{"id":1164,"date":"2026-02-12T08:30:21","date_gmt":"2026-02-12T08:30:21","guid":{"rendered":"https:\/\/hirekhan.com\/blog\/?p=1164"},"modified":"2026-02-12T08:30:24","modified_gmt":"2026-02-12T08:30:24","slug":"modernization-of-cosmetics-regulation-act-of-2022-mocra-comprehensive-compliance-guide-for-cosmetic-brands","status":"publish","type":"post","link":"https:\/\/hirekhan.com\/blog\/2026\/02\/12\/modernization-of-cosmetics-regulation-act-of-2022-mocra-comprehensive-compliance-guide-for-cosmetic-brands\/","title":{"rendered":"Modernization of Cosmetics Regulation Act of 2022 (MoCRA): Comprehensive Compliance Guide for Cosmetic Brands"},"content":{"rendered":"\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/joanmorais.com\/wp-content\/uploads\/2023\/09\/MoCRA-3.png\" alt=\"MoCRA 2022 cosmetics, US FDA cosmetic law, MoCRA compliance, cosmetic product listing USFDA, cosmetic facility registration, safety substantiation cosmetics, adverse event reporting USFDA, cosmetic GMP expectations, cosmetic labeling compliance, US FDA consultancy, XPRO America, Modernization of cosmetics regulation act of 2022 pdf, Modernization of cosmetics regulation act of 2022 summary, FDA cosmetic regulations 2025, MoCRA cosmetics, FDA cosmetic regulations 2024, FDA MoCRA, FDA Cosmetic Registration Search, MoCRA exemptions small business, What is the new Drug and cosmetic Act 2022?, Are &quot;organic&quot; cosmetics FDA approved?, Who is exempt from MoCRA?, What is Section 22 of drugs and cosmetic Act?, What significant regulatory change was introduced by the Modernization of cosmetics regulatory Act of 2022 in the US?, What are the 4 categories of drugs?, What are tier 1, 2, 3, 4 and 5 drugs?, What is the Drugs and Cosmetics Act 2025?, Which 26 drugs are banned in India?, What is the 1% rule in skincare?, What are the 8 types of products regulated by the FDA?, How much is the MoCRA fee?, what is MoCRA?\"\/><\/a><\/figure>\n\n\n\n<p>In December 2022, the United States enacted a landmark law that fundamentally reshaped cosmetic regulation\u2014<strong>the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)<\/strong>. This legislation represents the most significant update to cosmetic law in over 80 years and dramatically expanded <strong>US FDA authority<\/strong> over cosmetic products marketed in the United States.<\/p>\n\n\n\n<p>Before MoCRA, cosmetic regulation was primarily voluntary, relying on the responsibility of manufacturers to ensure product safety and truthful labeling. With MoCRA, compliance became legally enforceable, creating new obligations for cosmetic companies, including facility registration, product listing, safety substantiation, adverse event reporting, and good manufacturing practice expectations.<\/p>\n\n\n\n<p>XPRO America is a professional<a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\"> <strong>US FDA Consultancy<\/strong> <\/a>that helps cosmetic manufacturers, brand owners, and importers understand and meet MoCRA requirements with accuracy and confidence.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">What Is the Modernization of Cosmetics Regulation Act (MoCRA)?<\/a><\/h2>\n\n\n\n<p>The <strong>Modernization of Cosmetics Regulation Act of 2022<\/strong> is a federal statute that amended the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) to strengthen regulatory oversight of cosmetics. MoCRA codified requirements that were previously voluntary and introduced several new legal obligations with which cosmetic companies must comply.<\/p>\n\n\n\n<p>Key highlights of MoCRA requirements include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Mandatory facility registration<\/li>\n\n\n\n<li>Cosmetic product listing<\/li>\n\n\n\n<li>Safety substantiation<\/li>\n\n\n\n<li>Adverse event reporting<\/li>\n\n\n\n<li>Good manufacturing practice expectations<\/li>\n\n\n\n<li>Recordkeeping standards<\/li>\n\n\n\n<li>Mandatory recalls under specific conditions<\/li>\n<\/ul>\n\n\n\n<p>These requirements apply to all cosmetic products sold in the United States, including those manufactured abroad.