The FDA wants drugmakers to conduct new tests to make sure that any glycerin and other ingredients are not coming from a recently embraced plant that contains toxins.
The agency has issued new guidance about ingredients made from the Jatropha curcas, a plant that has become popular in making biodiesel. The glycerin extracted in that process may contain toxins that would be unhealthy in drugs but which conventional testing may not find. Jatropha plants may contain phorbol esters, which could be toxic "both acute and chronic, to exposed humans and animals."
The agency says it has not discovered any problems yet but is trying to get out in front of the issue with the new rules. The plant has become popular in biodiesel production, the FDA says, because its seeds contain high levels of oil, the drought-resistant plant grows well in tropical and semi-tropical climates and it is relatively cheap to grow.
The agency is trying to develop a test for the presence of Jatropha, and InPharm says it welcomes any assistance in that effort from the industry. Until then it is asking drugmakers to pay close attention to their supply chain for any indication ingredientmakers are using products derived from the plant.
"Given the significant overlap among the supply chains of FDA-regulated products," the agency is advising the industry to audit its suppliers for "the potential for substitution or use of oils, glycerin, and proteins derived from the Jatropha plant."
- here's the FDA guidance
- more from InPharm