Tattoo Ink Bacterial Infection Risks Addressed by FDA

New federal guidelines have been introduced to help reduce the risk of tattoo ink becoming contaminated by unsanitary equipment or environments.

To reduce the risk of severe infections from tattoo ink, federal safety regulators have issued new guidance for manufacturers and distributors, which are designed to help them recognize and prevent situations in which tattoo ink may be contaminated by microorganisms.

The U.S. Food and Drug Administration (FDA) announced the Insanitary Conditions in Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination Guidance on October 24, indicating that these new recommendations are not legally enforceable requirements, but the industry has been encouraged to follow the suggestions to avoid causing tattoo ink infections.

In recent decades, tattoos have increased in popularity in the United States, with about 30% of Americans now having at least one tattoo. However, tattooing punctures the skin, allowing contaminated tattoo ink to introduce harmful bacteria and other substances into the body, which pose a risk of serious infections and injuries if certain safety protocols are not followed.

Symptoms of tattoo ink infections may include rashes, blisters, granulomas, impetigo, cellulitis or systemic infections, which can lead to severe and life-threatening consequences, such as endocarditis, septic shock or organ failure.

The FDA issued a safety alert in 2019, to warn consumers, tattoo artists and retailers about the potential risks associated with using contaminated tattoo ink. Between 2003 and 2019, tattoo ink manufacturers conducted 15 voluntary recalls, 14 of which were due to microbial contamination.

In addition, a 2018 study found that 49% of tattoo inks on the U.S. market contained potentially harmful bacteria. Contaminated tattoo ink was also responsible for a multistate outbreak of nontuberculous mycobacterial skin infections in 2012.

Tattoo Ink Safety Concerns

Federal health officials recognize that tattoo inks are used by a diverse group of people, including those who are immunocompromised or have underlying medical conditions. Since the ink bypasses the skin, which is the body’s primary barrier against pathogens, microorganisms that might otherwise be harmless can become extremely dangerous.

For this reason, the FDA indicates that steps must be taken to avoid contaminating tattoo inks through unsanitary preparation, packing or storage conditions. This includes making sure the tattoo ink is not mixed with dirty equipment, stored in facilities that are hard to clean, or placed near open air ducts.

Employees can also contribute to tattoo ink contamination if they fail to wear proper attire, like hairnets, lab coats, masks or gloves. Bacteria can also be introduced if protective gear is not properly disposed of, or workers fail to wash their hands correctly.

The new FDA guidelines (PDF) provide the following suggestions manufacturers can use to ensure tattoo inks are not being held under unsanitary conditions:

• Test ink and ink components for contamination, or purchase materials from suppliers that conduct contamination testing. Materials that contain microorganisms that may harm consumers should be discarded.
• Ensure the manufacturing process is in a sanitary environment and does not introduce microbial contamination.
• Use validated sterilization methods for equipment and final products.
• Ensure any cleaning or sterilization methods do not change the finished product.
• Take corrective measures to prevent the release of any final product that has microbial contamination which may harm consumers, and reexamine procedures to determine causes of contamination.

Additional Risks Associated With Tattoos

Although tattoos are widely regarded as safe, they have been associated with a number of adverse health effects in recent years.

In March, the FDA issued a warning urging consumers to avoid using certain lidocaine topical painkillers before tattooing as a numbing agent, due to risks that the products may interact with other medications or dietary supplements, potentially causing serious injuries, such as irregular heartbeat, seizures and breathing difficulties.

A study conducted by Swedish researchers in May found that tattooed individuals face an increased risk of lymphoma, a rare form of blood cancer.

An FDA report from 2017 also detailed over 363 adverse reactions involving problems with tattoos from 2004 to 2016. The type and severity of injuries varied, although many of them involved ink contaminated with mold and unsterile tools.

The new federal safety guidelines announced by the FDA address the safety concerns associated with microbial contamination and offer recommendations for manufacturers, tattoo artists and retailers to ensure consumer safety.