FDA Drafts Recommendations to Reduce Microbial Contamination in Tattoo Inks


With an estimated 30% of Americans living with a tattoo, the federal agency has developed guidance designed to give manufacturers information and resources to prevent potential health issues.

On Monday, the FDA announced it had developed recommendations to reduce the risk of microbial contamination for tattoo inks. The federal agency has received multiple reports of illness caused by infected tattoo inks, and subsequent testing has found many sealed tattoo inks in the United States 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.

“Pathogens or other harmful substances in these inks can cause infections and serious injuries,” FDA Chief Scientist Namandjé Bumpus, PhD, said in a statement. “The FDA is issuing this draft guidance to help tattoo ink manufacturers and distributors recognize situations in which tattoo ink may become contaminated with microorganisms and take steps to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 says on its site draft recommendations may include the following:

  • 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.

As the recommendations are just a draft version of the guidance, public comment on the guidance is being accepted within 90 days of publication in the Federal Register on Regulations.gov.

In addition, the federal agency asks consumers and healthcare providers to report adverse reactions from tattoos. People can do so report problems to MedWatch, the FDA’s problem-reporting program, by calling 1-800-332-1088, or by contacting the nearest FDA Consumer Coordinator.

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