The Maharashtra FDA has canceled Johnson & Johnson’s (J&J) baby powder manufacturing license from its sole plant in Mulund state, officials said.
The FDA said the license was canceled after samples of Johnson’s Fast-Moving Baby Powder collected from Nashik and Pune failed quality checks and ordered the company to withdraw all its stock from the markets. .
These samples were declared by the FDA as “Not of Standard Quality” after failing to comply with IS5339:2009 (Second Amendment No. 3) Specification for Baby Skin Powder in the pH test.
The dust samples were collected in November 2019, following a show-cause notice issued to the company following the FDA report.
However, J&J challenged the FDA notice in court, even as the report from the Central Drug Laboratory (CDL), Kolkata was awaited.
The CDL Kolkata upheld the earlier report of the government analyst and issued its final conclusion on the matter, after which the FDA swung into action and revoked J&J’s license.
In a statement about its order on September 15, the FDA said: “The product Johnsons Baby Powder is popularly used in newborn babies. The sample declared substandard in pH and the use of the product may affect the health of the skin of newborn babies”.
Experts, activists and pediatricians have expressed concern over the delay in the FDA’s license cancellation order after the first notice to J&J, as millions of babies may have used Johnson’s baby powder during the intermediate period
