FDA warns of toxins in glycerin source
pharmafile | July 10, 2012 | News story | Manufacturing and Production |Â Â FDA, glycerin, jatropha curcas, toxinsÂ
The FDA has asked pharma companies to make sure that glycerin and other ingredients used in their products are not derived from a plant used in the production of biodiesel as they may contain toxic chemicals.
The plant – called Jatropha curcas – has become an attractive source material for biodiesel because it has a high oil content in its seeds and is both plentiful and cheap. It is thought to produce around four times the biodiesel yield per hectare as soybeans and ten times the yield of corn.
However, the oil derived from the seeds is finding its way into international trade channels and can contain toxic chemicals such as phorbol esters which may not be picked up during routine impurity testing methods.
The FDA said it 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”.
There is no evidence yet of any contamination of products, says the agency, but it is issuing the warning “given the significant overlap among the supply chains of FDA-regulated products”.
The agency is advising companies to keep close tabs on the supply chains of naturally-derived ingredients to guard against the inadvertent use of Jatropha-derived ingredients, and to confirm the composition of ingredients using ‘appropriate testing’.
The FDA also said it is currently working to develop test methods of Jatropha-based ingredients, and would welcome any assistance from industry in that effort.
Meanwhile, manufacturers should conduct comprehensive risk assessments for naturally-derived ingredients “unless the composition of ingredients has been verified and does not pose a risk”, according to agency.
The text of the FDA’s notification to industry can be found here.
Phil Taylor
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