As parents continue to worry over the use of Johnson and Johnson's (J&J) products on their babies, the company today sought to clear itself of its products being carcinogenic or cancer causing in nature.
"The notice issued by the Food and Drug Administration, Maharashtra, to Johnson & Johnson on its baby products nowhere refers to carcinogenicity or the existence of paraffin in Johnson's baby oil," a late-evening communication from the company said.
Further, it clarified, that Johnson's baby oil contains a superior grade of mineral oil that is obtained after distillation and purification of liquid paraffin. Paraffin has a wide base of applications and is used in various therapeutic and cosmetic products, from petroleum jelly to lip balms to laxatives, the note said.
"Safety, toxicology and other assessments of ingredients and final formulations have confirmed repeatedly that the final product is mild and gentle on a baby's sensitive skin," the note claimed.
J&J's specifications for products and formulations have been accepted by the FDA in India for more than 40 years and globally for more than 100 years, the company said and added that it meets the Bureau of Indian Standards (BIS norms) "where they exist in India" i.e., in the case of Johnson's baby powder and Johnson's baby soap.
"Where there are no BIS standards — as in the case of baby oils, baby creams and baby lotions — Johnson and Johnson adheres to its own stringent global standards. These standards have established the safety and efficacy of these products over a period of time," the note said.
J&J has been using the term "Johnson's baby" worldwide and in India for the last four decades, the company said and pointed out that it had applied for registration of "Johnson's baby" as a trademark in India in 2001. The application is going through the normal process of approval.
Meanwhile, the FDA top brass said that investigations are on regarding baby products from companies such as Himalaya, Wipro, Emami and Dabur. According to the FDA commissioner, Mr A. Ramakrishnan, Dabur's baby oil seemed to clear the FDA's parameters. However, an FDA official told Business Line that no notices had been issued by the regulator to the companies.