‘Not of Standard Quality’: FDA cancels Johnson & Johnson's licence to make baby powder

In a big setback for Johnson & Johnson India, Maharashtra's Food and Drugs Administration (FDA) has cancelled the product manufacturing licence of its baby powder.

In the press note, FDA said that the samples of Johnson's Baby Powder were declared ‘Not of Standard Quality'. The samples of Johnson's Baby Powder were taken from Pune and Nashik for quality check purposes.

"The sample does not comply with IS 5339: 2004 (Second Revision Amendment No. 3) Specification for Skin powder for infants in the test pH," the press note stated. The administration issued show cause notice to the firm under the Drugs and Cosmetics Act, 1940 and also issued instructions to the firm to recall the stock of the said product from the market.

As per the press note, the firm also challenged the quality tests to be sent to the Central Drugs Laboratory (CDL) Government of India. However, the Director of CDL also issued the final conclusive report in line with the Maharashtra FDA.

The FDA said that that the powder is ‘Not of Standard in pH’ and it may affect the health of the skin of the newborn babies.