Rumor: Johnson & Johnson's license suspended by FDA

The pharmaceutical company's cosmetic license was suspended by India's FDA at one plant, but no US supplies were affected.

TRUE

India's FDA orders cancellation of company's India license at one plant, but it does not affect US supplies

A newspaper clipping with a headline reading "Johnson & Johnson's licence (sic) for cosmetics cancelled" has sparked rumors that the company can no longer sell cosmetics in the US. But according to Snopes.com and Niti Central it was India's Food and Drug Administration, not the US FDA, that cancelled the pharmaceutical company's license.  

The topic has been shared on Facebook and discussed on Reddit and baby-related blogs and websites. Johnson & Johnson did not return a request for comment from MSN News at the time this story was published.

The Maharashtra FDA suspended the license of Johnson & Johnson to manufacture cosmetic products at a plant in Mulund, which is a suburb of Mumbai. According to Niti Central, the order dates back to 2007 when residues of carcinogenic substances were found in 15 batches of Johnson & Johnson baby powder. It was later found that the residue was found because the talcum powder was sterilized by ethylene oxide, which in is a carcinogenic and irritant.

As a result, the Mulund plant can no longer produce cosmetics products. Johnson & Johnson has until the end of 2013 to appeal the suspension.

Niti Central reports that Kamlesh B Shende, FDA joint commissioner said: “There were unacceptable levels of ethylene oxide, which is a trigger for cancer. Ethylene oxide was being used to bring down microbial load in the powder by sterilization (sic). But it was found that there was ethylene oxide residue in the talcum powder, which is primarily used on infants. In light of this, we have suspended the licence (sic).”  

A Johnson & Johnson spokesperson was also quoted in the report saying, “The FDA raised concerns about following ethylene oxide treatment, which was not included as part of the manufacturing process submitted to the FDA.”  

While Johnson & Johnson cannot produce cosmetic products at the Mulund plant, the company can still sell the products in the US and other countries, according to Snopes.com.

 

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