FDA and CDC warn that tattoo ink can be hazardous to your health

If you’re among the the 21% of American adults who have tattoos, you might be surprised to learn that there’s no law or regulation that requires tattoo inks to be sterile. The Food and Drug Administration, which has oversight over the inks, treats them like cosmetics and says only that ink manufacturers must use ingredients that have received pre-market approval.

But the Centers for Disease Control and Prevention is now calling for higher standards. In this week’s edition of its Morbidity and Mortality Weekly Report, a group of public health experts writes:

“Because tattoo inks are injected intradermally, CDC recommends that ink manufacturers be held to higher product safety standards, which should include production of sterile inks.”

That might have spared about two dozen people some nasty skin infections with an organism called Mycobacterium chelonae. M. chelonae causes what are called nontuberculous mycobacterial (NTM) skin infections, which “are difficult to treat and an require a minimum of 4 months of treatment with a combination of two or more antibiotics,” according to the report.

The first patient to come to the attention of public health officials was a 20-year-old man from the Rochester, N.Y., area who had many tattoos and was otherwise healthy. As recounted this week in the New England Journal of Medicine, the man had “a persistant granulomatous rash” on his arm right where he got a tatto last October. Treatment with a glucocorticoid (perhaps hydrocortisone) didn’t work, so his primary care doctor sent him to a dermatologist who alerted the Monroe County Department of Public Health.

Department investigators ultimately tracked down 14 tattoo parlor customers with definite M. chelonae infections, four more who probably had it, and one more who was suspected of having it. These customers – 13 men and six women – ranged in age from 18 to 48.

Samples from two of the Rochester-area patients were tested for drug resistance. One patient’s infection was resistant to the antibiotics ciprofloxacin (Cipro) and cefoxitin (Mefoxin); the other patient’s infection was also resistant to Mefoxin and also had lost some of its sensitivity to Cirpo, according to the New England Journal of Medicine report.

Altogether, all but one of the 19 patients required treatment, and all of them eventually recovered.

The investigators also visited the tattoo artist who worked on the patient and determined that he and his colleagues at the parlor were doing everything right: “The artists used sterile instruments, wore clean disposable gloves, poured ink into single-use containers, and provided appropriate aftercare to the tattooed site.”

But there was a problem: a line of premixed gray inks produced in Arizona. FDA inspectors visited the plant and collected samples of inks and ingredients, which they sent to the CDC for analysis. Investigators there discovered that cultures from the unidentified company’s inks contained the same strain of M. chelonae that had sickened the tattoo parlor customers. The company recalled its inks.

Infectious ink is not a a major public health problem, but it is becoming more common. Israeli dermatologists reported the first case of M. chelonae infection tied to tattoo ink in 2003, and 13 cases in France were reported in 2010. A cluster of six American patients was detailed the same year.

The Rochester-area cases prompted CDC officials to send out a nationwide alert about potential problems with tattoo ink. That prompted state health officials to report back on a handful of M. chelonae infections in Washington and Iowa that were tied to ink made by another company.

The extent of the problem is not clear, but the Morbidity and Mortality Weekly Report report cited a 2010 test of 58 unopened bottles of ink made by a variety companies. In that test, 10% of the ink bottles were contaminated with some kind of organism (they weren’t screened for M. chelonae or any other NTM).

You can read the full report from the CDC online here, and the New England Journal of Medicine study here.

In a “Perspective” essay that accompanies the study, doctors and public health experts from the FDA’s Center for Food Safety and Applied Nutrition warned that “even if a person receives a tattoo at a tattoo parlor that maintains the highest standards of hygienic practice, there remains a risk of infection from the use of contaminated ink. People who get tattoos must be made aware of this risk.”

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