Monday, July 9, 2012

FDA Office of Regulatory Affairs Notification to Industry

Products using oils, glycerin, or protein that were derived from the Jatropha plant may have toxic effects


On July 6, 2012, the FDA Office of Regulatory Affairs issued a "Notification to Industry" advising 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.

Unlike other benign materials used to produce biodiesel fuel, Jatropha plants may contain toxic compounds, including phorbol esters. These compounds exhibit potential toxicity, both acute and chronic, to exposed humans and animals. Conventional impurity test methods may not detect the presence of these toxins.

View the entire Notification to Industry here.

FDA is seeking validated testing methodologies for the detection of Jatropha-based toxins. If Jatropha-based toxins are suspected in an FDA regulated product, FDA requests that the methodology and information about the contamination be sent by e-mail to:

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