Potential Toxicity Associated with Oils, Glycerin, and Proteins Derived from the Jatropha Plant
July 20, 2012
Dear International Colleague:
The United States Food and Drug Administration (FDA) is notifying industry and stakeholders of the potential toxicity associated with oils, glycerin, and proteins derived from the Jatropha plant. Many FDA-regulated products including human and animal food, medical products, and cosmetics may contain toxins if they are derived from the Jatropha plant. FDA’s recent notification to industry about the potential toxicity of products derived from the Jatropha plant can be found on FDA’s website: http://www.fda.gov/downloads/ForIndustry/IndustryNoticesandGuidanceDocuments/UCM310867.pdf. The notification is listed under ‘General and Crosscutting Topics’.
Jatropha is a drought-resistant shrub that grows well in tropical and semi-tropical climates throughout the world. The Jatropha plant may be commonly used in biodiesel fuel production through the extraction of its oil. When vegetable oils and animal fats are used in biodiesel fuel production, the co-products include oils, glycerin and protein. However, unlike other benign materials used to produce biodiesel fuel, Jatropha plants may contain toxic compounds. Consequently, the oils, glycerin, and protein sourced from Jatropha seeds may also contain toxic compounds. Although crude Jatropha extracts have protein levels comparable to soybeans and could be an attractive protein source for humans and animals, Jatropha-derived protein may contain toxic ingredients. The presence of these toxins might go undetected using conventional impurity test methods.
Please share this information with industry and other stakeholders. As additional information becomes available, FDA will update its website. FDA welcomes relevant information about FDA-regulated products from our international regulatory counterparts as well as industry. Please send information to: IntentionalAdulteration@fda.hhs.gov.
If you have any questions, please contact me at 301-796-4600.
Mary Lou Valdez, MSM
Associate Commissioner for International Programs