Mumbai: License of ‘Johnson’s Baby Powder’ Revoked Forever By FDA

Mumbai, 16th September 2022: The Food and Drug Administration (FDA) has taken action to permanently cancel the manufacturing license of ‘Johnson’s Baby Powder’ cosmetics manufactured by the multinational company Johnson & Johnson Pvt Ltd. Samples of these cosmetics were sent for quality testing by drug inspectors of the administration at Nashik and Pune. The license has since been canceled citing defects in the manufacturing process.


The Government Analyst and Drug Control Laboratory had recorded both the above samples as unfit as per national standards and declared them uncertified. Accordingly, a show cause notice was issued as to why the license should not be canceled, or the permission to manufacture cosmetics granted under the said license should not be suspended or canceled. The company was also instructed to recall the stock of the product from the market.


As the government analyst’s report of the sample received was not acceptable, the company applied to the Nashik and Pune courts for re-testing by the Central Drug Laboratory. It was then announced by the Central Drug Laboratory to conduct the re-examination. However, the Central Drug Laboratory in Kolkata declared the test of these samples inconclusive. As the report of the Central Drug Laboratory, Kolkata is conclusive evidence, the concerned product manufactured by the licensee is proved to be substandard.


Joint Commissioner of Food and Drug Administration Gaurishankar Bayle said that “Johnson’s Baby Powder is primarily used for newborn babies and the pH of this product is not up to the certified standard due to defects in the manufacturing process by which it is likely to harm the skin of newborns and children. Therefore, the continuation of the production of this product would not be appropriate in the wider public interest. Therefore, the license of the company’s Mulund manufacturing plant for the product “Johnson Baby Powder” has been canceled permanently.”