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. ソース
工場側の概要です。正式な原文が優先されます。法的助言ではありません。
- 主管機関
- U.S. Food and Drug Administration (FDA)
- 主要規制
- 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
- 有効
- 2022-12-29
- 市場参入
- 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.
- 責任者
- 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.
- 安全性ファイル
- 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.
- ラベリング
- 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.
- 動物実験
- 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.
- 成分表
- 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.
- 備考
- 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.
- この在庫をこちらで確認
- 美国 · FDA prohibited and restricted cosmetic ingredients; color additives
- 公式文書
- https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
2025〜2026年の変遷
- 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. ソース
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. お問い合わせを送信する