MANILA, Philippines - It is a common practice by those who go to the beach to get a temporary henna tattoo as a reminder of a fun-filled summer.
But what seems to be a harmless alternative to getting a real tattoo may not be as safe as people think it to be. The USFDA (US Food and Drug Administration) has sent out a warning to the public regarding skin-staining cosmetic products after it received several reports of adverse reactions including severe reddening or inflammation in a five-year-old boy.
All temporary skin-staining products, commonly known as henna dye products, need Philippine FDA approval as cosmetic products before they are marketed or used in the country. It is important that tattoo dye preparations are approved by the FDA.
Ingredients used in the preparations have to be disclosed by the manufacturers, importers, traders, or distributor and evaluated by the FDA if they are approved for cosmetic use. It is the extra ingredients that are potentially harmful, especially if these are from coal-tar hair dye containing p-phenylenediamine (PPD).
PPD evokes skin reactions in some, which may lead to severe inflammation and scar formation. These is no way of telling if PPD is mixed in henna preparations unless they are properly labeled according to the Philippine standard. Consumers need to be assured that the temporary skin-staining products are manufactured under current Good Manufacturing Practice (cGMP) as prescribed in the ASEAN Cosmetic Directive (ACD). These steps will help consumers to identify and report the specific cosmetic product that caused the adverse reaction to FDA.
Consumers are advised to ask for FDA market authorization or cosmetic notification before receiving a temporary tattoo. Consumers who experienced adverse reactions are requested to send their report at info@fda.gov.ph.
So far, the Philippine FDA has not yet received any consumer complaint, but unlicensed temporary tattoo dye manufactures, importers, traders or distributors are strongly advised to apply for license to operate and market authorization from the FDA. Failure to do so is a direct violation of Republic Act No. 3720. (as amended), otherwise known as the Food, Drugs and Devices, and Cosmetic Act and Republic Act No. 9711, otherwise known as the FDA Act of 2009.