On October 25, 2024, FDA issued final guidance to the tattoo industry on the preparation, packing and holding of tattoo inks aimed at preventing the risk of microbial contamination. FDA is getting involved because tattoo ink is considered a cosmetic product regulated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
FDA’s new guidance is aimed at tattoo ink manufacturers, distributors, and packers and describes situations that may result in contamination and recommended steps to prevent contamination or remediate any insanitary conditions.
Specifically, the guidance lists the following examples of insanitary conditions that could result in contamination:
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- Preparing or packing the inks in unsuitable facilities, such as carpeted areas;
- Uncovered packaging containers near open air ducts;
- Storing or packing tattoo ink or ink components in non-sanitized containers;
- Personnel failing to wear appropriate attire such as hairnets, lab coats, masks, and/or gloves;
- Failure to equip facilities with signage for employees to wash hands and equipping facilities with restrooms, soap, and water;
- Failure to properly dispose of used personnel protection clothing;
- Insanitary mixing of tattoo inks with non-sanitized utensils;
- Storing products in places susceptible to contamination, including near dust or debris.
FDA also suggests the following nonbinding recommendations to prevent contamination:
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- Testing ink and ink components for contamination (or ensuring any purchased ink components are tested by supplier);
- Ensuring the manufacturing process does not contaminate products;
- Validating any sterilization method;
- Ensuring that the cleaning method does not introduce any contamination; and
- Preventing the release of any product that tests positive for harmful microorganisms.
While these recommendations are nonbinding, they do provide insight on what FDA considers when determining whether a cosmetic product in the tattoo industry is adulterated.
This guidance is timely as FDA has recently received multiple reports of illnesses allegedly caused by contaminated tattoo ink. Indeed, recent studies have demonstrated that many U.S. tattoo inks are microbially contaminated.
Back in July 2024, FDA published a study in the Applied Environmental Microbiology Journal after finding that over 30% of tattoo ink and permanent makeup product samples were contaminated with bacteria. FDA tested 75 tattoo and permanent makeup inks from 14 different manufacturers and found that 26 of the samples were contaminated with 22 different types of bacteria. The study concluded that both tattoo and permanent makeup inks may contain aerobic and anaerobic bacteria.
FDA’s guidance and its latest study on the potential contamination of tattoo and permanent makeup inks were published in the wake of industry efforts to comply with existing MoCRA requirements for adverse event reporting and safety substantiation, product listing and facility registration requirements (enforced by FDA starting July 1, 2024), and concerns about FDA’s Good Manufacturing Practices (GMPs) for cosmetics.
The October 2024 guidance notes that FDA will be implementing GMPs under MoCRA, but in the meantime, encourages the tattoo industry to establish practices consistent with International Organization for Standardization (ISO) standard 22716 “Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices.”
FDA’s final guidance and published study may suggest that, pursuant to its authority under MoCRA, FDA will focus its efforts to regulate tattoo and permanent makeup products at least initially on microbial contamination. Accordingly, companies should expect to see FDA issue untitled or warning letters to address issues of microbiological contamination in cosmetic products in the future.