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                Industry Notices and Guidance Documents

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          Industry Notices and Guidance Documents
          Notification to Industry: Products using oils, glycerin, or protein derived from the <em>Jatropha</em> plant may have toxic effects (Updated from July 2012)Industry Notices and Guidance Documents Notification to Industry: Products using oils, glycerin, or protein derived from the <em>Jatropha</em> plant may have toxic effects (Updated from July 2012)
  
  	
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    PrintApril 2014**Fast Facts**Industry should continue to be vigilant in preventing the use of *Jatropha*-derived ingredients in FDA-regulated products.A recent supply chain study for Malaysia and Indonesia showed that *Jatropha* production appears to be minimal, though this finding might not hold for other regions.FDA has no evidence that *Jatropha*-derived ingredients have entered U.S. food and drug supply chains to date.**Why is FDA updating its July 2012 1 Notification to Industry?**FDA is updating industry and stakeholders about results of a recent study relating to the risks of *Jatropha*-derived ingredients being included in FDA-regulated products.**What industry segments could be affected?**Manufacturers that receive or use biodiesel-derived ingredients could be affected.  Oils, glycerin, and protein ingredients in many FDA-regulated products can be derived from biodiesel fuel production.  These ingredients are found in human and animal food, medical products, cosmetics, and others products.**What have we learned from the study?**FDA commissioned a private-sector partner to study the *Jatropha*supply chain in Malaysia and Indonesia and to assess potential threats and vulnerabilities.  The study found that *Jatropha*cultivation and its use in the production of biofuels and related by-products (e.g., glycerin) appear to be minimal, at least in the limited area of the study.  The *Jatropha*plant has not become commercially viable in Malaysia or Indonesia as a large-scale source of biodiesel fuel.  The *Jatropha*plant is labor-intensive to cultivate, is not as hardy as expected, and has a lower yield than projected.  Consequently, it does not appear to be economically competitive with comparable biofuels. This study also found no evidence that *Jatropha*-derived ingredients have entered U.S. food and drug supply chains.  At this time, FDA remains unaware of any intentional substitution or contamination in FDA-regulated finished products or components derived from the *Jatropha* plant.**What are the limitations of the study?**These results are reassuring; however, this study’s finding may not hold for *Jatropha* production and its co-products in regions outside of this study, including China, India, and Mexico.  It is also possible that advances in science and agriculture, coupled with changing economic conditions, may result in a new set of *Jatropha*-related activities that could alter the study’s findings.**What should industry do?**Given potential risks and the significant overlap among the supply chains of FDA-regulated products, FDA continues to advise industry to be aware of the potential for substitution or use of oils, glycerin, and proteins derived from the *Jatropha*plant.  For establishments receiving or using biodiesel-derived ingredients (e.g., glycerin), the FDA recommends:Continue to know, monitor, and audit the supply chains of naturally-derived ingredients.Employ appropriate controls to prevent the use of *Jatropha*-derived ingredients in FDA-regulated products.If *Jatropha*-derived ingredients are suspected in FDA-regulated products or components, share the findings with FDA by sending an email to: IntentionalAdulteration@fda.hhs.gov.1.The July 6, 2012 Notification to Industry said that oils, glycerin, and proteins commonly used in the production of human and animal food, medical products, cosmetics, and other FDA-regulated products may contain toxins if they are derived from the *Jatropha*plant.  In recent years, the *Jatropha*plant (of the Euphorbiaceae family) was projected to become an attractive source for biodiesel fuel because of the high oil content of its seed, availability of the plant in certain parts of the world, and relatively low cost.  However, unlike other benign sources of biodiesel fuel (e.g., palm oil), products from *Jatropha* plants may contain toxic compounds, including phorbol esters, that may cause acute and chronic toxicity to humans and animals.

                                                                                  Content current as of:
      02/02/2018Industry Notices and Guidance Documents
 
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