A Korean State Permit Is an American Lawsuit Waiting to Happen
South Korea licenses cosmetic claims. Eleven categories are written into the enforcement rule of its Cosmetics Act, and wrinkle improvement, skin whitening and UV protection are three of them; 524 functional-cosmetic filings cleared in the first half of 2023, 89 percent of them domestic. The United States pre-approves no cosmetic product or ingredient at all, colour additives aside. The same sentence is a state-issued permit in Seoul and a change of legal category in the United States.
What does a claim do to a product's legal category?
The Federal Food, Drug, and Cosmetic Act defines a cosmetic at section 201(i) as an article applied to the body for cleansing, beautifying, promoting attractiveness or altering the appearance. It defines a drug at section 201(g)(1) as 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. Nothing in either definition refers to what is in the jar. Both turn on intended use.
Intended use is established from the label, the packaging, the website, advertising and promotional material, from why consumers buy the product and what they expect it to do, and from ingredients with a well-known therapeutic reputation. A product can satisfy both definitions at once, and a great many do: anti-dandruff shampoo, fluoride toothpaste, antiperspirant deodorant and any moisturiser carrying an SPF number are each a cosmetic and a drug simultaneously, and have to meet both sets of requirements.
The consequence follows mechanically. A cosmetic that claims to affect the structure or function of the body is a drug. A drug marketed without an approved application is an unapproved new drug under section 505(a). At no point in that sequence does anyone examine the formulation.
Why is the same claim ordinary business in Korea?
Korea built a licensing route for exactly the claims the American definition treats as drug claims. The eleven functional-cosmetic categories cover prevention of melanin formation, lightening of existing pigmentation, skin elasticity and wrinkle improvement, tanning and UV protection, UV blocking and scattering, hair colouring, hair removal, relief of hair-loss symptoms, relief for acne-prone skin in rinse-off products, skin barrier restoration for itch relief, and reduction in the appearance of stretch marks.
Two routes lead into that list. A full evaluation at the National Institute of Food and Drug Safety Evaluation applies to novel ingredients or non-standard formulations and requires a safety and efficacy dossier. A simplified report applies where a product uses ministry-notified ingredients at specified concentrations, or matches a product already approved for the same manufacturer. Either way the claim ends up certified by the state before the product ships.
The volume is the point. Of the single-efficacy filings cleared in the first half of 2023, UV filters accounted for 52.5 percent, hair-loss relief for 19.7 percent, hair dye for 7.9 percent, acne relief for 6.6 percent, whitening for 5.5 percent and wrinkle improvement for 4.4 percent. Ninety-two more products cleared carrying all three of whitening, wrinkle improvement and UV protection at once. Stacking certified claims is a normal competitive move in the domestic market, not an act of marketing excess.
What does the United States offer in place of that licence?
Nothing equivalent. The Food and Drug Administration does not pre-approve cosmetic products or ingredients, with the narrow exception of some colour additives. There is no American filing that converts a wrinkle claim into a cleared claim, because there is no American category between cosmetic and drug for it to land in.
The Modernization of Cosmetics Regulation Act does not create one. It requires facilities to register with the FDA, renew every two years and update within 60 days of a change; it requires a responsible person to list each marketed product with its ingredients and update annually; it requires adequate substantiation of safety, with records to support it; and it adds adverse event reporting and new labelling rules covering fragrance allergens and asbestos testing in talc. Efficacy is absent from that list. Registration under this regime is a filing, not a clearance.
That distinction is worth stating plainly because the registration numbers are read as progress. Korean facilities registered with the FDA reached 947 by the end of June 2026, up from 617 in January of the previous year, a rise of 53.5 percent. None of those 947 registrations approves a single claim. Authority over the claims themselves is split: the FDA decides what the product legally is and governs its labelling, and the Federal Trade Commission polices whether the advertising is truthful, not misleading and adequately supported.
Which sentences has the agency actually objected to?
The record is specific rather than abstract. Language the FDA has cited in warning letters to cosmetic sellers includes enhancing the production of elastin and collagen in the skin, supporting the synthesis of new skin fibres and boosting cell regeneration, reducing the depth of wrinkles by attenuating muscle contraction, repairing the DNA of the skin, and healing damaged skin from scars and burns. Avon and Lancome received letters of this kind in 2012, and smaller sellers have received them steadily since.
The enforcement continues under current law. A warning letter dated 2 April 2026 to a Michigan contract manufacturer addressed products marketed for shingles and for genital herpes relief, citing sections 501(a)(2)(A) and 501(a)(2)(B) for adulteration, sections 301(d) and 505(a) for unapproved new drugs, and the current good manufacturing practice regulations at 21 CFR parts 210 and 211. The firm was directed to identify discontinued drugs by national drug code, engage a qualified consultant for manufacturing compliance, and respond within 15 working days.
One tool did disappear. Import Alert 66-38, covering skin care products labelled as anti-aging creams, operated for roughly three decades and was withdrawn in late 2017. Withdrawing a detention instrument changed nothing about the statutory definition it had been enforcing.
Does Korea let overclaiming pass at home?
