IPEC Federation Issues Statement of Phthalate Use

The International Pharmaceutical Excipients Council (IPEC) Federation issued a statement on the use of phthalates in pharmaceutical products in response to reports of adulteration of certain nutritional supplements, vitamins, foods, and beverages imported from Taiwan. Two phthalates, di-ethyl hexyl phthlate (DEHP) and di-isononyl phthalate (DINP), which are commonly used as plasticizers for polyvinyl chloride (PVC)-based plastics, were found in certain adulterated products and subsequently recalled by Taiwan authorities. It is believed that the phthlates were added as a form of economically motivated adulteration as a low-cost replacement for palm oil.

Phthalate-based compounds are used in a variety of industrial, consumer, and pharmaceutical products, and the specific compounds used vary by the targeted application. Certain phthalates, such as di-ethyl phthalate (DEP) and di-butyl phthalate (DBP), are approved for use in pharmaceuticals. “These phthalates can be legally used as plasticizers in drug applications in many countries, and they do not pose safety concerns in these applications,” said the IPEC Federation in its statement.

The adulterated products of concern from Taiwan were produced with emulsifiers manufactured by Yu Shen Chemical Co. and Pin Han Perfumery Co., and were contaminated with the prohibited ingredients, DEHP and/or DINP, plasticizers used in PVC products. Although DEHP may be detected in certain food products as a result of leaching from plastic containers, Taiwanese authorities detected DEHP in various beverages at levels of up to 600 ppm. It is believed that these were added as a form of economically motivated adulteration as a low-cost replacement for the more expensive palm oil. “It is important to stress that the Taiwan incident was limited to only DEHP and DINP and the emulsifier products of concern were only produced by the two companies,” said IPEC in its statement.

In its statement, IPEC said that at this time, only materials originating from the specifically identified manufacturers in Taiwan are at risk. “Drug manufacturers should review their supply chains to determine if they are sourcing emulsifiers that may be implicated in the Taiwanese recalls. To facilitate communication between drug manufacturers and their suppliers, the supply-chain reviews should focus only on the two phthalates of concern, DEHP and DINP,” according to the statement. IPEC issued a list of frequently asked questions in its statement to facilitate the communication between suppliers and drug manufacturers.

Rx-360, a pharmaceutical supply-chain consortium, issued an alert on the DEHP adulteration. IPEC pointed to the two questions noted in the alert that can address the potential risk from the Taiwan incident.