The U.S. Food and Drug Administration released a draught advisory on June 12, 2023, to assist producers and distributors in identifying circumstances that will stop microbial contamination in tattoo inks. According to FDA Chief Scientist Namandjé Bumpus, Ph.D., around 30% of Americans have tattoos, so the FDA must take all necessary measures to help assure that tattoo inks are free from contamination.
“These inks may include pathogens or other dangerous elements resulting in severe wounds and infections. The FDA provides this drafting guideline to assist tattoo ink distributors and producers in identifying instances where tattoo ink could get contaminated with germs and take precautions to safeguard the public’s health.
Numerous reports of infections caused by contaminated tattoo inks have been sent to the FDA, and further testing has revealed that numerous sealed tattoo inks sold in the United States are microbially contaminated. The FDA issued a Safety Alert in May 2019 warning people to avoid using or purchasing specific tattoo inks contaminated with germs.
Tattoo inks, injected in the outermost layer of the skin, unlike other cosmetics, can bring dangerous microorganisms into the body. As a result, tattoo inks must be produced utilizing processes that guarantee a product’s safety, according to Linda Katz, M.D., M.P.H., head of the FDA’s Office of Cosmetic and Colors. The FDA’s suggested actions, detailed in the drafted guidance, give producers the knowledge and tools they need to ensure that tattoo inks do not become contaminated.
Draught suggestions could be the following;
Checking for microbiological contamination in ink and ink components, such as pigments, water, and other solvents, or obtaining these products from vendors who do so. Any materials that include microorganisms of a kind or concentration that, if present in the finished product, could be harmful to any customer should be discarded;
Ensuring that the production process does not introduce microbiological contamination (for example, by providing workers with personal protective equipment and properly cleaning and sanitizing industrial equipment); Confirming the validity of any sterilization technique being utilized; Ensuring that the end product is not contaminated by cleaning or sterilization procedures; Taking appropriate action to stop the release of any tattoo inks found to contain germs at any level by microbiological testing;
The FDA implores customers and medical professionals to report tattoo-related adverse effects. Medical professionals and patients can report issues to the FDA’s MedWatch program by calling 1-800-332-1088 or contacting the local FDA Consumer Coordinator.
The manufacturer, packer, or distributor of cosmetics, including tattoo inks, whose name is on the label, is additionally obligated to report serious adverse events to MedWatch that are connected to the use of the product to the FDA under the Modernization of Cosmetics Regulation Act of 2022. Within 90 days of the draught guidance’s publication in the Federal Register on Regulations.gov, the FDA will receive comments on it.