It does not, and assuming otherwise gets the comparison backwards. Article 13 of the Cosmetics Act prohibits labelling or advertising that leads consumers to mistake a cosmetic for a drug, that presents a non-functional cosmetic as a functional one, or that departs from the safety and efficacy review result. Article 14 requires a company to be able to substantiate factual claims and to produce the evidence within 15 days of a ministry request.
Enforcement runs at scale. Between January 2021 and September 2025 the drug safety ministry identified 12,617 instances of improper cosmetic advertising, and 8,727 of them — roughly 70 percent — involved language creating confusion with medicines, such as skin regeneration, inflammation relief and acne improvement. Between 13 March and 15 April 2026 ten companies were penalised, with advertising or sales suspensions running from 15 days to four months, and three manufacturing registrations cancelled outright.
So the difference between the two markets is not vigilance. It is what the violation does to the product. In Korea the advertisement is punished and the product remains a cosmetic on the shelf. In the United States the product stops being a cosmetic, and a consignment of goods that are legally unapproved new drugs does not enter.
What does sunscreen show that nothing else does?
Sunscreen is the clean case, because the product is identical and only the classification moves. Korea treats UV protection as a functional cosmetic, and UV filters made up more than half of all single-efficacy filings cleared in the first half of 2023. The United States treats sunscreen as an over-the-counter drug, which brings with it monograph compliance, a Drug Facts panel and drug establishment registration.
The ingredient list moves with the classification. A University of Miami law review analysis of the pathway for bemotrizinol, a UV filter long available outside the United States, put the American route at roughly $18 million and more than ten years of safety testing, followed by two to three years of FDA review and a 45-day comment period. The same analysis put the Korean route at four to six months once clinical data is submitted, with a 60-day comment period. The FDA has approved no new UV filter since 1999.
A Korean sunscreen does not fail in the United States because it performs badly. It fails because the filter that gives it its texture has no American monograph, and because the sentence describing what it does moves it into a category with a ten-year queue.
What happens when that question is put directly?
I once sat down with a manufacturing team whose formulation capability was, by any measure, world-class. Their launch deck was another matter. Skimming it, you would have concluded they were selling a fountain of youth. Before raising a single ingredient, I asked the question the whole document turned on: did they intend to launch the line overseas as an OTC drug?
There was a long pause. They did not, not at that stage — which I had already assumed, because neither the budget nor the international compliance function was there. My reply was that almost everything written in the deck therefore had to go. None of that exchange concerned the quality of the formulation, which was never in doubt. It concerned which of two regulatory objects the document had just described.
Domestic selling absorbs a stretched claim, because a pitch can be qualified in the room and a certificate can be produced on request. Export does not work that way. A buyer gives a label a second of attention on a shelf or a screen, and a customs officer gives it less. The claim has to survive alone.
Where does the cost of a rewritten claim actually land?
A deck built for the domestic licence has to be dismantled before it travels, and the dismantling is not a copywriting exercise. Removing the claim is the cheap outcome. Keeping it means the drug pathway: establishment registration, a national drug code, a Drug Facts panel in place of the marketing panel, and manufacturing under 21 CFR parts 210 and 211, with the documentation burden that carries. For a manufacturer whose compliance function was built to file functional-cosmetic reports with one ministry, that is not a budget line. It is a different company.
The border keeps the score. American refusals of Korean cosmetics reached 171 product lines in fiscal 2026, against 158 across the whole of fiscal 2025, in the same period that registered Korean facilities rose 53.5 percent. Registrations and refusals are rising together, which is what happens when entry volume grows faster than the compliance function behind it.
Why do strong technical teams write the deck this way?
The habit is structural, not a failure of judgement. In a market where the state certifies eleven claim categories, claim strength is a legitimate axis of competition and a formulation team can win on it directly. A triple-efficacy certificate is evidence of laboratory work, obtained through a filing, defensible against a regulator. Ninety-two products cleared on that basis in a single half-year.
Export strips out the certificate and leaves the habit intact. The deck still reads as a list of proven functions, because in the market it was written for, the functions were proven — to the satisfaction of the only authority that was asked. The document that made the product credible at home is the document that reclassifies it abroad.
This is why claim review belongs before formulation review in any export assessment, and why a supplier's launch deck is diligence material rather than marketing collateral. The deck states, in the supplier's own words, which regulatory regime they have been operating in.
What does this look like from three sides?
For manufacturers, formulation capability and claim capability are licensed separately, and only one of them crosses a border. Engineering depth transfers intact; the certificate that made the engineering sayable does not. A firm that can build the formula and cannot fund the drug pathway has a real product and no legal sentence to sell it with.
For brands and buyers, a Korean functional-cosmetic certificate is a Korean clearance and nothing else. A supplier presenting one as evidence of export readiness has disclosed something useful about their regulatory function, and the disclosure is free. Reading the claims before reading the ingredient list reverses the usual order of diligence and catches the expensive problem first.
For regulators and investors, 947 registered facilities counts filings, not cleared products, and the refusal line has risen alongside it. A registration figure describes how many Korean plants have told the FDA they exist. It describes nothing about how many of their products can legally say what their labels say.
The formula crosses the border. The claim does not.
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