Category Archives Issue 494

A recent study has reportedly concluded that “higher glucose levels may be a risk factor for dementia, even among persons without diabetes.” Paul Crane, et al., “Glucose Levels and Risk of Dementia,” New England Journal of Medicine, August 2013. Relying on data from 2,067 men and women enrolled in the Adult Changes in Thought study, researchers apparently used 35,264 clinical measurements of glucose levels and 10,208 measurements of glycated hemoglobin levels in tracking the development of dementia in 524 participants during a median follow-up of 6.8 years. The results evidently suggested that among participants without diabetes, “higher average glucose levels within the preceding 5 years were related to an increase risk of dementia.” In particular, the study’s authors found that for those without diabetes, “risk for dementia was 18 percent higher for people with an average glucose level of 115 milligrams per deciliter compared to those with an average glucose…

Citing a shortage of naturally raised beef due to last year’s drought, Chipotle Mexican Grill Inc. has apparently told media sources that it may allow its restaurants to begin using beef treated with antibiotics. Although Chipotle only reached its goal to use antibiotic- and hormone-free meat a few years ago, the company reportedly said that it plans to review its “never-ever” antibiotic policy and possibly allow suppliers to sell animals that have been treated with antibiotics “when necessary.” The policy change would still bar the use of beef from animals given antibiotics to prevent disease or promote weight gain. “Many experts, including some of our ranchers, believe that animals should be allowed to be treated if they are ill and remain in the herd,” Chipotle founder and co-CEO Steve Ells was quoted as saying. “We are certainly willing to consider this change, but we are continuing to evaluate what’s best…

The Pew Charitable Trusts’ Food Additive Project has published a paper in Reproductive Toxicology claiming that gaps in the toxicity data for food additives raise questions about the Food and Drug Administration’s (FDA’s) safety assessments for these substances. Thomas Neltner, et al., “Data Gaps in Toxicity Testing of Chemicals Allowed in Food in the United States,” Reproductive Toxicology, August 2013. Comparing data from FDA’s Priority-based Assessment of Food Additives database, the Accelrys Toxicity Database of chemical studies and the U.S. National Library of Medicine’s TOXLINE database, the study’s authors apparently determined that “almost two-thirds of chemical additives appear to have been declared safe for use in food without the benefit of being fed to an animal in a controlled toxicology study,” while approximately 78 percent of additives lack adequate data to estimate a safe level of exposure and 93 percent lack reproductive or development toxicity testing. They also reported that, according to…

In the first investigation subject to a pilot program, the International Trade Commission (ITC) has agreed with an administrative law judge (ALJ) that a company alleging infringement of its patents for laminated packaging by the importers of liquor, wine, toys, electronics, and cosmetics failed to show that it had a domestic industry that would be harmed by the alleged infringement. In re Certain Prods. Having Laminated Packaging, & Components Thereof, No. 337-TA-874 (ITC, decided August 6, 2013). Several alleged infringers, including Camus Wine & Spirits Group of Cognac, France, were terminated from the investigation before it was resolved on the basis of settlement agreements with claimant Lamina Packaging Innovations, Inc. of Longview, Texas. ITC has the authority to bar imports of products deemed harmful to a domestic industry and announced earlier this year that it would test expedited procedures in cases alleging unfair practices in import trade. Under the program, ITC…

A federal court in California has issued an order granting the motion for preliminary approval of a class settlement in five lawsuits alleging that Naked Juice Co. misrepresented its beverages as “All Natural” and “Non-GMO.” Pappas v. Naked Juice Co. of Glendora, Inc., No. 11 8276 (C.D. Cal., order entered August 7, 2013). According to the court, the proposed settlement was reached after the defendant’s motion to dismiss was granted in part, extensive and contentious discovery was undertaken, and four mediation sessions occurred under the guidance of an experienced retired judge. Under the terms of the settlement, the company will pay $9 million into a settlement fund that will be used to make cash payments to class members and pay the costs of notice and settlement administration, attorney’s fees—not to exceed $3.1 million—and expenses, and incentive awards $2,500 each for four of the five named plaintiffs. Class members with purchase receipts…

