L'Oreal may face action for further violation: FDA

Statement comes a day after agency issued a notice to recall two fairness creams for containing mercury

The Maharashtra Food & Drug Administration (FDA) has said the Indian unit of French beauty major L'Oreal may face suspension, cancellation of licence and prosecution if further violations are found during investigation of its products.

The statement comes a day after the FDA issued a notice of recall to the company, saying two of its fairness creams had mercury in them. The notice of recall was issued after a second test was conducted on the two products using the method of analysis adopted by L'Oreal.

"Mercury has been found in two products so far. These products are not fit for use. The FDA has asked the company to withdraw the stock," an FDA official told Business Standard.

"According to the World Health Organisation, presence of mercury may cause skin rashes, discolouration and scarring. It could also lead to kidney damage. Besides, mercury is prohibited by EU directives," the official added.

"Our products in India have the same stringent quality and safety standards we employ across the globe. We do not add mercury to any of our products anywhere in the world," a L'Oreal spokesperson said.

"Mercury occurs naturally in air, water and soil, and unavoidable traces of it may also be found in raw ingredients used in different industries, including cosmetics. International cosmetic regulations recognise the presence of trace levels of mercury in spite of the best manufacturing practices and allow 1-3 parts per million. However, there is no such provision in the Indian Drugs & Cosmetics Act of 1945," the person added. L'Oreal said there was no safety issue with its products and it would continue to work with the FDA to resolve this matter.

Mercury was found at 234.9 parts per billion in the batch (5N036C) of Garnier Men Power Light Face Wash manufactured in February. In Garnier Men Power Light Fairness moisturiser (batch 5M147C), mercury had touched 20.16 parts per billion, the FDA said. The moisturiser was manufactured in May 2015.

Under Rule 145 (d) of the Drugs and Cosmetics Act, 1945, no cosmetic containing a compound of mercury could be manufactured in India, the FDA official pointed out.

This is not the first time the Maharashtra FDA has had a run-in with a multinational company. Earlier this year, the agency had tested samples of Johnson's baby powder following reports of it being carcinogenic. A US jury had in May ordered Johnson & Johnson to pay $55 million to a woman who said using the powder had caused her to develop ovarian cancer.

The FDA had then said Johnson's baby powder samples were tested to weed out chances of contamination in the Indian product.