Think before you ink: US FDA issues guidance on preventing serious risk from contaminated tattoos

13 Jun 2023 --- Following multiple reports of illnesses caused by microbially contaminated tattoo inks, the US FDA issued draft guidance to tattoo ink manufacturers and distributors to help recognize situations in which a tattoo ink may become contaminated with microorganisms, and thus, be potentially harmful to health.

“Between 2003 and 2023, firms conducted 18 recalls of tattoo inks that were contaminated with a variety of microorganisms, some of which can cause serious infections,” outlines the government agency in a recent statement.

“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.”

The newly issued guidance also recommends certain steps that manufacturers and distributors could take to help prevent the occurrence of these conditions, or to identify and remediate insanitary conditions that already exist during manufacturing and distribution.

Life-threatening complications
Contaminated tattoo ink can cause infections and serious injuries. Because these inks are injected, pathogens or other harmful substances in these inks can travel from the injection site through the blood and lymphatic systems to other parts of the body.

Tattoos associated with microbiological infections can also include impetigo, erysipelas, cellulitis and systemic infections that can cause life-threatening complications such as endocarditis, septic shock and multi-organ failure.

Indications of an infection can be difficult to recognize, as other conditions – such as allergic reactions or other sources of inflammation – may initially have similar signs and symptoms, leading to misdiagnosis and ineffective treatments.

Tattoos associated with microbiological infections can also include impetigo, erysipelas, cellulitis and systemic infections.“In 2012, contaminated tattoo inks caused a multi-state outbreak of nontuberculous mycobacterial skin infections,” reveals the FDA.

“Nontuberculous mycobacterial skin infections can produce a range of symptoms, from mild inflammation (such as rash, papules and nodules) to severe abscesses requiring extensive and multiple surgical debridements and antimicrobial therapies.”

Between 2003 and 2019, tattoo ink firms conducted 15 voluntary ink recalls, 14 of which resulted from findings of microbial contamination. Eight of these recalls occurred after the FDA conducted multiple surveys of tattoo inks available in the US market and tested them for microbial contamination.

“Many of these inks were heavily contaminated with a variety of microorganisms, some of which (such as Pseudomonas aeruginosa and Bacillus cereus) can cause serious infections,” details the FDA.

In 2018, an article in the Journal of Applied Microbiology reported that 49% of the surveyed tattoo inks on the US market were contaminated with microorganisms.

“In 2019, we alerted consumers, tattoo artists and retailers of the potential for serious injury from use of certain tattoo inks contaminated with bacteria, and we worked with manufacturers and retailers to remove the products from the market,” notes the FDA.

Safeguarding health
The FDA has outlined measures manufacturers can take to help ensure that tattoo inks are not prepared, packed or held under insanitary conditions whereby they may be contaminated with microorganisms.

These include measures to regularly test ink and its components for microbial contamination, discard materials that may harm consumers, ensure a clean manufacturing process, validate sterilization methods and take corrective actions if contamination is detected.

Heightening action on tattoo contamination in the US reflects similar movements to ensure societal health and safety globally. Last January, the European Chemicals Agency published the draft Community Rolling Action Plan that outlines of 24 substances suspected of posing a risk to human health or the environment, of which seven are cosmetic ingredients subject to evaluation.

Last year, the UK government investigated the purported health and safety risks of certain tattoo pigments following a large-scale ban in the EU by the European Chemical Agency. Around two-thirds of colors ordinarily used by tattoo artists have since been banned.

Additionally, more than 4,000 substances commonly found in tattoo ink were prohibited in the UK from January 2022 onward.

The demand for alternatives to permanent tattoos drove Société Bic’s January acquisition of semi-permanent tattoo company Inkbox for US$65 million to strengthen its position in the growing “skin creative,” and the creation of a new category in Bic: “skin merch.”

In other tattoo innovations, L’Oréal invested in Prinker Korea, a micro-printing start-up, to further research the technology of temporary tattoos, especially for enhancing eyebrows. The corporate venture fund Business Opportunities for L’Oreal Development (BOLD) carried out the financial move.

By Benjamin Ferrer

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