Maharashtra FDA Cancels License Of Johnson’s Baby Powder, Company Says Its Product 'Is Safe'

Johnson & Johnson License: Later, the Maharashtra FDA said in a press release that it has revoked Johnson & Johnson's license to manufacture baby powder in the state with immediate effect.

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The Maharashtra government revoked Johnson & Johnson's product manufacturing licence to make baby powder in the state on Friday. During a normal quality check, the state's Food and Drug Administration (FDA) discovered a sample drawn for inspection to be of sub-standard quality, news agency ANI reported.

Later, the Maharashtra FDA said in a press release that it has revoked Johnson & Johnson's license to manufacture baby powder in the state with immediate effect.

The corporation has also been requested to recall the powder stockpiles that were discovered to be of poor quality. The usage of the product may have an impact on the skin health of newborn newborns, according to the FDA statement.

In response, Johnson and Jhonson in an issued statement stated: "Johnson & Johnson stands firmly behind the decades of independent scientific analysis by medical experts around the world that confirms talc-based Johnson's baby powder is safe, does not contain asbestos, and does not cause cancer."

Johnson & Johnson stands firmly behind the decades of independent scientific analysis by medical experts around the world that confirms talc-based Johnson's baby powder is safe, does not contain asbestos, and does not cause cancer: Johnson & Johnson

— ANI (@ANI) September 16, 2022

According to the FDA statement, the tested sample "did not meet with IS 5339: 2004 (Second Revision Amendment No. 3) Specification for Skin powder for infants in the teat pH."

After the samples failed quality checks in Nashik and Pune, an FDA analyst issued a show cause notice under the Drugs and Cosmetics Act, 1940 and Rules, asking the American FMCG behemoth why an action such as suspension or cancellation of a manufacturing licence or product manufacturing licence should not be taken against it.

The company refused to accept the FDA's test results and filed a lawsuit, requesting that samples be forwarded to the referral laboratory, the Central Drugs Laboratory of the Government of India in Kolkata.

The Director CDL, Kolkata, also corroborated the Maharashtra FDA report and issued a final conclusive report indicating that the sample does not conform to IS5339: 2004 in terms of the pH test.

(With Inputs From ANI)