Revoking the manufacturing license for Johnson & Johnson talcum powder.

Indian authorities have revoked the talcum powder manufacturing license of a Johnson & Johnson (J&J) factory located outside Mumbai after discovering that the factory had been using an illegal process to sterilize its baby talcum powder product.

In a statement on May 3, J&J said it is currently “in discussions” with Indian authorities on the matter.

Peggy Ballman, a spokesperson for J&J, said, “We understand their concerns and are actively working with them to resolve this issue.” She also stated that there have been no consumer complaints or reported hazards resulting from the use of this process.

An investigation conducted by the Maharashtra State Food and Drug Administration revealed that J&J's Mulund plant used ethylene oxide (a substance used in the production of industrial chemicals and for disinfecting medical equipment) as a disinfectant in its baby powder products and failed to conduct mandatory tests to ensure that no traces of this chemical remained in the powder.

According to the U.S. Department of Labor, acute exposure to ethylene oxide can cause lung damage, nausea, vomiting, and cancer.

Ms. Ballman stated that the plant has not been shut down and the company is appealing for a review of the decision. She said that the sterilization process in question was used only once with a limited amount of talcum powder. Baby talcum powder is made from corn or talc and is typically sterilized by steam.

"For a short period in 2007, we used an alternative sterilization process," she said.

Ms. Ballman was unable to explain why the alternative process was used but stated that it is a “safe and widely accepted sterilization process in the manufacture of many medical devices and consumer products and leaves no toxic residue.”

"However, this process is not registered with the Food and Drug Administration here, and they consider this a violation," she said.

This is the latest in a long list of quality control issues at J&J facilities. Over the past few years, the company's consumer healthcare division has recalled millions of bottles of over-the-counter products such as Motrin and Tylenol for children.

J&J is trying to rebuild its image as a trusted family product brand. Last month, it launched an advertising campaign “For All You Love” with a black-and-white video filled with images of babies and parents accompanied by the words “Love is family, love is life, and for this life, you sacrifice everything.”

In her statement, Ms. Ballman said the company wanted to assure everyone that "baby powder manufactured and sold exclusively in India is safe and does not cause any health problems."

According to Dan Tri - NT