India regulators pull J&J plant license on baby powder concerns

Fri May 3, 2013 5:45pm EDT

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(Reuters) - Health officials in India have revoked Johnson & Johnson's license to make cosmetics at a plant outside Mumbai after they discovered the company had used an unauthorized process for sterilizing its baby powder.

J&J said in a statement on Friday that it is in "ongoing discussions" with Indian regulators.

"We understand their concerns and are diligently working with them to resolve the issue," Peggy Ballman, a J&J spokeswoman, said in a statement, adding that there were no consumer complaints or adverse events reported due to its use of the process.

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.

Ballman said the plant has not been shut down and the company is appealing the decision. She said the sterilization process in question was used on a one-time basis on a limited amount of baby powder. Baby powder is made from corn or talc and is usually sterilized using steam, she said.

"For a brief time in 2007, we used an alternative sterilization process," she said.

Ballman was unable to explain why the alternative process was used but said it is a "widely accepted and safe practice of sterilization used when making many medical devices and consumer products and leaves no harmful residue."

"However," she said, "the process was not registered with the local FDA and they viewed this step as out of compliance."

The news is the latest in a long list of quality control problems at J&J facilities. Its consumer healthcare division has, over the past few years, recalled millions of bottles of over-the-counter products such as Motrin and children's Tylenol.

And it comes just as J&J is seeking to rebuild its image as a trusted family brand. Last month it launched an ad campaign, "For All You Love," with a black-and-white video full of babies and parents, with lines including, "Love is family, love is life, and for that life, you sacrifice it all."

In her statement, Ballman said the company wants to assure people that "the baby powder manufactured and sold only in India was safe and did not pose any health risk at any time."

(Reporting by Toni Clarke in Washington; editing by Matthew Lewis)

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Comments (1)
MSPrabhakar wrote:
Compliments to FDA for cancelling the manufacturing licence for such a serious offence, but this should only be the first step. What about prosecution as the logical next step? In the context of US FDA, such a defect would qualify under Class I Recall (dangerous or defective products that predictably could cause serious health problems or death). Ethylene oxide is a confirmed carcinogen and its use as a sterilant is highly regulated or even banned in developed countries. Were the carcinogenic effects of ethylene oxide not known to Johnson & Johnson? It’s highly improbable since Johnson & Johnson had pioneered alternatives to ethylene oxide decades back. If such a gruesome offense that puts several thousands of Indian infants at risk of contracting cancer (if not already) has been committed, why were the batches of baby powder not publicly recalled? Is this the same Johnson & Johnson that set standards in corporate ethics in 1982 when it recalled 31 million bottles of Tylenol capsules at a cost of over $ 100 million to save innocent American lives?

Several unanswered questions emerge: (a) When was it first realized by local Johnson & Johnson management that its baby powder could contain toxic levels of ethylene oxide? (b) If during its useful shelf life period, why was the decision taken not to issue a public recall? (c) If after expiry of shelf life, why hasn’t Johnson & Johnson issued a public notice informing its customers of its potential carcinogenic and toxic effects? It should have also invited all surviving customers for a free health check-up to confirm absence of carcinoma. (d) Was Johnson & Johnson subject to internal corporate audits before FDA investigation? Why was this fact not highlighted and what reasons were cited for not issuing a public recall? (e) What is the culpability of Johnson & Johnson’s senior management in this episode? (f) What would Johnson & Johnson have done if such a serious incident of public health concern happened in the United States?

The burning issues to be immediately addressed are: 1. Issue a public notice in all leading newspapers (a) informing about the seriousness of the incident, (b) invite consumers to come forward with complaints, if any, and (c) invite all consumers who have used baby powder since 2007 for a free check-up for absence of carcinoma. 2. Prosecute all those who are found responsible for suppression of critical life-threatening information. 3. Legislate laws to hold parent organizations that hold controlling interest in local organizations to be directly responsible for such incidents. Till the corporate veil is lifted, no meaningful end to exploitation in poorly regulated countries such as India will occur.

May 03, 2013 8:03pm EDT  --  Report as abuse
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