Category Archives Issue 362

Linking a Salmonella Typhi outbreak to frozen mamey fruit pulp, the Food and Drug Administration (FDA) has urged consumers to discard La Nuestra® or Goya® fruit products in their possession and find out what brand is in use by street vendors before purchasing the mamey fruit-based juices and fruit shakes they sell. At least nine consumers in California and Nevada have apparently developed typhoid fever from the outbreak. FDA has also indicated that it will increase its border sampling to prevent contaminated product from entering the United States. See Product Liability Law 360, August 20, 2010.

The Food and Drug Administration (FDA) has released draft and final guidance to assist restaurateurs and vending machine operators in implementing the labeling provisions set out in section 4205 of the Patient Protection and Affordable Care Act of 2010. The Act requires food retail establishments with 20 or more locations to post the calorie content for standard items on menus and menu boards; provide additional nutrition information in writing; and post calorie information for self-serve items and foods on display. The draft document offers proposed guidance on the execution of these standards, while the final explains the impact of the federal measure on state and local laws. According to an August 24, 2010, FDA press release, the agency “realizes that industry may need additional information and time to comply with the new provisions, and that the agency expects to refrain from enforcement action for a time period that will be provided…

The Food and Drug Administration (FDA) has announced two public meetings to consider the labeling of food derived from genetically engineered (GE) salmon. During the first meeting slated for September 19-20, 2010, the Veterinary Medicine Advisory Committee will address general scientific issues surrounding GE animals, statutory and regulatory constraints, and “a new animal drug application (NADA) concerning AquAdvantage salmon produced by AquaBounty Technologies, Inc.,” which has inserted Chinook and ocean pout genes into Atlantic salmon to accelerate maturation. In addition, FDA has called a September 21, 2010, public hearing to explain “the relevant legal principles for food labeling and to solicit information and views from interested persons on the application of these principles to food derived from AquAdvantage Salmon.” FDA has specifically invited participants to consider the following: (i) “Which facts about the AquAdvantage Salmon seem most pertinent for FDA’s consideration of whether there are any ‘material’ differences between foods…

Representative Rosa DeLauro (D-Conn.), who chairs the Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) appropriations subcommittee, is seeking information from the agencies about the unfolding Salmonella outbreak linked to two Iowa egg producers. Representatives Henry Waxman (D-Calif.) and Bart Stupak (D-Mich.) have also stepped into the massive egg recall, requesting information from the same agencies and demanding documents and information from the egg company owners. Stupak’s oversight subcommittee of the House Committee on Energy and Commerce has scheduled a September 14, 2010, hearing into the matter and has apparently invited Wright County Egg owner Austin “Jack” DeCoster and Hillandale Farms owner Orland Bethel to testify. More than a half-billion eggs, representing less than 1 percent of the U.S. egg supply, have been recalled after an upswing in Salmonella cases came to the attention of state regulators and the Centers for Disease Control and Prevention beginning in May.…

President Barack Obama (D) recently announced his intention to “recess appoint” Elisabeth Hagen as the U.S. Department of Agriculture’s (USDA’s) under secretary for food safety. According to a White House press release, Hagen is among four key administrative nominees who have waited an average of 303 days for Senate confirmation. Obama said he chose to appoint all the nominees while Congress was away on its August recess in accordance with his “authority to do what is best for the American people. At a time when our nation faces so many pressing challenges, I urge members of the Senate to stop playing politics with our highly qualified nominees and fulfill their responsibilities of advice and consent.” Hagen is currently the USDA’s chief medical officer and senior executive within USDA’s Food Safety and Inspection Service. USDA Secretary Tom Vilsack was quoted as saying that Hagen’s background “will enable her to successfully lead…

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