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A California federal court has denied Boulder Brands, Inc.’s motion to dismiss a lawsuit alleging that the company misrepresents the cholesterol-blocking effect of the plant sterols in its Smart Balance® butter products because the amount of plant sterols is “not enough to generate a ‘clinically meaningful cholesterol blocking effect.’” Mitchell v. Boulder  Brands, Inc., No. 12-1862 (S.D. Cal., order entered April 16, 2015). The court declined to reconsider its earlier decision that “the products’ labels could plausibly be read as implying a ‘clinically meaningful cholesterol blocking benefit’ and that this implied representation is ‘specific, measurable, and falsifiable.’” The expert report upon which the court has based its decision stated that a minimum of 800 milligrams of plant sterols—eight times the content in one serving of the Smart Balance® product—would be the minimum to meaningfully block cholesterol.   Issue 563

A federal court in California has denied the defendant’s motion to dismiss a putative class action alleging that the company misleads consumers by claiming that its Smart Balance® butter products contain plant sterols that can block the absorption of cholesterol; according to the plaintiff, a single serving of the product contains insufficient sterols to achieve the stated benefit. Aguilar v. Boulder Brands, Inc., No. 12-1862 (S.D. Cal., order entered June 10, 2013). Among other matters, the court determined that the named plaintiff had standing to assert claims involving two products that she did not purchase, because the products “advertise the same health benefits arising from the same additional ingredients found on the label in the same position” as the product she did purchase. According to the court, her ability to represent class members allegedly injured by similar products must be analyzed under Rule 23 and not on a motion to…

A recent meta-analysis has reportedly concluded that, contrary to previous assumptions, “higher consumption of eggs (up to one egg per day) is not associated with an increased risk of coronary heart disease [CHD] or stroke.” Ying Rong, et al., “Egg consumption and risk of coronary heart disease and stroke: dose-response meta-analysis of prospective cohort studies,” British Medical Journal, January 2013. To investigate “the potential dose-response association between egg consumption and risk of [CHD] and stroke,” researchers analyzed eight articles with 17 reports totaling 3,081,269 person years and 5,847 incident cases for CHD and 4,148,095 person years and 7,579 incident cases for stroke. The results evidently failed to show any significant association between consuming up to one egg per day and the risk of developing CHD or stroke, although in diabetics “higher egg consumption was associated with a significantly elevated risk of [CHD].” To explain these findings, the study’s authors not…

A California resident has filed a putative class action against Smart Balance, Inc., alleging that the 100 mg of plant sterols in a single serving of the company’s spreadable butter products do not, as advertised, block the absorption of dietary cholesterol. Aguilar v. Smart Balance, Inc., No. 12-1862 (S.D. Cal., filed July 27, 2012). The named plaintiff seeks to represent either a multistate class of consumers or a California class. According to the complaint, studies show that, to reduce cholesterol, “a minimum of 0.8 grams, and preferably 2 grams, of plant sterols must be consumed daily.” Given the purportedly modest amount of sterols in the defendants’ products, the plaintiff claims that half a container would need to be consumed in one day “to realize even the minimum amount of cholesterol reduction benefit.” The plaintiff claims that she purchased the product relying on the cholesterol benefit representations and did not get…

A recent study has reportedly questioned the role of HDL cholesterol in lowering heart disease risk, suggesting instead that one specific protein or compound in so-called “good” cholesterol might be better than others at removing bad cholesterol. Amit Khera, et al., “Cholesterol Efflux Capacity, High-Density Lipoprotein Function, and Atherosclerosis,” New England Journal of Medicine, January 13, 2011. According to the study abstract, researchers measured cholesterol efflux capacity—or how well HDL extracted cholesterol from cells—in “203 healthy volunteers who underwent assessment of carotid artery intima–media thickness, 442 patients with angiographically confirmed coronary artery disease, and 351 patients without such angiographically confirmed disease.” The results evidently showed that overall HDL levels were “a less effective” predictor of heart disease than HDL’s ability to remove cholesterol. As one study author noted, these findings could help researchers identify “a particular protein that’s a major determinant” of cholesterol efflux capacity, thus allowing them to test for poor…

