpose rather than by composition:

The term "cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.

The term "drug" means ... (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals ...

Neither definition mentions an ingredient, a concentration or a mechanism. Both hinge on the word intended, and that word has its own regulation. Under 21 CFR 201.128, intended use “refer[s] to the objective intent of the persons legally responsible for the labeling of an article”, and that intent “may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives”.² The marketing is not evidence of the category in a loose journalistic sense. It is the evidence the regulation names.

FDA gives three examples of how intended use is established: claims in labelling, advertising or on the internet; consumer perception, established through a product's reputation; and ingredients carrying a well-known therapeutic use, its example being fluoride in toothpaste. The same page gives the claims that flip a product across the line — “restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells” — and disposes of a marketing word: the Act “does not recognize any such category as ‘cosmeceuticals’ … the term ‘cosmeceutical’ has no meaning under the law”.³

This is enforced on live copy. In a warning letter dated 14 May 2026, FDA told a Minnesota seller its skin creams were unapproved new drugs, citing as evidence of intended use “as defined in 21 CFR 201.128” the exact sentences on the seller's own product pages: “Reduce acne, freckles, dark spots and tighten pores.”⁴ The formula was not what moved the product into the drug category. The webpage was.

A product can also be both at once — FDA's example is an antidandruff shampoo, a cosmetic because it cleanses the hair and a drug because it treats dandruff.³ The regulations say it in one line: “Any cosmetic product which is also a drug or device or component thereof is also subject to the requirements of Chapter V of the act.”⁵

2. Nobody approves a cosmetic — and MoCRA registration is not approval

FDA's own summary of its authority opens with the point: “The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market.”⁶ A drug takes the opposite route — an approved New Drug Application, or conformity with a monograph FDA has finalised for its category.³

The Modernization of Cosmetics Regulation Act of 2022 changed a great deal and did not change that. It added, at FD&C §607 (21 U.S.C. 364c), a duty on facilities manufacturing or processing cosmetic products for US distribution to register and renew biennially, and a duty on the responsible person to list each marketed product with its ingredients.⁸ Both duties fall away, at §612 (21 U.S.C. 364h), for responsible persons and facilities whose average annual US cosmetic sales over the previous three years are under $1,000,000, adjusted for inflation — unless they handle one of four listed product kinds: eye-mucosa contact, injected, internal use, or appearance-altering for more than 24 hours.²⁶ It added, at §608 (21 U.S.C. 364d), a duty to hold records showing “adequate substantiation of safety”, with an explicit carve-out for coal-tar hair dye.⁹ Neither is a licence.

The scale is the scale of a filing system, not a review system: FDA's published summary table records 16,398 unique, active facility registrations and 1,298,361 unique, active product listings, data as of 30 June 2026. The same page carries the sentence that settles the question:

Cosmetic product facility registration and product listing is neither a cosmetic approval program nor a promotional tool. FDA does not issue “certificates” for cosmetic product facility registrations or product listings.

MoCRA also gave the phrase “cosmetic product” a statutory meaning that will matter in section 4 below: “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product”.⁷

3. The same line in Europe and in Brazil

The European definition is drawn the same way — by purpose, with the word exclusively or mainly doing the work:

‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours

A product whose main purpose is to treat a disease is not covered by that definition and falls to the medicinal-products regime instead. Article 20(1) forbids text, names, trade marks, pictures and other signs “to imply that these products have characteristics or functions which they do not have”, and Regulation (EU) No 655/2013 sets the common criteria that give it teeth. Its first criterion is the one an English-language reader rarely expects: “Claims that indicate that the product has been authorised or approved by a competent authority within the Union shall not be allowed.”¹² In the EU it is not merely untrue to say a cosmetic was approved. It is prohibited to say it.