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Why MoCRA Matters for Cosmetic Compliance<\/a><\/h2>\n\n\n\n<p>Prior to MoCRA, the US FDA had limited authority over cosmetics. While cosmetic products had to be safe and properly labeled, the US FDA did not require manufacturers to report safety data or register products and facilities.<\/p>\n\n\n\n<p>MoCRA changed that paradigm. Today, cosmetic companies must proactively demonstrate compliance with a comprehensive regulatory framework enforced by the US FDA.<\/p>\n\n\n\n<p>This shift impacts nearly every aspect of cosmetic operations, from manufacturing to labeling, safety documentation, and market surveillance.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Facility Registration Under MoCRA<\/a><\/h2>\n\n\n\n<p>One of MoCRA\u2019s foundational requirements is the <strong>mandatory registration of cosmetic manufacturing and processing facilities<\/strong> with the US FDA.<\/p>\n\n\n\n<p><strong>Who must register?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Domestic manufacturers<\/li>\n\n\n\n<li>Foreign manufacturers exporting cosmetics to the US<\/li>\n<\/ul>\n\n\n\n<p><strong>Key registration features:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Initial submission to US FDA<\/li>\n\n\n\n<li>Renewals every two years<\/li>\n\n\n\n<li>Updates required for changes in ownership, address, or operations<\/li>\n\n\n\n<li>Foreign facilities must designate a US Agent<\/li>\n<\/ul>\n\n\n\n<p>Failure to register can result in enforcement actions, including import detentions and refusal of entry.<\/p>\n\n\n\n<p>XPRO America assists companies with complete facility registration and US Agent designation as part of its US FDA Consultancy offerings.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Cosmetic Product Listing<\/a><\/h2>\n\n\n\n<p>MoCRA requires that cosmetic products marketed in the United States be <strong>listed with the US FDA<\/strong>.<\/p>\n\n\n\n<p>Product listing includes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Product name and category<\/li>\n\n\n\n<li>Ingredient list<\/li>\n\n\n\n<li>Facility registration reference<\/li>\n\n\n\n<li>Responsible person details<\/li>\n<\/ul>\n\n\n\n<p>Cosmetic product listings must be updated annually and when product formulations change.<\/p>\n\n\n\n<p>Accurate listing enhances traceability and allows the US FDA to monitor products effectively.<\/p>\n\n\n\n<p>XPRO America prepares and manages product listing submissions to ensure regulatory accuracy.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Safety Substantiation Requirements<\/a><\/h2>\n\n\n\n<p>MoCRA mandates that cosmetic companies maintain <strong>adequate safety substantiation<\/strong> for every product they market.<\/p>\n\n\n\n<p>This means having scientific evidence demonstrating that a cosmetic product is safe for its intended use.<\/p>\n\n\n\n<p>Safety substantiation may include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Toxicological risk assessments<\/li>\n\n\n\n<li>Ingredient safety profiles<\/li>\n\n\n\n<li>Product performance data<\/li>\n\n\n\n<li>Scientific literature reviews<\/li>\n<\/ul>\n\n\n\n<p>Companies must have documentation ready for US FDA inspection if requested.<\/p>\n\n\n\n<p>XPRO America helps brands develop safety documentation that aligns with MoCRA expectations.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Adverse Event Reporting Obligations<\/a><\/h2>\n\n\n\n<p>Under MoCRA, companies must report serious adverse events to the US FDA within 15 business days.<\/p>\n\n\n\n<p><strong>What qualifies as a serious adverse event?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Hospitalization<\/li>\n\n\n\n<li>Life-threatening reaction<\/li>\n\n\n\n<li>Permanent impairment<\/li>\n\n\n\n<li>Birth defect<\/li>\n\n\n\n<li>Death<\/li>\n<\/ul>\n\n\n\n<p>Companies must keep adverse event records for six years.