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Indian authorities ask J&J to get DCI nod
By agencies
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Friday, 06 May 2005, 19:30 IST
MUMBAI: The Food and Drug Administration (FDA), Maharashtra has asked U.S. based Johnson & Johnson to get the approval from the Drugs Controller of India for its baby care products by August 1.
In case J&J fails to secure the necessary approval from the Drugs Controller of India, the company will be prohibited from the manufacture and sale of baby cosmetics products in Maharashtra, the order said.
However, if J&J drops the word `Baby' from the products, then the stipulation would not be applicable and the products could be sold as regular cosmetics.
In a 10-page order, the FDA asked J&J to carry prominent safety warnings on its products such as `Johnson's Baby Oil' regarding the side effect that may be caused on account of use of these products due to the presence of chemicals such as light liquid paraffin and isopropyl mysterate.
The order is in response to the consumer complaints that that on application of the Johnson & Johnson baby oil, infants developed rashes.
On March 15, the FDA had issued a show cause notice to J&J, on the grounds that `claims' about "Baby Products", labeled for use by infants and children were not justified.
The order also mentions that J&J submitted a data for clinical safety based on the trials conducted on adult volunteers and have extrapolated the data to children to come to the conclusion that the products are clinically safe.
J& J on its baby oil label had claimed that the "baby oil was ideal massage oil for babies and that daily massage has clinically shown to benefit over all growth and development", it was also enriched with Vitamin D.
In its investigation, the FDA found that Vitamin D3 was present in the oil to the extent of 0.1 per cent in the total formulation along with Vitamin A.
However, the benefits accruing to babies by absorption of Vitamin D from such low concentration present in the baby oil could not be established by J&J.
In its investigations, the FDA also referred to research paper published by Indian Journal of Medical Sciences and found that "Vegetable oils appear comparatively better in terms of growth and blood flow. Sesame Oil is better choice for massage as it significantly improved growth as well as blood flow as compared to the mineral oil (Johnson Baby Oil), which showed reduced blood flow.
The available literature shows that, vegetable oils are well absorbed from the skin while there is negligible absorption of the mineral oil. Further, mineral oils may clog the pores the skin."