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. แหล่งที่มา
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- หน่วยงานกำกับดูแล
- U.S. Food and Drug Administration (FDA)
- กฎระเบียบหลัก
- 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
- บังคับใช้แล้ว
- 2022-12-29
- การเข้าสู่นิยามตลาด
- 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.
- ผู้รับผิดชอบ
- 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.
- ไฟล์ความปลอดภัย
- 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.
- ฉลาก
- 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.
- การทดสอบในสัตว์
- 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.
- รายการส่วนผสม
- 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.
- หมายเหตุ
- 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.
- ค้นหาสินค้าคงคลังรายการนี้ที่นี่
- 美国 · FDA prohibited and restricted cosmetic ingredients; color additives
- ข้อความทางการ
- https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
การเปลี่ยนแปลง 2025–2026
- FDA withdraws talc-asbestos testing rule while other MoCRA rules stay pending
FDA withdrew the December-2024 proposed talc testing rule, issued its PFAS-in-cosmetics report (2025-12-29) and draft mandatory-recall guidance (2025-12-18); GMP, fragrance-allergen and formaldehyde hair-smoothing rules missed statutory deadlines with NPRMs now targeted for November 2026, and biennial facility-registration renewals began two years after each initial registration. แหล่งที่มา
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
คำถามที่ผู้ซื้อมักถาม
- We are promoting a Retinol eye cream on Amazon US with the text 'clinically proven' and 'dramatically reduces wrinkles.' If complained about by professional complainers, can the factory provide efficacy substantiation files compliant with FTC standards and a response strategy?
- Shampoo and conditioner OEM for the United States: what matters in a sulfate-free formula and on the label?
- Launching a skincare product (serum or cream) in the United States: what does the OEM factory need to prepare, and how long does notification take?
- Body lotion and body wash OEM for the United States: how are fragrance allergens and labeling handled?
- Lip gloss and foundation OEM for the United States: how are colourant lists and heavy-metal limits met?
- What is the difference between MoCRA compliance and routine GMPC audits in US cosmetics manufacturing, and how should a factory prepare for inspections?
Entering United States? Send the product type and we reply with the factory-side document list and lead time. ส่งคำสอบถาม