Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Guidance for Industry; Availability, 85217-85219 [2024-24841]

Download as PDF Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Notices Food and Drug Administration [Docket Nos. FDA–2024–N–0783 and FDA– 2024–N–0021] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: The following is a list of FDA information SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice. 85217 collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control number Title of collection Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices .................................................................................................................................................... Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types ....................................................................................................................................................... Dated: October 21, 2024. Eric Flamm, Acting Associate Commissioner for Policy. You may submit either electronic or written comments on Agency guidances at any time as follows: ADDRESSES: [FR Doc. 2024–24822 Filed 10–24–24; 8:45 am] Electronic Submissions BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–D–1083] Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. 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. DATES: The announcement of the guidance is published in the Federal Register on October 25, 2024. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:40 Oct 24, 2024 Jkt 265001 Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 Date approval expires 0910–0052 9/30/2027 0910–0744 10/31/2027 Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2023–D–1083 for ‘‘Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit E:\FR\FM\25OCN1.SGM 25OCN1 85218 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Notices both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave WO1, Silver Spring, MD 20993. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Jennifer Ross, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993–0002, 301–796–4880 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: ddrumheller on DSK120RN23PROD with NOTICES1 I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination.’’ Tattooing has become increasingly popular in the United States. Polling and data suggest that about 30 percent of all Americans, and 40 percent of those aged 18–34, have at least one tattoo (Refs. 1 and 2). State and local jurisdictions generally regulate the practice of intradermal tattooing, including permanent makeup and microblading. FDA regulates, among VerDate Sep<11>2014 17:40 Oct 24, 2024 Jkt 265001 other things, the inks used in that practice. Tattoo inks are cosmetics as defined by section 201(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(i)) because they are articles intended to be introduced into or otherwise applied to the human body for beautifying, promoting attractiveness, or altering the appearance. Microorganisms normally regarded as nonpathogenic when applied topically may become opportunistically pathogenic and virulent when introduced in other ways (e.g., in wounds or via cosmetics introduced into or through the skin). Tattoo inks bypass the body’s primary physical barrier against pathogens because they are inserted below the epidermis. We have received multiple reports of illness caused by microbially contaminated tattoo inks, and subsequent testing has found many sealed tattoo inks in the United States with microbial contamination. Among other things, between 2003 and 2019, tattoo ink firms conducted 15 ink recalls, 14 of which resulted from findings of microbial contamination. Eight of these recalls (Refs. 3 to 8) occurred after FDA conducted multiple surveys of tattoo inks available in the U.S. market and tested them for microbial contamination. Many of these inks were heavily contaminated with a variety of microorganisms, some of which can cause serious infections (Refs. 8 and 9). This guidance will help tattoo ink manufacturers and distributors understand examples of what could adulterate a tattoo ink because it has been prepared, packed, or held under insanitary conditions that could render it injurious to health. We also recommend certain steps that manufacturers and distributors could take to help prevent the occurrence of these conditions, or to identify and remediate insanitary conditions that already exist during manufacturing and distribution. This guidance finalizes the draft guidance entitled ‘‘Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination’’ issued on June 13, 2023 (88 FR 38516). