The Maharashtra FDA has canceled the license of Johnson & Johnson baby powder and has stopped its sale and manufacturing.
This has been banned in the state after it was found that the powder for infants has 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 so new-born babies have slightly higher pH, almost close to neutral.
Any pH value other than 5.5 can severely damage sensitive skin.
Show cause notice
Maharashtra FDA sources said that they have issued a show cause notice to the firm under the Drugs and Cosmetics Act, 1940, to explain why their license shouldn’t be canceled.
However, the firm did not accept the reports of the government and challenged it in court, the statement read.
The FDA had collected two samples of the Johnson & Johnson baby powder — one from Pune and the other from Nashik.
The government analyst had declared the samples as “not of the standard quality” as they do not comply with IS 5339:2004 specification for skin powder for infants in the test pH, it said.
The FDA has told the company to recall the faulty products from the market
Switch to cornstarch-based powder
Last month, Johnson & Johnson had said it would stop selling talc-based baby powder globally in 2023 and move to a cornstarch-based baby powder portfolio.
“As part of a worldwide portfolio assessment, we have made the commercial decision to transition to an all cornstarch-based baby powder portfolio,” J&J had said in a press release.
Its cornstarch-based baby powder is already sold in many nations.
The decision came over two years after it ended sales in the US and Canada due to safety lawsuits and falling demand.
“We continuously evaluate and optimize our portfolio to best position the business for long-term growth.
This transition will help simplify our product offerings, deliver sustainable innovation, and meet the needs of our consumers, customers and evolving global trends,” the statement added.
A detailed statement from Johnson & Johnson Pvt Ltd is awaited.
The Maharashtra FDA has canceled the license of Johnson & Johnson baby powder and has stopped its sale and manufacturing. Explaining pH This has been banned in the state after it was found that the powder for infants has pH value above the mandated limit. The pH is a measure of the acidity and alkalinity Business, FDA, johnson and johnson, MaharashtraTrak.in