The FDA stopped the manufacturing and selling of the product in the state after it found that the powder for infants, drawn at Pune and Nashik, has a pH value above the mandated limit.
Maharashtra’s Food and Drugs Administration on Friday cancelled the manufacturing license of a Johnson & Johnson plant in Mulund in Maharashtra’s Thane after samples of baby powder were found “not of standard quality”.
The FDA stopped the manufacturing and selling of the product in the state after it found that the powder for infants, drawn at Pune and Nashik, has a pH value above the mandated limit.
The pH is a measure of the acidity and alkalinity of a substance. It is measured on a pH scale or bar, where 0 indicates acidic and 14 indicates alkaline. A baby’s skin varies from an adult’s skin. The new-born babies have slightly higher pH, almost close to neutral. Any pH value other than 5.5 can severely damage sensitive skin.
According to a statement issued by the FDA, the state administration had issued a show cause notice to the firm under the Drugs and Cosmetics Act, 1940 as to why action should not be taken. However, the firm did not accept the reports of the government and challenged it in court, the statement read.
The baby powder is popularly used in new born babies and the sample is declared not of standard in pH. The product may affect the health of the skin of the new born babies, the FDA added.
Last month, Johnson & Johnson said it would stop selling talc-based baby powder globally in 2023 and move to a cornstarch-based baby powder due to safety lawsuits and falling demand.