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft to the final guidance include addition of a definition of injection for purposes of this guidance. In addition, editorial changes were made to improve clarity. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 thinking of FDA on ‘‘Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/CosmeticGuidances, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. IV. References The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https:// www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. Although FDA verified the website addresses in this document, please note that websites are subject to change over time. 1. Giulbudagian, M., I. Schreiver, A.V. Singh, et al., ‘‘Safety of Tattoos and Permanent Make-up: A Regulatory View.’’ Archives of Toxicology, 94: 357–369 (2020). 2. Ipsos poll. ‘‘More Americans Have Tattoos Today than Seven Years Ago,’’ August 29, 2019. Available at: https:// www.ipsos.com/en-us/news-polls/moreamericans-have-tattoos-today (accessed January 19, 2023, July 22, 2024). *3. FDA, ‘‘Fusion Ink’’: Recall, posted November 30, 2017; available at https:// www.accessdata.fda.gov/scripts/ires/ index.cfm?Product=158974 (accessed January 19, 2023, July 22, 2024). *4. FDA, ‘‘Radiant Colors’’: Recall, posted December 21, 2017; available at https:// www.accessdata.fda.gov/scripts/ires/ index.cfm?Product=160130 (accessed January 19, 2023, July 22, 2024). *5. FDA, ‘‘Solid Ink’’: Recall, posted June 20, 2018; available at https:// www.accessdata.fda.gov/scripts/ires/ index.cfm?Product=164628 (accessed E:\FR\FM\25OCN1.SGM 25OCN1 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Notices January 19, 2023, July 22, 2024). *6. FDA, ‘‘Intenze Ink’’: Recall, posted July 31, 2018; available at https:// www.accessdata.fda.gov/scripts/ires/ index.cfm?Product=165649 (accessed January 19, 2023, July 22, 2024). *7. FDA, ‘‘Eternal Ink’’: Recall, posted October 24, 2018; available at https:// www.accessdata.fda.gov/scripts/ires/ index.cfm?Product=167698 (accessed January 19, 2023, July 22, 2024). *8. FDA, ‘‘FDA Advises Consumers, Tattoo Artists, and Retailers to Avoid Using or Selling Certain Tattoo Inks Contaminated with Microorganisms’’; available at https://www.fda.gov/cosmetics/ cosmetics-recalls-alerts/fda-advisesconsumers-tattoo-artists-and-retailersavoid-using-or-selling-certain-tattoo-inks (accessed January 19, 2023, July 22, 2024). *9. Nho, SW, S–J. Kim, O. Kweon, et al. ‘‘Microbiological Survey of Commercial Tattoo and Permanent Makeup Inks Available in the United States.’’ Journal of Applied Microbiology, 124: 1294–1302 (2018). Dated: October 21, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024–24841 Filed 10–24–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–4777] Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on December 4, 2024, from 8 a.m. to 3 p.m. Eastern Time. ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:40 Oct 24, 2024 Jkt 265001 20993–0002. The public will also have the option to participate, and the advisory committee meeting will be heard, viewed, captioned, and recorded through an online teleconferencing and/ or video conferencing platform. Answers to commonly asked questions about FDA advisory committee meetings, including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2024–N–4777. The docket will close on December 3, 2024. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time on December 3, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. Comments received on or before November 19, 2024, will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 85219 do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2024–N–4777 for ‘‘Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments— Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/ blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[Federal Register Volume 89, Number 207 (Friday, October 25, 2024)]
[Notices]
[Pages 85217-85219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24841]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1083]

