Reducing Microbial Contamination in Tattoo Inks: FDA Issues Draft Guideline

The Food and Drug Administration (FDA) recognizes that tattoos are becoming increasingly popular, even though they have existed for thousands of years. In the new FDA guidance issued today, June 12, 2023, the information attempts to assist tattoo ink manufacturers and distributors in identifying areas and circumstances where microorganisms could contaminate tattoo inks and cause severe infections. Other dermatologic conditions can occur as well, such as the Koebner phenomenon.

This guidance covers the popularity of tattooing, what tattooing is, why it can be dangerous, and examples of unsanitary (“Insanitary” is used in the draft guideline) conditions. The suggested guideline also gives recommendations that manufacturers and distributors can use to prevent incorrectly creating, packaging, and storing tattoo inks. 

Tattooing is achieved by “puncturing the epidermis about 100 times per second with needles and depositing ink 1.5 to 2 millimeters below the surface of the skin, deep into the dermis,” according to the draft guideline.

“Tattooing creates openings in the skin, and these pricks can introduce bloodborne viruses into the body, such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus,” Isis Lamphier, MPH, CIC, noted in an Infection Control Today^® (ICT^®) article. Organisms can also contaminate equipment such as tattoo machines and inks Therefore, cleaning, disinfection, sterilization, aftercare, and safe needle practices are imperative for tattoo artists.”

The guideline discusses other types of infection that may appear immediately up to a few days after receiving the tattoo. Bernard Cohen, MD, told ICT in an earlier interview that “the individual receiving the tattoo might not see signs of infection immediately. It may take up to 12 to 24 hours or even a few days. “You may develop a fever as a sign of infection. You may develop pus draining from the lesions from the areas where the pigment was poked into the skin. You might develop lymphadenopathy or swollen lymph glands up the stream if you had [a tattoo] on your arm. You may find it in your armpit or your neck crease for lymph nodes upstream from that area. The skin may feel warm, and it's going to hurt.”

These FDA draft guidelines are in addition to state and local regulations on intradermal tattooing. Specifically, “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 (the 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,” according to the Draft Guidance.

Some of the unsanitary situations that could occur during the manufacturing and distribution process that could lead to infections include facilities that need to be more sanitary and any time or place where any of the components that create the ink, including pigments, water, or solvents, are not covered correctly, “especially near open air ducts, potentially exposing them to airborne microbial contaminants and filth,” according to the draft guidelines.

Other conditions include improper personnel attire, workers’ restrooms without soap and water, and storing any products in creating the finished product of tattoo ink around possible contamination, such as dust or debris.

Some recommendations to ensure tattoo ink safety include testing inks and their components, regulating the creation process to avoid microscopic contamination, and verifying that the sterilization processes are not adding impurities.

“The FDA urges consumers and healthcare providers to report adverse reactions from tattoos,” the draft guidelines state. “Consumers and health care providers can report problems to MedWatch, the FDA’s problem-reporting program, by calling 1-800-332-1088 or contacting the nearest FDA Consumer Coordinator. In addition, the manufacturer, packer, or distributor of cosmetic products, including tattoo inks, whose name appears on the label is required to report serious adverse events to MedWatch that are associated with the use of the product to the FDA.”

The entire guidance can be found here.