FDA Issues warning on black henna’ tattoos following burn reports

USA – The FDA has issued a fresh warning concerning “black henna” temporary tattoos following multiple reports of serious skin injuries, including chemical burns. 

These products often contain p-phenylenediamine (PPD), a coal-tar hair dye chemical that is illegal for use in cosmetics applied directly to the skin. 

PPD can cause severe allergic reactions, blistering, scarring, and lifelong sensitivity, even from a single application.

Black henna tattoos typically combine natural henna, which produces a reddish-brown stain, with PPD to achieve a darker, longer-lasting black stain. 

However, this makes them adulterated and illegal under US law because henna is approved only for hair dye, not for skin application. 

The FDA has received numerous adverse event reports, including cases such as a 5-year-old girl developing severe reddening and blisters weeks after application, and a teenager whose skin resembled that of a burn victim leading to permanent scarring.

Some reactions appear immediately, while others may take two to three weeks to manifest.

The FDA cautions consumers to avoid black henna tattoos, as products lacking proper ingredient labeling and those falsely claiming FDA approval are misbranded and subject to enforcement actions. 

The agency encourages reporting adverse reactions to its MedWatch program and advises caution with all temporary tattoos. 

In contrast, scientific research, such as a recent study by Henkel and the University of Hamburg, is exploring safer, enzyme-activated henna products that could offer natural colorant alternatives compliant with safety standards.

This renewed warning comes amid growing consumer interest in natural and plant-based colorants, underscoring the need for safer innovations and regulatory compliance in temporary tattoo products.

Meanwhile, FDA recently issued a safety communication warning consumers, patients, and healthcare providers about serious complications linked to radiofrequency (RF) microneedling devices. 

These devices use arrays of tiny electrodes to deliver RF energy beneath the skin for aesthetic or dermatologic procedures intended to improve skin appearance.

Over the past few months, these devices have been reported to cause severe adverse events such as burns, scarring, permanent subcutaneous fat loss (lipoatrophy), disfigurement, nerve damage, and injuries requiring surgical repair or medical intervention. 

The FDA stresses that RF microneedling is a medical procedure that must be performed only by licensed healthcare providers trained in the safe and proper use of these devices. 

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