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 This guidance finalizes the draft
guidance of the same title issued on June 13, 2023.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