Category Archives Issue 471

Citing public concerns about the presence of horsemeat in beef products, European Union (EU) Health and Consumer Policy Commissioner Tonio Borg recently called an emergency meeting of agricultural ministers and urged member states to conduct random DNA testing on processed beef products for three months beginning March 1, 2013. The measure builds on an ongoing investigation initiated by the U.K. Food Safety Agency (FSA) and Food Safety Authority of Ireland, which first reported finding equine and porcine DNA in beef products in January 2013 and have since ramped up testing protocols after other member states, including France and Germany, allegedly received contaminated products from suppliers across the European Union. See European Food Safety Authority, February 11, 2013. According to various media reports, retailers in 16 countries have sold mislabeled horsemeat to millions of consumers, a development that has prompted officials to demand criminal sanctions against those deemed responsible for what…

The Food and Drug Administration (FDA) has announced two additional public meetings to discuss proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule), and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls proposed rule). The meetings are scheduled for March 11-12 in Chicago and March 27-28 in Portland, Oregon. FDA anticipates that the proposed produce safety rule would “reduce foodborne illnesses associated with the consumption of produce.” The proposed preventative controls rule would evidently apply to human food and require domestic and foreign facilities that must register under the Federal Food, Drug, and Cosmetic Act to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, monitor results and act to correct problems that arise. See…

The Food and Drug Administration (FDA) has extended until April 26, 2013, the comment period for two draft environmental assessments of the proposed conditions of use submitted by AquaBounty Technologies, Inc., in support of a new animal drug application concerning a genetically engineered (GE) Atlantic salmon and a preliminary finding of no significant impact for those specific conditions of use. FDA has pushed back the deadline in response to “a request for an extension to allow interested persons additional time to submit comments.” Additional details about the proposed rule appear in Issue 466 of this Update. See Federal Register, February 14, 2013.

The Food and Drug Administration (FDA) recently entered a consent decree with Puerto Rico-based Jonlly Fruits, Inc. requiring the company to hire independent experts in labeling, sanitation and Hazard Analysis Critical Control Point (HACCP) before it can begin again to make and sell its fruit and juice products. United States v. Jonlly Fruits, Inc., No. 13-1043 (D.P.R., approved January 17, 2013). The labeling expert is required to “review Defendants’ labeling and ensure that all such labels are in compliance with the applicable FDA regulations.” The other experts are required to develop written protocols and employee training programs and to conduct comprehensive facility inspections. In the meantime, the company has agreed to destroy “all in-process and finished articles of food” currently in its custody, control or possession. According to FDA, the company and its president, Bartolo Pérez Romàn, “have a long history” of failing to comply with current good manufacturing practice…

Evidently in response to public comments, the Federal Trade Commission (FTC) has modified its agreement with Phusion Projects, LLC to require an alcohol facts panel on certain-sized cans of its Four Loko fruit-flavored malt beverage. In re Phusion Projects, LLC, No. C-4382 (FTC, order entered February 6, 2013). The agreement resolves charges that the company and its principals falsely claimed that a 23.5-ounce can contained “the alcohol equivalent of one or two regular 12-ounce beers, and that a consumer could drink one entire can safely on a single occasion.” To the contrary, according to FTC’s administrative complaint, the products contain the alcohol equivalent of four to five 12-ounce cans of beer. Without admitting liability, the company has agreed to label any container of Four Loko or other flavored malt beverage with more than two servings of alcohol with an alcohol facts panel. The panel will set forth the “the container…

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