Category Archives Issue 412

A federal court in Illinois has determined that the government did not allege facts sufficient to pierce the corporate veil of related U.S. and foreign corporations and thus could not bring the foreign corporations before the court on charges of avoiding $80 million in customs duties on honey imported into the United States between 2002 and 2009. United States v. Alfred L. Wolff GMBH, No. 08-417 (N.D. Ill., decided September 26, 2011). A federal grand jury indicted the foreign defendants and a U.S. corporate entity on 44 counts in August 2010. The U.S. entity’s attorneys voluntarily accepted service on its behalf and on behalf of its parent and then appointed, via a shareholder resolution, a limited-authority corporate representative to appear before the court and enter a not-guilty plea for the U.S. defendants. This representative did so, and, immediately after the arraignment, the government served the representative with summonses for each of…

A federal multidistrict litigation (MDL) court has granted several motions to dismiss in consolidated actions alleging a conspiracy by egg producers and trade associations to restrict the domestic supply of eggs. In re: Processed Egg Prods. Antitrust Litig., MDL No. 2002 (E.D. Pa., decided September 26, 2011). Among other allegations, the plaintiffs contend that the defendants agreed over a period of years to reduce the size of egg-laying flocks and require larger cages to reduce overall hen densities as part of an alleged collective plan to keep egg prices high. In their motions to dismiss, the defendants argued that while the second amended complaint alleged sufficient facts to support the antitrust conspiracy claim as to some of the defendants, “the pleading is deficient with respect to each of the movants by failing to allege facts that they specifically were parties to the conspiracy.” Examining each motion in turn, the court dismissed…

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has issued a notice indicating that it has changed the proposed regulation establishing a No Significant Risk Level (NSRL) for 4-MEI and augmented the record with additional references. The new proposed NSRL is 29 micrograms per day, increased from the proposed 16 micrograms per day level. The chemical, 4 Methylimidazole, has been identified as a by-product of fermentation, heating or roasting in certain foods and beverages, such as coffee, some carbonated beverages, beer and wine, soy sauce, molasses and crackers. Comments are requested by October 24, 2011.

The Carcinogen Identification Committee of California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) will meet October 12-13, 2011, to consider, among other matters, whether bisphenol A (BPA) should be designated as a high priority for preparation of hazard identification materials and further considered for inclusion on the state’s list of chemicals known to cause cancer (Prop. 65). Among those filing comments on the proposal are the Polycarbonate/BPA Global Group of the American Chemistry Council, North American Metal Packaging Alliance, Grocery Manufacturers Association, and Toy Industry Association. They contend that BPA should be designated as a low priority.

In a move garnering international attention, the Danish government has reportedly approved a new excise tax on butter, cream, cheese, and other foods that contain more than 2.3 percent saturated fat per total weight. According to the Copenhagen Post, the levy took effect October 1, 2011, and “amounts to a 16 kroner duty per solid kilo of saturated fat,” raising the price of a standard butter package to 18 kroner from 15.50 kroner and 500 grams of 45 percent fat cheese to 36 kroner from 34.50 kroner. This so-called fat tax has already drawn criticism from some retailers and industry groups such as the Danish Agriculture and Food Council, which has estimated the annual cost per family at 1,000 kroner. But the measure has also piqued curiosity abroad, where health advocates are purportedly eager to see whether consumers will alter their diets or pay the higher prices. “It’s the first ever…

The Food and Drug Administration (FDA) has issued industry guidance concerning new fee provisions under the Food Safety Modernization Act. The guidance aims to provide answers to common questions about FDA’s plans for implementing the fees in fiscal year 2012. In particular, the guidance addresses such topics as fees for import re-inspections and non-compliance of a recall order, and FDA’s process for requesting fee reductions. FDA will accept comments at any time. See Federal Register, October 6, 2011.

The Food and Drug Administration (FDA) recently announced the availability of its draft Foods and Veterinary Medicine Strategic Plan 2012 – 2016, which takes into account “all of the activities within the jurisdictions of the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine and includes activities supported by the Office of Regulatory Affairs.” According to the executive summary, the Foods and Veterinary Medicine (FVM) Program aims to protect the American food supply by securing high rates of compliance with science-based food safety and labeling standards as well as implementing “integrated, prevention-oriented and risk-based programs.” To this end, the 2012-2016 plan identifies one cross-cutting goal—to “improve effectiveness and efficiency across all levels of the FVM program”—as well as seven program goals: (i) “Establish science-based preventive control standards across the farm-to-table continuum”; (ii) “Achieve high rates of compliance with preventive control standards domestically and internationally”; (iii) “Strengthen…

The Food and Drug Administration (FDA) has issued a report as part of a transparency initiative offering eight draft proposals “to make FDA’s publicly available compliance and enforcement data more accessible and user-friendly.” Based on public comments, an initiative task force will recommend specific draft proposals for FDA Commissioner Margaret Hamburg to consider by January 31, 2012. In particular, the report recommends that FDA explore (i) “different ways to improve data quality and facilitate more timely data disclosure,” (ii) “how to present its compliance and enforcement data graphically and better utilize mobile web applications,” (iii) “whether posting additional data compilations or analysis… would increase transparency,” and (iv) “ways to better utilize social media.” FDA requests comments by December 2, 2011. See Federal Register, October 4, 2011.

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has issued a proposed rule that would amend and republish “the list of selected agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products.” The Agricultural Bioterrorism Protection Act of 2002 requires APHIS to review the list on a biennial basis and submit revisions as necessary. Among the criteria APHIS considers when determining the status of an agent or toxin are (i) the effects of exposure on animal or plant health and on the “production and marketability” of an animal or plant product, (ii) the pathogenicity of the agent or toxin, (iii) the ability to treat or prevent any illness caused by the agent or toxin, and (iv) any other factors deemed essential for the protection of animal and plant health. The agency requests comments…

The Federal Trade Commission (FTC) has entered a 20-year consent order with Phusion Projects, LLC, the maker of Four Loko®, an alcoholic beverage that has generated significant controversy for its “super-size” container and previous inclusion of caffeine, which some allege has led to binge-drinking and adverse health effects. In re: Phusion Projects, LLC, No. 112-3084 (FTC). According to an FTC news release, “The marketers of Four Loko have agreed to re-label and repackage the supersized, high-alcohol, fruit-flavored, carbonated malt beverage, to resolve Federal Trade Commission charges of deceptive advertising.” FTC alleged that the company’s advertisements, packaging and promotional material misrepresented the amount of alcohol in its products and, in fact, implied that a 23.5-ounce can of the beverage contains the alcohol equivalent of just one or two regular 12-ounce beers. The product actually contains alcohol equivalent to 4.7 regular beers, according to FTC. “As a result, consuming a single can…

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