FDA Provides New Regulations on Tattoo Inks

The FDA estimates that 30% of Americans, including 40% of those between the ages of 18 and 34, have at least one tattoo. While tattoos can be an artistic way to express oneself, it is important to stay safe while getting inked up.

On June 12, the FDA furnished a novel manual regarding tattoo inks in the United States to prohibit microbial contamination. Colored liquid combinations are used to create tattoo inks, and depending on the ink, pigments inside are combined with water and may also contain a number of additional ingredients.

Some inks are said to contain pigments used in printer toner or auto paint, according to published studies, and no pigments for injection into the skin for aesthetic reasons have received FDA approval.

"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," announced FDA Chief Scientist Namandjé Bumpus.

He continued that these inks may include pathogens or other dangerous elements that can result in infections and severe damage.

The FDA has received complaints of patients getting infections from tattoo inks that were tainted, as well as allergic responses to the inks themselves. The FDA issued a safety notice in 2019 regarding certain tattoo inks that were bacterially tainted.

The FDA released a new recommendation in June 2023 to assist distributors and makers of tattoo ink in identifying circumstances in which tattoo ink may get contaminated with germs such as bacteria or mold. The draught guidance also offers distributors and manufacturers a number of protective tips.

The draught guideline is being provided by the FDA to assist tattoo ink distributors and producers in identifying circumstances in which tattoo ink may become contaminated with germs and taking preventative measures to safeguard public health.

Numerous reports of illnesses brought on by contaminated tattoo inks have been sent to the FDA, and further testing has revealed that many sealed tattoo inks sold in the U.S. are microbially contaminated. The FDA issued a Safety Alert in May 2019 warning people to avoid using or purchasing certain tattoo inks that are contaminated with germs.

"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," states the director of the FDA's Office of Cosmetics and Colors, Linda Katz.

She says the FDA's suggested actions give manufacturers the knowledge and tools necessary to assist in guaranteeing that tattoo inks are not contaminated. The FDA specifies these measures in the drafted advice.

Customers and medical professionals are urged by the FDA to report any negative effects of getting a tattoo. Under the Modernization of Cosmetics Regulation Act of 2022, the maker, packer, or distributor of cosmetic items, including tattoo inks, whose name is on the label, is additionally obligated to report significant adverse events to MedWatch that are linked to the use of the product to the FDA.


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