[Federal Register Volume 88, Number 113 (Tuesday, June 13, 2023)]
[Notices]
[Pages 38516-38518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Tattoo Inks and the Risk of Microbial Contamination; Draft Guidance for 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availability of a draft guidance for industry entitled ``Insanitary 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 The draft guidance, when 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DATES: Submit either electronic or written comments on the draft 
guidance by September 11, 2023 to ensure that FDA considers your 
comment on the draft guidance before it begins work on the final 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:
     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.'' 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 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

[[Page 38517]]

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 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 https://www.fda.gov/CosmeticGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. 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 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. 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: https://www.ipsos.com/en-us/news-polls/more-americans-have-tattoos-today (accessed January 19, 
2023).
* 3. Food and Drug Administration, ``Fusion Ink'': Recall, posted 
November 30, 2017; available at https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=158974 (accessed January 19, 2023).
* 4. Food and Drug Administration, ``Radiant Colors'': Recall, 
posted December 21, 2017; available at https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=160130 
(accessed January 19, 2023).
* 5. Food and Drug Administration, ``Solid Ink'': Recall, posted 
June 20, 2018; available at https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=164628 (accessed January 19, 2023).
* 6. Food and Drug Administration, ``Intenze Ink'': Recall, posted 
July 31, 2018; available at https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=165649 (accessed January 19, 2023).
* 7. Food and Drug Administration, ``Eternal Ink'': Recall, posted 
October 24, 2018; available at https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=167698 (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 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).

    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