Insanitary Conditions in the Preparation, Packing, and Holding of
Tattoo Inks and the Risk of Microbial Contamination; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: 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.

DATES: The announcement of the guidance is published in the Federal
Register on October 25, 2024.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-D-1083 for ``Insanitary Conditions in the Preparation,
Packing, and Holding of Tattoo Inks and the Risk of Microbial
Contamination.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit

[[Page 85218]]

both copies to the Dockets Management Staff. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to Office
of the Chief Scientist, Office of the Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave WO1, Silver Spring, MD 20993.
Send two self-addressed adhesive labels to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jennifer Ross, Office of the Chief
Scientist, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-4880 (this is
not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry
entitled ``Insanitary Conditions in the Preparation, Packing, and
Holding of Tattoo Inks and the Risk of Microbial Contamination.''
Tattooing has become increasingly popular in the United States.
Polling and data suggest that about 30 percent of all Americans, and 40
percent of those aged 18-34, have at least one tattoo (Refs. 1 and 2).
State and local jurisdictions generally regulate the practice of
intradermal tattooing, including permanent makeup and microblading. FDA
regulates, among other things, the inks used in that practice. Tattoo
inks are cosmetics as defined by section 201(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(i)) because they are
articles intended to be introduced into or otherwise applied to the
human body for beautifying, promoting attractiveness, or altering the
appearance.
Microorganisms normally regarded as nonpathogenic when applied
topically may become opportunistically pathogenic and virulent when
introduced in other ways (e.g., in wounds or via cosmetics introduced
into or through the skin). Tattoo inks bypass the body's primary
physical barrier against pathogens because they are inserted below the
epidermis. We have received multiple reports of illness caused by
microbially contaminated tattoo inks, and subsequent testing has found
many sealed tattoo inks in the United States with microbial
contamination. Among other things, between 2003 and 2019, tattoo ink
firms conducted 15 ink recalls, 14 of which resulted from findings of
microbial contamination. Eight of these recalls (Refs. 3 to 8) occurred
after FDA conducted multiple surveys of tattoo inks available in the
U.S. market and tested them for microbial contamination. Many of these
inks were heavily contaminated with a variety of microorganisms, some
of which can cause serious infections (Refs. 8 and 9).
This guidance will help tattoo ink manufacturers and distributors
understand examples of what could adulterate a tattoo ink because it
has been prepared, packed, or held under insanitary conditions that
could render it injurious to health. We also recommend certain steps
that manufacturers and distributors could take to help prevent the
occurrence of these conditions, or to identify and remediate insanitary
conditions that already exist during manufacturing and distribution.
This guidance finalizes the draft guidance entitled ``Insanitary
Conditions in the Preparation, Packing, and Holding of Tattoo Inks and
the Risk of Microbial Contamination'' issued on June 13, 2023 (88 FR
38516). FDA considered comments received on the draft guidance as the
guidance was finalized. Changes from the draft to the final guidance
include addition of a definition of injection for purposes of this
guidance. In addition, editorial changes were made to improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Insanitary Conditions in the Preparation,
Packing, and Holding of Tattoo Inks and the Risk of Microbial
Contamination.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

III. Electronic Access

Persons with access to the internet may obtain the guidance at
https://www.fda.gov/CosmeticGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

IV. References

The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. Although FDA verified the website addresses
in this document, please note that websites are subject to change over
time.

1. Giulbudagian, M., I. Schreiver, A.V. Singh, et al., ``Safety of
Tattoos and Permanent Make-up: A Regulatory View.'' Archives of
Toxicology, 94: 357-369 (2020).
2. Ipsos poll. ``More Americans Have Tattoos Today than Seven Years
Ago,'' August 29, 2019. Available at: https://www.ipsos.com/en-us/news-polls/more-americans-have-tattoos-today (accessed January 19,
2023, July 22, 2024).
*3. FDA, ``Fusion Ink'': Recall, posted November 30, 2017; available
at https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=158974 (accessed January 19, 2023, July 22, 2024).
*4. FDA, ``Radiant Colors'': Recall, posted December 21, 2017;
available at https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=160130 (accessed January 19, 2023, July 22, 2024).
*5. FDA, ``Solid Ink'': Recall, posted June 20, 2018; available at
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=164628
(accessed

[[Page 85219]]

January 19, 2023, July 22, 2024).
*6. FDA, ``Intenze Ink'': Recall, posted July 31, 2018; available at
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=165649
(accessed January 19, 2023, July 22, 2024).
*7. FDA, ``Eternal Ink'': Recall, posted October 24, 2018; available
at https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=167698 (accessed January 19, 2023, July 22, 2024).
*8. FDA, ``FDA Advises Consumers, Tattoo Artists, and Retailers to
Avoid Using or Selling Certain Tattoo Inks Contaminated with
Microorganisms''; available at https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-advises-consumers-tattoo-artists-and-retailers-avoid-using-or-selling-certain-tattoo-inks (accessed
January 19, 2023, July 22, 2024).
*9. Nho, SW, S-J. Kim, O. Kweon, et al. ``Microbiological Survey of
Commercial Tattoo and Permanent Makeup Inks Available in the United
States.'' Journal of Applied Microbiology, 124: 1294-1302 (2018).

Dated: October 21, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-24841 Filed 10-24-24; 8:45 am]
BILLING CODE 4164-01-P

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