Category Archives 4th Circuit

The U.S. Department of Justice (DOJ) has obtained a consent decree against Valley Milk Products LLC prohibiting the sale of more than four million pounds of milk powder products and preventing the company from manufacturing the products in the future. U.S. v. All 50 pound high heat nonfat dry milk powder (Grade A), No. 16-­0076, (W.D. Va., order entered March 17, 2017). DOJ seized dry milk and dry buttermilk products at the company’s Strasburg, Virginia, facility in November 2016 after FDA inspections found unsanitary conditions and confirmed samples of Salmonella and Listeria. According to the U.S. Food and Drug Administration, the Salmonella strains were “nearly identical” to strains found at Strasburg in 2010, 2011 and 2013, indicating “the existence of persistent/resident strain and harborage” of the bacteria at the facility. DOJ also alleged the products were “contaminated with filth” after inspectors found dark brown droplets forming on metal surfaces of…

Three environmental and conservation advocacy groups have moved to intervene in a lawsuit filed by a group of seafood processing, distribution and retail companies to block implementation of the Seafood Import Monitoring Program. Alfa Int’l Seafood, Inc. v. Sullivan, No. 17-­0031 (D.D.C., motion filed March 7, 2017). Natural Resources Defense Council, Oceana and the Center for Biological Diversity are asking to defend the oversight program, known as the Seafood Traceability Rule, which gives the National Oceanic and Atmospheric Administration power over stringent reporting and recordkeeping of fish catches, vessel and species identification, names of buyers and other chain-­of-­custody information. The National Marine Fisheries Service published the rule in December 2016 to combat U.S. imports of seafood alleged to be the product of illegal, unreported and unregulated fishing, along with fraudulent practices such as mislabeling of species.   Issue 627

The Fourth Circuit Court of Appeals has upheld a lower court’s determination that the U.S. Food and Drug Administration (FDA) had the discretion to issue an incorrect contamination warning about Salmonella-tainted tomatoes, which devalued a tomato farmer’s crop by $15 million. Seaside Farm v. United States, No. 15-2562 (4th Cir., order entered December 2, 2016). Details about the lower court’s decision appear in Issue 588 of this Update. The lawsuit stemmed from FDA’s warning against eating raw tomatoes in 2008 following an outbreak of Salmonella that was later traced to jalapeno and Serrano peppers. Seaside Farm filed suit alleging FDA negligently issued the warning, impairing the value of its crop. The trial court found that FDA was acting within its discretion to issue the warning. Seaside argued that FDA’s warning was overly broad and based on insufficient evidence, noting that the agency failed to test any tomatoes before issuing its…

A D.C. federal court has denied McCormick & Co.’s motion to dismiss a competitor’s lawsuit alleging the company’s black pepper packaging contains too much slack fill. In re McCormick & Co., Inc., Pepper Prods. Mktg. & Sales Practices Litig., No. 15-1825 (D.D.C., order entered October 17, 2016). The lawsuit is part of multidistrict litigation joining several consumer class actions with similar allegations. McCormick challenged Watkins Inc.’s standing to sue and asserted that the company failed to state a claim under the Lanham Act, arguing that its packaging does not constitute advertising. The court disagreed, noting, “McCormick argues that size of its pepper tins is not commercial speech, but it is difficult to understand how the size of a package or container could possibly not be considered a form of ‘advertising or promotion.’ [] The size of a package signals to the consumer vital information about a product and is as…

The Center for Science in the Public Interest (CSPI) has filed a lawsuit seeking to compel the U.S. Food and Drug Administration (FDA) to act on the organization’s 2012 citizen petition seeking establishment of a performance standard for controlling Vibrio vulnificus, bacteria responsible for several deaths related to seafood consumption. Ctr. for Sci. in Pub. Interest v. FDA, No. 16-0995 (D.D.C., filed May 25, 2016). CSPI argues that FDA has violated the Administrative Procedure Act by delaying its response to CSPI’s citizen petition urging the agency “to establish a performance standard of nondetectable for V. vulnificus in raw molluscan shellfish” under the Food Safety Modernization Act. “Every year, people are getting sick and some are dying from what is a completely preventable disease,” CSPI Senior Food Safety Attorney David Plunkett said in a May 26, 2016, press release. “For too long the FDA has observed these illnesses and deaths from…

