{"id":2024,"date":"2026-04-30T20:22:41","date_gmt":"2026-04-30T20:22:41","guid":{"rendered":"https:\/\/link2america.us\/?page_id=2024"},"modified":"2026-04-30T20:27:32","modified_gmt":"2026-04-30T20:27:32","slug":"used-makeup","status":"publish","type":"page","link":"https:\/\/link2america.us\/en\/cosmetici-usa-mocra\/","title":{"rendered":"USA Cosmetics Registration MoCRA | FDA Compliance for Italian Companies"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Selling cosmetics in the United States is a great opportunity for Italian companies, but it requires compliance with specific regulations imposed by the Food and Drug Administration.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">With the introduction of&nbsp;<strong>MoCRA (Modernization of Cosmetics Regulation Act)<\/strong>, regulations have become stricter, making facility registration, product listing, and compliance with new safety and labeling requirements mandatory.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In this guide you will discover everything you need for the&nbsp;<strong>cosmetics registration in the USA<\/strong>&nbsp;and how we can support you in the process.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">What is MoCRA and why it is essential for selling cosmetics in the USA<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">He&nbsp;<strong>MoCRA<\/strong>&nbsp;it is the most important regulatory reform in the US cosmetics sector in recent decades.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This legislation introduces key obligations for all companies that want to market cosmetic products in the United States:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA cosmetic facility registration<\/li>\n\n\n\n<li>cosmetics product listing<\/li>\n\n\n\n<li>label adjustment<\/li>\n\n\n\n<li>adverse event management<\/li>\n\n\n\n<li>stricter controls by the FDA<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Companies that fail to comply with these rules risk:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>import ban<\/li>\n\n\n\n<li>product recall<\/li>\n\n\n\n<li>sanctions and warning letters<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Who needs to register cosmetics in the USA<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MoCRA registration is mandatory for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>cosmetics manufacturers<\/li>\n\n\n\n<li>brand owner (including private label)<\/li>\n\n\n\n<li>companies that sell on Amazon USA<\/li>\n\n\n\n<li>distributors\/importers<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udc49 Italian companies must also comply with these obligations, even if they manufacture in Europe.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">MoCRA requirements: what you need to do to be compliant<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. FDA Facility Registration<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">To sell cosmetics in the USA, it is necessary to:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>get a&nbsp;<strong>FEI (Facility Establishment Identifier)<\/strong><\/li>\n\n\n\n<li>register the facility with the FDA<\/li>\n\n\n\n<li>update the registration every 2 years<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">2. Cosmetics Product Listing<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Each product must be registered with the FDA with:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ingredients (INCI)<\/li>\n\n\n\n<li>product category<\/li>\n\n\n\n<li>company data<\/li>\n\n\n\n<li>information about the Responsible Person<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">3. FDA compliant labeling<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The labels must include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>product name<\/li>\n\n\n\n<li>net quantity<\/li>\n\n\n\n<li>ingredient list<\/li>\n\n\n\n<li>Warnings<\/li>\n\n\n\n<li>adverse event contacts<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">4. Adverse event management<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Companies must:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>monitor product safety<\/li>\n\n\n\n<li>report serious events within 15 days<\/li>\n\n\n\n<li>keep records up to date<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">5. US Agent for foreign companies<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Non-US companies must appoint a&nbsp;<strong>US Agent<\/strong>, which serves as the contact point with the FDA.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Warning: when a cosmetic becomes a drug (OTC)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">One of the most common mistakes concerns product classification.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">If a cosmetic contains:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>SPF (sunscreen)<\/li>\n\n\n\n<li>therapeutic claims<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">could be classified as&nbsp;<strong>OTC drug<\/strong>, with much more complex requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udc49 A preliminary assessment is essential.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">U.S. Cosmetics Registration Services (MoCRA)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Link2America supports Italian companies in all aspects of FDA compliance management.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u2714 Preliminary MoCRA Analysis<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>check products and variants<\/li>\n\n\n\n<li>cosmetic vs OTC classification<\/li>\n\n\n\n<li>Identification of Critical Issues<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2714 FDA Facility Registration<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FEI request<\/li>\n\n\n\n<li>facility registration<\/li>\n\n\n\n<li>periodic updates<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2714 Cosmetics Product Listing<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Product Registration<\/li>\n\n\n\n<li>Variant Management<\/li>\n\n\n\n<li>technical support<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2714 US Agent Service<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Assistance with the appointment of a U.S. Agent for foreign companies.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2714 Responsible Person Support<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Assistance with managing regulatory obligations.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2714 Label Review<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Preliminary verification of compliance with FDA regulations.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Why choose Link2America<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">We are an operational partner in the United States for Italian companies looking to enter the U.S. market.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We support you with:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>firsthand experience in the U.S. market<\/li>\n\n\n\n<li>hands-on and operational approach<\/li>\n\n\n\n<li>network of local professionals<\/li>\n\n\n\n<li>support in Italian and English<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-center\">FILL OUT THE QUESTIONNAIRE<\/h2>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n            <div \n                class=\"elfsight-widget-contact-form elfsight-widget\" \n                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blocchi.<\/p>","protected":false},"excerpt":{"rendered":"<p>Vendere cosmetici negli Stati Uniti \u00e8 una grande opportunit\u00e0 per le aziende italiane, ma richiede il rispetto di precise normative imposte dalla&nbsp;Food and Drug Administration. Con l\u2019introduzione del&nbsp;MoCRA (Modernization of Cosmetics Regulation Act), la regolamentazione \u00e8 diventata pi\u00f9 rigorosa, rendendo obbligatoria la registrazione degli stabilimenti, il product listing e il rispetto di nuovi requisiti di [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2025,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-2024","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Registrazione Cosmetici USA MoCRA | FDA Compliance per Aziende Italiane - Link2America Consulenti Mercati USA e LATAM<\/title>\n<meta name=\"description\" content=\"Registrazione cosmetici USA secondo MoCRA: supporto FDA completo per aziende italiane. Facility registration, product listing, US Agent e compliance etichette. 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