FDA warns against toxins - No Jatropha derivatives in medical devices
The FDA (US Food and Drug Administration) warns against the use of oils, glycerin or protein derived from the Jatropha plant, which may have toxic effects. Derivatives from the Jatropha plant can be used in the production of food, cosmetics and Medical Devices. The FDA requests all manufacturers to monitor and audit their supply chains and naturally derived ingredients.
Boom of the Jatropha plant
Jatropha is a genus of flowering plants in the spurge family (Euphorbiaceae). The undemanding shrub flourishes excellently in tropical and sub-tropical climates and can be easily and cost-effectively cultivated at commercial level. Jatropha seeds contain over 30% oil. With a cetane number of around 60, Jatropha oil is one of the world‘s most suitable vegetable oils for use in technical applications. At present, the global cultivation area is under one million hectares. However, according to new studies, global cultivation potential amounts to around 30 million hectares. Around 80% of the areas currently used for Jatropha cultivation are located in Asian countries, above all India, China and Indonesia. However, commercial Jatropha cultivation is also booming in Latin America and Africa. The oil is primarily used in biodiesel production. However, the by products of biodiesel production, namely oil, glycerin and proteins, can also be used in the production of food, cosmetics and Medical Devices.
Toxins suspected in Jatropha derivatives
In its notification of July 6, 2012, the FDA points out that the Jatropha plant may contain toxic compounds including phorbol esters, which may exhibit potential toxicity, acute and chronic, to exposed humans and animals. Given this, the FDA warns against consciously or unconsciously using derivatives of the Jatropha plant in the production of food, cosmetics and Medical Devices. An especially problematic aspect according to the FDA is that conventional impurity test methods may not detect the presence of these toxins. Given this, the FDA advises industry to monitor their supply chains and the composition of naturally derived ingredients that may contain Jatropha derivatives. The FDA recommends that manufacturers
are familiar with, monitor, and audit supply chains of naturally derived ingredients,
conduct comprehensive risk assessment for naturally derived ingredients, even if the composition of ingredients has been verified and so far did not pose a risk, and
confirm the composition of naturally derived ingredients and conduct appropriate testing of these ingredients.
Call for cooperation
The FDA is monitoring this situation to assess possible impacts on FDA regulated products and will provide updates as additional information becomes available. Furthermore, the FDA is working on developing test methods for Jatropha-based ingredients and asks all suppliers and manufacturers of FDA regulated products to share their information about Jatropha derivatives or to contact the FDA if Jatropha-based toxins are suspected. The FDA particularly asks for notification if effective testing methodologies are developed.