A federal court in California has determined that the Food and Drug Administration (FDA) has violated the Food Safety Modernization Act (FSMA) and Administrative Procedure Act (APA) by failing to promulgate, within FSMA deadlines, food-safety rules that implement the law. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., decided April 22, 2013). According to the court, Congress “intended that the implementing regulations be promulgated and finalized by a date certain. The dates set for completion of the regulations in the seven areas identified in the complaint have passed. However, that does not mean that the FSMA now should be interpreted as granting the FDA total discretion in deciding when to finalize the regulations. . . . Thus, the court finds that the imposition of an injunction imposing deadlines for finalization of the regulations would be consistent with the underlying purposes of the FSMA.” Still, agreeing with FDA “that the purpose…
Category Archives Issue 481
After a state court in California granted the American Chemistry Council’s (ACC’s) request for preliminary injunction and ordered Cal/EPA’s Office of Environmental Health Hazard Assessment (OEHHA) to remove bisphenol A (BPA) from the list of chemicals known to the state to cause reproductive toxicity, OEHHA did so. OEHHA had argued that ACC’s request to enjoin OEHHA from “listing, or taking any further action in listing” BPA was moot because the Proposition 65 (Prop. 65) listing action took effect April 11, but the court said it had the authority to order OEHHA to remove the chemical from the list. According to the court, ACC demonstrated that it had a reasonable probability of prevailing on the merits of its claim that the National Toxicology Program report on which OEHHA relied for its listing did not identify BPA as causing reproductive toxicity. “[T]here was no definitive statement that BPA is a developmental toxicant…
Citing the loss of millions of euros, the Danish government is reportedly abandoning its 80-year tax on soft drinks because consumers are crossing the border to shop in Germany instead. “This decision is the result of concerted efforts to highlight the negative impact of the tax,” said Niels Hald, secretary general of the Danish soft drinks association, Bryggeriforeningen. “In taking this step the Danish government acknowledged the regressive nature of the tax, its negative impact on regional jobs close to the borders and the adverse environmental consequences of border trade.” Removal of the tax will reportedly take place in two stages, with a 50-percent reduction as of July 1, 2013, and full elimination as of January 1, 2014. The decision comes months after the Danish government repealed a similar tax on foods with high concentrations of saturated fat and stopped a proposed sugar tax last year. See UNESDA News Release, April…
The consumer regulatory agency of Sao Paulo, Brazil, has reportedly fined McDonald’s US $1.6 million for allegedly marketing to children. Procon SP has claimed that franchisee Arcos Dorados Holdings Inc. violated the state’s consumer code by using children’s characters and toys to promote Happy Meals®. “This is not an isolated case,” a Procon SP lawyer was quoting as saying. “There’s no need to appeal as they do to children without the maturity or the rationality to enter the market as consumers.” In 2011, the Brazilian Consumer Defense Foundation fined the fast-food corporation US$1.8 million after a nonprofit organization complained that Happy Meal® incentives encouraged “unhealthy eating habits” among children. A McDonald’s spokesperson has since told media sources that the company plans to appeal the latest ruling. Additional details about the Consumer Defense Foundation matter appear in Issue 420 of this Update. See Law360 and Reuters, April 23, 2013.
The U.S. Department of Agriculture and Food and Drug Administration have announced a June 18, 2013, public meeting in Washington, D.C., to provide information and receive public comments on agenda items and draft U.S. positions for discussion at the 36th Session of the Codex Alimentarius Commission in Rome on July 1-5. Agenda items include (i) a report by the chair of the 68th session of the executive committee; (ii) revocation of existing Codex standards and related texts; (iii) “Amendments to the Codex Standards and Related Texts”; (iii) “Financial and Budgetary Matters”; and (iv) chair and vice chair elections and coordinator appointments. See Federal Register, April 23, 2013.
Several dozen trade associations representing the interests of food and beverage producers, processors, shippers, and retailers have submitted their concerns about the Obama administration’s proposed 2014 Food and Drug Administration (FDA) budget, which includes $59 million in food facility registration and inspection fees to fund FDA activities under the Food Safety Modernization Act (FSMA). In their April 17, 2013, letter to the chair and ranking member of the Senate Appropriations Subcommittee for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, the industry groups call for FDA to submit requests for FSMA implementation funding through the appropriations process, “rather than seeking authorization of new regulatory taxes, which Congress has repeatedly rejected.”
U.S. Sen. Barbara Boxer (D-Calif.) and Rep. Peter DeFazio (D-Or.) have introduced companion bills (S. 809; H.R. 1699) that would amend the federal Food, Drug, and Cosmetic Act to require the makers of genetically engineered (GE) foods and foods with GE ingredients to include this information on their labels. Noting that the Food and Drug Administration stated in 1992 that such labels were unnecessary because GE foods were not “materially” different from other foods, Boxer characterized this approach as antiquated and said, “Common sense would indicate that GE corn that produces its own insecticide—or is engineered to survive being doused by herbicides—is materially different from traditional corn that does not. Even the U.S. Patent and Trademark Office has recognized that these foods are materially different and novel for patent purposes.” One Republican representative has agreed to co-sponsor the legislation; the remaining support is from Democratic senators and representatives. According to…
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