SHB Pharmaceutical & Medical Device Practice Chair Madeleine McDonough and Associate Lael Awong have co-authored a chapter in a Food and Drug Law Institute (FDLI) primer titled FDA’s Regulation of Veterinary Drug Products. Researched, referenced and edited by experienced professionals, FDLI primers are designed to be practical and user-friendly. McDonough and Awong contributed to the “Human Food Safety” chapter, which addresses Food and Drug Administration (FDA) regulations aimed at ensuring that food is safe for human consumption regardless of the use of an animal drug in a food-producing animal. They explain how veterinary drug sponsors can meet FDA requirements for the analysis of drug residues in food-producing animals in the preparation of new animal drug applications. The primer is available for purchase on FDLI’s website.    

Public Health Advocacy Institute (PHAI) Staff Attorney Cara Wilking and President Richard Daynard, a self-described “strategic litigation expert with a focus on combating the epidemics caused by tobacco and obesity,” have co-authored an article titled “Beyond Cheeseburgers: The Impact of Commonsense Consumption Acts on Future Obesity-Related Lawsuits.” 68 Food & Drug Law Journal 229 (2013). Beginning with the premise that “[a]ffirmative litigation is an important tool in the public health toolkit to recover healthcare costs stemming from harmful commercial practices and to prevent future health harms,” they provide a detailed analysis of the “Common Sense Consumption” acts (CCAs) enacted in 25 states to shield the food industry from civil liability for obesity-related harms allegedly caused by the long-term consumption of food. According to the authors, the National Restaurant Association took a leadership role in getting the measures before state legislatures. Noting that CCAs “have yet to be meaningfully tested in the…

According to a news source, the Turkish Competition Authority has concluded a 15-month investigation and imposed a fine of 17.9 million Turkish Liras (US $8.6 million) on Frito-Lay, finding that it engaged in practices to ensure that it was the only salty snack brand available for sale in retail shops. While the initial decision and fine have apparently been issued to the company, a more detailed “reasoned decision” will be forthcoming. The company, which contends that it “has strong policies in place to achieve compliance with the laws and regulations everywhere we do business,” will reportedly have the right to file an appeal. See BakeryandSnacks.com, September 6, 2013.    

California’s pesticide regulator has reportedly filed a petition against Whole Foods alleging that several of its pet products, including cat litter and dog and cat flea spray, contain pesticides that have not been registered with the state. Cal. Dep’t of Pesticide Registration v. Whole Foods Mkt. Cal., Inc., No. 2013-00150499 (Cal. Super. Ct., Sacramento Cty., filed September 9, 2013). State law evidently requires pre approval of pesticide products so they can be tested and approved for safe use. The company is reportedly cooperating with the state and has indicated that it “looks forward to addressing the matter before a judge.” If Whole Foods has violated state law, California may impose fines. According to an agency spokesperson, failure to register pesticide products has been an ongoing issue with the Austin-based retail grocery chain and the agency intends to investigate it for a range of purportedly unregistered products. See Huffington Post, September…

A federal court in California has granted a motion for final settlement approval in a nationwide class action alleging that Kellogg Co. falsely advertised its Frosted Mini-Wheats cereal products as a food that could help improve children’s attentiveness by 20 percent. Dennis v. Kellogg Co., No. 09-1786 (S.D. Cal., order entered September 10, 2013). Details about prior rulings in the case appear in Issue 483 of this Update. The court had previously given reluctant approval to the preliminary settlement, concerned that the class relief appeared to have diminished after remand from the Ninth Circuit, with attorney’s fees appearing to remain constant—the original settlement had a cash value of about $10.5 million with $2 million for attorney’s fees and claims administration; the revised settlement has a cash value of $4 million with $1.5-2 million reserved for attorney’s fees and claims administration. According to the court, the plaintiffs demonstrated that “the seemingly unchanged total…

A second amended complaint has been filed in a putative nationwide class action alleging that The Hain Celestial Group’s food and beverage product labels render their products misbranded and further mislead consumers because they use the terms “No Trans Fat,” “Evaporated Cane Juice” or “All Natural” in violation of state law. Smedt v. The Hain Celestial Group, Inc., No. 12-3029 (N.D. Cal., filed August 30, 2013). Details about the court ruling dismissing the claims with leave to amend appear in Issue 495 of this Update. The plaintiff has omitted any claims that the company’s website misled consumers and has otherwise attempted to address the court’s concerns about ambiguous fraud allegations in her initial pleadings.    

While dozens of consumers have purportedly experienced nausea and cramps after eating Chobani Greek Yogurt products allegedly contaminated with mold, a California resident without apparent physical injury has filed a putative class action against the company to recover damages for purchasing a defective product. Green v. Chobani, Inc., No. 13-2106 (S.D. Cal., filed September 9, 2013). Plaintiff Harold Green alleges that he purchased 16 cups of yogurt subject to a company recall and that he and his family members consumed some of them before the September 5, 2013, recall date. After receiving notice of the recall, the plaintiff claims that he returned six cups to the store. Seeking to represent a nationwide class and statewide subclass of purchasers, the plaintiff alleges negligence and breach of the implied warranty of merchantability for food. He requests restitution, disgorgement, interest, compensatory damages, attorney’s fees, and costs. See NBCNews.com, September 10, 2013.   Issue…

A federal court in Colorado has reduced the damages awarded to a man who allegedly contracted bronchiolitis obliterans, a debilitating respiratory condition, after consuming microwave popcorn containing the butter flavoring compound diacetyl. Watson v. Dillon Cos., Inc., No. 08-91 (D. Colo., judgment entered September 5, 2013). The jury awarded the plaintiff and his wife more than $7 million, including punitive damages, apportioned among a number of defendants, and the court reduced the total award by more than half to $3.04 million with interest. Additional information about the lawsuit appears in Issues 244, 454 and 480 of this Update. The court agreed with defendant Gilster-Mary Lee, a private label food manufacturer, that a statutory cap applied to the $800,000 non economic damages award against it because the plaintiff discovered or should have discovered his lung injury and its cause before a statutory cut-off in January 2008. The court further refused to…

A federal court in the District of Columbia has denied the American Meat Institute’s motion for a preliminary injunction in a challenge to the amended country-of-origin labeling (COOL) rules adopted by the U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service in response to a World Trade Organization (WTO) determination that the original rules violated the WTO Agreement on Technical Barriers to Trade by according less favorable treatment to foreign livestock. Am. Meat Inst. v. USDA, No. 13-1033 (D.D.C., decided September 11, 2013). The court was not persuaded that the plaintiffs, meat processing interests, were likely to succeed on the merits of their First Amendment and statutory challenges to the amended rule. Additional information about the challenge appears in Issue 495 of this Update. Assessing the First Amendment claims under a lenient reasonableness standard because the rule involved commercial speech that mandated purely factual and uncontroversial disclosures, the court determined that…

The Ninth Circuit Court of Appeals has affirmed a lower court ruling denying the request for a preliminary injunction to halt the application of a California statute that forbids the sale of products resulting from force feeding a bird to enlarge its liver and prohibits force feeding birds to enlarge their livers beyond normal size. Association des Éleveurs de Canards et d’Oies du Québec v. Harris, No. 12-56822 (9th Cir., decided August 30, 2013). While the court dismissed the governor and state as defendants on the basis of immunity, it agreed with the district court that the state attorney general was not immune from suit under the Eleventh Amendment. Additional information about the lawsuit appears in issues 446 and 454 of this Update. Because the court found that the plaintiffs, out-of-state foie gras producers and a California restaurant that sold the product before the law took effect, were not likely…

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