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New York and New Jersey residents have filed a putative class action in an Illinois federal court against the company that makes a line of kefir dairy products, alleging that they are falsely promoted as providing “clinically proven therapeutic benefits for various health conditions.” Keatley v. Lifeway Foods, Inc., No. 12-3521 (N.D. Ill., filed May 8, 2012). According to the complaint, Lifeway claims, without adequate proof, that its kefir products containing ProBoost, “an exclusive blend of live and active probiotic cultures,” can support immunity, enhance digestion, boost well-being, alleviate diarrhea, and otherwise address autoimmune disorders, bad breath, celiac disease, Crohn’s and colitis, high cholesterol, immune deficiency, infantile colic, irritable bowel syndrome, lactose intolerance, seasonal allergies, and yeast infections. The plaintiffs contend that they would not have purchased the products if they had known that ProBoost products “did not have the quality, health benefits or value as promised.” Seeking to certify a…

The U.S. Government Accountability Office (GAO) has issued a March 2012 report urging the U.S. Department of Agriculture (USDA) to adopt several measures to reduce Shiga toxin-producing Escherichia coli (STEC) in cattle before they are slaughtered. According to GAO, USDA currently recognizes bacteriophages, probiotics, vaccines, and sodium chlorate as preslaughter interventions able to control STEC, but has received few applications for commercial products that use these methods. The report notes that even in the case of STEC vaccines, USDA’s requirements for approval are “unclear” and do not address “some of the unique challenges faced by manufacturers of animal health products.” GAO found that, unlike the Canadian Centre for Veterinary Biologics, USDA fails to specify when it requires laboratory or field demonstrations of vaccine efficacy, resulting in delayed application approval. There is also apparently a lack of available products designed to test for six STEC strains—other than STEC O157:H7—that are now considered…

A federal court in California has denied a motion for summary judgment filed by the company that makes YoPlus® probiotic yogurt and certified a class of consumers alleging that it misled them in its product marketing. Johnson v. General Mills, Inc., No. 10-00061 (C.D. Cal., summary judgment denied March 3, 2011; class certification granted March 7). The court disagreed with the company’s attempt to characterize its product statements as “either true or . . . untestable and subjective statements of opinion” or “mere puffing.” According to the court, General Mills sought to “isolate each particular statement or image and divorce it from its full context.” Rather, the court determined that “properly considered in context, General Mills successfully communicated a ‘common message that eating Yo-Plus aids in the promotion of digestive health in ways that eating normal yogurt does not.’” The court reportedly granted class certification from the bench. See Law360, March…

The European Food Safety Authority’s (EFSA’s) Panel on Dietetic Products, Nutrition and Allergies has rejected an article 13.5 application submitted by Piimandusühistu E-Piim, the manufacturer of a probiotic cheese, claiming that its product “helps to maintain the cardio-vascular system/heart health through reduction of blood pressure.” The applicant evidently submitted 38 publications and four proprietary reports related to the maintenance of normal blood pressure and the Lactobacillus plantarum TENSIA™ bacteria found in its “semi-hard Edam-type” Harmony™ “heart cheese.” EFSA ruled, however, that “none of these publications addressed the effects of L. plantarum,” while three of the four unpublished proprietary reports were uncontrolled and therefore inadmissible. The fourth study, according to EFSA, “was a randomised, double-blind, placebo-controlled, cross-over human intervention,” but ultimately failed “to show an effect of L. plantarum TENSIA™ on blood pressure.” The panel therefore concluded that “a cause and effect relationship has not been established between the consumption of Lactobacillus plantarum…

The Federal Trade Commission (FTC) has announced that final approval was given to a settlement reached with a Nestlé S.A. subsidiary over claims that its children’s drink, BOOST Kid Essentials®, conferred specific health benefits, such as reducing the risk of colds and flu and reducing the duration of acute diarrhea. More information about the settlement appears in Issue 356 of this Update. And the summary of a related lawsuit that the National Consumers League filed against the company can be found in Issue 360 of this Update. The FTC said that this case was the agency’s “first one challenging advertising for probiotics.” See FTC News Release, January 18, 2011.

