FDA – Regulatory Updates: FDA is Monitoring Certain Foods and Beverages Imported from Taiwan that May Contain Plasticizers – June 27, 2011

June 27, 2011 By


June 22, 2011

The U.S. Food and Drug Administration (FDA) is notifying the public about the possible presence of a plasticizer called diethylhexyl-phthalate (DEHP) in certain food and beverages imported from Taiwan.

The Taiwan authorities responsible for food safety have informed the FDA of products shipped to the United States which they believe may be contaminated with DEHP. FDA is screening suspect food products from Taiwan for DEHP and for additional plasticizers such as butylbenzylphthalate, di-n-butylphthalate, dioctyl phthalate, and di-isodecyl phthalate. We expect that the number of suspect products may change as we continue to receive updated information from the Taiwan investigation.

Phthalates such as DEHP are primarily used as plasticizers in polyvinyl chloride (PVC) and polyvinylidene chloride (PVDC) polymers to increase their flexibility. The direct addition of DEHP to food is not permitted in the United States under the U.S. Federal Food, Drug and Cosmetic Act.


June , 2011

New Menu and Vending Machines Labelling Requirements

On March 23, 2010, the President signed the health care reform legislation1 into law. Section 4205 of the Patient Protection and Affordable Care Act of 2010 requires restaurants and similar retail food establishments with 20 or more locations to list calorie content information for standard menu items on restaurant menus and menu boards, including drive-through menu boards. Other nutrient information – total calories, fat, saturated fat, cholesterol, sodium, total carbohydrates, sugars, fiber and total protein – would have to be made available in writing upon request. The Act also requires vending machine operators who own or operate 20 or more vending machines to disclose calorie content for certain items.


June 20, 2011

FDA unveils new global strategy to help ensure safety and quality of imported products

The U.S. Food and Drug Administration today unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the “Pathway to Global Product Safety and Quality.”

“Global production of FDA-regulated goods has exploded over the past ten years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “There has been a perfect storm – more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented.”

The FDA report calls for the agency to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change:

1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.

2. The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.

3. The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.

4. The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.