Brazil arrives at the same boundary through different furniture. Art. 3 XVI of RDC 907/2024 defines the class as “preparações” for external use with an exclusive or main cosmetic purpose; Art. 3 XVII–XVIII then splits it into Grau 1 and Grau 2 by four criteria, of which the last is the sanitary impact of “das finalidades de uso declaradas” — the declared purposes of use. What the product says it is for is written into the risk class itself, as intended use is written into the American category. (Grau 2 is a risk grade and not a registration status, a distinction we take apart separately in In Brazil, “Grau 2” Does Not Mean “Registered”.) The label rule states the prohibition directly:

Art. 12. A rotulagem não deve conter nome comercial, marcas, imagens, links eletrônicos ou dizeres que:
[...]
II - representem alegações terapêuticas atribuídas ao uso do produto ou de seus ingredientes, como, por exemplo, prevenção ou tratamento de hematomas, feridas, rachaduras, dores, inflamações, câimbras, varizes, pediculose [...];
[...]
IV - mencionem a propriedade desinfetante ou que se refiram à eliminação completa de microrganismos

Nine groups require registro under Art. 34; everything else goes through comunicação prévia under Art. 35, which is a filing rather than an assessment.¹³

4. Applicators are not cosmetics

A brush, a sponge, a lash comb and a powder puff are not cosmetics in any of the three markets, and the reason is in the definitions already quoted. The European one reaches “any substance or mixture”; a brush is neither.¹¹ The American registration and listing scheme reaches a “cosmetic product”, which MoCRA defines as a preparation of cosmetic ingredients with a set composition.⁷ The Brazilian definition reaches “preparações”.¹³ An implement is not a preparation.

General consumer product law governs it instead. In the European Union that is the General Product Safety Regulation, which applies “to products that are placed or made available on the market insofar as there are no specific provisions with the same objective under Union law which regulate the safety of the products concerned” and imposes one obligation: “Economic operators shall place or make available on the market only safe products.”¹⁴ In the United States the Consumer Product Safety Act's definition of “consumer product” excludes “drugs, devices, or cosmetics”; an article that is none of the three is left inside the Consumer Product Safety Commission's remit.¹⁷

This matters most for one claim. A brush sold as antibacterial is not making a cosmetic claim, because the brush is not a cosmetic — it is making a biocidal or pesticidal one, and both the EU and the US have a separate regime waiting for it. In the EU an article treated with or intentionally incorporating a biocidal product is a “treated article” under Regulation (EU) No 528/2012. Article 58(2) bars placing it on the market unless every active substance is on the approved list for the relevant product-type, and Article 58(3) requires the label to say the article incorporates biocidal products and to name every active substance — triggered precisely when “a claim is made by the manufacturer of that treated article regarding the biocidal properties of the article”.¹⁵

The American rule turns on who the treatment protects. 40 CFR 152.25(a) exempts from the Federal Insecticide, Fungicide, and Rodenticide Act “[a]n article or substance treated with, or containing, a pesticide to protect the article or substance itself …, if the pesticide is registered for such use”.¹⁶ A brush treated to stop the bristles going mouldy is inside the exemption. A brush advertised as protecting the person using it is outside it, and outside it the claim is a pesticide claim. In Brazil, Art. 12 IV of RDC 907/2024 forbids disinfectant claims on cosmetics outright; which Brazilian regime governs an antimicrobial claim on the implement itself is one of the things we could not establish, and it is recorded below.

5. Sunscreen: the cleanest split in the subject

One molecule shows the whole argument. Bemotrizinol — Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, CAS 187393-00-6 — sits at entry 25 of Annex VI to Regulation (EC) No 1223/2009, the list of UV filters allowed in cosmetic products, at a maximum of 10 % in the ready-for-use preparation. It is in the base text of the Regulation, not an amendment.¹¹

In the United States the same molecule is a drug active, because a sunscreen is a drug: its purpose is to affect the structure or function of the body. On 10 June 2026 FDA announced the availability of final order OTC000039, issued under FD&C Act §505G(b)(1) (21 U.S.C. 355h(b)(1)), amending OTC Monograph M020 “to add bemotrizinol at concentrations up to 6 percent as a sunscreen active ingredient” — on a request filed by DSM Nutritional Products LLC on 23 September 2024.¹⁸ So the same substance is capped at 10% as a cosmetic ingredient in Europe and at 6% as a drug active in the United States, and the American ceiling arrived in 2026 against a European entry that has stood in the base text of a 2009 regulation.

