Tattoos are more popular than ever. About 30% of all Americans, and 40% of those aged 18-34 years old, have at least one tattoo, according to polling by the firm Ipsos.
While state and local authorities oversee the practice of tattooing, inks and pigments used in tattoos are subject to U.S. Food and Drug Administration oversight as cosmetics. The FDA takes action to protect consumers when safety issues arise related to the inks.
Over the years, the FDA has received reports of people developing infections from contaminated tattoo inks, as well as allergic reactions to the inks themselves. In 2019, the FDA issued a safety alert about certain tattoo inks contaminated with microorganisms. In June 2023, the FDA issued a draft guidance to help tattoo ink manufacturers and distributors recognize situations in which tattoo ink may become contaminated with microorganisms, such as bacteria or mold. The draft guidance also recommends certain steps manufacturers and distributors can take to help prevent it.
Questions to Consider Before Getting a Permanent Tattoo or Permanent Makeup
A tattoo is permanent when a needle inserts colored ink into skin. Permanent makeup is a type of tattoo applied to look like makeup, such as eyeliner, lip liner, or eyebrows.
Permanent tattoos are designed to last a lifetime and are difficult to remove. With that in mind, consider these key questions, answered below by Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors. For information on temporary tattoos, please visit, “Temporary Tattoos, Henna/Mehndi, and “Black Henna”: Fact Sheet”
Should I have any concerns about the tattoo ink itself?
While you can get serious infections from unhygienic practices and equipment that isn’t sterile, infections can also result from ink that was contaminated with bacteria, mold, or other microorganisms. Using non-sterile water to dilute the pigments (ingredients that add color) is a common culprit, although not the only one.
There’s no sure-fire way to tell if the ink is safe without testing. An ink can be contaminated even if the container is sealed, or the label says the product is sterile.
What is in tattoo ink?
Tattoo inks are colored liquid mixtures used to create body art. The inks contain pigments that are mixed with water and may contain a variety of other components, depending on the ink.
Published research has reported that some inks contain pigments used in printer toner or in car paint. The FDA has not approved any pigments for injection into the skin for cosmetic purposes.
What kinds of reactions may happen after getting a tattoo?
Following a tattoo you may notice some redness, swelling, or warmth of the skin. Your tattooist should advise you how to care for a newly tattooed area and how long you may experience some local discomfort.
If you notice that the area seems not to be healing or if you notice a rash — redness or bumps — near your tattoo, contact the tattooist and your health care professional especially if you develop a fever.
More aggressive infections may cause high fever, shaking, chills, and sweats. Treating such infections might require a variety of antibiotics — possibly for months — or even hospitalization and/or surgery. A rash may also mean you’re having an allergic reaction. And because the inks are permanent, the reaction may persist.
Contact your health care professional if you have any concerns. The FDA reviews reports of adverse reactions or infections from consumers, health care professionals, and industry. We may also learn about outbreaks from state authorities who oversee tattoo parlors.
Can scar tissue build up after getting a tattoo?
Scar tissue may form when you get a tattoo, or you could develop “granulomas,” small knots or bumps that may form around material that the body perceives as foreign. If you tend to get keloids — scars that grow beyond normal boundaries — you may develop the same kind of reaction to the tattoo.
What do I need to know about MRIs if I get a tattoo?
Some people may have swelling or burning in the tattoo when they have magnetic resonance imaging (MRI), although this happens rarely and does not last long. Let your health care professional know that you have a tattoo before having this type of medical imaging.
What about do-it-yourself tattoo inks and kits?
Inks and kits sold as “do-it-yourself” to consumers have been associated with infections and allergic reactions. The FDA is also concerned that consumers may not know how to control and avoid all sources of contamination.
Could other problems occur later?
Although research is ongoing at the FDA and elsewhere, there are still a lot of questions about the long-term effects that may be caused by the pigments, other ingredients, and possible contaminants in tattoo inks. The FDA has received reports of bad reactions to tattoo inks right after tattooing and even years later. You also might become allergic to other products, such as hair dyes, if your tattoo contains p-phenylenediamene (PPD).
Then there’s tattoo removal. We don’t know the short- or long-term consequences of how pigments break down after laser treatment. However, we do know some tattoo removal procedures may leave permanent scarring and may fail to remove the tattoo completely.
If I get a tattoo and develop an infection or other reaction, what should I do?
Contact your health care professional.
Notify the tattoo artist so they can identify the ink and avoid using it again. Ask for the brand, color, and any lot or batch number of the ink or diluent to help determine the source of the problem and how to treat it.
Whether you’re a consumer, tattoo artist, or health care professional, tell the FDA. 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.
Source: https://www.fda.gov/consumers/consumer-updates/think-you-ink-tattoo-safety
