Tattoo Ink Safety in the US: What MoCRA Changed and What the FDA Found

In Europe, tattoo ink rules made headlines when the EU restricted hundreds of chemicals and two popular pigments. In the United States, the story is different, and less well known. Tattoo inks are regulated as cosmetics by the Food and Drug Administration, and a 2022 law gave the agency significant new powers. Here is how FDA tattoo ink oversight works today.

Here is how US tattoo ink regulation works, what the Modernization of Cosmetics Regulation Act changed, and what an FDA study found inside sealed bottles of ink.

Tattoo ink is regulated as a cosmetic

In the US, the FDA considers tattoo inks to be cosmetics, and the colour additives used in them are subject to FDA rules. Tattooing itself, meaning the studio, the artist and the procedure, is regulated separately by states and local authorities, as we explain in our guide to tattoo licensing in the US.

For decades, the FDA's powers over cosmetics were limited, largely resting on a law dating back to 1938.

What MoCRA is

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law in December 2022 as part of a larger spending bill. It was the most significant update to FDA cosmetics oversight since 1938, and because tattoo inks count as cosmetics, it applies to them too.

What MoCRA changed

Mandatory recalls

Previously, recalls of cosmetics, including tattoo inks, were voluntary. MoCRA gave the FDA mandatory recall authority when there is a reasonable probability that a product is adulterated or misbranded and could cause serious harm.

Serious adverse event reporting

Companies responsible for cosmetic products must now report serious adverse events, such as serious infections, to the FDA, generally within 15 business days of receiving the report.

Facility registration and product listing

Manufacturers must register their facilities and list their products with the FDA, giving the agency a clearer picture of who makes what. The FDA delayed enforcement of these requirements until July 2024 to give companies time to comply.

Manufacturing standards and records

MoCRA also directs the FDA to set good manufacturing practice standards for cosmetics and gives the agency access to certain safety records.

What the FDA found in sealed tattoo inks

Contamination has long been one of the FDA's main concerns about tattoo ink, and several contaminated inks have been recalled over the years. In July 2024, FDA scientists published a study in the journal Applied and Environmental Microbiology that tested 75 tattoo and permanent makeup inks from 14 manufacturers, all unopened.

• 26 of the 75 samples were contaminated with bacteria, around a third.
• Among the 49 products labelled as sterile, 16 were contaminated.
• The researchers found both aerobic bacteria and anaerobic bacteria, which can grow in low-oxygen environments such as the deeper layers of skin.

The findings showed that a "sterile" label is not a guarantee, and highlighted the risk of infection from ink itself, not only from unhygienic equipment. The FDA has also issued guidance to tattoo ink manufacturers on preventing contamination.

What it means if you are getting tattooed

• Choose a licensed studio with strict hygiene, and ask which ink brands your artist uses.
• Ink should be poured into single-use caps, never dipped from the main bottle, and never diluted with tap water.
• Know the signs of infection: spreading redness, heat, pain, pus or fever. See a doctor if they appear, and mention the tattoo.
• Report problems. Consumers and healthcare providers can report reactions to tattoo inks to the FDA through its MedWatch program.

For signs a reaction might be something other than infection, read our guides to raised tattoos and itchy old tattoos. For the European approach, see the EU tattoo ink ban explained.

Sources: Congressional Research Service on FDA regulation of cosmetics under MoCRA; "Detection of anaerobic and aerobic bacteria from commercial tattoo and permanent makeup inks," Applied and Environmental Microbiology, 2024; FDA guidance on tattoo inks.