Category Archives Issue 600

A study reevaluating “the traditional diet-heart hypothesis” concludes that replacing dietary saturated fat with vegetable oils lowers serum cholesterol but does not reduce the risk of death from coronary heart disease or other causes. Christopher Ramsden, et al., “Re-evaluation of the traditional diet-heart hypothesis: analysis of recovered data from Minnesota Coronary Experiment (1968-73),” BMJ, April 2016. Using previously unpublished data from the Minnesota Coronary Experiment (MCE)—“a double blind randomized controlled trial designed to test whether replacement of saturated fat with vegetable oil rich in linoleic acid reduces coronary heart disease and death by lowering serum cholesterol”—researchers examined data on diet, serum cholesterol and health outcomes for 9,423 women and men ages 20 to 97 years. Their results evidently showed that substituting saturated fat with linoleic acid showed no benefits for coronary atherosclerosis or myocardial infarcts, even though participants in the dietary intervention group exhibited a significant reduction in serum cholesterol…

Ganeden Biotech Inc. has filed a lawsuit against American Brewing Co., Inc. and its 2015 acquisition, B&R Liquid Adventure, alleging the companies infringe its patents on a particular strain of probiotic bacteria through the marketing and sale of their búcha® beverage. Ganeden Biotech, Inc. v. Am. Brewing Co., Inc., No. 16-0876 (N.D. Ohio, filed April 13, 2016). Ganeden asserts that it holds a patent on a specific GBI-30 strain of Bacillus coagulans as used in tea and another patent on the strain as used in all other products. B&R began selling búcha® in 2013 and lists the GBI-30 strain as an ingredient, according to the complaint. “Because Ganeden holds a patent on GBI-30 and is the legitimate source of GBI-30, Ganeden believes that Defendants’ products likely contained Bacillus coagulans (which Defendants could have obtained elsewhere) but not always the GBI-30 strain as labeled,” the biotech company argues. For allegations of patent infringement and unfair…

A consumer has filed a putative class action alleging Outernational Brands, Inc. mislabels its Vivaloe aloe-vera beverages as “All Natural” and preservative-free even though the products contain citric acid. Chen v. Outernational Brands, Inc., No. 16-1634 (E.D.N.Y., filed April 4, 2016). “The term ‘All Natural’ only applies to those products that contain no non-natural or synthetic ingredients and consist entirely of ingredients that are only minimally processed,” the complaint asserts. The plaintiff argues that the presence of citric acid, “which is not extracted from citric fruits but industrially synthesized via complex chemical synthetic routes and thus cannot be considered ‘minimally processed,’” precludes Outernational from labeling Vivaloe as “All Natural” or free of preservatives. The complaint admits the U.S. Food and Drug Administration has not defined “natural,” but argues “there is no reasonable definition of ‘All Natural’ that includes ingredients that, even if sourced from ‘nature,’ are subjected to extensive transformative…

A putative class action against Melitta USA Inc. alleges the company’s coffee product packaging fails to distinguish between “natural and/or artificial flavor” per federal regulations. Decerbo v. Melitta USA Inc., No. 16-0850 (M.D. Fla., filed April 11, 2016). The plaintiff argues that under U.S. Food and Drug Administration rules, food manufacturers must “accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food and its characterizing properties or ingredients,” including whether a characterizing flavor is natural or artificial. However, “‘Hazelnut Crème’ is not flavored with hazelnuts, there is no vanilla in ‘French Vanilla,’ and ‘Pumpkin Spice’ flavor contains neither nutmeg nor cinnamon, or pumpkin or any customary pumpkin spice either, as these Products’ labels would explicitly lead a consumer to conclude,” the complaint argues. The plaintiff further notes that other coffee-product manufacturers “have responsibly decided to correctly label their products,” purportedly giving the…

