Cosmetics rules compared: the US (FDA and MoCRA), Korea (MFDS) and Malaysia (NPRA)
Every country draws its own line between a cosmetic and a medicine, and decides who checks a product before it reaches a shelf. For anyone who buys American skincare in Malaysia, or Korean sunscreen in the US, these differences explain why the same product can carry two labels, why some products can't be sold in some countries, and what protection a buyer actually has.
- US: cosmetics need no FDA approval before sale, but since MoCRA (2022) facilities register, products are listed, safety must be substantiated and serious adverse events reported. Sunscreens and acne products are OTC drugs.
- Korea: general cosmetics are the manufacturer's responsibility; functional cosmetics (brightening, anti-wrinkle, UV protection and others) need MFDS review or a report before sale.
- Malaysia: every cosmetic must be notified to the NPRA by a local company before it is imported or sold; sunscreens are cosmetics under the ASEAN system.
- In all three, the company is responsible for safety. Regulators mostly act after problems appear.
United States: FDA and MoCRA
US law defines a cosmetic by intended use: articles applied to the body for cleansing, beautifying, promoting attractiveness or altering the appearance. If a product is intended to treat or prevent disease or affect the body's structure or function, it is a drug, or both a cosmetic and a drug. Sunscreens, acne treatments, antiperspirants and anti-dandruff shampoos fall in the "both" group and follow over-the-counter drug rules, including approved active ingredients and a Drug Facts label.
For ordinary cosmetics, the FDA does not approve products or most ingredients before sale (color additives are the main exception). The Modernization of Cosmetics Regulation Act of 2022, which the FDA describes as the most significant expansion of its authority over cosmetics since 1938, added:
- Facility registration, renewed every two years, and product listing, updated annually; enforcement of these began on 1 July 2024.
- Safety substantiation: companies must have adequate evidence that a product is safe. Animal testing is not required by the law.
- Serious adverse event reporting to the FDA within 15 business days.
- Mandatory recall authority and access to safety records.
- Rules the FDA must write on good manufacturing practice, fragrance allergen labelling and asbestos testing of talc-containing products. Not all of these were final at the time of writing.
Small businesses have some exemptions. MoCRA does not create pre-market approval.
South Korea: MFDS and functional cosmetics
Korea's Cosmetics Act is administered by the Ministry of Food and Drug Safety (MFDS). General cosmetics can be sold without pre-market approval, with the responsible seller accountable for safety and labelling. A separate category, functional cosmetics, covers products with specific efficacy claims. It began with whitening (brightening), wrinkle improvement and UV protection, and was widened in 2017 to include, among others, hair-loss relief, acne-relief rinse-off products and products easing dryness linked to atopic skin. Functional cosmetics must undergo an MFDS efficacy and safety evaluation, or a report for those using pre-approved ingredients and standards, before they can carry their claims.
Sunscreens are functional cosmetics, not drugs, and SPF and PA values have to be supported by testing. That is one reason Korean brands can launch new sunscreen formulas quickly with a wide range of UV filters. In August 2026, the MFDS also proposed allowing in-vitro test methods for SPF and PA alongside human testing.
Malaysia: NPRA notification
Malaysia regulates cosmetics through the Control of Drugs and Cosmetics Regulations 1984 and the Guidelines for Control of Cosmetic Products, managed by the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health. The system follows the ASEAN Cosmetic Directive, which harmonizes ingredient lists across Southeast Asia, including the list of permitted UV filters.
- Notification before sale: a local company, the notification holder, must notify each product to the NPRA through its online system before it is manufactured, imported or sold. Notification is valid for two years and must be renewed.
- Ingredient rules: products must comply with the annexes of prohibited and restricted substances, permitted preservatives, colours and UV filters. The annexes are updated regularly; a 2026 circular, for example, removed the UV filter 4-methylbenzylidene camphor from the permitted list, with a transition period for products already notified.
- Labelling: in Bahasa Malaysia and/or English.
- Public search: the NPRA's website has a product search where consumers can check whether a product is notified.
- Enforcement: the NPRA regularly announces cancelled notifications for products found to contain prohibited substances, such as mercury, hydroquinone or tretinoin in products sold as cosmetics.
Sunscreens are cosmetics in Malaysia, as in the EU. A US sunscreen sold there needs to be notified like any other cosmetic, and its UV filters must be on the ASEAN list at permitted levels.
Comparison table
| Question | United States | South Korea | Malaysia |
|---|---|---|---|
| Regulator | FDA | MFDS | NPRA (Ministry of Health) |
| Pre-market approval for ordinary cosmetics | No; registration and listing | No | No approval, but mandatory notification |
| Sunscreen status | OTC drug | Functional cosmetic | Cosmetic |
| UV filter list | FDA monograph | MFDS list | ASEAN Annex VII |
| Claims needing review | Drug claims (OTC rules) | Functional claims | Claims must comply with guidelines; no drug claims |
| Adverse events | Serious events reported by companies in 15 business days | Reported to MFDS | Reported to NPRA by notification holders; consumers can complain |
What it means for you
- "FDA approved" on a US cosmetic is a red flag. The FDA does not approve cosmetics. Approved drug products, such as adapalene, are a different matter.
- In Malaysia, check the notification. A product sold locally without notification may be a grey import or a counterfeit. Our guide to buying US beauty products from abroad explains the practical checks.
- Sunscreens differ most. The same brand may sell different formulas in the US and Asia because of different filter lists. See US and Asian sunscreens.
- Rules explain style. Our overview of US and Asian skincare philosophies shows how these frameworks shape products.
Sources
- US Food and Drug Administration, "Modernization of Cosmetics Regulation Act of 2022 (MoCRA)", FDA, consulted October 2026.
- US Food and Drug Administration, "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)", FDA, consulted October 2026.
- National Pharmaceutical Regulatory Agency (NPRA), Guidelines for Control of Cosmetic Products in Malaysia, and Circular 1/2026 on ASEAN Cosmetic Directive annexes, NPRA, 2022–2026.
- Ministry of Food and Drug Safety (Korea), Cosmetics Act and Regulation on the Evaluation of Functional Cosmetics; draft amendment on in-vitro SPF and PA testing, August 2026, as summarized by regulatory publications.
- ASEAN Cosmetic Committee, ASEAN Cosmetic Directive and annexes.
US and Asian skincareUS and Asian skincare: two philosophies
Drug-category actives and dermatologist branding versus layering, textures and 'functional cosmetics': where the differences come from.
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Why a Korean SPF 50+ PA++++ and a US 'broad spectrum SPF 50' are labelled so differently, and what the filters are.