FDA Warns Inks Used in Certain Tattoo Kits Cause Infections

Recently, the Food and Drug Administration (FDA) became aware of a problem after testing inks in home-use tattoo kits marketed by White and Blue Lion, Inc. FDA has confirmed bacterial contamination in unopened bottles of the company’s inks.

According to Linda Katz, MD, MPH, director of FDA’s Office of Cosmetics and Colors, using these inks for tattoos could cause infection. “FDA has confirmed one case of skin infection involving a consumer that used this company’s tattoo products,” Katz says, “and we are aware of other reports linked to tattoo products with similar packaging.”

According to Katz, “Tattooing poses a risk of infection to anyone, but the risk is particularly high for those with pre-existing heart or circulatory disease, diabetes or compromised immune systems.”

She notes that injecting contaminated ink into the skin or using contaminated needles may result in infections at the site of the tattoo. Signs of localized infection include redness, swelling, weeping wounds, blemishes, or excessive pain at the site. If you experience any of these signs, seek medical care right away. Even after a localized infection has healed, the area may be permanently scarred.

Further, an infection that is left untreated or inadequately treated could spread through the bloodstream (sepsis). These infections may be associated with fever, shaking chills and sweats. If these symptoms arise, treatment with antibiotics, hospitalization and/or surgery may be required.

White and Blue Lion, Inc. recalled contaminated products on July 11, 2014, but the FDA is still concerned that consumers and professional tattoo artists may be purchasing or using contaminated home tattoo kits and inks from other distributors.

Specifically, how can you identify kits and inks that you should not use because they may be contaminated? FDA advises you to watch out for inks intended for permanent makeup or traditional body tattoos that:
- have no brand name, carry a dragon logo, and/or are missing the name and place of business of the manufacturer or distributor,
- are sold singly and in kits containing anywhere from five to 54, or perhaps more, bottles of inks of various colors, and
- are marked with “Lotch” [sic] and Batch numbers, and “Date produced” and “Best if used by” dates.

“If you’re buying tattoo inks or getting a tattoo from a professional tattoo artist, you should first examine the products to determine whether the inks or kits meet the above descriptions,” cautions Katz.

FDA’s goal is to encourage consumers and tattoo and permanent make-up artists to take certain precautions and to urge potentially infected clients to seek medical care.

“Reporting an infection to FDA and the artist is important in order for FDA to investigate, and to enable the artist to take steps to prevent others from becoming infected,” says epidemiologist Katherine Hollinger, DVM, MPH, from the Office of Cosmetics and Colors.

Consumers and tattoo artists should do the following:
- Seek immediate medical care if you experience any signs of infection.
- Don’t use tattoo inks and kits that have no brand name, carry a dragon logo, and/or are missing the name and place of business of the manufacturer or distributor.
- Dispose of tattoo inks that meet this description.
- Do not use recalled kits.
- Report adverse events or side effects through FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Source: FDA