Brazil takes the third position. Sunscreen is Grau 2, listed at item II nº 41 of Anexo I to RDC 907/2024, and it is one of the nine groups at Art. 34 that require registro rather than notification; permitted UV filters are set out in RDC 600/2022.¹⁹ A drug in one market, a cosmetic subject to a positive list in the second, a cosmetic subject to pre-market registration in the third.

6. What this does to the sentences on the pack

Once the category follows the claim, the copywriting becomes the regulated act. A cosmetic may say what it does to appearance; the moment it says what it does to a disease or to the structure or function of the body, it has asked to be judged as a drug, and in the United States as an unapproved one, because almost none of these products has an approved application or a finalised monograph behind it.

Two further prohibitions close the obvious escape routes. Criterion 1(3) of the EU common criteria bars claims “which convey the idea that a product has a specific benefit when this benefit is mere compliance with minimum legal requirements”, and criterion 3(6) requires a claim extrapolating an ingredient's properties to the finished product to be supported by evidence “such as by demonstrating the presence of the ingredient at an effective concentration”.¹² Brazil's Art. 12 II bans therapeutic claims by naming them — bruises, wounds, cracks, pain, inflammation, cramps, varicose veins, head lice.¹³ All of it is written down in advance; none of it is read by anybody before the product ships.

7. On the other side of the line: what the regulated version is, and what it costs

Hair reduction is a useful test case, because there is a cosmetic version and a regulated version and they claim different things. The regulated version is a device in all three markets. In the United States a laser for this purpose is classified at 21 CFR 878.4810, Class II, product code GEX, and reaches the market through a 510(k) clearance. The indication wording is precise, and it is a reduction claim rather than a removal claim. Clearance K180353 reads: “Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.”²²

The European Union reaches the same equipment from the other direction, by extending the Medical Devices Regulation to a listed group of products that have no medical purpose at all:

5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.

Brazil says it in one sentence, at Art. 2 §6 of RDC 751/2022: “Os dispositivos ativos (equipamentos) indicados para correção estética e embelezamento são considerados dispositivos médicos.” The same article's §5 expressly excludes cosmetics.²¹

What that regime costs can be read off published price lists rather than estimated. Three were opened on 6 August 2026, one in each market. A course of six sessions on a single area is listed at US$599 to US$899 on the American list, which was showing no promotion²⁴. The London list prices its individual areas, also over six sessions, at £399 to £749, marked down on the day to £329 to £529, and prints per-session equivalents of £55 to £89 against the marked-down figures.²³ The Brazilian page sells a pacote completo with no session count stated, at list prices of R$899 to R$3.890, marked down on the day to R$99 to R$1.342,60.²⁵ The largest single package on each list is US$2,500, £2,069 — reduced to £1,449, or £242 a session — and R$3.890. No clinic is named in this section, deliberately. One of the three exhibits belongs to this site's publisher and is labelled as such where it is cited.

8. Why the price gap is the engine of the overstated claim

Set the two side by side. A device course that may lawfully claim long-term stable reduction, measured at 6, 9 and 12 months, is priced in the hundreds. A depilatory cream — in Brazil a Grau 2 cosmetic, item II nº 15 of Anexo I, Depilatório químico, carrying the mandated warnings at Art. 24 VII — is priced the way supermarket toiletries are priced.¹³ The cheaper product cannot make the more valuable claim, because that claim is a structure-or-function claim, and making it moves the product into a category with an application, a monograph or a conformity assessment attached.

That is the pressure that produces the sentences this site keeps correcting. Not “permanently reduces hair”, which is a device claim, but a word beside it carrying the same suggestion without triggering the definition. The regulators have named the manoeuvre: Article 20(1) bars implying characteristics or functions a product does not have, and criterion 4(1) of the common criteria bars presentations of performance going “beyond the available supporting evidence”.¹²

Be plain about the status of this section. The definitions, the categories and the prices are documented. That the price gap causes the overstatement is an argument about incentives, not a finding: we did not locate a study measuring claim inflation against price differentials, and none is cited above.