A recent study purportedly ties compounds in nonstick cookware and waterproof fabrics to higher cholesterol levels in children. Stephanie Frisbee, et al., “Perfluorooctanoic Acid, Perfluorooctanesulfonate, and Serum Lipids in Children and Adolescents,” Archives of Pediatrics & Adolescent Medicine, September 2010. Researchers from West Virginia University evaluated 12,476 children and teens in the mid-Ohio River Valley to determine possible connections between their cholesterol levels and the compounds perfluorooctanoic acid (PFOA) and perfluorooctanesulfonate (PFOS). According to the abstract, researchers determined that the compounds were “significantly associated” with increased total cholesterol and low-density lipoprotein (LDL). Results also apparently indicated that the children with the highest levels of PFOA had total cholesterol levels 4.6 points higher and LDL levels 3.8 points higher than those with the lowest levels. See Reuters, September 6, 2010.

Finding the plaintiffs’ state-law claims preempted, a federal court in California has dismissed a putative class action alleging that the Kroger Co. falsely labeled its margarine and graham crackers as “0g Trans Fat per serving” and “a Cholesterol Free Food,” when they actually contain various hydrogenated oils. Red v. The Kroger Co., No. 10-01025 (C.D. Cal., decided September 2, 2010). According to the court, the Food and Drug Administration has promulgated specific regulations on the use of these terms, and because the products at issue comply with the requirements under which the terms can be used, the plaintiffs’ claims are expressly preempted under the National Labeling and Education Act of 1990. In the court’s words, “Plaintiffs cannot escape the fact that they seek to enjoin exactly what federal law expressly permits.” Alleging the violation of California consumer protection statues, the plaintiffs had sought an order compelling the defendant to (i) cease…

A federal court in California has denied in part and granted in part the motion to dismiss filed by Smart Balance, Inc., which is defending a putative class action alleging that the company misled consumers by marketing its Nucoa margarine as cholesterol-free and healthy despite the artificial trans fat in the product. Yumul v. Smart Balance, Inc., No. 10-00927 (C.D. Cal., order entered July 30, 2010). The plaintiff alleges violations of the state’s unfair competition and false advertising laws and violation of the Consumer Legal Remedies Act. She seeks an injunction requiring that the misleading advertising practices cease, a corrective advertising campaign, restitution, and an injunction requiring the destruction of all misleading and deceptive materials and products. The defendant asserted that the factual allegations lacked sufficient specificity and also contended that the complaint be dismissed because it was based on conduct outside the applicable limitations period. Declining to consider some materials submitted…

A federal court in the District of Columbia has remanded to the D.C. Superior Court a lawsuit brought by the National Consumers League (NCL) against General Mills alleging that the company falsely misrepresents that Cheerios® “has drug-quality properties that would reduce total and ‘bad’ cholesterol levels when eaten.” Nat’l Consumers League v. General Mills, Inc., No. 09-01881 (D.D.C., decided January 15, 2010). The cereal maker removed the case to federal court claiming that it was removable either as a class action under the Class Action Fairness Act (CAFA) or under the court’s diversity jurisdiction. The NCL disclaimed Article III standing because it did not sustain any injury in fact, but was instead bringing the suit under the “private attorney general” provision of the D.C. Consumer Protection Procedures Act. This provision allows a person to bring an action on behalf of the general public to seek relief “from the use by…

The Food and Drug Administration has issued a warning letter to General Mills, Inc., alleging that labeling for the company’s Cheerios® Toasted Whole Grain Oat cereal contains “serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR).” FDA has specifically alleged that this Cheerios product “is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation and treatment of disease.” The warning letter singles out claims suggesting that Cheerios can “lower your cholesterol 4 percent in 6 weeks” and “reduce bad cholesterol by an average of 4 percent,” as well as a claim that “Cheerios is.. clinically proven to lower cholesterol. A clinical study showed that eating 1½ cups servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet…

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