A California federal court has refused to dismiss a lawsuit alleging that Danone US Inc. creates "a misleading impression regarding the health-promoting benefits" of its Silk Coconutmilk because it markets the product with an accurate representation of the product as free of cholesterol. Marshall v. Danone US, Inc., No. 19-1332 (N.D. Cal., entered September 13, 2019). Danone argued that the cholesterol representation was made in close proximity to the nutrition panel showing that the product contained three grams of saturated fat, but the court noted that the total is one gram more than permitted under federal regulations on the use of "cholesterol-free." "Danone is missing the point," the court held. It noted that the U.S. Food and Drug Administration (FDA) "has expertise in, and responsibility for, determining what food labeling practices may mislead consumers" and that the agency "believes that consumers may understand 'cholesterol-free' to convey certain health benefits that…
Tag Archives cholesterol
Aaron Carroll, a professor at the Indiana University School of Medicine, argues in a New York Times editorial that “panic-du-jour” about unhealthy foods encourages people to unnecessarily live “in terror or struggling to avoid certain foods altogether." Carroll asserts that the repeated condemnation of various food ingredients—including fat, cholesterol, meat, monosodium glutamate, genetically modified organisms and gluten—“shows how susceptible we are to misinterpreting scientific research and how slow we are to update our thinking when better research becomes available.” For example, fewer than one percent of Americans have a wheat allergy or celiac disease, Carroll states, but at least one in five regularly chooses gluten-free foods. “Gluten-free diets can lead to deficiencies in nutrients such as vitamin B, folate and iron. Compared with regular bagels, gluten-free ones can have a quarter more calories, two and a half times the fat, half the fiber and twice the sugar. They also cost more,” he…
University of Copenhagen researchers have apparently found that extremely high levels of “good” cholesterol, or high-density lipoprotein (HDL), may be associated with premature death rates. Christian M. Madsen, et al., “Extreme high high-density lipoprotein cholesterol is paradoxically associated with high mortality in men and women: two prospective cohort studies,” European Heart Journal, August 21, 2017. The medical community has generally accepted that higher levels of HDL may protect against cardiovascular disease and that “bad” cholesterol, or low-density lipoprotein (LDL), contributes to atherosclerosis, leading to increased risk of heart disease and stroke. The study followed more than 116,000 people for an average of six years and found that men with extremely high levels of HDL had a 106 percent higher chance of dying prematurely than men with normal levels, while women with high levels had a 68 percent higher chance of premature death. Extremely high levels were defined as ≥3.0 millimoles…
The American Heart Association (AHA) has issued an advisory concluding that replacing saturated fats with unsaturated fats will lower the incidence of cardiovascular disease (CVD), especially if combined with an “overall healthful dietary pattern." Frank M. Sacks, et al, "Dietary Fats and Cardiovascular Disease: A Presidential Advisory From the American Heart Association," Circulation, June 15, 2017. AHA reviewed multiple studies on the effects of dietary saturated fat intake and its replacement with other types of fats, as well as replacement with carbohydrates, and concluded that replacing saturated fat with polyunsaturated vegetable fat and changing dietary patterns reduces the risk of CVD by as much as 30 percent. Key recommendations of the review include lowering intake of saturated fat, increasing intake of polyunsaturated fat and avoiding coconut oil, which more than 70 percent of Americans regard as “healthy,” despite that it actually increases LDL cholesterol. Issue 640
A consumer has filed a putative class action against Dole Packaged Foods, LLC alleging the company’s products contain too much added sugar to be labeled as “rich in nutrients” or “healthy.” Amaya v. Dole Packaged Foods, LLC, No. 15-7734 (C.D. Cal., filed October 18, 2016). The complaint first details research connecting added sugar intake to detrimental health effects, including type 2 diabetes, cardiovascular disease and metabolic syndrome, then asserts that Dole’s products containing added sugar are misleadingly labeled. “Dole’s representations that Dole Fruit & Oatmeal contains ‘real fruit!’ and ‘No Trans Fat or Cholesterol,’ and is ‘a healthy . . . Breakfast’ are false, or even if literally true at least highly misleading, in light of the substantial added sugar in the Dole Fruit & Oatmeal products,” the plaintiff argues. The complaint also alleges the labeling claims are unlawful because (i) a statement indicating that the product is free of…
A California federal court has dismissed a lawsuit alleging the U.S. Department of Agriculture (USDA) and Department of Health and Human Services (HHS) allowed the American Egg Board to unduly influence the government’s nutrition advice on dietary cholesterol. Physicians Comm. for Responsible Med. v. Vilsack, No. 16-0069 (N.D. Cal., San Francisco Div., order entered October 12, 2016). Physicians Committee for Responsible Medicine (PCRM) filed the lawsuit following a change to the 2015 Dietary Guidelines that removed the recommended limit of 300 milligrams per day of dietary cholesterol; instead, the guidelines recommended consuming “as little dietary cholesterol as possible while consuming a healthy eating pattern.” PCRM alleged that the advisory body’s analysis and recommendations were compromised by the presence of scientists who had received funding from the American Egg Board or Egg Nutrition Center. The court assessed whether it had subject matter jurisdiction to consider PCRM’s claim by examining the underlying statutes…
The U.S. Food and Drug Administration (FDA) has opened a docket and released industry guidance on the use of the term “healthy” in the labeling of human food products. Responding to Kind LLC’s citizen petition asking the agency to align its nutrient content claim regulations with federal dietary guidance, FDA invites “public comment on the term ‘healthy’, generally, and as a nutrient content claim in the context of food labeling.” Current regulations reportedly establish “the parameters for use of the implied nutrient content claim ‘healthy’ or related terms… on the label or in labeling of a food to suggest that a food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations, if the food meets certain nutrient conditions, and the claim is made with an explicit or implicit claim or statement about a nutrient.” Among other things, the conditions take into…
Researchers with the University of California, San Francisco, including its Center for Tobacco Control Research and Education, published a September 12, 2016, JAMA article claiming that studies funded by the Sugar Research Foundation (SRF) “singled out fat and cholesterol as the dietary causes of CHD [coronary heart disease] and downplayed evidence that sucrose consumption was also a risk factor.” Titled “Sugar Industry and Coronary Heart Disease Research: A Historical Analysis of Internal Industry Documents,” the special communication analyzes correspondence, internal documents, historical reports, and other statements obtained from SRF and its scientific advisors. The article authors allege that SRF initiated its own CHD research in 1962, after preliminary studies suggested that a low-fat diet high in sugar raises serum cholesterol levels. To this end, the SRF purportedly funded a New England Journal of Medicine (NEJM) literature review “arguing that epidemiologic, animal, and mechanistic studies associating sucrose with CHD were limited, implying…
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…
The nonprofit advocacy group Physicians Committee for Responsible Medicine (PCRM) has brought suit in the U.S. District Court for the Northern District of California seeking to prevent the U.S. Departments of Agriculture (USDA) and Health and Human Services (HHS) from adopting a recommendation of the 2015 Dietary Guidelines Advisory Committee (DGAC). The DGAC is a joint committee formed by USDA and HHS that recommended the agencies drop from the newly issued 2015-2020 Dietary Guidelines for Americans the advice that healthy individuals limit their daily dietary cholesterol consumption to 300 milligrams per day. PCRM seeks to permanently enjoin the agencies from incorporating the recommendation into the guidelines and to instead maintain current recommended daily limits. The complaint alleges the data underlying the DGAC’s recommendation is not “fairly balanced” within the meaning of the Federal Advisory Committee Act because it omits evidence unfavorable to the egg industry. Rather, PCRM contends that the DGAC…
12