A California federal court has dismissed a lawsuit alleging that Diageo PLC misrepresents Red Stripe® beer as brewed in Jamaica, finding “no reasonable consumer would be misled into thinking that Red Stripe is made in Jamaica with Jamaican ingredients based on the wording of the packaging and labeling.” Dumas v. Diageo PLC, No. 15-1681 (S.D. Cal., order entered April 6, 2016). Details about the complaint appear in Issue  574 of this Update. Bottle trays for six and 12-packs of Red Stripe® include, as the court explained, “the language ‘Jamaican Style Lager and ‘The Taste of Jamaica,’” the Diageo-Guinness USA logo and a disclaimer on the bottom of the packaging that states, “Brewed and bottled by Red Stripe Beer Company Latrobe, PA.” Citing a Second Circuit opinion finding that the description of a knife as a “Swiss Army knife” does not imply it was made in Switzerland, the court found that the “mere…

The Salt Institute has penned an April 11, 2016, letter asking the U.S. Department of Agriculture (USDA) and Department of Health and Human Services (HHS) to withdraw the sodium provisions included in the 2015-2020 Dietary Guidelines for Americans, which advise individuals to consume less than 2,300 milligrams (mg) per day of sodium. According to the Salt Institute, these provisions—in addition to those that appear in the 2010 Dietary Guidelines for Americans—violate the statutory mandate that requires them to reflect “the preponderance of the scientific and medical knowledge which is current at the time the report is prepared.” In particular, the letter argues that both the 2010 and 2015 Dietary Guidelines Advisory Committees (DGACs) based their sodium recommendations on a 2004 Institute of Medicine (IOM) report that failed to contain enough evidence to set a recommended dietary allowance. “Rather than thoroughly assessing the current scientific and medical knowledge, the Agencies reached…

The U.S. Food and Drug Administration (FDA) has approved folic acid fortification of corn masa flour in response to a 2012 petition from the March of Dimes Foundation, National Council of La Raza and other groups. FDA’s action allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour. Used in tortillas, tamales and other foods, corn masa flour is a dietary staple for many people of Mexican and Central American descent, and the petitioners sought the voluntary fortification to increase the folic acid intake for U.S. women of childbearing age who regularly consume such products. Folic acid is a synthetic form of folate, a B vitamin linked to the decreased incidence of neural tube defects. See Federal Register, April 15, 2016.

The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) has proposed amendments to organic livestock and poultry production requirements to clarify “how producers and handlers must treat their livestock and poultry to ensure their health and well-being throughout life.” Based on recommendations from the National Organic Standards Board, the draft rules also specify “which physical alterations are allowed and prohibited” and establish “minimum indoor and outdoor space requirements for poultry.” In particular, the proposed amendments provide for “a feed ration sufficient to meet nutritional requirements, including vitamins, minerals, protein and/or amino acids, fatty acids, energy sources, and fiber (ruminants), resulting in appropriate body condition.” They also limit physical alterations to those performed only at “a reasonably young age, with minimal stress and pain and by a competent person,” and only in cases determined to “benefit the welfare or hygiene of the animals, or for identification purposes or safety.” In…

“The U.S. Supreme Court recently deviated from its historically stringent view on class certification and affirmed an Eighth Circuit decision to uphold certification of a class of Tyson Foods, Inc. employees who brought suit against Tyson for a violation of the Fair Labor Standards Act of 1938 (FLSA),” Shook Miami attorneys Frank Cruz-Alvarez and Rachel Canfield explain in an April 13, 2016, analysis for the Washington Legal Foundation’s Legal Pulse. The article first describes the suit’s origins; Tyson initially paid all employees for an equal amount of time spent donning and doffing protective gear but later adjusted the policy to pay some employees for additional “don and doff” time. Cruz-Alvarez and Canfield note that “Plaintiffs alleged Tyson’s failure to compensate them for time spent performing this ‘integral and indispensable’ work activity violated the FLSA by lengthening their workweek beyond forty hours without providing them with overtime pay.” They also note…

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