North America · United States
What does it take to sell cosmetics in United States? Entry route, responsibility, labeling
No pre-market approval — MoCRA requires facility registration (renewed every two years) a…; Responsible person: A 'responsible person' is the manufacturer, packer or distr…; Labeling: English labelling per 21 CFR 701 and the FPLA (id….
Latest change 2025-11-28 — FDA withdrew its Dec-2024 proposed rule on asbestos testing of talc-containing cosmetics; the statutory GMP and fragrance-allergen rules remain overdue (allergen and formaldehyde hair-smoothing NPRMs now targeted for Nov 2026), FDA issued its PFAS-in-cosmetics report on 2025-12-29 and first biennial facility-registration renewals fell due from Dec 2025. Sumber
Ringkasan pihak pabrik; teks resmi tetap berlaku; bukan nasihat hukum.
- Otoritas
- U.S. Food and Drug Administration (FDA)
- Regulasi utama
- 21 U.S.C. §§ 361–364k; MoCRA (Pub. L. 117-328, Div. FF, Title III, Subtitle E) · Federal Food, Drug, and Cosmetic Act (FD&C Act) Chapter VI as amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), plus the Fair Packaging and Labeling Act for labelling
- Berlaku
- 2022-12-29
- Masuk pasar
- No pre-market approval — MoCRA requires facility registration (renewed every two years) and product listing (updated annually) through FDA's Cosmetics Direct portal, enforced since 2024-07-01; color additives need FDA approval and sunscreens/anti-dandruff products are OTC drugs.
- Orang yang bertanggung jawab
- A 'responsible person' is the manufacturer, packer or distributor whose name appears on the label; a U.S. address is not mandated, but foreign facilities must name a U.S. agent and the responsible person must handle adverse-event reporting.
- Dokumen keamanan
- Adequate safety-substantiation records (tests, studies or other evidence) must be kept for each product; serious adverse events must be reported to FDA within 15 business days and records kept 6 years.
- Pelabelan
- English labelling per 21 CFR 701 and the FPLA (identity, net contents, ingredients in descending order, warnings, responsible person name/address); MoCRA adds a domestic address/phone or e-mail for adverse-event contact and professional-use statements; fragrance-allergen disclosure starts only once FDA's pending rule is final.
- Pengujian pada hewan
- No federal ban (FDA does not require animal testing); about a dozen states, e.g. California and New York, prohibit selling cosmetics newly tested on animals.
- Daftar bahan
- No annex system — 21 CFR 700 (prohibited/restricted ingredients such as mercury and chloroform), 21 CFR 73/74/82 approved color additives, plus MoCRA-mandated talc and fragrance-allergen rules still pending.
- Catatan
- Rule status comes from FDA registration/renewal pages and a March-2026 Foley & Lardner review; NPRM target dates are Unified Agenda estimates, not published rules. MoCRA's main provisions took effect 2023-12-29.
- Cari inventaris ini di sini
- 美国 · FDA prohibited and restricted cosmetic ingredients; color additives
- Teks resmi
- https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
Perubahan 2025–2026
- FDA withdraws talc-asbestos testing rule while other MoCRA rules stay pending
FDA mencabut aturan uji talc yang diusulkan pada Desember 2024, menerbitkan laporannya tentang PFAS dalam kosmetik (2025-12-29) dan pedoman penarikan wajib draf (2025-12-18); aturan GMP, alergen pewangi, dan formaldehida untuk pelurus rambut melewati batas waktu yang ditetapkan undang-undang, dengan NPRM kini ditargetkan untuk November 2026, dan pembaruan pendaftaran fasilitas setiap dua tahun dimulai dua tahun setelah setiap pendaftaran awal. Sumber
FAQ
Does United States require notification or registration before sale?
No pre-market approval — MoCRA requires facility registration (renewed every two years) and product listing (updated annually) through FDA's Cosmetics Direct portal, enforced since 2024-07-01; color additives need FDA approval and sunscreens/anti-dandruff products are OTC drugs.
Is a local responsible person mandatory in United States?
A 'responsible person' is the manufacturer, packer or distributor whose name appears on the label; a U.S. address is not mandated, but foreign facilities must name a U.S. agent and the responsible person must handle adverse-event reporting.
What are the labeling requirements in United States?
English labelling per 21 CFR 701 and the FPLA (identity, net contents, ingredients in descending order, warnings, responsible person name/address); MoCRA adds a domestic address/phone or e-mail for adverse-event contact and professional-use statements; fragrance-allergen disclosure starts only once FDA's pending rule is final.
What changed recently in United States cosmetic regulation?
2025-11-28 FDA withdrew its Dec-2024 proposed rule on asbestos testing of talc-containing cosmetics; the statutory GMP and fragrance-allergen rules remain overdue (allergen and formaldehyde hair-smoothing NPRMs now targeted for Nov 2026), FDA issued its PFAS-in-cosmetics report on 2025-12-29 and first biennial facility-registration renewals fell due from Dec 2025.
Manufacturing for United States · by category
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Entering United States? Send the product type and we reply with the factory-side document list and lead time. Kirim pertanyaan