FDA Notification to Industry Regarding Potential Adulteration of Pharmaceutical Ingredients used as Emulsifying Agents and Flavorings

FDA's Center for Drug Evaluation and Research (CDER) recently learned that there have been recent instances when clouding and flavoring agents, which have been used outside the U.S. in certain food manufacturing processes, contain undeclared phthalate plasticizers, specifically diethylhexyl-phthalate (DEHP) and diisononyl-phthalate (DINP).

CDER is not aware at this time of any intentional phthalate substitution, in part or whole, in finished pharmaceuticals or pharmaceutical ingredients used in the U.S. market. Nonetheless, significant overlap of global food and pharmaceutical ingredient supply chains raises the potential for adulterated food ingredients to enter the U.S. pharmaceutical supply chain.

CDER advises manufacturers of drug products and suppliers of pharmaceutical ingredients, both in the U.S. and abroad, to be aware of the potential substitution of phthalate plasticizers for vegetable oils in clouding and flavoring agents. Manufacturers using emulsions containing vegetable oils should exercise caution to prevent the use of ingredients that might be intentionally adulterated with phthalates