Los 5 requirements · activos hoy · pendientes 2026.
Section 609 de MoCRA establece 5 distinct labeling requirements con timing diferente. Activos hoy: (α) domestic contact information — USA-based address, phone, o electronic contact info on label for AE reporting (mandatory + enforceable); (γ) professional-use-only statement — “Administered or used only by licensed professionals” si applicable; (δ) INCI naming compliance — International Nomenclature standardized names, not common names. Pending: (β) fragrance allergen disclosure — FDA proposed rule esperada mayo 2026 NPRM; (ε) net contents standards — FPLA + 21 CFR 701 (active pero updates esperados).
Para LatAm exporters, el requirement con highest LatAm-specific impact es (α) domestic contact info. Foreign manufacturers sin USA presence direct must designate USA-based Responsible Person + contact info on label. Common LatAm gap: contact info es manufacturer Latin American directly (Mexican phone, Brasilian email) instead of USA Responsible Person contact. Esto renders product technically misbranded. Plus: contact info debe ser monitored regularly + responsive — actual customer/regulator contact must reach Responsible Person dentro de reasonable time. Phone que no responde, email que bounces, address obsoleta = labeling failure during inspection or FDA verification.
LatAm cosmetics exporters con labels mostrando manufacturer-side contact (Latin American phone/email/address): technically misbranded bajo MoCRA. Common pattern: legacy labels desde pre-MoCRA era cuando regulation no requería USA contact. Update needed across product portfolio — every SKU sold a USA requires label revision. Investment label refresh: $500-2K per SKU. Vs port-of-entry detention cost $20K-100K. Cost-benefit favorable.
Label audit comprehensive para LatAm cosmetics portfolio: (α) verify USA-based domestic contact info on every SKU sold a USA, (β) confirm contact is functional + monitored + responsive, (γ) verify INCI naming compliance ingredient-by-ingredient, (δ) check professional-use-only statements donde applicable, (ε) net contents font size verification per package. Annual label audit + update protocol. Camex articula label audit framework + bilingual review.
Fuente: MoCRA Section 609 · 21 USC §364e · Fair Packaging and Labeling Act · 21 CFR 701 · FDA Guidance for Cosmetic Industry


