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Example: [Collected via e-mail, April 2013] Did Johnson & Johnson really lose their license to sell cosmetics effective 28 Apr? It's a Facebook post going around with a copy of a newspaper clipping. Origins: This item circulated on the Internet beginning in April 2013 features an image of a news clipping bearing a headline proclaiming that Johnson & Johnson, a New Jersey-based multi-national manufacturer of medical devices, pharmaceuticals, and consumer goods, had seen its cosmetics license canceled. Although the image is a reproduction of a genuine print news account, it is not the case, as has been widely assumed, that Johnson & Johnson has been stripped of its ability to sell cosmetics products throughout the U.S. The issue at hand is that in March 2013, India's Food and Drug Administration office ruled on a case dating back to 2007 in which 15 batches of Johnson & Johnson baby powder manufactured at a plant in Mulund (a suburb of Mumbai), India, were found to have been sterilized with ethylene oxide (an irritant and potential carcinogen) without having been subjected to appropriate post-testing to determine whether the amount of ethylene oxide residue left in the product was within acceptable limits. As a result of that case, the Indian FDA ordered the cancellation of Johnson & Johnson India's license to produce cosmetics products at its Mulund plant (an order which Johnson & Johnson has until the end of June 2013 to appeal). This action does not mean that Johnson & Johnson is completely barred from selling any products classified as cosmetics throughout the U.S. (and elsewhere) — it means that, for now, the company may not produce cosmetics products at its Mulund plant. Johnson & Johnson may still sell cosmetics products manufactured at other plants, and the plant in Mulund remains open for the manufacture of non-cosmetic products: Maharashtra's Food & Drug Administration (FDA) has cancelled Johnson & Johnson India's licence to manufacture cosmetics at its facility in Mulund, a Mumbai suburb. The action relates to a few batches of baby powder produced in 2007, the shelf life of which ended in July 2010. FDA has expressed concern over use of ethylene oxide for sterilisation to bring down the microbial load.An FDA investigation revealed that before release of these batches, the company did not conduct the mandatory test to ensure absence of traces of ethylene oxide, a carcinogenic substance. Since it was used in a product meant for infants, FDA observed, it was more objectionable. The cancellation order was issued on March 30, though J&J has been given 90 days (up to June) to plead its case before the state government, if the company wants. J&J has two company-owned facilities in India — at Mulund and Baddi in Himachal Pradesh. At Mulund, the company manufactures J&J Baby Powder, Band-Aid adhesive bandages and Stayfree sanitary napkins. It produces other products at its Baddi unit. The company also uses third-party manufacturers for production, but the Mulund facility, set up in 1959, is a large one and also its oldest.Confirming the cancellation, FDA Commissioner Mahesh Zagde said the company had carried out sterilisation of 15 batches (of 160,000 retail containers) of baby powder by using ethylene oxide, against the normal practice of steam sterilisation.A J&J spokesman confirmed the company had received the FDA order, which pertained to cosmetic products only, and the company would continue to manufacture non-cosmetic products at the same site. The matter in question as cited by the FDA order relates to a limited number of batches produced in 2007. FDA raised concern about ethylene oxide treatment, which was not included as part of the manufacturing process submitted to FDA. This method is widely used for medical devices around the world. This was followed as an exception and all internal safety protocols were followed to ensure that safety of the consumer was not compromised. In addition, we have ascertained that there were no complaints or unexpected/undesirable effects reported concerning any of the batches in question.
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