{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination.\" The final guidance provides our current view of insanitary conditions of tattoo ink preparation, packaging, or holding that may render the inks injurious to health because of microbial contamination. This guidance finalizes the draft guidance of the same title issued on June 13, 2023.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2024/10/25/2024-24841.html","cfr_references":[],"citation":"89 FR 85217","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on October 25, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-1083"],"dockets":[{"supporting_documents":[{"title":"Reference 17- Nho-Microbiological survey of commercial tattoo inks RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0011"},{"title":"Reference 9- CDC-Tattoo-Associated Nontuberculous Mycobacterial Skin Infections RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0010"},{"title":"Reference 8- Serup-Tattoo Complaints and Complications RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0009"},{"title":"Reference 6- Stedmans Medical Dictionary RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0008"},{"title":"Reference 5- Klugl-Incidence of Health Problems Associated With Tattooed Skin RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0007"},{"title":"Reference 4- Laumann-Body Art RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0006"},{"title":"Reference 3- Grant-Tattoo ink Nanoparticles in Skin Tissue RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0005"},{"title":"Reference 1-  Giulbudagian-Safety of Tattoos and Permanent Make-up RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0004"},{"title":"List of References","document_id":"FDA-2023-D-1083-0003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-10-25","updated_at":"2024-10-25T09:57:40.878-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-1083-0028","allow_late_comments":false,"id":"FDA-2023-D-1083-0028","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":9,"id":"FDA-2023-D-1083","title":"Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Draft Guidance for Industry; Availability"}],"document_number":"2024-24841","effective_on":null,"end_page":85219,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/10/25/2024-24841.xml","html_url":"https://www.federalregister.gov/documents/2024/10/25/2024-24841/insanitary-conditions-in-the-preparation-packing-and-holding-of-tattoo-inks-and-the-risk-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-24841?publication_date=2024-10-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-10-25/2024-24841/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":275,"last_updated":"2026-04-04 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-25/pdf/2024-24841.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-24841.pdf?1729773931","publication_date":"2024-10-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/10/25/2024-24841.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 17- Nho-Microbiological survey of commercial tattoo inks RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0011"},{"title":"Reference 9- CDC-Tattoo-Associated Nontuberculous Mycobacterial Skin Infections RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0010"},{"title":"Reference 8- Serup-Tattoo Complaints and Complications RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0009"},{"title":"Reference 6- Stedmans Medical Dictionary RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0008"},{"title":"Reference 5- Klugl-Incidence of Health Problems Associated With Tattooed Skin RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0007"},{"title":"Reference 4- Laumann-Body Art RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0006"},{"title":"Reference 3- Grant-Tattoo ink Nanoparticles in Skin Tissue RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0005"},{"title":"Reference 1-  Giulbudagian-Safety of Tattoos and Permanent Make-up RE: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance","document_id":"FDA-2023-D-1083-0004"},{"title":"List of References","document_id":"FDA-2023-D-1083-0003"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-D-1083","supporting_documents_count":9,"docket_id":"FDA-2023-D-1083","document_id":"FDA-2023-D-1083-0028","regulation_id_number":null,"title":"Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-10-26T13:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":85217,"subtype":null,"title":"Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Guidance for Industry; Availability","toc_doc":"Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination","toc_subject":"Guidance","topics":[],"type":"Notice","volume":89}