Four years after filing a citizen petition with the U.S. Food and Drug Administration (FDA) seeking a prohibition on the use of partially hydrogenated oils containing artificial trans fat in food for human consumption, 98-year-old University of Illinois Emeritus Professor of Comparative Biosciences Fred Kummerow has filed a lawsuit seeking an order compelling an agency response to his petition and a declaration that its failure to ban trans fats violates the Food, Drug, and Cosmetic Act. Kummerow v. Hamburg, No. 13-2180 (C.D. Ill.,  filed August 9, 2013). The complaint details the history of the ingredient’s invention and research, including the plaintiff’s own, demonstrating its “harmful effects,” including inhibition of an enzyme necessary to prevent blood clots in the arteries and veins. The plaintiff also distinguishes between artificial and natural trans fats, noting that he does not seek a ban on the latter. According to the complaint, Kummerow learned in 2004…

A Florida resident has filed a putative statewide class action against Gruma Corp., alleging that the company falsely advertises its Mission® Restaurant Style Tortilla chip products as “all natural” when they contain genetically modified organisms (GMOs). Griffith v. Gruma Corp., No. 13-80791 (S.D. Fla.,  filed August 12, 2013). Alleging violations of the Florida Deceptive and Unfair Trade Practices Act and contending that her claims “mirror the labeling, packaging, and advertising requirements mandated by federal regulations and laws,” the plaintiff claims that the products are misbranded and the labels are false and misleading because GMOs are not natural and she understood that product representation to mean that the chips contained no GMO ingredients. Alleging damages in excess of $5 million, the plaintiff seeks injunctive relief, restitution, disgorgement, actual damages, attorney’s fees, costs, and interest.    

A New Jersey resident has filed a putative nationwide class action against the Campbell Soup Co. and American Heart Association (AHA) claiming that the “Heart-Check Mark” which AHA allows Campbell to place on more than 30 varieties of its canned soups in exchange for a fee misleads consumers into believing that these products meet AHA’s heart-healthy nutritional guidelines when a single serving actually contains nearly three times the amount of sodium permitted under those guidelines. O’Shea v. Campbell Soup Co., No. 13-4887 (D.N.J., filed August 13, 2013). According to the plaintiff, “Properly characterized, the real meaning of the AHA’s Heart-Check Mark certification is, ‘Unhealthy, but maybe not as bad for you as other products.’” Also characterizing the certification program as a “scheme,” the plaintiff alleges, “By the AHA selling, and Campbell’s buying, the right to affix the AHA’s seal of approval to its products, they falsely represent to the public…

A federal court in Georgia has issued an order continuing the criminal trial against former Peanut Corp. of America officials and employees, including owner Stewart Parnell, until February 10, 2014. United States v. Parnell, No. 12-12 (M.D. Ga., order entered August 15, 2013). The company was the source of a nationwide Salmonella outbreak in 2009, and the 76-count indictment charges four individuals with conspiracy, mail and wire fraud, obstruction of justice and other counts related to the distribution of adulterated and misbranded food. Details about the indictment appear in Issue 472 of this Update.  

A federal court in California has denied a motion to dismiss in a contract dispute between the supplier of molasses allegedly contaminated with lead and the company that used the ingredient to make licorice subject to a nationwide recall. Am. Licorice Co. v. Total Sweeteners, Inc., No. 13-1929 (N.D. Cal., order entered August 13, 2013). Relying on a sales contract it had prepared, the molasses supplier contended that the plaintiff had failed to comply with its notice provisions and therefore was precluded from seeking relief for its alleged breach. Relying on a purchase order with different terms it had prepared and issued before the first shipment under the contract, the plaintiff candy maker argued that the shipments were subject to its terms. The court was unwilling to determine as a matter of law whether the purchase order altered the terms and conditions of the contract, finding that “this issue is…

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