On June 12, the U.S. Food and Drug Administration issued a draft guidance to help manufacturers and distributors recognize situations that will prevent microbial contamination in tattoo inks.
“With about 30 percent of people living in the U.S. having a tattoo, it’s imperative that the FDA take all necessary steps to help ensure that tattoo inks are free of contamination,” said FDA Chief Scientist Namandjé Bumpus, Ph.D. “Pathogens or other harmful substances in these inks can cause infections and serious injuries. The FDA is issuing this draft guidance to help tattoo ink manufacturers and distributors recognize situations in which tattoo ink may become contaminated with microorganisms and take steps to protect public health.”
The FDA has received multiple reports of illness caused by infected tattoo inks, and subsequent testing has found many sealed tattoo inks in the U.S. with microbial contamination. In May 2019, the FDA issued a Safety Alert advising consumers, tattoo artists and retailers to avoid using or selling certain tattoo inks contaminated with microorganisms.
“Unlike most cosmetics, tattoo inks are injected into the dermal layer of the skin, and therefore have the potential to introduce harmful pathogens directly into the body. Because of this, it is particularly important for tattoo inks to be manufactured using methods to ensure a product is safe,” said Linda Katz, M.D., M.P.H., director of the FDA's Office of Cosmetics and Colors. “The recommended steps outlined by the FDA in the draft guidance provide manufacturers the information and resources needed to help ensure that tattoo inks are not contaminated.”
Draft recommendations may include:
- Testing ink and ink components (e.g., pigments, water, other solvents) for microbial contamination or purchasing these materials from suppliers that test for microbial contamination. Discard any materials that contain microorganisms of a type or at a level that may harm any consumer if present in the finished product;
- Ensuring that the manufacturing process itself does not introduce microbial contamination (e.g., by conducting adequate cleaning and sanitization of manufacturing equipment, providing personal protective equipment to employees);
- Ensuring that any sterilization method used is validated;
- Ensuring that any cleaning or sterilization method used does not adulterate the finished product; and
- Taking corrective measures to prevent the release of any tattoo inks that microbiological testing shows contains any type of level of microorganisms.
The FDA urges consumers and healthcare providers to report adverse reactions from tattoos. Consumers and healthcare providers can report problems to MedWatch, the FDA’s problem-reporting program, by calling 1-800-332-1088, or by contacting the nearest FDA Consumer Coordinator. In addition, under the Modernization of Cosmetics Regulation Act of 2022 , the manufacturer, packer or distributor of cosmetic products, including tattoo inks, whose name appears on the label is required to report serious adverse events to MedWatch that are associated with the use of the product to the FDA.
The FDA is accepting comments on the draft guidance within 90 days of publication in the Federal Register on Regulations.gov.