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FDA Proposes Tougher Rules for Tattoo Providers to Curb Contaminated Inks

Medically reviewed by Drugs.com.

By Physician’s Briefing Staff HealthDay Reporter

THURSDAY, June 15, 2023 -- The U.S. Food and Drug Administration has issued a draft of new guidance aimed at helping manufacturers and distributors of tattoo inks prevent microbial contamination.

"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," FDA Chief Scientist Namandjé Bumpus, Ph.D., said in an agency news release. "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 The FDA is issuing this draft guidance to help tattoo ink manufacturers and distributors recognize situations in which tattoo ink may become contaminated with microorganisms and take steps to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 issued a safety alert on tattoo inks in May 2019. It advised consumers, tattoo artists, and retailers to avoid using or selling certain tainted inks. Many people have reported to federal regulators illness caused by contaminated tattoo inks. Testing has found that many sealed tattoo inks in the United States have microbial contamination.

"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," Linda Katz, M.D., director of the FDA Office of Cosmetics and Colors, said in the release. "Because of this, it is particularly important for tattoo inks to be manufactured using methods to ensure a product is safe."

The recommendations call for testing ink and its pigments, water, and solvents for microbial contamination or purchasing these from suppliers who do test their products. Recommendations include discarding any materials that contain microorganisms of a type or at a level that may be harmful if included in the finished product; ensuring that the manufacturing process does not introduce contamination through cleaning; giving personal protective equipment to workers, and validating sterilization methods. Those using these components would also need to ensure that the manufacturing process itself does not introduce contamination, the FDA said.

The agency will take comments on this draft guidance within 90 days of publication in the Federal Register.

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Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

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Posted June 2023

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