A California appeals court has affirmed a lower court’s ruling dismissing a putative class action alleging that Safeway misbranded its Lucerne-brand of Greek yogurt because U.S. Food and Drug Administration (FDA) regulations prohibit the use of “milk protein concentrate” (MPC) in foods labeled as yogurt. Tamas v. Safeway, Inc., No. RIC1206341 (Cal. Ct. App., 4th Dist., Div. 3, order entered February 23, 2015). The plaintiff argued that a 1981 FDA regulation determining yogurt’s “Standard of Identity” (SOI) dictated what ingredients are allowable in products sold as yogurt despite the agency’s stay of the regulation soon after it was issued. FDA promised to schedule a public hearing on the regulation but, as of January 2009, “due to competing priorities and limited resources, FDA has not held a public hearing to resolve these issues and the effective date for these provisions remains stayed. Therefore, these provisions were never in effect. Consequently, cultured milk…
Posts By Shook, Hardy & Bacon L.L.P.
A California federal court has dismissed a lawsuit arguing that PepsiCo Inc. should provide medical monitoring for a class of Diet Pepsi or Pepsi One purchasers because the company does not warn consumers that 4-methylimidazole (4-MEI), a compound in caramel coloring, has allegedly been linked to potential health risks in rodent studies. Riva v. PepsiCo, Inc., No. 14-2020 (N.D. Cal., order entered March 4, 2015). The case was severed from a consolidated class action after the plaintiffs decided to pursue medical monitoring and personal injury claims not included in the consolidated action. Information about the case’s transfer of venue appears in Issue 523 of this Update. The court determined that the plaintiffs lacked standing to pursue the claim because “they have not established that the alleged risk of bronchioloalveolar cancer (for which they seek lung scans and testing) is both credible and substantial.” The studies cited as support for the…
The Technical University of Denmark’s (DTU’s) National Food Institute has rejected the European Food Safety Authority’s (EFSA’s) recent bisphenol A (BPA) assessment, claiming that the agency’s decision to set the tolerable daily intake (TDI) at 4 micrograms per kilogram body weight per day does not adequately protect consumers. After examining EFSA’s toxicological evaluation, National Food Institute’s researchers criticized the scientific opinion for not applying an appropriate uncertainty factor and failing to take into account animal studies allegedly showing the effects of BPA on reproductive health and neurological development. The National Food Institute has instead proposed a TDI of less than 0.7 µg/ kg bw/day to protect against “endocrine disrupting effects.” In particular, the scientists note that, according to EFSA, men and women at the highest exposure levels are currently exposed to more than 1 microgram of BPA per kilogram per day, “while children and teenagers are exposed to between 1.26 and…
The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has announced its intent to list styrene as a chemical known to the state to cause cancer under the authoritative bodies listing mechanism of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). Styrene is used in the manufacture of various consumer products, including polystyrene packaging, synthetic rubber and food containers. Two previous attempts to list styrene as known to cause cancer under Prop. 65’s Labor Code listing mechanism failed. The agency’s latest attempt relies on findings in the National Toxicology Program’s (NTP’s) 2011 Report on Carcinogens, which concluded that styrene is “reasonably anticipated to be a human carcinogen” based on studies showing that inhalation and oral exposure to the chemical increased the incidence of malignant and combined incidence of benign and malignant lung tumors in male and female mice. The National Research Council confirmed…
The U.S. Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service is soliciting public comment on its current list of select agents and toxins with the potential to pose a severe threat to animal or plant health or to animal or plant products. The agency’s biennial review and republication of the list is required under provisions of the Agricultural Bioterrorism Protection Act of 2002. Criteria for determining whether an agent or toxin is placed on the list include the (i) effect of exposure to the agent/toxin on animal or plant health and on the production and marketability of animal or plant products; (ii) pathogenicity of the agent/toxin and the methods of transference to animals or plants; and (iii) availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by exposure to the agent/ toxin. Comments should be submitted by April 28, 2015. See Federal Register,…
