When Your EU Cosmetic Becomes an FDA Drug: What European Exporters Must Know

A French skincare brand spends two years developing a serum, completes the EU notification process on the Cosmetic Products Notification Portal (CPNP) without incident, and begins planning its US launch. Then FDA’s customs partner flags the first shipment at a port of entry. The reason? The brand’s website described the product as “clinically proven to stimulate collagen production” — four words that, in FDA’s framework, reclassified a duly notified EU cosmetic as an unapproved new drug.

This scenario plays out with regularity. And it’s almost always preventable.

The EU and US approaches to cosmetic regulation share some DNA but diverge in ways that matter enormously at the border. European brands entering the US market without a claim-by-claim regulatory review are taking on considerably more risk than they realise.

Two Regulators, Two Definitions — and a Meaningful Gap

EU Regulation 1223/2009, Article 2(1)(a), defines a cosmetic product as one applied to the human body “exclusively or mainly” to clean, perfume, change appearance, protect, keep in good condition, or correct body odours. The phrase exclusively or mainly creates some regulatory room. It allows European brands to speak to the physiological basis of their product’s effect — provided the primary purpose is cosmetic, not therapeutic.

FDA operates under a binary framework with no such flexibility. The Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 201(i) defines cosmetics as products intended to cleanse, beautify, promote attractiveness, or alter appearance. Section 201(g) defines a drug as any article “intended to affect the structure or any function of the body” or intended for “use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” There is no middle category.

The word “cosmeceutical” — used constantly in European trade press, at industry congresses, in supplier pitch decks — has no legal meaning under US federal law. FDA has stated this position repeatedly over the years, and it continues to govern enforcement. A product is either a cosmetic or a drug (or in some cases, both). The deciding factor is almost always the claimed intended use.

Practically, this means a claim that is routine on a CPNP-notified EU product can automatically reclassify that same product as an unapproved drug the moment it enters US commerce — even if the formulation itself is unchanged.

The Claims That Most Consistently Trigger FDA Drug Status

FDA’s determination of intended use draws on every consumer-facing communication associated with a product: physical labelling, website copy, social media posts, influencer briefs, press releases, and distributor sales materials. All of it is in scope. Brands receive warning letters for website claims that don’t appear anywhere on the physical product label.

Several claim categories produce the most enforcement activity against European-origin products.

Mechanism-of-action language. “Stimulates collagen synthesis,” “activates epidermal stem cells,” “modulates sebum production at the follicular level.” Describing what a product does at a cellular or physiological level crosses from altering appearance to affecting the body’s structure or function — the Section 201(g) trigger. In the EU, such claims are regulated under Regulation (EC) No 655/2013 on cosmetic claim criteria and require substantiation, but they are legally permissible. Under FDA rules, the underlying science is irrelevant; the intent implied by the language is what governs classification.

Disease treatment or prevention language. “Treats eczema-prone skin,” “prevents UV-induced DNA damage,” “reduces the risk of infection.” The verb treats is almost categorically disqualifying. So is prevents when it attaches to a recognised pathological condition. “Soothes dry, sensitive skin” generally survives scrutiny; “prevents atopic dermatitis flare-ups” does not.

Hair loss and scalp claims. “Promotes hair regrowth” or “reduces hair thinning due to hormonal changes” positions a shampoo or treatment as an unapproved drug. Minoxidil — the only FDA-recognised OTC active ingredient for hair regrowth — is regulated as a drug. Any product making growth-adjacent claims without minoxidil at approved concentrations is effectively marketing an unapproved drug.

Antiperspirant claims. This is the one that reliably surprises European brands. In the US, antiperspirants are classified as OTC drugs, not cosmetics. A product sold freely as a deodorant in the EU — including those containing aluminium-based actives — must be registered under the OTC antiperspirant monograph if it claims to reduce sweating. Labelling it a “natural deodorant” while describing sweat reduction benefits doesn’t resolve the issue. FDA looks at the claim, not the marketing framing.

Anti-dandruff and anti-acne claims. Both categories fall under recognised OTC monographs. A shampoo that claims to “control dandruff” must contain an FDA-recognised active — zinc pyrithione, selenium sulfide, ketoconazole, or coal tar — at the correct concentration and meet monograph labelling requirements exactly. Many EU anti-dandruff formulations use actives that are not on FDA’s monograph list.

The Sunscreen Problem: Europe’s Most Common Classification Trap

If there is one area where EU-to-US market entry produces the most import refusals and the most expensive surprises, it is sunscreens.

EU Annex VI of Regulation 1223/2009 lists approximately 28 approved UV filter substances. Many of the most effective modern filters — Tinosorb S (bis-ethylhexyloxyphenol methoxyphenyl triazine), Tinosorb M (methylene bis-benzotriazolyl tetramethylbutylphenol), Mexoryl SX (ecamsule), and Mexoryl XL — are fully approved in the EU and widely used in European prestige and mass-market sunscreens. They’re not exotic; they’re standard.

