Since the federal government filed a 76-count indictment against the owner and managers of Peanut Corp. of America, the source of a nationwide Salmonella outbreak in 2009, the defendants have entered not guilty pleas and been released on bonds ranging from $25,000 to $100,000. United States v. Parnell, No. 13-12 (M.D. Ga., Albany Div., filed February 15, 2013). Additional details about the charges appear in Issue 472 of this Update. The court has also entered orders designating the case as complex and excluding time under the Speedy Trial Act, as well as setting a scheduling conference for April 22, 2013.

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.

Beekeepers, environmentalists and advocacy organizations have filed an action for declaratory and injunctive relief against the U.S. Environmental Protection Agency (EPA), claiming that the agency has failed to take any regulatory action on pesticide products containing the active ingredients clothianidin and thiamethoxam in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Endangered Species Act (ESA) and Administrative Procedure Act. Ellis v. EPA, No. 13-1266 (N.D. Cal., filed March 21, 2013). According to the complaint, “In a vast and extremely risky experiment, EPA has allowed over two million pounds of clothianidin and thiamethoxam to be used annually on more than 100 million acres and on dozens of different plant corps without adhering to existing procedural frameworks and with no adequate risk assessments in place.” The plaintiffs allege that this inaction has “been a major factor in excessive honey bee mortality and the decline of pollinator populations in the same…

A federal court in California has dismissed as preempted putative class claims filed against Target Corp. and Honeytree, Inc., alleging that they retail and manufacture honey products falsely advertised as “honey” or “pure honey” despite the absence of all pollen, an allegedly “defining characteristic of honey under applicable law.” Cardona v. Target Corp., No. 12-1148 (C.D. Cal., decided March 20, 2013). The court rejected the defendants’ challenge to the plaintiff’s standing, finding that she had sufficiently alleged an injury under Kwikset Corp. v. Superior Court, 51 Cal. 4th 310 (2011). But the court determined that the claims were preempted under the Nutrition Labeling and Education Act, agreeing with the defendants that the plaintiff “cannot plausibly allege that ‘pollen’ is a ‘characterizing ingredient’ of ‘honey,’ and that the ‘common and usual name’ of honey is honey, irrespective of pollen content.” According to the court, “the requirement that pollen-less honey be labeled as…

The Legislature of Suffolk County, New York, has adopted new measures (1920-2012, 1085-2013 and 1086-2013) designed to curtail the marketing of energy drinks to minors within county limits. Introduced by William Spencer (D-Centerport), the three new laws will (i) prohibit companies from providing free energy drink samples and coupons to individuals younger than age 18; (ii) ban the sale and distribution of these products to minors in county parks; and (iii) establish a “Truth About Stimulant Drinks” public education campaign “to increase awareness of side effects associated with energy drink consumption.” The legislation also specifies civil penalties between $500 and $1,000 per violation of the new rules. “Far too many people are unaware of the effects excessive caffeine consumption can have on the body,” Spencer told reporters. “Excessive consumption of caffeine can aggravate pre-existing conditions and contribute to a variety of health problems. My plan levels the playing field and…

The Idaho Senate has approved a joint memorial bill (S.J.M. 102) that would (i) state legislative findings, including that “taxpayers have a right to expect that their tax dollars will purchase fresh, healthy food that meets nutritional standards that will not contribute to health issues and higher medical costs,” and (ii) urge the federal government “to prohibit the purchase of unhealthy food items with Supplemental Nutritional Assistance Program (SNAP) benefits.” Introduced on March 19, 2013, the proposal was adopted by voice vote on March 22 and sent to the state House. The bill lists the types of foods that the legislature deems unhealthy, including “energy drinks defined as a beverage containing at least sixty-five milligrams of caffeine per eight fluid ounces that is advertised as being specifically designed to provide metabolic stimulation or an increase to the consumer’s mental or physical energy; a sweetened beverage or ‘soft drink’ defined as…

The European Food Safety Authority’s (EFSA’s) Scientific Committee has issued an opinion “that clarifies the scientific criteria for identifying an endocrine disruptor.” Requested by the European Commission, the opinion addresses “the testing and assessment of endocrine active substances (EASs) and endocrine disruptors (EDs)” by adopting the World Health Organization’s definition for EDs, which must meet the following three criteria: “the presence of (i) an adverse effect in an intact organism or a (sub)population; (ii) an endocrine activity; and (iii) a plausible causal relationship between the two.” The opinion also identifies “a reasonably complete suite of standardized assays for testing the effects of EASs [that] is (or will soon be) available for the oestrogenic, androgenic, thyroid and steroidogenic modalities in mammals and fish” known to be sensitive to endocrine disruption. The Scientific Committee has stressed, however, that not all EASs are EDs, ultimately advocating “a risk assessment approach” that evaluates substances…

According to the Food and Drug Administration (FDA), a federal court has approved a consent decree with Clifton, New Jersey-based Butterfly Bakery, Inc. over claims that it distributed misbranded food products, such as muffins and snack cakes. United States v. Butterfly Bakery Inc., No. 13-669 (D.N.J., order entered March 5, 2013). Under the agreement, the bakery will be unable to process or distribute food until it complies with the Food, Drug, and Cosmetic Act. FDA and state testing apparently showed that foods labeled as “sugar free” contained sugar, and some products contained three times the amount of declared or labeled sugar and two times the amount of fat or saturated fat. See FDA News Release, March 13, 2013.

Two agricultural organizations have filed a citizen petition with the Food and Drug Administration (FDA) seeking to ban the use of antibiotics in ethanol production so that the leftover mash, known as “distillers grains with solubles (DGS),” which is fed to livestock, does not add to the levels of antibiotics used in the production of poultry and meat in the United States and thus contribute to the development of “superbugs,” that is, bacteria resistant to multiple antibiotics. In re Ctr. for Food Safety, No. __, (FDA, filed March 15, 2013). In the alternative, the petitioners request that FDA adopt regulations that deem antibiotics sold to ethanol producers for DGS production as new animal drugs, require drug sponsors to seek FDA approval for their use and ban the sale of antibiotics that have not been approved as new animal drugs. According to the Center for Food Safety and Institute for Agriculture…

A group of physicians, researchers and public health experts has urged Food and Drug Administration (FDA) Commissioner Margaret Hamburg to consider the purported adverse health effects, particularly for children and adolescents, posed by energy drinks containing high levels of caffeine, apply existing generally recognized as safe standards to such beverages and require manufacturers to provide caffeine content on product labels. In their March 19, 2013, letter, the signatories cite their own and others’ research to claim that an increase in the consumption of products with added caffeine has been associated with fatalities and injuries, increased emergency room visits, cardiovascular complications, seizures, childhood obesity, and risky behaviors when combined with alcohol. They contend that while caffeine’s effects on adults are known, safe levels for teenagers have not been sufficiently shown. In a related development, several energy drink companies, including Monster Beverage, have reportedly changed their product labels to declare the caffeine…

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