A federal judge in California has reportedly dismissed a putative class action against the manufacturer of melatonin-laced brownies marketed as a relaxation and sleep aid. According to media sources, the plaintiff alleged that HBB LLC failed to disclose the potential effects of its Lazy Larry® or Lazy Cakes® baked goods, including “extreme fatigue, exhaustion and slurred speech.” The products have also come under fire from lawmakers and the Food and Drug Administration, which in August 2011 warned the company that the brownies were adulterated under federal law. Despite the ongoing debate over whether the brownies are conventional food or a dietary supplement, U.S. District Judge Manuel Real concluded that the product packaging adequately displayed its contents. “It is undisputed that the packaging on the product accurately disclosed the quantity of melatonin in each serving as well as the relevant serving size [and] that the product contained a disclaimer of the…
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A California resident has filed a pair of putative class actions in state court against companies that market their coconut water with purportedly exaggerated nutrient claims and overstated hydrating benefits or as a miracle cure for a host of medical problems. Shenkman v. All Mkt., Inc., No. BC 467166; Shenkman v. One World Enters. LLC, No. BC467165 (Cal. Super. Ct., Los Angeles Cty., filed August 8, 2011). Seeking to certify statewide consumer classes, the plaintiff alleges intentional and negligent misrepresentation, fraud, and violations of California’s False Advertising Act and Unfair Business Practices Act. The plaintiff requests compensatory and punitive damages, disgorgement, restitution, payment to a cy pres fund, a corrective advertising campaign, and an apology. Among other matters, the plaintiff claims that One World Enterprises sells “O.N.E. Coconut Water” throughout the United States in more than 18,000 retail outlets and promotes it “as a miracle product, curing various medical problems and…
A California consumer who alleged that he gained weight while using a diet drink has reportedly failed to demonstrate that he has standing to pursue putative class consumer-fraud claims against the manufacturer because he did not keep track of his caloric intake when he used the product. Fletcher v. Celsius Holdings, Inc., No. BC439055 (Cal. Super. Ct., decided August 10, 2011). Granting the manufacturer’s motion for summary judgment, the court apparently determined that, without the caloric intake data, it would be impossible for the plaintiff to prove that the product did not, as advertised, burn up to 100 calories when consumed. According to a news source, the plaintiff alleged that he used the product while training to become a firefighter from October 2009 to January 2010, and gained 10 pounds. He also alleged that he maintained a healthy diet and a rigorous exercise regimen during this period. The court suggested that…
The Food and Drug Administration (FDA) has warned the company that makes Lazy Larry® brownies containing melatonin that they are adulterated under federal law. According to FDA, “Your ‘Lazy Larry’ product is represented for use as a conventional food, and accordingly is not a dietary supplement.” The company apparently uses the term “dietary supplement” in the product’s “statement of identity” and a “Supplement Facts” panel for its nutrition labeling. FDA contends that these statements do “not make your product a dietary supplement,” because it is marketed alongside snack foods, its website refers to the product as a conventional food, and the appearance and packaging make the product look like a brownie. Noting that the agency “is not aware of data to establish the safety of melatonin for use as an ingredient in conventional foods” and that “reports in the scientific literature have raised safety concerns about the use of melatonin,” FDA…
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.
According to counsel for a company that makes dietary supplements containing selenium, the Food and Drug Administration (FDA) has agreed to allow the company to make qualified health claims for the products that include brief disclaimers. The company will apparently be able to label its products with claims that selenium “may reduce the risk” of prostate, colon, bladder, and thyroid cancers as long as it includes the following: “Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of these cancers.” The negotiations that led to the breakthrough reportedly followed a federal district court ruling in May that FDA violated First Amendment commercial speech standards by censoring specific qualified health claims for the company’s products and requiring the use of a lengthy contradictory qualification. The parties are apparently continuing to discuss disagreements over the effect of selenium on other…
The Federal Trade Commission (FTC) has taken action against companies that sell açai berry supplements, “colon cleansers” and other products online by featuring false Oprah Winfrey and Rachael Ray endorsements and illegally billing customer credit cards. According to an agency press release, a U.S. district court has temporarily ordered a halt to “an internet sales scheme that allegedly scammed consumers out of $30 million or more in 2009 alone through deceptive advertising and unfair billing practices.” The court order also imposes an asset freeze and appoints a temporary receiver over several companies “while the FTC moves forward with its case to stop the company’s bogus health claims and other deceptive and unfair conduct.” The companies purportedly made “free” trial offers for an açai berry supplement pitched as a rapid weight-loss product and a colon cleanser said to prevent cancer. The companies purportedly claimed that they would provide full refunds to…
“Energy bars and energy drinks are just the tip of this antioxidant-enhanced, vitamin-enriched, high-fiber iceberg,” writes Anneli Rufus in an August 3, 2010, AlterNet article examining health claims based on nutraceuticals such as “vitamins, minerals, amino acids, herbs, other botanicals, and that amorphous category known as dietary supplements.” According to Rufus, “nutraceuticals hark back to preindustrial folk remedies,” but are not yet proven to work in people. As Stephen DeFelice of the Foundation for Innovation in Medicine told her, the functional-foods industry “is all marketing, marketing, marketing without the clinical research to back it up.” Rufus goes on to trace the history and development behind “the nutraceutical boom,” noting that consumers are again seeking “good for you” foods after a century of focusing “entirely on flavor, speed and ease.” To meet this demand, functional-food companies must walk “a tricky linguo-legislative tightrope” in marketing their products, with restrictions placed on claims linking…
The Food and Drug Administration (FDA) has submitted to the Office of Management and Budget a proposed information collection related to food labeling regulations. According to FDA, these regulations govern the submission of food labeling petitions and require food producers to: (i) disclose specific information about themselves or their products on labeling; (ii) retain records establishing the basis for the information contained on labeling; and (iii) provide these records to regulatory officials. The information collection notice provides estimated annual reporting and recording keeping burdens for these regulations. FDA has noted that it is no longer combining these burden hour estimates with those in information collections titled, “Food Labeling: Nutritional Labeling of Dietary Supplements on a ‘Per Day’ Basis” and “Food Labeling: Trans Fatty Acids in Nutrition Labeling,” although “[s]uch consolidation may occur in the future.” The agency will accept comments until August 16, 2010. See Federal Register, July 15, 2010.
Consumers Union (CU) has issued the results of its investigation into protein drinks, concluding that many products are at best superfluous and at worst unsafe. Published in the July 2010 edition of Consumer Reports, the findings allegedly support the watchdog’s position that Food and Drug Administration (FDA) oversight under the Dietary Supplement Health and Education Act “is inadequate to ensure that protein drinks and other dietary supplements are consistently low in heavy metals and other contaminants.” CU apparently conducted outside laboratory tests on 15 protein powders and drinks purchased in the New York-metro area, in addition to reviewing government documents and interviewing health experts and consumers. According to CU, “All drinks in our tests had at least one sample containing one or more of the following contaminants: arsenic, cadmium, lead, and mercury.” In three cases, consumers who drank more than three servings per day purportedly risked exceeding the U.S. Pharmacopeia’s…
