After finding samples of baby powder to be “not of standard quality,” the Food and Drugs Administration of Maharashtra on Friday revoked the manufacturing licence of a Johnson & Johnson facility in Mulund in Thane.
The Maharashtra FDA halted production and sales of the product in the state after discovering that the infant powder, produced in Pune and Nashik, has a pH value that is higher than the permitted limit.
A substance’s acidity and alkalinity are determined by its pH. On a pH scale or bar, where 0 represents acidic and 14 represents alkaline, it is measured. The skin in a baby is different from the skin in an adult. The pH of newborns is slightly higher and almost neutral. Sensitive skin can suffer severe damage at any pH level below 5.5.
The state administration had given the company a show cause notice under the 1940 Drugs and Cosmetics Act, the FDA said in a statement, asking it to explain why no further action should be taken. According to the statement, the company did not accept the government reports and contested them in court.
Baby powder is frequently used on newborns, but the sample’s pH level was found to be out of the norm. According to the FDA, the product may have an impact on the newborn’s skin’s health.
Due to safety lawsuits and declining demand, Johnson & Johnson announced last month that it would stop selling talc-based baby powder globally in 2023 and switch to cornstarch-based baby powder.