[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]


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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.

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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 This guidance finalizes the draft 
guidance of the same title issued on June 13, 2023.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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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

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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