A California federal court has granted plaintiffs’ motion to vacate the judgment and reopened a proposed class action against Attune Foods Inc., finding that the delay in guidance from the U.S. Food and Drug Administration (FDA) on whether “sugar” is the “common or usual name” for “evaporated cane juice” (ECJ), an ingredient that appears on Attune’s labels, could unfairly disadvantage the plaintiffs’ case. Swearingen v. Attune Foods Inc., No. 13-4541 (U.S. Dist. Ct., N.D. Cal., Oakland Div., order entered January 28, 2015). Citing the primary jurisdiction doctrine, the court had dismissed the case without prejudice in May 2014 to await FDA guidance after the agency reopened the comment period in March of that year to determine whether sugar and ECJ are materially different substances. After the plaintiffs sought relief from the judgment, the court has now determined that FDA’s delay could unfairly disadvantage the plaintiffs if the statute of limitations prohibits…
Category Archives Legislation, Regulations and Standards
The European Ombudsman has issued a January 28, 2015, decision directing the European Food Safety Authority (EFSA) to revise its conflict-of-interest rules after the agency “failed to ensure that those experts who work in academia declare all relevant information to EFSA.” Stemming from a complaint filed by GeneWatch, the decision focused on an EFSA working group on genetically modified (GM) insects that included an academic expert whose employer has financial ties to a biotechnology company that “promotes genetically modified insects.” In particular, the European Ombudsman dismissed the agency’s reasoning that “employment by a university has never been considered a conflict of interest at EFSA,” as such a prohibition would disqualify the most qualified individuals from working groups. The decision instead places the onus on EFSA to gather additional information about the nature of the university’s financial relationships and the mechanisms in place “to prevent communication and instructions from the investment arm…
U.S. Immigration and Customs Enforcement (ICE) and Homeland Security Investigations and Customs and Border Protection (CBP) officers have reportedly confiscated since October 2014 about 450,000 pounds of honey produced in China but falsely declared to be from Latvia on import documents. Chinese honey has been subject to a high import tax—currently 221 percent—since 2001, when the U.S. Department of Commerce found that Chinese producers were dumping honey on the market by selling it for lower than production costs. An assistant special agent in charge of Homeland Security Investigations in Houston reportedly identified the city as a “key point of entry” into the United States; in November 2013, agents there seized Chinese honey worth $4.2 million that was falsely labeled as Malaysian and Indian. Chinese honey was also the subject of a 2002 U.S. Food and Drug Administration warning after concerns that it was adulterated with the antibiotic chloramphenicol, which is…
The U.S. Food and Drug Administration (FDA) has extended the deadline for public comments about whether to expand the products included in its guidance titled “Toxicological Principles for the Safety Assessment of Food Ingredients”—also known as the “Redbook.” The agency is apparently considering this expansion “to include chemical safety assessments for all products over which FDA’s Center for Food Safety and Applied Nutrition (CFSAN) has statutory authority including regulatory contexts such as food additives, food contact substances, dietary supplement ingredients, food contaminants, and cosmetics.” According to FDA, “The Redbook would describe toxicological principles which apply across regulatory categories while still providing specific guidance for applying these principles within each particular context. The safety of foods containing microbial contaminants will continue to remain outside of the scope of the Redbook.” Comments may now be submitted until May 11, 2015. See Federal Register, February 2, 2015.
The Food and Drug Administration (FDA) has extended until February 27, 2015, the deadline for submitting materials related to (i) nominations for a non-voting industry representative to serve on the Food Advisory Committee and (ii) statements from organizations interested in participating in the selection process for the non-voting committee member. The Food Advisory Committee evaluates data and makes recommendations on such matters as food ingredient safety, food and cosmetic labeling, nutritional issues, and exposure limits for food contaminants. See Federal Register, February 2, 2015. Issue 554
According to the February 3, 2015, issue of the Centers for Disease Control and Prevention’s (CDC’s) Morbidity and Mortality Weekly Report, the U.S. Department of Agriculture has reported the first cases of highly pathogenic avian influenza A (HPAI) in wild or domestic birds found in the United States. Of the 14 recorded incidents, seven were associated with H5N2, six with H5N8 and one with H5N1. The detections occurred in the northwestern states of California, Idaho, Oregon, Utah, and Washington and involved five domestic “backyard” flocks, two captive wild birds and seven wild aquatic birds. “Until more is known about these viruses, CDC is taking a cautious approach, and recommendations are largely consistent with guidance for influenza viruses associated with severe diseases in humans,” notes CDC. “State health departments are encouraged to investigate all possible human infections with HPAI H5 virus and should notify CDC promptly when testing for influenza in…
The U.S. Department of Agriculture’s Office of the Under Secretary for Food Safety, Food and Drug Administration, and Department of Health and Human Services have announced a February 23, 2015, public meeting in College Park, Maryland, to discuss draft positions for consideration at the 9th Session of the Codex Committee on Contaminants in Food in New Delhi, India on March 16-20. The lengthy agenda for the February meeting includes (i) maximum levels for lead in ready-to-drink fruit juices and nectars as well as in canned fruits and vegetables; (ii) proposed draft maximum levels for inorganic arsenic in husked rice; (iii) a proposed draft Code of Practice for the Prevention and Reduction of Arsenic Contamination in Rice; (iv) proposed draft maximum levels for cadmium in chocolate and cocoa-derived products; (v) a discussion paper about the feasibility of developing a Code of Practice for mycotoxins in spices; and (vi) a priority list…
The D.C. Circuit Court of Appeals has affirmed a Federal Trade Commission (FTC) order that found POM Wonderful’s advertising to be misleading for claiming that its products treat or reduce the risk of several medical conditions, including prostate cancer and heart disease. POM Wonderful, LLC v. FTC, No. 13-1060 (D.C. Cir., order entered January 30, 2015). In 2013, FTC ordered POM to stop making misleading health claims about its product, and POM challenged the ruling. POM argued that its ads were protected by the First Amendment, but the court dismissed this argument, finding that deceptive and misleading ads have no First Amendment protection. The juice company also asserted that it had clinical studies to support its health claims. The circuit court affirmed FTC’s finding that POM had cherry-picked its results when presenting them to the public, which invalidated them as support for the claims. The court agreed with POM, however, that…
The U.S. Department of Agriculture’s Food Safety and Inspection Service, Food and Drug Administration, and Centers for Disease Control and Prevention (CDC) are hosting a February 24, 2015, public meeting in Washington, D.C., to update stakeholders and solicit input about the agencies’ collaborative initiatives to improve foodborne illness source attribution. The discussion will target the agencies’ effort to develop a single approach to creating harmonized foodborne illness source attribution estimates from outbreak data for Salmonella, E. coli O157, Listeria, and Campylobacter. Those interested in attending the meeting should register online by February 17. See Federal Register, January 28, 2015. Issue 553
Rep. Rosa DeLauro (D-Conn.) and Sen. Richard Durbin (D-Ill.) this week introduced legislation (Safe Food Act of 2015) that would consolidate food safety duties currently managed by 15 different agencies to the oversight of a single food safety authority. “The fragmented nature of our food safety system has left us more vulnerable to the risk of foodborne illness, it has too often forced citizens to go it alone in the case of outbreak,” Durbin said. Among other things, the proposal would transfer responsibility for inspections, enforcement and labeling to the new Food Safety Administration. DeLauro and Durbin introduced similar legislation in 1999, 2004, 2005 and 2007. See Press Release of Rep. Rosa DeLauro and Sen. Richard Durbin, January 28, 2015. Issue 553
