6 July 2012
FDA Notification to Industry
Products using oils, glycerin, or protein that were derived from the Jatropha plant may have toxic effects
The U.S. Food and Drug Administration (FDA) is notifying the regulated community 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.
When vegetable oils and animal fats are used in biodiesel fuel production, the co-products include oils, glycerin and protein. Recently, the Jatropha plant1 has become an attractive source material 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. Jatropha is a drought-resistant shrub that grows well in tropical and semi-tropic climates throughout the world. However, unlike other benign materials used to produce biodiesel fuel, Jatropha plants may contain toxic compounds, including phorbol esters.2, 3 These compounds exhibit potential toxicity, both acute and chronic, to exposed humans and animals.
As part of the biodiesel fuel production process, oil is extracted from the Jatropha plant. This oil contains a portion of the toxic compounds; however, toxic compounds are retained in the glycerin and protein co-products. Consequently, the oils, glycerin, and protein derived from Jatropha seeds may contain toxic compounds.4, 5, 6 Even though crude Jatropha extracts have protein levels comparable to soybeans and, therefore, could be an attractive protein source for human and animals, Jatropha-derived protein may contain these toxic ingredients.7, 8 Conventional impurity test methods may not detect the presence of these toxins.
At this time, the FDA is unaware of any intentional substitution or contamination in FDA-regulated finished products or components derived from the Jatropha plant. However, given the significant overlap among the supply chains of FDA-regulated products, the FDA is advising industry to be aware of the potential for substitution or use of oils, glycerin, and proteins derived from the Jatropha plant. This increased attention to supply chains is important for ingredient suppliers and manufacturers of FDA-regulated products, both in the U.S. and abroad. Suppliers and manufacturers should take steps to prevent the use of ingredients that might be intentionally, or otherwise, adulterated with Jatropha. The following practices may help suppliers and manufacturers identify the presence of Jatropha-derived ingredients:
- Know, monitor, and audit supply chains of naturally-derived ingredients9.
- Unless the composition of ingredients has been verified and does not pose a risk, conduct comprehensive risk assessments for naturally-derived ingredients.10
- Confirm the composition of naturally-derived ingredients and conduct appropriate testing of these ingredients.11
The FDA is monitoring this situation to assess impacts on FDA-regulated products and is working to develop test methods for Jatropha-based ingredients. As additional information becomes available, the FDA intends to provide updates. FDA welcomes relevant information from suppliers and manufacturers of FDA-regulated products. In particular, please share findings with FDA if validated testing methodologies are developed, for the detection of Jatropha-based toxins, or if Jatropha-based toxins are suspected, by sending an email to: IntentionalAdulteration@fda.hhs.gov.
1. For the purpose of this notification, the term Jatropha refers to ingredients or materials that are derived from the plant Jatropha of the Euphorbiaceae family.
2. A New Tumor Promoter from the Seed Oil of Jatropha curcas L., an Intramolecular Diester of 12-Deoxy-16hydroxyphorbol (1988) Cancer Res. 48: 5800-5804.
3. Toxicity Studies of Detoxified Jatropha Meal (Jatropha curcas) in Rats (2008) Food and Chem. Toxicol. 46:3621-3625.
4. Dynamic Analysis of Phorbol Esters in the Manufacturing Process of Fatty Acid Methyl Esters from Jatropha curcas Seed Oil (2011) J. Am. Oil Chem. Soc. 88: 851-861.
5. Jatropha Toxicity – A Review (2010) J. Toxicology and Environmental Health, Part B, 13: 476-507.
6. Comparative Evaluation of Non-toxic and Toxic Varieties of Jatropha curcas for Chemical Composition, Digestibility, Protein Degradability and Toxic Factors (1998) Food Chemistry 62: 207-215.
7. Nutritional, Biochemical, and Pharmaceutical Potential of Proteins and Peptides from Jatropha: Review (2010) J. Agric. Food Chem. 58: 6543-6555.
8. Ozone for Phorbol Esters Removal from Egyptian Jatropha Oil Seed Cake (2011) Adv. Appl. Sci. Research 2:221-232.
9. See, e.g. 21 CFR Part 110; 21 CFR Part 211; 21 CFR Part 820
10. This is a general industry recommendation whenever a manufacturer of medical products uses any mixture containing undeclared or undisclosed components. See, e.g., ICH Q9 and/or ISO14971 for guidance on risk management.
11. See, e.g., Isolation, Stability and Bioactivity of Jatropha curcas Phorbol Esters (2012) Fitoterapia 83: 586-592.