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U.S. FDA Notification to Industry Regarding Potential Adulteration of Food Products used as Emulsifying/Clouding Agents and Flavorings

The U.S. Food and Drug Administration (FDA) is notifying manufacturers of food products and suppliers of food ingredients, both in the U.S. and abroad, that certain food and beverages exported from Taiwan to the U.S., particularly fruit juices, were produced with emulsifiers containing undeclared phthalate plasticizers, specifically diethylhexyl-phthalate (DEHP). The direct addition of DEHP to food is not permitted in the U.S. under the U.S. Federal Food, Drug, and Cosmetic Act. FDA does not believe that these products from Taiwan containing added DEHP present any immediate, acute risks to consumers. FDA expects that long term exposure is unlikely due to the nature of the intentional ingredient substitution and therefore does not anticipate a hazard associated with chronic exposure. However, further investigation into this potential is ongoing.

The Taiwan authorities responsible for food safety have informed FDA that, as of June 21, 2011, 57 types of products they believe were shipped to the U.S. may be contaminated with DEHP. We expect that the number of suspect products may increase as we continue to receive updated information from the Taiwan investigation.

The products are primarily fruit juices (grape, litchi, mango, passion fruit, lemon, blue coral, kiwi, melon, strawberry, passion, pineapple, peach), syrups (litchi, kiwi, mango, melon, orange, passion fruit, pineapple, grape, strawberry, peach, blueberry, lemon, sour plum, crowberry, honeydew, lychee), drinks (passion fruit, lemon, mango, orange) and jam (passion fruit, honeydew, peach). One dietary supplement was also identified as potentially contaminated with DEHP. Taiwan has identified that these products were exported by eight companies in Taiwan (Possmei International Co. Ltd., Seven Strong Co. Ltd., Dashing Industrial Co. Ltd., Patio Master International Co. Ltd., Tasty Enterprise Company, Jin Ji Wang Food Co. Ltd., Mao-Hon International Foods Material Corp., and Chang Gung Biotechnology Co., Ltd.).

FDA instituted a heightened surveillance program and has been screening suspect food products from Taiwan for DEHP and for additional plasticizers such as butylbenzylphthalate, di-n-butylphthalate, di-n-octyl phthalate, and di-isodecyl phthalate since May 31. Our current focus on imported products includes juices, soft drinks and teas; jams and syrups; yogurt powder and pudding products; pet foods; dietary supplements; and bulk colors and flavors. As these products of concern from Taiwan are offered for entry into the U.S., we are collecting and analyzing samples for the presence of plasticizers.

In addition to our increased surveillance of products that are offered for entry into the U.S., we are also reviewing and following up on recent shipments from firms identified by Taiwan as having produced suspected contaminated product, and recent shipments imported by U.S. firms identified by Taiwan as having received suspected contaminated product. In both cases, we are focusing on the firms identified by Taiwan, and then looking for products in the categories listed above. We are visiting firms to track down those shipments and collect samples, if the products are still in the U.S.

Our review continues and as we receive additional information, we will conduct further follow up investigations and take actions as warranted.

FDA advises manufacturers of food products and suppliers of food ingredients, both in the U.S. and abroad, to be aware of the potential substitution of phthalate plasticizers for vegetable oils in emulsifiers/clouding agents and flavorings. Manufacturers using emulsions containing vegetable oils should exercise caution to prevent the use of ingredients that might be intentionally adulterated with phthalates. For example, manufacturers may take steps to confirm the composition of oil-in-water emulsions and conduct appropriate testing of at-risk emulsions.

FDA is monitoring this situation to assess any impact on the U.S. food supply and will provide additional information as it becomes available.

Page Last Updated: 06/04/2014
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