Great Harvest Franchising, Inc. and two franchisees of Great Harvest Bread Co. have filed a lawsuit against Panera Bread Co., alleging the company has been using a tagline—“Food as it should be”—that infringes on Great Harvest’s trademarked slogan, “Bread. The way it ought to be.” Great Harvest Franchising, Inc. v. Panera Bread Co., No. 16-0121 (W.D.N.C., Charlotte Div., filed March 10, 2016). Great Harvest established its tagline in October 2014 and registered the mark in December 2015, and it alleges that Panera began using its similar slogan in July 2015. The plaintiffs seek an injunction, destruction of infringing materials and damages for allegations of unfair competition, trademark infringement and false designation of origin.   Issue 597

The U.S. Court of Appeals for the D.C. Circuit has affirmed a lower court’s dismissal of Food & Water Watch’s challenge to the New Poultry Inspection System (NPIS). Food & Water Watch, Inc. v. Vilsack, No. 15-5037 (D.C., order entered December 22, 2015). The organization argued that the NPIS did not comply with the Poultry Products Inspection Act and would increase the risk of foodborne illnesses resulting from contaminated poultry. The lower court found that Food & Water Watch leaders did not have standing to sue because they could not show that the increased risk and probability of harm was substantial. The appeals court agreed, noting that the organization’s arguments ignored some provisions of the NPIS requiring more “offline” inspections, which could lower the risk of foodborne illness. Additional information about the lower court’s ruling appears in Issue 555 of this Update.   Issue 589

A South Carolina federal court has ruled that the U.S. Food and Drug Administration (FDA) was not negligent in issuing a tomato recall during a 2008 outbreak of Salmonella, dismissing a tomato farm's claim of $15 million in damages. Seaside Farm Inc. v. U.S., No. 11-1199 (D.S.C., order entered December 16, 2015). The farm had argued that FDA should have been more specific in its recall, while FDA argued it never issued an official recall, only warnings about tomatoes. The court had previously dismissed allegations of defamation and takings against the government.   Issue 588

The Judicial Panel on Multidistrict Litigation has consolidated three putative consumer class actions and a competitor lawsuit challenging McCormick’s alleged under-filling of its non-transparent black pepper containers. In re McCormick & Co. Inc. Pepper Prods. Mktg. & Sales Practices Litig., MDL No. 2665 (D.D.C., transfer order filed December 8, 2015). The court found that the actions involved common factual questions “about the propriety of McCormick’s pricing and packaging of its pepper products under various federal and state laws.” The transfer order notes that the plaintiffs of one consumer suit argued the competitor action be excluded, but the court found the action had a “clear factual overlap with the other cases.” The cases will continue in the District of District of Columbia and may involve additional tag-along actions as well. Additional information about the competitor action, brought by Minnesota-based Watkins Inc., appears in Issue 568 of this Update; details about a putative…

The Center for Science in the Public Interest (CSPI) has filed a lawsuit against the U.S. Food and Drug Administration (FDA) to compel the agency to act on the advocacy group’s 2005 citizen petition requesting regulations about the use of salt as a food additive. Ctr. for Sci. in Pub. Interest v. FDA, No. 15-1651 (D.D.C., filed October 8, 2015). The petition called for FDA to revoke salt’s status as generally recognized as safe, amend prior approvals of salt use, require food manufacturers to reduce sodium levels in processed foods, and mandate labeling messages about the health effects of salt in foods containing more than half an ounce of the substance. The complaint alleges that while “[n]early all Americans consume more sodium than is safe,” “[c]onsumers can exert relatively little control over their sodium intake by adjusting discretionary use of salt” because such use amounts to only 5 to 10…

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