The same day that the Federal Trade Commission announced a settlement over alleged deceptive advertising claims for DanActive® beverage and Activia® yogurt, Ohio’s attorney general filed a lawsuit alleging that The Dannon Co. has violated the state’s Consumer Sales Practices Act (CSPA) by failing to substantiate the health-related claims it makes for the products. Ohio v. Dannon Co., Inc., No. 10-12-18225 (Ct. Com. Pl., Franklin Cty., filed December 15, 2010). The complaint takes issue with marketing claims that the products either promote digestive health or boost immunity. Under the authority of the CSPA, Attorney General Richard Cordray (D) brings the action “in the public interest” and seeks declaratory and injunctive relief, liability for “the reasonable costs and expenses of the investigation and prosecution of the Defendant’s actions, including attorneys’ fees,” as well as $25,000 “for each unfair or deceptive act or practice alleged herein.” According to the complaint, Activia® has…

The Federal Trade Commission has announced the settlement of allegations that The Dannon Co. exaggerated the health benefits of its Activia® yogurt and DanActive® dairy beverage. Under the terms of the settlement, Dannon does not admit any law violations, but agrees to stop promoting its yogurt as a product that relieves temporary irregularity or its dairy beverage as a product that reduces the likelihood of getting a cold or the flu, unless certain conditions are met. These include that the immunity claims are specifically permitted by the Food and Drug Administration and the irregularity claims are substantiated by competent and reliable scientific evidence. The company also agreed to pay $21 million to the 39 states whose attorneys general were also investigating its advertising claims. According to a news source, Dannon has indicated that it will in the future clarify that Activia’s benefits require three servings of the product daily. The…

In its ongoing review of food product health claims, the European Food Safety Authority (EFSA) has adopted 75 new opinions addressing 808 claims. EFSA’s independent scientists opined that claimed functional-food effects, such as improves the “immune system” or “immune function,” “supports immune defences,” “reduces inflammation,” or “decreases potentially pathogenic gastro-intestinal microorganisms,” were either insufficiently defined or unsupported by scientific data. The authority also turned aside claims that the probiotic bacteria in a specific brand of yogurt maintain immune defenses against the common cold. According to a news source, the scientific studies that yogurt-maker Yakult submitted to justify such claims were inadequate. Some suggest that this week’s rulings by EFSA have seriously compromised industry efforts to promote functional foods, in which companies have made significant investment. Industry is reportedly challenging the determinations, complaining that the authority is applying excessively rigorous standards, and has asked for meetings to discuss the criteria used.…

For the second time in less than a month, Heartland Sweeteners has apparently been told by an advertising industry self-regulatory body that the company should not promote its Nevella with Probiotics® artificial sweetener with immune system and digestive health claims unless it can support them with “competent and reliable evidence.” Information about action taken against the company in August 2010 by the appellate arm of the National Advertising Division (NAD) of the Council of Better Business Bureaus appears in Issue 362 of this Update. NAD apparently took its latest action in response to a challenge filed by Heartland rival McNeil Nutritionals, LLC, which makes Splenda®. Among Heartland’s claims were that its product “Provides digestive and immune system health benefits in every packet,” “Promotes digestive health” and “Supports a healthy immune system.” According to NAD, the company based its claims on studies about the benefits of individual ingredients. “[W]hen the substantiation…

The Federal Trade Commission (FTC) has announced a settlement with Nestlé HealthCare Nutrition, Inc., which the agency contends has deceptively marketed a children’s drink, BOOST Kid Essentials®, as a product clinically shown to reduce illness in children by strengthening the immune system and helping them recover more quickly from diarrhea. The beverage, intended for children ages 1 to 13, contains probiotics embedded in a straw that was “prominently featured in ads for the product.” According to the FTC, the company has agreed to stop making health-related claims about cold or flu viruses “unless the claim is approved by the Food and Drug Administration.” The company has also agreed to cease making claims about diarrhea and reduced absences from day care or school “unless the representation is non-misleading and, at the time of making such representation, the [company] possesses and relies upon competent and reliable scientific evidence that substantiates that the…

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