{"id":206,"date":"2023-05-02T20:42:02","date_gmt":"2023-05-02T20:42:02","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-support\/?p=206"},"modified":"2023-05-02T20:42:02","modified_gmt":"2023-05-02T20:42:02","slug":"mocra-modernization-of-cosmetics-regulation-act-of-2022","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-support\/2023\/05\/02\/mocra-modernization-of-cosmetics-regulation-act-of-2022\/","title":{"rendered":"MOCRA &#8211; Modernization of Cosmetics Regulation Act of 2022"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Recently US Congress passed the Consolidated Appropriations Act, bringing changes to how <a href=\"https:\/\/www.fdahelp.us\/cosmetics.html\">cosmetic<\/a> products are regulated in the US. MOCRA or the Modernization of Cosmetics Regulation Act of 2022 provides regulatory authority to US FDA over cosmetic industry. Key requirements of MOCRA are as below:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"https:\/\/www.fdahelp.us\/fda-cosmetic-registration.html\">Facility Registration<\/a> <\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers and processors must\nregister their facilities with the FDA and renew such registration biennially.\nFDA no longer accepts VCRP registrations so Facilities that were registered\nunder the VCRP program will have to register again under the new system. <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"https:\/\/www.fdahelp.us\/fda-cosmetic-registration.html\">Product Listing <\/a>&nbsp;<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">A responsible person must list each\nmarketed cosmetic product and ingredients with the FDA and must renew such\nlisting annually.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Good Manufacturing Practices (GMP) <\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Cosmetic manufacturing and processing\nfacilities must comply with GMP standards.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"https:\/\/www.fdahelp.us\/cosmetics-labeling.html\">Product Labeling<\/a><\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Cosmetic product labels must adhere to new <a href=\"https:\/\/www.fdahelp.us\/fda-cosmetic-label-review-form.html\">cosmetic\nlabeling<\/a> requirements. <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Adverse Event Report<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">A responsible person is required to report\nserious adverse events associated with the use of cosmetic products in the US to\nthe FDA. FDA will have access to adverse event reports during an inspection.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Product Safety Substantiation <\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">A responsible person is required to\nensure and maintain records supporting adequate safety &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; substantiation for their products.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Mandatory Recall <\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">FDA has the authority to order a\nmandatory recall, if deemed necessary, if the responsible person refuses to do\nso voluntarily.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A responsible person means the manufacturer, packer, or\ndistributor of a cosmetic product whose name appears on the label of such\ncosmetic product in accordance with section 609(a) of the FD&amp;C Act or\nsection 4(a) of the Fair Packaging and Labeling Act.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.fdahelp.us\/\">Liberty Management Group Ltd.<\/a>\ncan help you with Facility Registration, Product Listing, Label compliance and\nother FDA regulations.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Namrata <\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Regulatory Consultant<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>support@libertymanagement.us<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">www.fdahelp.us<\/a><em><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Recently US Congress passed the Consolidated Appropriations Act, bringing changes to how cosmetic products are regulated in the US. MOCRA or the Modernization of Cosmetics Regulation Act of 2022 provides regulatory authority to US FDA over cosmetic industry. Key requirements of MOCRA are as below: Facility Registration Manufacturers and processors must register their facilities with &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-support\/2023\/05\/02\/mocra-modernization-of-cosmetics-regulation-act-of-2022\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;MOCRA &#8211; Modernization of Cosmetics Regulation Act of 2022&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[10,71,70],"class_list":["post-206","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-cosmetic-registration","tag-fda-registration-for-cosmetic","tag-mocra"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/206","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/comments?post=206"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/206\/revisions"}],"predecessor-version":[{"id":207,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/206\/revisions\/207"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/media?parent=206"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/categories?post=206"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/tags?post=206"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}