<\/p>\n\n\n\n<p>XPRO America establishes reporting procedures and adverse event tracking systems to meet MoCRA requirements.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Good Manufacturing Practice (GMP) Expectations<\/a><\/h2>\n\n\n\n<p>Although MoCRA does not yet mandate detailed cosmetic GMP regulations, it directs the US FDA to issue guidance and, eventually, enforceable GMPs.<\/p>\n\n\n\n<p>In the meantime, MoCRA requires:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Sanitary manufacturing conditions<\/li>\n\n\n\n<li>Appropriate quality systems for cosmetics<\/li>\n\n\n\n<li>Adequate recordkeeping<\/li>\n\n\n\n<li>Controls to prevent contamination and ensure safety<\/li>\n<\/ul>\n\n\n\n<p>Good manufacturing practices help ensure product consistency, safety, and regulatory compliance.<\/p>\n\n\n\n<p>XPRO America assists with developing and implementing compliant quality systems.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Labeling and Claims Under MoCRA<\/a><\/h2>\n\n\n\n<p>Cosmetic labels must continue to comply with existing law, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Fair Packaging and Labeling Act (FPLA) requirements<\/li>\n\n\n\n<li>Ingredient declaration using INCI names<\/li>\n\n\n\n<li>Truthful and non-misleading claims<\/li>\n<\/ul>\n\n\n\n<p>MoCRA reinforces the importance of accurate labeling and adds expectations for product listing and documentation.<\/p>\n\n\n\n<p>XPRO America conducts detailed label reviews to ensure cosmetic labeling meets MoCRA and other federal compliance standards.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Recordkeeping Requirements<\/a><\/h2>\n\n\n\n<p>MoCRA requires cosmetic companies to maintain:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Product formulation records<\/li>\n\n\n\n<li>Safety substantiation documentation<\/li>\n\n\n\n<li>Adverse event records<\/li>\n\n\n\n<li>Listing and registration records<\/li>\n\n\n\n<li>Manufacturing and quality control records<\/li>\n<\/ul>\n\n\n\n<p>These records must be accessible for US FDA inspection when necessary.<\/p>\n\n\n\n<p>XPRO America helps brands establish organized and compliant recordkeeping systems.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Import Compliance Under MoCRA<\/a><\/h2>\n\n\n\n<p>Cosmetics manufactured abroad must meet the same MoCRA requirements as domestic products.<\/p>\n\n\n\n<p>Foreign facilities must:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Register with the US FDA<\/li>\n\n\n\n<li>Appoint a US Agent<\/li>\n\n\n\n<li>List products<\/li>\n\n\n\n<li>Maintain safety documentation<\/li>\n<\/ul>\n\n\n\n<p>Non-compliant products may be detained or refused entry at US ports.<\/p>\n\n\n\n<p>XPRO America provides import compliance support to foreign manufacturers and exporters.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">US FDA Enforcement Under MoCRA<\/a><\/h2>\n\n\n\n<p>MoCRA significantly enhanced US FDA enforcement authority, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Warning letters<\/li>\n\n\n\n<li>Mandatory recalls under certain conditions<\/li>\n\n\n\n<li>Product seizures<\/li>\n\n\n\n<li>Import alerts<\/li>\n\n\n\n<li>Injunctions<\/li>\n<\/ul>\n\n\n\n<p>Companies that fail to comply expose themselves to legal action, financial loss, and brand damage.<\/p>\n\n\n\n<p>Proactive compliance with MoCRA helps mitigate these risks.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Strategic Advantages of MoCRA Compliance<\/a><\/h2>\n\n\n\n<p>By complying with MoCRA, cosmetic companies gain:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Increased transparency and traceability<\/li>\n\n\n\n<li>Better safety documentation<\/li>\n\n\n\n<li>Enhanced consumer trust<\/li>\n\n\n\n<li>Stronger retailer confidence<\/li>\n\n\n\n<li>Reduced regulatory risk<\/li>\n\n\n\n<li>Improved market competitiveness<\/li>\n<\/ul>\n\n\n\n<p>Compliance becomes a business advantage, not just a legal requirement.