The University of San Francisco Law Review has published a student comment titled “Snake Oil in Your Pomegranate Juice: Food Health Claims and the FTC,” that examines existing statutes and regulatory authorities enabling the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) to regulate the burgeoning “functional food” market. 47 U.S.F.L. Rev. 783. The author focuses on litigation involving health claims made by the manufacturers of POM Wonderful® pomegranate juice products, noting that the industry has been watching it closely to learn what standards will be applied to the science supporting health-related claims thus allowing companies to make such claims. According to the author, the case illustrates why the current regulatory framework is inadequate. She concludes, “If case-by-case litigation continues to define the parameters of permissible claims, consumers will continue to be misled, and all brands will pay the price.”
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A federal court in California has issued an order granting the motion for preliminary approval of a class settlement in five lawsuits alleging that Naked Juice Co. misrepresented its beverages as “All Natural” and “Non-GMO.” Pappas v. Naked Juice Co. of Glendora, Inc., No. 11 8276 (C.D. Cal., order entered August 7, 2013). According to the court, the proposed settlement was reached after the defendant’s motion to dismiss was granted in part, extensive and contentious discovery was undertaken, and four mediation sessions occurred under the guidance of an experienced retired judge. Under the terms of the settlement, the company will pay $9 million into a settlement fund that will be used to make cash payments to class members and pay the costs of notice and settlement administration, attorney’s fees—not to exceed $3.1 million—and expenses, and incentive awards $2,500 each for four of the five named plaintiffs. Class members with purchase receipts…
A California court has tentatively determined, following a 10-day bench trial, that the levels of lead in canned or packaged fruit, vegetable and grape drink products, or baby foods, are below the regulatory “safe harbor” exposure level under Proposition 65 (Prop. 65) and therefore that the companies which make them are not required to provide Prop. 65 warnings to consumers. Envtl. Law Found. v. Beech-Nut Corp., No. RG11 597384 (Cal. Super. Ct., Alameda Cty., tentative decision entered July 15, 2013). Because few Prop. 65 cases go to trial, the court was faced with a number of questions of first impression, primary among them application of the “naturally occurring” defense. The parties did not dispute the presence of lead in the products or that it has been identified as a known carcinogen and reproductive toxin under Prop. 65. Beech-Nut Corp., the original defendant, was joined at trial by a number of other…
Naked Juice Co. has agreed to settle putative class claims that it falsely advertised some of its juice and smoothie products as “all natural” and not genetically modified (GMO); while denying the allegations, the company will establish a $9 million settlement fund. Pappas v. Naked Juice Co. of Glendora, Inc., No. 11-8276 (C.D. Cal., motion for preliminary approval filed July 2, 2013). Members of the putative nationwide class will each be eligible under the proposed agreement to recover a maximum of $45 dollars. The agreement will also require Naked Juice to establish a product verification program, hire or assign a quality control manager to oversee the independent testing process for the company’s product line, establish a database to allow the electronic tracking and verification of product ingredients, and modify future labeling, advertising and marketing to cease using “All Natural” and related statements.
A California resident has filed consumer fraud claims on behalf of a putative statewide class against a company that makes fruit juices with “No Sugar Added” statements on the product labels and without a statement that the juice is not a “low calorie” or “calorie reduced” product allegedly in violation of federal regulatory requirements. Cuzakis v. Hansen Beverage Co., No. BC513620 (Cal. Super. Ct., Los Angeles Cty., filed June 27, 2013). According to the complaint, the juices are made from fruit juice concentrate and thus cannot be labeled “No Sugar Added,” and with 120 calories per reference serving greater than 30 grams (“about as much as a conventional soft drink”) must include a disclosure that they are not “low calorie.” While the plaintiff alleges that he is a diabetic and must purchase products low in sugar, he does not seek damages for personal injury; rather, he claims he would not…
The Food and Drug Administration (FDA) has proposed “an ‘action level’ of 10 parts per billion (ppb) for inorganic arsenic in apple juice,” the same level established by the U.S. Environmental Protection Agency for drinking water. According to a July 12, 2013, press release, FDA set this threshold based on its latest analysis of organic and inorganic arsenic in apple juice as part of its draft guidance to industry. “The FDA is committed to ensuring the safety of the American food supply and to doing what is necessary to protect public health,” said FDA Commissioner Margaret Hamburg. “We have been studying this issue comprehensively, and based on the agency’s data and analytical work, the FDA is confident in the overall safety of apple juice for children and adults.” The agency will accept comments on the proposed action level and draft guidance for 60 days after publication in the Federal Register.…
A federal court in California has denied the class certification motion filed by a woman who sought to represent anyone in the state who had purchased products in entire beverage lines produced by the defendant, because she had purchased just five specific products and thus her labeling and misbranding claims were not typical of those of the putative class. Major v. Ocean Spray Cranberries, Inc., No. 12-3067 (N.D. Cal., decided June 10, 2013). The amended complaint alleged that the company’s juice and drink products were unlawfully labeled “No Sugar Added” or had improper nutrient claims or false representations that the products were “free from artificial colors, flavors or preservatives.” While the plaintiff had purchased five beverages, including a Diet Sparkling Pomegranate Blueberry drink, she sought to certify a class of purchasers of entire product lines, such as 100% juice and Sparkling. According to the court, the plaintiff “has not met her…
U.S. Reps. Rosa DeLauro (D-Conn.) and Frank Pallone Jr. (D-N.J.), have written a letter to the Office of Management and Budget asking for the release of the Food and Drug Administration’s (FDA’s) voluntary industry guidelines for levels of arsenic in fruit juices currently under review by the Office of Information and Regulatory Affairs. Citing studies that have found “concerning” levels of arsenic in food and beverages, DeLauro and Pallone assert that FDA’s guidance document will be “instrumental” to industry members and consumers in their efforts to address “this public health issue.” It is “inexcusable that the guidelines are stalled while consumers continue to be exposed to potentially dangerous levels of arsenic,” the letter states. “Inorganic arsenic is a known carcinogen that can increase the risk of bladder, lung and skin cancers, [which is] particularly concerning because children consume large quantities of juice and may be at risk for more harmful…
POM Wonderful LLC has filed a petition seeking review in the D.C. Circuit Court of Appeals of a Federal Trade Commission (FTC) order requiring two randomized, controlled clinical trials before the company can make a claim that its pomegranate juice products treat, prevent or reduce the risk of heart disease, prostate cancer or erectile dysfunction. POM Wonderful LLC v. FTC, No. 13-1060 (D.C. Cir., filed March 8, 2013). In its January ruling, FTC found that the company made false and misleading claims by advertising its products with health-benefit assertions that POM contended were backed by medical research. Additional information about the FTC rulings in the case appears in issues 441 and 467 of this Update.
The Federal Trade Commission (FTC) has issued a final decision in a complaint alleging that POM Wonderful made false and misleading claims by advertising its pomegranate juice products with health-benefit assertions that the company contended were backed by medical research. In re POM Wonderful LLC, No. 9344 (FTC, decided January 10, 2013). Additional information about the matter appears in Issue 441 of this Update. Henceforth, two randomized, controlled clinical trials (RCTs) will be required before POM can make a claim that any of its products treat, prevent or reduce the risk of heart disease, prostate cancer or erectile dysfunction (ED). Any efficacy or health benefit claims falling short of disease claims will require substantiation consisting of “competent and reliable scientific evidence . . . that must be sufficient in quality and quantity when considered in the light of the entire body of relevant and reliable scientific evidence, to substantiate that the…