In a recent article for Law360, Shook, Hardy & Bacon Class Actions & Complex Litigation Co-Chair Jim Muehlberger and Agribusiness & Food Safety Associate Jeff Lingwall discuss the new wave of putative class action litigation against food and nutraceutical companies brought by plaintiffs bearing product test results that allegedly indicate deviations from labeled amounts. They explain U.S. Food and Drug Administration (FDA) standards for evaluating nutrition labeling and attendant provisions of the Federal Food, Drug, and Cosmetic Act/Nutrition Labeling and Education Act, advocating anticipatory measures by companies, given the advent of product testing websites, crowdfunded research and the increased scrutiny of the dietary supplement industry. Such measures, they say, include ensuring that (i) production processes (and those of any contract manufacturers) produce FDA-compliant test results and (ii) performing regular product testing to assure compliance with nutrition labeling per FDA-testing procedures. Issue 557
After conducting a systematic review of studies examining the impact of brand mascots and cartoon media characters on children’s diets, Virginia Tech and Duke University researchers have claimed that “familiar media character branding appears to be a more powerful influence on children’s preferences, choices and intake of less healthy foods compared with fruits or vegetables.” V.I. Kraak and M. Story, “Influence of Food Companies’ Brand Mascots and Entertainment Companies’ Cartoon Media Characters on Children’s Diet and Health: A Systematic Review and Research Needs,” Obesity Reviews, February 2015. The results also apparently indicated that “an unfamiliar cartoon media character may increase children’s appetite, preference for, choice and intake of health of fruits and vegetables compared with no character branding.” Adapted from a paper commissioned by the Robert Wood Johnson Foundation’s Health Eating Research program, the review summarized “11 published experimental studies involving children aged 2-11 years” while noting some limitations, including…
A joint study by Consumer Reports and the Johns Hopkins Center for a Livable Future claims that 4-methylimidazole (4-MEI) exposures “associated with average rates of soft drink consumption pose excess cancer risks exceeding one case per 1,000,0000 exposed individuals, which is a common acceptable risk goal used by U.S. federal regulatory agencies.” Tyler Smith, et al., “Caramel Color in Soft Drinks and Exposure to 4-Methylimidazole: A Quantitative Risk Assessment,” PLOS One, February 2015. Researchers apparently used ultra-high-performance liquid chromatography-tandem mass spectrometry to estimate 4-MEI concentrations in 12 beverages purchased in California and New York City, then assessed exposure levels based on data obtained from the National Health and Nutrition Examination Survey, California Environmental Protection Agency Office of Environmental Health Hazards Assessment (OEHHA) and U.S. Census Bureau. In addition to ranking 4-MEI concentrations by brand, product and geographic location, the study authors calculated the lifetime average daily dose and lifetime excess cancer…
A series of six articles published online February 18, 2015, by The Lancet reportedly “examines false dichotomies and proposes a reframing of obesity as a consequence of the ‘reciprocal nature of the interaction between the environment and the individual,’ where feedback loops perpetuate food choices and behaviors.” “Our understanding of obesity must be completely reframed if we are to halt and reverse the global obesity epidemic,” Christina Roberts, who co-authored the first article in the series with Kelly Brownell and others, was quoted as saying.“On one hand, we need to acknowledge that individuals bear some responsibility for their health, and on the other hand recognize that today’s food environments exploit people’s biological, psychological, and social and economic vulnerabilities, making it easier for them to eat unhealthy foods.” Among other things, the series’ fourth article, “Child and adolescent obesity: part of a bigger picture,” asserts that the “food industry has a…
Researchers from the Johns Hopkins Bloomberg School of Public Health have authored an overview of litigation and governmental actions related to health claims on food and beverages marketed to children. Lainie Rutkow, et al., “Legal Action Against Health Claims on Foods and Beverages Marketed to Youth,” American Journal of Public Health, March 2015. By identifying 115 instances of legal action—including consumer class actions and governmental warnings—the authors review “lessons learned for policymakers, practitioners, and other stakeholders seeking to limit the untruthful or misleading marketing of foods and beverages to children.” Those looking to challenge health claims “should first determine whether scientific evidence supports the claim,” the researchers said. In addition, plaintiffs should be selected carefully, they recommend, noting that they “may prefer, if possible, to bring a lawsuit in a state such as California, which has a well-developed body of law about deceptive and misleading advertising and marketing.” In addition,…
