FDA warns against use of Jatropha oil ingredients11-Jul-2012
Pharma companies should be on their guard that glycerin and other raw materials used in the manufacture of medicines are not sourced from a plant which can introduce toxic contaminants not picked up by routine testing, says the US Food and Drug Administration (FDA).
The FDA is concerned that a thriving industry growing up around the use of oil from the plant Jatropha curcas in biodiesel could lead to contaminated ingredients being offered to pharma, food and personal care/cosmetics manufacturers.
Jatropha oil - as well as glycerin and other components such as proteins that can be derived from it - may be contaminated with compounds such as phorbol esters that exhibit "potential toxicity, both acute and chronic, to exposed humans and animals".
Companies involved in the manufacture of FDA-regulated products should pay close attention to the supply chains of naturally-derived ingredients to guard against the inadvertent use of Jatropha-derived ingredients, and should confirm the composition of ingredients using "appropriate testing".
They should also carry out risk assessments for naturally-derived ingredients "unless the composition of ingredients has been verified and does not pose a risk", according to the agency.
Jatropha has become an attractive source of oil for biodiesel production because its seeds have a high oil content, it is easy to cultivate and is in plentiful supply. However, the toxic compounds contained in the oil are likely to be retained in glycerin and protein co-products, according to the FDA warning.
The FDA warns that conventional impurity testing protocols are unlikely to pick up the toxic components, and notes it is trying to develop new test methods for Jatropha-based ingredients.
It is asking for assistance in this regard from suppliers and manufacturers of FDA-regulated products, as well as any other insights on the trade in the ingredients.
"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," says the agency's notice.
There is "significant overlap" among the supply chains of FDA-regulated products, however, so companies should be aware of the "potential for substitution or use of oils, glycerin, and proteins derived from the Jatropha plant", it adds.
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