cGMP Consulting Inc.’s Post

The U.S. #FDA published a draft guidance on cosmetic product facility registration and product listings, as required under MoCRA, writes Husch Blackwell's Magda Patitsas, Esq., Seth Mailhot, and Paula Pastuskovas. Learn more about the draft guidance that aims to clarify submission requirements, responsibilities, details, timing, and exemptions, including those for small businesses: https://lnkd.in/gC6z78DM   #cosmeticindustry #productsafety  

US FDA has issued guidance draft documents on the upcoming MoCRA, The recently issued draft guidance (Can be accessed at: https://lnkd.in/d56MAUsk) clarifies the information required to submit to the FDA. Kye points need to consider are as follows-    🖊  Every person that owns or operates a facility that ‘engages in the manufacturing or processing of a cosmetic product for distribution in the United States’ register that facility with FDA, update content within 60 days of any changes, and renew their registration every two years.   🖊   Now, unless a facility qualifies for an exemption, registration will be mandatory.    🖊  Within one year of the act’s passing, all facilities operating before 29 December 2022 must be registered with the FDA.    🖊  There is a little more leeway for newcomers; those who’ve owned or operated a facility launched after 29 December 2022 must register within 60 days of first engaging in operations, or by 27 February 2024.  🖊    FDA’s new submission portal is expected to be operational in October 2023, with FDA encouraging electronic submissions well in advance of the 29 December 2023 statutory deadline – and provides information regarding product categories.    🖊  For each cosmetic product, a designated responsible person must submit to FDA annually ‘a cosmetic product listing’, including ingredients.    🖊   The guidance also provides clarification as to what information companies can expect to remain confidential, or be publicly available via FOIA following submission.    🖊  To prepare for the portal’s roll out, companies should carefully review the draft guidance, determine what, if any, facilities or products they would need to register and/or list, begin compiling the required information for submission and raise any questions or issues with counsel, Reference: Cosmeticsbusiness.com

MoCRA Mass Confusion! MoCRA Deadline Remains Dec. 29, 2023 The FDA announcement that it would not enforce Product Registration and Facility Registration mandates until July 1, 2024 does NOT mean that all of MoCRA has been delayed until July 1, 2024. The Product Safety Substantiation and Serious/Adverse Event Recordkeeping and Reporting mandates remain effective Dec. 29, 2023. The FDA intends to publish the Registration website Cosmetics Connect by the end of 2023, but will not enforce non-compliance on specifically, and only, the Product & Facility Registration mandates until July 1, 2024. All other mandates of MoCRA have a compliance deadline of Dec. 29, 2023. We recommend preparing for MoCRA compliance for the effective date Dec. 29, 2023, including your Product and Facility Registration files. You can upload the Product and Facility Registration as soon as Cosmetics Connect is published. #USFDA #cosmetics #beautyindustry #cleanbeauty #indiebeauty #beautybrands #indiebrands #cosmeticbrands #cosmeticsindustry #cosmeticscience #skincareproducts #Mocra

🚀 Exciting News for the Cosmetics Industry! MoCRA Update 🌟 The FDA has just launched the Cosmetics Direct electronic submission portal. This portal, mandated by MoCRA, facilitates seamless registration and listing of cosmetic products and facilities. 💻✅ It simplifies the submission process, making it easier for cosmetic facilities to register and list products directly with the FDA. To aid the industry, the FDA will delay enforcing these requirements for an additional six months after the December 29, 2023, deadline, giving more time for compliance until July 1, 2024. 🗓️✨ Let's embrace this new avenue for smoother compliance and improved efficiency in the cosmetic sector. Stay tuned for more updates. 📢 Read more here: https://lnkd.in/d7-bhgJJ #FDA #CosmeticsCompliance #MoCRA #Cosmeservice

𝐀𝐫𝐞 𝐲𝐨𝐮 𝐩𝐫𝐞𝐩𝐚𝐫𝐞𝐝 𝐟𝐨𝐫 𝐂𝐨𝐬𝐦𝐞𝐭𝐢𝐜 𝐅𝐚𝐜𝐢𝐥𝐢𝐭𝐲 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧 𝐮𝐧𝐝𝐞𝐫 𝐌𝐨𝐂𝐑𝐀? Let's make sure you are! Join us for an insightful webinar on cosmetic facility registration, where we will delve into key topics essential for a seamless registration process. 📅 Date: Wednesday 31st January ⏰ Time: 13:00 GMT 🔍 Key Topics: 1️⃣ Preparing for MoCRA Facility Registration 2️⃣ Facility Overview: Learn the essential information required for each facility before initiating the registration process. 3️⃣ Brand Overview: Uncover the specifics needed for each brand before completing facility registration within FDA Cosmetics Direct. 🌐 Registration Link: https://lnkd.in/ggQSDnbC #MoCRA #CosmeticFacilityRegistration #CosmeticRegulation #Cosmetics

