Notice2023-12380
Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Draft Guidance for Industry; Availability
Primary source
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Published
June 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination." The draft guidance, when finalized, will provide our current view of insanitary conditions of tattoo ink preparation, packaging, or holding that may render the inks injurious to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.
Full Text
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<title>Federal Register, Volume 88 Issue 113 (Tuesday, June 13, 2023)</title>
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[Federal Register Volume 88, Number 113 (Tuesday, June 13, 2023)]
[Notices]
[Pages 38516-38518]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12380]
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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Tattoo Inks and the Risk of Microbial Contamination; Draft Guidance for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 we) is announcing the
availability of a draft guidance for industry entitled ``Insanitary
Conditions in the Preparation, Packing, and Holding of Tattoo Inks and
the Risk of Microbial Contamination.'' The draft guidance, when
finalized, will provide 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.
DATES: Submit either electronic or written comments on the draft
guidance by September 11, 2023 to ensure that FDA considers your
comment on the draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the
[[Page 38517]]
electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 draft guidance to
the Office of Colors and Cosmetics, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740. Send two self-addressed adhesive labels to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Elizabeth Anderson, Office of Colors
and Cosmetics, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
1130; or Deirdre Jurand, Office of Regulations and Policy, Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance for industry
entitled ``Insanitary Conditions in the Preparation, Packing, and
Holding of Tattoo Inks and the Risk of Microbial Contamination.'' We
are issuing the draft guidance consistent with our good guidance
practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
Tattooing has become increasingly popular in the United States:
about 30 percent of all Americans, and 40 percent of those aged 18 to
34 years, have at least one tattoo (Refs. 1 and 2). State and local
jurisdictions generally regulate the practice of intradermal tattooing,
including permanent makeup. FDA regulates, among other things, the inks
used in that practice. These 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. Section 301(a) of the FD&C
Act (21 U.S.C. 331(a)) prohibits the introduction, or delivery for
introduction, into interstate commerce of cosmetics that are
adulterated or misbranded. Cosmetics are adulterated within the meaning
of section 601(c) of the FD&C Act (21 U.S.C. 361(c)) if they have been
prepared, packed, or held under insanitary conditions whereby they may
have become contaminated with filth, or whereby they may have been
rendered injurious to health.
Microbes normally regarded as nonpathogenic when introduced in
certain ways (e.g., 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
7) 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 draft guidance, when finalized, 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.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this draft 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 draft guidance
at <a href="https://www.fda.gov/CosmeticGuidances">https://www.fda.gov/CosmeticGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but 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: <a href="https://www.ipsos.com/en-us/news-polls/more-americans-have-tattoos-today">https://www.ipsos.com/en-us/news-polls/more-americans-have-tattoos-today</a> (accessed January 19,
2023).
* 3. Food and Drug Administration, ``Fusion Ink'': Recall, posted
November 30, 2017; available at <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=158974">https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=158974</a> (accessed January 19, 2023).
* 4. Food and Drug Administration, ``Radiant Colors'': Recall,
posted December 21, 2017; available at <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=160130">https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=160130</a>
(accessed January 19, 2023).
* 5. Food and Drug Administration, ``Solid Ink'': Recall, posted
June 20, 2018; available at <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=164628">https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=164628</a> (accessed January 19, 2023).
* 6. Food and Drug Administration, ``Intenze Ink'': Recall, posted
July 31, 2018; available at <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=165649">https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=165649</a> (accessed January 19, 2023).
* 7. Food and Drug Administration, ``Eternal Ink'': Recall, posted
October 24, 2018; available at <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=167698">https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=167698</a> (accessed
[[Page 38518]]
January 19, 2023).
* 8. 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).
* 9. Food and Drug Administration, ``FDA Advises Consumers, Tattoo
Artists, and Retailers to Avoid Using or Selling Certain Tattoo Inks
Contaminated with Microorganisms''; available at <a href="https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-advises-consumers-tattoo-artists-and-retailers-avoid-using-or-selling-certain-tattoo-inks">https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-advises-consumers-tattoo-artists-and-retailers-avoid-using-or-selling-certain-tattoo-inks</a> (accessed January 19, 2023).
Dated: June 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12380 Filed 6-12-23; 8:45 am]
BILLING CODE 4164-01-P
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