The FDA issued a Safety Advisory on May 15, 2019 warning consumers, tattoo artists, and retailers about using or selling certain tattoo inks contaminated with microorganisms.

Español

There are many tattooed Americans. Surveys estimate that about one in five Americans now has at least one.

And with the rising popularity of tattoos, the U.S. Food and Drug Administration (FDA) is also seeing an increase in reports of people developing infections from contaminated tattoo inks, as well as having bad reactions to the inks themselves, according to Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors.

Before you get a tattoo, consider these seven important questions (as answered by Dr. Katz):

1. Should I be concerned about non-sterile needles, or the ink itself?

Both. While it’s true that you can get infections from unhygienic practices and equipment that isn’t sterile, in the last several years there have been cases in which people got infections because the ink itself was contaminated with microorganisms, such as bacteria and mold introduced either at the time of manufacture or at the tattoo parlor. Using non-sterile water to dilute the pigments is a common culprit, although not the only one.

There’s no sure-fire way to tell if the ink is safe. Just looking at it or smelling it won’t tell you if it’s contaminated. An ink can be contaminated even if the container is sealed or wrapped, or the label asserts the product is sterile. In fact, ink could become contaminated at any point in the production process.

State, county or local health departments oversee the operation of tattoo parlors. In situations in which firms recall tattoo inks, FDA is often involved in alerting firms to problems related to their inks and working with the firms to make sure recalls are effective. FDA also alerts the public when it becomes aware of a public health concern.

2. What does FDA know about inks?

The information the agency has about inks is limited. But FDA is analyzing tattoo inks and pigments for contaminants, heavy metals, degradants, potentially toxic chemicals—including pH stabilizers, microbicides and coating agents—and other materials that are not intended to be placed into the body. There are reports in the published scientific literature of tattoo inks that contain everything from pigments used in printer toner to pigments used in car paint.

3. What about do-it-yourself tattoo inks and kits?

Inks and kits sold online to consumers have been associated with reports of infection or allergic reaction. The agency is also concerned that, unlike most licensed tattoo artists, consumers will not have sufficient knowledge or the means to control and avoid all possible sources of contamination and subsequent infections in the process of giving themselves a tattoo.

4. What kinds of reactions have been seen with tattoos?

You might notice a rash—redness or bumps—in the area of your tattoo, and you could develop a fever. Serious infections can require months of treatment with a variety of antibiotics. More virulent or aggressive infections may be associated with high fever, shaking, chills, and sweats. If these symptoms arise, you may need antibiotics, hospitalization and/or surgery. Your physician or other health care professional will make that determination.

If you have an allergic reaction, the exact cause may be hard to pinpoint. You could have an allergic reaction to a pigment (one of the ingredients that add color to the ink) or to a diluent (the liquid used to dilute the pigments). Or you could have a reaction to a contaminant that got into the ink during manufacturing.

And because the inks are permanent, the reaction may persist.

5. If I get a tattoo and develop an infection or other reaction, what should I do ?

Three things: First, contact your doctor or other health care professional.

Second, notify the tattoo artist. That way he or she can identify the ink that was used, and avoid using it again. Plus, you can ask the tattoo artist for detailed information on the brand, color, and any lot or batch information that may be useful in determining the source of the problem and how to treat it.

Third, report the problem to FDA. FDA urges consumers, tattoo artists, and even health care professionals to report tattoo-related problems to FDA. Here’s how:

You can report a problem by contacting FDA’s Medwatch Program online by calling 1-800-FDA-1088.

You can also contact the FDA district office consumer complaint coordinator for your geographic area.

Provide as much detail as possible about the ink and your reaction and outcome. Reports from consumers are one of our most important sources of safety information.

6. What about later on? Could other problems occur?

Although research is ongoing at FDA and elsewhere, there are still a lot of questions the research hasn’t answered yet. These include questions about the long-term effects of the pigments, other ingredients, and possible contaminants in tattoo ink.

Then there’s the question of tattoo removal. We know that people have laser treatments to remove tattoos, but we don’t know the short- or long-term consequences of how the pigments break down after laser treatment. However, we do know that there may be permanent scarring from some of the tattoo removal procedures.

7. What’s the bottom line?

Think before you ink. Because of all the unknowns described above, this is not a decision to be made without careful consideration.

This is especially important because, despite advances in laser technology, removing a tattoo is a painstaking process and complete removal without scarring may be impossible.

If you do decide to get a tattoo, make sure the tattoo parlor and artist are in compliance with all state and local laws. The National Conference of State Legislatures has a Web page on state laws, statutes and regulations governing tattooing and body piercing. For information on local regulations, contact your county or city health department.

back to top