The Maharashtra Food & Drugs Administration (FDA) cancelled the manufacturing license of Johnson’s Baby Powder of Johnson’s & Johnson’s Pvt. Ltd., Mulund, Mumbai after samples of the powder drawn at Pune and Nashik were declared "Not of Standard Quality" by the government.
The Maharashtra FDA has also asked the company to recall the stocks of the powder that were found ‘Not of Standard Quality’. The FDA cited the fact that using the powder would affect the skin of new-born babies.
The FDA statement added that the drawn sample for testing "did not comply with IS 5339: 2004 (Second Revision Amendment No. 3) Specification for Skin powder for infants in the teat pH."
"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 statement by FDA read.
“In the interest of the public health at large the FDA, MS cancelled the manufacturing licence of the Johnson's Baby Powder of M/s Johnson's & Jonson's Pvt., Ltd., Mulund, Mumbai vide order dated 15/09/2022.", the statement added.
The Maharashtra FDA also informed in their press note that they have issued a show cause notice as to why the action like suspension or cancellation of manufacturing licence or product manufacturing licence should not be taken
The note further informed that Johnson & Johnsons' did not accept the test report of FDA and had challenged it. "not accepted the reports of Govt., Analyst and challenged it in the court for sending to the referral laboratory i.e Central Drugs Laboratory Govt., of India, Kolkata. The Director CDL, Kolkata confirms the report of Govt., Analyst, FDA Maharashtra and issued final conclusive report stating the conclusion that "The sample does not conform to IS5339: 2004 with respect to the test for pH"
The company had last month confirmed that they would 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.