📢Regulatory Update FDA has released a draft guidance on the "Registration and Listing of Cosmetic Product Facilities and Products." Key takeaways: 🔺 This guidance is for comment purposes and provides instructions for submitting cosmetic product facility registrations and product listings to the FDA. 🔺 MoCRA has introduced new requirements for cosmetic product facility registration and product listing. 🔺 The FDA's voluntary cosmetics registration program ended on March 27, 2023. A new electronic submission portal will be available in October 2023. 🔺 Small businesses with average gross annual sales in the U.S. of cosmetic products less than $1,000,000 (adjusted for inflation) over the past 3 years may be exempt from certain registration and listing requirements. 🧴💄Stay updated and ensure compliance with the latest guidelines! See the link in the comments below.

The new requirements enacted under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) become effective beginning December 29, 2023. First among these will be a requirement for cosmetic facilities to register and for cosmetic products to be listed with FDA. The FDA has issued guidance for facility registration and product listing and is now conducting beta-testing for the data-loading system. IT IS IMPORTANT FOR COSMETIC MANUFACTURERS AND MARKETERS TO BE PREPARED TO MEET THE DECEMBER 29, 2023 DEADLINE. EAS is conducting this free webinar to share the latest from the FDA about facility registration and product listing, and help companies prepare for MoCRA. Register - https://hubs.ly/Q025h-W80

<!-- .entry-header --> Continuing its implementation of the Modernization of Cosmetics Regulation Act’s (MoCRA), and following on the heels of FDA’s Draft Guidance on Facility Registration and Product Listing (previously discussed here), on September 15, 2023, FDA announced its newly developed draft electronic submission portal, Cosmetics Direct, to assist persons submitting cosmetic product facility registrations and product listings under newly added Section 607 of the federal Food, Drug and Cosmetic Act (FD&C Act). Draft screenshots of the electronic system, including example submissions, are available for review and comments, along with an interim Federal Register Notice, announcing the new system.draft guidance, To read the full post by Duane Morris attorney Kelly A, Bonner, please visit the Duane Morris Fashion, Retail and Consumer Branded Products Blog. <!-- .entry-content --> <!-- .entry-footer -->

FDA issues Guidance for Registration and Listing of Cosmetic Product Facilities and Products The FDA is currently working on approaches to strengthen its oversight in regard to the safety of cosmetic products. Therefore, the agency issued a draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products. According to the FDA, the guidance will help to accomplish several objectives:- For more information please follow below link #regulatoryaffairs #ectd #fda

Recent Development: #MoCRA provided new authorities to FDA including #cosmetics product facility registration and product listing with some exemptions to certain small businesses. The responsible person will need to obtain the relevant facility registration (FEI) number(s) for each facility where their cosmetic products are manufactured or processed, because the facility registration number(s) is required for the product listing submission. Timelines: Facility Registration: 1. Initial Registration: No later than December 29, 2023, if owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States on or before December 29, 2022. Every person that owns or operates a facility that first engages, after December 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, must register such facility within 60 days of first engaging in such activity or by February 27, 2024, whichever is later. 2. Amended Registration: Every person who is required to register must update their registration within 60 days of any changes to the information required for registration. 3. Renewal of Registration: Every two years (biennially). Product Listing: 1. Initial Listing: The responsible person of a cosmetic product that is marketed on December 29, 2022, must submit a cosmetic product listing not later than December 29, 2023, or for a cosmetic product that is first marketed after December 29, 2022, within 120 days of marketing such product in interstate commerce. FDA expects the product listing for a cosmetic product first marketed after December 29, 2022 to be submitted within 120 days of marketing the product, or within 120 days of December 29, 2023, whichever is later. 2. Update to Content and Renewal: The responsible person must provide any updates to such listing annually. Submission of registration and product listing portal: FDA is developing an electronic submission portal to streamline submission and receipt of registration and product listing information (probably the portal will be up and live by October 2023). #usfda is developing a paper form as an alternative submission tool. Both the electronic submission portal and the paper form will be accessible. #mocra #cosmetics #development #gmp #safety #registration