Henna tattoos may not be harmless, FDA warnsBy Philip C. Tubeza
Philippine Daily Inquirer
MANILA, Philippines—Don’t let a henna tattoo scar you for life.
The Food and Drug Administration (FDA) on Tuesday warned the public against henna tattoos that may be harmful to the skin and cause scarring.
In an advisory, acting FDA Director General Kenneth Hartigan-Go urged the public to ask henna tattoo artists to show that they were using FDA-approved dye products because some unregulated dyes may contain “extra ingredients” that could cause inflammation of the skin.
Hartigan-Go said he issued the advisory after the United States FDA last month warned Americans that it had received reports of adverse skin reactions produced by some “temporary skin-staining cosmetic products.”
Boy gets rashes
“A five-year-old boy developed severe reddening or inflammation of the skin where the temporary tattoo was placed,” he said.
However, Hartigan-Go said the Philippine FDA had yet to receive any complaint from consumers in the country. He said Filipinos who experience adverse skin reactions can e-mail their report to email@example.com.
Get FDA license
Hartigan-Go also urged unlicensed dye manufacturers and traders to secure a license from the Philippine FDA.
“Consumers are advised to ask for FDA market authorization or cosmetic notification before receiving a temporary tattoo… It is important that tattoo dye preparations are approved by the FDA,” Hartigan-Go said.
Unregulated products might have harmful “extra ingredients,” he said.
“It is the extra ingredients that are potentially harmful, especially if these are from coal-tar hair dye containing p-phenylenediamine (PPD),” Hartigan-Go said.
“In some people, PPD evokes skin reactions which may lead to severe inflammation and scar formations. There is no way of telling if PPD is mixed with henna preparations unless they are properly labelled according to the Philippine-FDA standard,” he added.
“Unlicensed temporary tattoo dye manufacturers, importers, traders and distributors are strongly advised to apply for a license to operate and market authorization from the FDA,” he said, adding that failure to do so was a violation of the FDA Act of 2009.
He said that FDA-approved dye preparations should be manufactured under current Good Manufacturing Practice prescribed in the Association of Southeast Asian Nations (Asean) Cosmetic Directive.
If the public uses FDA-approved products, they would also be able to identify and report to the FDA any specific cosmetic product that caused adverse skin reactions.