Three days after the U.S. Food and Drug Administration (FDA) filed a motion for emergency stay pending appeal before the Ninth Circuit, the federal district court that had established November 30, 2013, as the deadline for the agency to publish notices of proposed rulemaking (NPRM) for specific food safety rules under the Food Safety Modernization Act denied the motion for stay pending appeal that FDA filed before it in September. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., order entered October 21, 2013). Details about the emergency stay request based on delays attributable to the federal government shutdown appear in Issue 501 of this Update. According to the district court, FDA failed to show that it would be irreparably injured absent a stay. The court recognized that the agency was unprepared to issue a final rule on the intentional adulteration of food by the November 2013 deadline, “But…
Public Health England researchers have reported that the abnormal prion protein (PrP) linked to variant Creutzfeldt-Jakob Disease (vCJD) the human form of bovine spongiform encephalopathy (BSE)—is potentially more prevalent than previously thought, raising concerns about the cross-contamination risks associated with blood, blood products and surgical instruments. Noel Gill, et al., “Prevalent abnormal prion protein in human appendixes after bovine spongiform encephalopathy epizootic: large scale survey,” British Medical Journal, October 2013. After finding that 16 out of 32,411 appendix samples obtained between 2000 and 2012 tested positive for abnormal PrP, the study’s authors estimated an overall prevalence of 493 per million population, nearly double the 237 per million point estimate measured in an earlier survey of appendixes. “Unlike in clinical cases of variant CJD, no particular age group or geographic region was affected, and no susceptible genotype was identified,” according to a concurrent BMJ editorial. The researchers noted, however, the growing discrepancy…
A recent study has allegedly concluded that soft drink consumption “is significantly linked to overweight, obesity and diabetes worldwide, including in low- and middle-income countries.” Sanjay Basu, et al., “Relationship of Soft Drink Consumption to Global Overweight, Obesity, and Diabetes: A Cross-National Analysis of 75 Countries,” American Journal of Public Health, November 2013. Relying on soft drink industry data obtained from the EuroMonitor Passport Global Market Information Database, researchers analyzed soft drink sale records for 79 countries from 1997 to 2010 that included per capita annual purchases of both imported and domestically-produced carbonated soft drinks. They also examined age-standardized overweight prevalence data obtained from the World Health Organization’s Global Database on Body Mass Index, which reflects “the best available population-representative, survey-based estimates of the percentage of adults aged 20 years and older in each country who had a [BMI] of 25 kg/m2 of greater.” After assessing “global trends and variation…
Noting the difficulty of classifying products with probiotics, defined as live microorganisms that have a beneficial effect when consumed in sufficient quantities, due to their varied marketing as foods, dietary supplements, medical foods, foods for special dietary use, or drugs, University of Maryland professors in law, medicine and pharmacy suggest ways that the Food and Drug Administration (FDA) could regulate them. D.E. Hoffmann, et al., “Probiotics: Finding the Right Regulatory Balance,” Science, October 18, 2013. For example, probiotic products with drug claims “generally should be subject to the same rigorous requirements as other products making drug claims, including adequate and well-controlled investigations.” They also recommend an abbreviated approval format for “probiotic foods, dietary supplements, and dietary ingredients for which there is adequate evidence of safety in the target population; approved food additives; and substances generally recognized as safe (GRAS).” They further recommend that FDA “establish a monograph for probiotic foods…
A recent New York Times article focused on advances in synthetic biology has claimed that the exponential growth in genetically modified (GM) yeast applications “could revolutionize the production of some of the most sought-after flavors and fragrances,” including vanilla, saffron, patchouli, and stevia. According to the October 20, 2013, article, food, cosmetic and pharmaceutical companies seeking plant extract alternatives are increasingly turning to GM yeast and other micro-organisms “cultured in huge industrial vats” to synthesize vanillin, valencene, nootkatone, and other chemicals as byproducts of the fermentation process. Proponents of this technique have not only argued that the yeast-made flavorings are less expensive to manufacture than their plant-based counterparts, but that the end result is a natural ingredient because it originates in a living organism. “The need for natural is a key driver,” said Ahmet Baydar, director of research and development at International Flavors and Fragrances, which reportedly hopes that yeast-made…
