Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Draft Guidance for Industry; Availability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

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The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination.” The draft guidance, when finalized, will provide our current view of insanitary conditions of tattoo ink preparation, packaging, or holding that may render the inks injurious to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Submit either electronic or written comments on the draft guidance by September 11, 2023 to ensure that FDA considers your comment on the draft guidance before it begins work on the final version of the guidance.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 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 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).