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">How XPRO America Can Help<\/a><\/h2>\n\n\n\n<p>XPRO America operates as a dedicated <strong>US FDA Consultancy<\/strong> offering MoCRA compliance services such as:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Facility registration<\/li>\n\n\n\n<li>Cosmetic product listing<\/li>\n\n\n\n<li>Safety substantiation support<\/li>\n\n\n\n<li>Labeling and claim review<\/li>\n\n\n\n<li>Adverse event reporting systems<\/li>\n\n\n\n<li>Import compliance guidance<\/li>\n\n\n\n<li>Recordkeeping systems<\/li>\n\n\n\n<li>Quality and GMP consulting<\/li>\n<\/ul>\n\n\n\n<p>For expert regulatory assistance, contact XPRO America at <strong><a>support@xproamerica.com<\/a><\/strong>.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Conclusion<\/h2>\n\n\n\n<p>The <a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Modernization of Cosmetics Regulation Act of 2022 <\/a>ushered in a new era of cosmetic regulation in the United States. MoCRA\u2019s expanded requirements and strengthened US FDA authority make compliance mandatory and enforceable.<\/p>\n\n\n\n<p>With professional guidance from XPRO America, cosmetic brands can navigate these regulatory complexities and ensure their products meet all legal expectations while focusing on growth and innovation.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In December 2022, the United States enacted a landmark law that fundamentally reshaped cosmetic regulation\u2014the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This legislation represents the most significant update to cosmetic law in over 80 years and dramatically expanded US FDA authority over cosmetic products marketed in the United States. Before MoCRA, cosmetic regulation [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[342,343,344,3332,3343,83,3333,3306,3283,179,183,185,40,3335,3330,81,3245,3345,3347,3346,3331,3265,3305,325,191,341,3342,3336,3338,3344,3340,3337,3341,70],"class_list":["post-1164","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-342","tag-343","tag-4-and-5-drugs","tag-adverse-event-reporting-usfda","tag-are-organic-cosmetics-fda-approved","tag-cosmetic-facility-registration","tag-cosmetic-gmp-expectations","tag-cosmetic-labeling-compliance","tag-cosmetic-product-listing-usfda","tag-fda-cosmetic-registration-search","tag-fda-cosmetic-regulations-2024","tag-fda-cosmetic-regulations-2025","tag-fda-mocra","tag-how-much-is-the-mocra-fee","tag-mocra-2022-cosmetics","tag-mocra-compliance","tag-mocra-cosmetics","tag-mocra-exemptions-small-business","tag-modernization-of-cosmetics-regulation-act-of-2022-pdf","tag-modernization-of-cosmetics-regulation-act-of-2022-summary","tag-safety-substantiation-cosmetics","tag-us-fda-consultancy","tag-us-fda-cosmetic-law","tag-what-are-the-4-categories-of-drugs","tag-what-are-the-8-types-of-products-regulated-by-the-fda","tag-what-are-tier-1","tag-what-is-section-22-of-drugs-and-cosmetic-act","tag-what-is-the-1-rule-in-skincare","tag-what-is-the-drugs-and-cosmetics-act-2025","tag-what-is-the-new-drug-and-cosmetic-act-2022","tag-what-significant-regulatory-change-was-introduced-by-the-modernization-of-cosmetics-regulatory-act-of-2022-in-the-us","tag-which-26-drugs-are-banned-in-india","tag-who-is-exempt-from-mocra","tag-xpro-america"],"_links":{"self":[{"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/posts\/1164","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/comments?post=1164"}],"version-history":[{"count":1,"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/posts\/1164\/revisions"}],"predecessor-version":[{"id":1165,"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/posts\/1164\/revisions\/1165"}],"wp:attachment":[{"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/media?parent=1164"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/categories?post=1164"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/tags?post=1164"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}