Communications and health policy researchers report that while perceptions about government interventions to address childhood obesity are correlated with political ideology, certain approaches to—or framing of—the childhood obesity message can affect whether conservatives accept the seriousness of the problem and are willing to (i) endorse responsibility beyond the individual, and (ii) support policy action. Sarah Gollust, et al., “Framing the Consequences of Childhood Obesity to Increase Public Support for Obesity Prevention Policy,” Research & Practice, November 2013. Their findings were based on two Web-based public opinion surveys. The first involved testing perceptions as to a series of common messages about the consequences of childhood obesity. And from those viewed as the strongest, the researchers selected four to use in the second study to assess beliefs about responsibility for addressing childhood obesity and support for policies intended to curb its incidence, including a tax on sugar-sweetened beverages, physical activity requirements in schools,…
A California resident has filed a putative nationwide class action against Lifeway Foods, Inc., alleging that many of its kefir, lassi and frozen yogurt products are misbranded under federal law and the state’s Sherman Law because they list as ingredients “Evaporated Cane Juice” or “Organic Cane Juice,” terms that purportedly render the products illegal. Figy v. Lifeway Foods, Inc., No. 13-4828 (N.D. Cal., San Francisco Div., filed October 17, 2013). The plaintiff avers that he and the class purchased these illegal products at a premium price and have sustained economic damages under the unlawful business acts and practices law. According to the complaint, the “unlawful sale of an illegal product is the only element necessary for the UCL claim. No reliance is necessary.” The plaintiff requests restitution, injunctive relief, corrective action, attorney’s fees, costs, and interest.
New York and California residents have filed a putative nationwide class action against Hain Celestial Group, Inc., alleging that its fruit and vegetable juice products, labeled as “Unpasteurized” and “100% Raw” are false and misleading because the products undergo high pressure processing, “which neutralizes the benefits of the live enzymes, probiotics, vitamins, proteins, and nutrients that would otherwise be retained in a raw and unpasteurized juice.” Stark v. Hain Celestial Group, Inc., No. 13-7246 (S.D.N.Y., filed October 15, 2013). The plaintiffs claim that they purchased a variety of these juices—“Red Juice,” “Gold Juice,” “Green Juice,” “Yellow Juice,” and “White Juice”—at a price premium, relying on representations that the products were, as labeled, able to deliver the nutritional benefits associated with a raw-food diet. According to the plaintiffs, raw juice products have, at best, a 5-day shelf-life, while the defendants’ products have a 30-day shelf-life, which is possible only with processing…
According to a news source, Jack Daniel’s Properties, Inc. has filed a trademark infringement action against the companies that produce and sell Popcorn Sutton’s® Tennessee white whiskey. Jack Daniels Props., Inc. v. J&M Concepts, LLC, No. 13-1156 (M.D. Tenn., filed October 18, 2013). The whiskey is apparently named after an Appalachian moonshiner who killed himself rather than serve a federal sentence after he was convicted of offenses relating to moonshine production. The defendants purportedly sold their product first in mason jars, but then switched to bottles that allegedly copy Jack Daniel’s bottle—“a square-shaped bottle with angled shoulders that house a signature and beveled corners, and labeling with a white-on black color scheme, filigree designs, and font style reminiscent of that of the Jack Daniel’s trade dress,” the complaint said. Alleging willful trademark infringement, deceptive trade, fraudulent misrepresentation, and unfair competition, the company seeks injunctive relief, disgorgement of unjust profits and…
Jensen Farms has filed a lawsuit against the company that hired the food-safety auditor who gave the cantaloupe grower a “superior” rating during a 2011 audit not long before the grower shipped fruit allegedly contaminated with Listeria to a distributor that required the cantaloupe to be certified by the auditor, giving rise to a nationwide outbreak that killed 33 people and hospitalized many others. Jensen Farms v. Primus Group, Inc., No. ___ (Colo. Dist. Ct., filed October 15, 2013). The farm has since ceased operation, and the Jensen brothers have entered guilty pleas to charges of adulteration of food and aiding and abetting. According to the complaint, a Primus auditor indicated in 2010 that the cleaning technology used at the farm could potentially contaminate cantaloupe because it used re-circulating chlorinated water. The 2011 auditor, a different individual, was told about changes to the system made in response to the 2010 concerns,…