None of them are FDA-approved for use in US sunscreens.

FDA’s OTC sunscreen monograph, as updated through a 2019 proposed rule and further refined under the CARES Act framework, currently recognises exactly 2 UV filter substances as generally recognised as safe and effective (GRASE): zinc oxide and titanium dioxide. The remaining filters that appeared in earlier versions of the monograph are under active safety review, with FDA requesting additional safety data. Tinosorb S, Tinosorb M, Mexoryl SX, and Mexoryl XL are in the category FDA terms “not yet GRASE” — which means, in practice, that a US sunscreen containing them is formulated with an unapproved new drug ingredient.

A European brand selling a high-SPF sunscreen in the EU that uses any of those filters cannot sell that product in the US without either reformulating entirely or pursuing a New Drug Application (NDA) route — not a commercially viable path for most cosmetics companies. Reformulating to zinc oxide and titanium dioxide only while preserving the SPF performance and cosmetic texture of a European formulation is technically demanding and typically pushes manufacturing costs up substantially.

This is probably the single highest-impact regulatory gap for European beauty brands entering the US market, and it continues to catch out companies that assume EU regulatory approval translates in any meaningful way to FDA acceptance.

What FDA Reclassification Actually Looks Like in Practice

The consequences of entering the US market with a misclassified product range from operationally disruptive to brand-damaging.

At the border. FDA works with US Customs and Border Protection to flag suspect shipments. A product suspected of being an unapproved new drug can be refused entry without physical examination of the goods. Once an import alert is issued under FDA’s Automatic Detention system (commonly called the “Red List”), every subsequent shipment from the same foreign establishment is detained at the port of entry until the alert is resolved. Clearing an import alert requires a formal response to FDA with documented corrective action — a process that typically takes between 6 and 18 months from submission to resolution, depending on the nature of the violation.

Products already in US commerce. If a misclassified product is already available through a US distributor, on Amazon’s US marketplace, or via direct-to-consumer shipping, FDA can issue a warning letter. Warning letters are public — posted to FDA’s database and indexed by media and compliance monitoring services. Retail partners and Amazon’s Brand Registry compliance team actively track these publications. A warning letter can trigger delistings from major e-commerce and retail accounts before the brand has even had an opportunity to respond to the agency.

Under MoCRA. The Modernization of Cosmetics Regulation Act of 2022 — which came into force for large companies in late 2023 and for smaller businesses in stages through 2024 — gave FDA mandatory recall authority over cosmetic products for the first time. For products that straddle the cosmetic-drug classification line and involve a genuine safety concern, FDA now has the authority to compel a recall rather than request one voluntarily. This materially changes the risk calculus for brands operating in classification gray zones.

How to Audit Your Claims Before Entering the US Market

Most classification risks are identifiable — and correctable — before a product ever ships. The following audit sequence is what we walk European clients through before any US market entry begins.

Step 1: Map every consumer touchpoint. Collect all consumer-facing communications: physical label, outer carton, product insert, website (all language versions), social media accounts, influencer briefs, retail sales decks, and any press releases issued since launch. FDA’s intended use determination is not limited to the label. It encompasses everything.

Step 2: Screen your formulation against OTC monograph actives. Some ingredients trigger drug classification based on the formulation itself, independent of marketing claims. Benzoyl peroxide, salicylic acid at concentrations above certain thresholds, fluoride in oral care products, and aluminium chlorohydrate are examples of ingredients with recognized drug uses that may attract FDA scrutiny even without explicit drug claims on the label.

Step 3: Audit every UV filter. If your product carries any SPF rating or contains a UV filter of any kind, cross-reference each filter against FDA’s current GRASE list. Any filter other than zinc oxide or titanium dioxide requires either reformulation or an NDA — full stop. This applies to products positioned as tinted moisturisers, daily face creams, and lip products with sun protection, not just dedicated sunscreens.

Step 4: Replace mechanism language with appearance language. “Visibly reduces the appearance of fine lines over 28 days” is a cosmetic claim in both EU and US frameworks. “Reduces fine lines by upregulating fibroblast collagen synthesis” is a drug claim under FDA rules. Your EU substantiation data can remain intact; it’s the claim language that needs to shift. An independent claim-by-claim review — not just a light edit — is the safest approach.

Step 5: Confirm facility registration under MoCRA. Since January 2024, foreign cosmetic manufacturers selling into the US market are required to register their manufacturing facilities with FDA and submit product listings. This doesn’t change classification rules, but an unregistered facility is itself a compliance violation — and registration triggers FDA visibility over your product portfolio.

The cost of a pre-market regulatory assessment is measurably smaller than the cost of clearing an import alert under time pressure, managing a public warning letter, or reformulating a product after it’s already in US retail channels. European brands that treat the US regulatory review as a launch-phase investment consistently have smoother entries than those who treat it as optional.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

Talk to our team about EU market entry before your US launch. Contact us

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