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An Indian News article says one of India's states suspended the Johnson & Johnson license for its products contain Ethylene oxide.

The Maharashtra Food and Drug Administration (FDA) has suspended the licence for manufacturing cosmetics of Johnson and Johnson after residues of carcinogenic substances were found in baby talcum powder produced by it.

The licence has been suspended as the FDA expressed serious concern over the presence of ethylene oxide in a batch of baby powder produced in 2007. Ethylene oxide was used to bring down microbial load in the powder by sterilisation. Consumers need not worry as the shelf life of the batch ended in July 2010 and it would not be available for sale in the market.

According to Wikipedia, Ethylene Oxide is a known class 1 carcinogenic element.

My questions is: Do any of Johnson & Johnson's products contain Ethylene oxide outside of allowed level? (If there is no Indian standard, a reference to US standard is fine)?

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The problem is a bit more subtle than that.

  • In 2007, J&J India sterilized a batch of talcum powder with ethylene oxide instead of steam
  • J&J India was not allowed to perform the procedure
  • J&J India did not test the talcum powder to make sure no residue of ethylene oxide was present
  • Ethylene oxide is a poisonous substance so clearly it can't be sold by J&J

These are the reasons why the license to produce and sell cosmetics was revoked (canceled, not suspended). It is unlikely that any product contained traces of the poison, however the company has apparently been grossly negligent and endangered its customer's babies.

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.

http://www.business-standard.com/article/companies/fda-cancels-j-j-s-licence-to-make-cosmetics-at-mulund-plant-113042400562_1.html

An investigation by the Maharashtra Food and Drug Administration revealed that J&J, at its plant in Mulund, had used ethylene oxide - a substance used to produce industrial chemicals and to sterilize medical equipment - to kill bacteria in its baby powder and had not conducted mandatory tests to make sure there were no remaining traces in the powder.

According to the U.S. Department of Labor, acute exposure to ethylene oxide can cause lung damage, nausea, vomiting and cancer.

http://www.reuters.com/article/2013/05/03/us-johnsonandjohnson-india-babypowder-idUSBRE9420ZG20130503

  • Perhaps "Ethylene oxide is a poison" could be reworded. We don't accept such a statement about Thiomersal without context about dosages, so it should probably be provided here too. – Oddthinking May 6 '13 at 2:07
  • @Oddthinking It's explicitly and implicitly commonly called a poison: "ethylene oxide itself is a very hazardous substance: at room temperature it is a flammable, carcinogenic, mutagenic, irritating, and anaesthetic gas", "As a poison gas that leaves no residue on items it contacts", etc. – Sklivvz May 6 '13 at 2:15
  • I agree it is toxic. But the doses are likely to very small, so it isn't immediately obvious that it can't be sold by J&J. After all, J&J also sell nicotine (Nicorette). – Oddthinking May 6 '13 at 4:04

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