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|Closing Time: How the Government Shutdown Affects Global Trade|
October 7, 2013, previously published on October 2013With no Cinderella story last night, as of October 1, 2013 at 12:01 AM, the Federal Government is officially shut down. As a result, all “non-essential” federal workers will be furloughed and federal agencies cannot continue their routine operations. However, not all agency operations...
|$5 Million Later, Truvia® is Still “Natural”|
Ricardo Carvajal, Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
October 4, 2013, previously published on October 3, 2013On September 19, 2013, Cargill entered into a $5 million settlement agreement to dispose of a class action lawsuit regarding its advertising for Truvia® products as “natural.” Plaintiffs charged that the products are not natural because they contain ingredients that are...
|An Old Fashioned Park Criminal Prosecution With Some Twists|
John R. Fleder; Hyman, Phelps & McNamara, P.C.;
October 4, 2013, previously published on October 2, 2013On September 26, 2013, the United States Attorney for the District of Colorado announced that he had filed a six count criminal Information against Eric and Ryan Jensen. The government alleges that the defendants violated the FDC Act by introducing adulterated cantaloupes into interstate commerce....
|The Regulation of Food Packaging in the Pacific Rim|
Mitzi Ng Clark, Catherine R. Nielsen; Keller and Heckman LLP;
October 4, 2013, previously published on September 2013As markets continue to emerge in the Pacific Rim, an increasing number of companies that produce food packaging materials are pursuing global expansion in this untapped arena. To best maximize their opportunities, companies must adapt to a myriad of regulatory systems to ensure compliance of their...
|As Partial Government Shutdown Kicks In, FDA’s Foods Program Is Hardest Hit|
Ricardo Carvajal, Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
October 3, 2013, previously published on October 1, 2013According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations - popularly referred to as a government shutdown. Now that the shutdown has materialized, the effects...
|Food “Front-of-Package Labeling” Bill Announced|
Daniel J. Herling; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
September 25, 2013, previously published on September 20, 2013Proposed legislation has been introduced by 3 members of the House, including Rep. Frank Pallone (D-NJ), senior Democrat on the House Energy & Commerce Health Subcommittee, which would direct the Secretary of Health & Human Services (HHS) to create a single, standard front-of-package...
|Time for Food Labeling Reform? Introducing the Food Labeling Modernization Act of 2013|
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
September 25, 2013, previously published on September 24, 2013Rep. Frank Pallone (D-NJ) introduced legislation - H.R. 3147, the Food Labeling Modernization Act of 2013 - that would grant FDA significant new authorities in the area of food labeling. In what is identified as the bill’s “signature initiative,” FDA would be directed to...
|CFSAN Priorities for 2013-2014 Include FSMA, Food Labeling, NDIs, Energy Drinks, and Cosmetic Safety|
Etan J. Yeshua; Hyman, Phelps & McNamara, P.C.;
September 20, 2013, previously published on September 16, 2013Three months after announcing a strategic research plan to support its regulatory agenda, FDA's Center for Food Safety and Applied Nutrition ("CFSAN") this week announced its regulatory priorities for 2013 and 2014, giving those in the food, dietary supplement, and cosmetic industries an...
|Medical Food Mumbo Jumbo: Confusing FDA Guidance Documents Will Discourage Medical Food Development|
Paul M. Hyman, A. Wes Siegner; Hyman, Phelps & McNamara, P.C.;
September 20, 2013, previously published on September 18, 2013The term “medical food” was first defined by statute in the Orphan Drug Act Amendments of 1988. The medical food category is closely related to the already existing category of “foods for special dietary use,” authorized by the Federal Food, Drug, and Cosmetic Act (FDC Act),...
|The Reasonable Consumer’s Understanding of “All Natural” - Legal or Factual Issue?|
Michelle Gillette; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
September 14, 2013, previously published on September 12, 2013Would “reasonable consumers” have regarded Paul Cezanne as highly had he painted numerous versions of still life with froot?