In December 2023, the U.S. Food and Drug Administration (FDA) released final guidance on cosmetic facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).<\/p>\n
This comprehensive document clarifies requirements, defines key terms such as “contract manufacturer,” “responsible person,” “facility,” and “Data Universal Numbering System (DUNS) number,” and provides detailed instructions on submission responsibilities, necessary documentation, submission methods, deadlines, and exemptions. The FDA has also launched “Cosmetics Direct,” an electronic portal designed to streamline the submission process for facility registrations and product listings.<\/p>\n
Below are the key requirements for product listing.<\/p>\n
Cosmetic responsible person, i.e., the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label, is mandated to submit the product listing.<\/p>\n
Much like the exemptions applicable to facility registration, there are two scenarios where product listing exemptions apply:<\/p>\n
“Small business” cosmetic responsible persons, provided their average gross annual cosmetics sales within the U.S. for the preceding three years remain below $1 million, and their products do not include mucus-membrane-contacting cosmetics, injected cosmetics, or some cosmetics categorized as high-risk.<\/p>\n
Enterprises whose product categories satisfy the definitions of both cosmetics and drugs.<\/p>\n
Mandatory Information<\/strong><\/p>\n Optional Information<\/strong><\/p>\n As outlined in the draft guidance, the product listing number and details of the manufacturing and processing enterprise associated with the product will remain confidential and will not be publicly disclosed. However, other relevant information will be made accessible to the public.<\/p>\n The FDA offers several options for submitting cosmetic facility registrations and product listings under MoCRA:<\/p>\n Cosmetics Direct Portal<\/strong>\u00a0\u2013 A user-friendly electronic platform for submitting registrations and listings without using the Electronic Submissions Gateway (ESG).<\/p>\n<\/li>\n Electronic Submissions Gateway (ESG)<\/strong>\u00a0\u2013 An alternative electronic method for submitting Structured Product Labeling (SPL) files.<\/p>\n<\/li>\n SPL Xforms<\/strong>\u00a0\u2013 An FDA-provided tool to assist in creating and submitting SPL files.<\/p>\n<\/li>\n Paper Forms<\/strong>\u00a0\u2013 Facilities can submit Form FDA 5066 (facility registration) and Form FDA 5067 (product listing) by mail or email:<\/p>\n Mail:<\/strong>\u00a0FDA Office of Cosmetics and Colors, 5001 Campus Drive, College Park, MD 20740-3835<\/p>\n<\/li>\n Email:<\/strong>\u00a0RLC-PaperSubmissions@fda.hhs.gov<\/a><\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n FDA does not impose any fees for the product listing process.<\/p>\n Since the launch of Cosmetics Direct on December 18, 2023, the FDA has officially started accepting facility registrations and product listings<\/strong> under the MoCRA. While the FDA has extended enforcement to July 1, 2024, companies are strongly advised to begin the process as soon as possible to ensure compliance.<\/p>\n In December 2023, the U.S. Food and Drug Administration […]<\/p>\n","protected":false},"author":2,"featured_media":271,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"none","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"categories":[],"tags":[],"class_list":["post-215","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/posts\/215","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/comments?post=215"}],"version-history":[{"count":10,"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/posts\/215\/revisions"}],"predecessor-version":[{"id":1449,"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/posts\/215\/revisions\/1449"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/media\/271"}],"wp:attachment":[{"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/media?parent=215"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/categories?post=215"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/tags?post=215"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
\n
Public Accessibility of Product Listing Information<\/h2>\n
Submission Methods<\/h2>\n
\n
\n
Product Listing Fees<\/h2>\n
Recommendations<\/h2>\n
\n