The U.S. Food and Drug Administration (FDA) has proposed two rules under the Food Safety Modernization Act (FSMA) for verifying foreign suppliers and accrediting third-party auditors. Part of the agency’s effort “to ensure that imported food meets the same safety standards as food produced in the United States,” the proposed rules would (i) require importers to verify “that their foreign suppliers are implementing modern, prevention-oriented food safety practices,” and (ii) “strengthen the quality, objectivity, and transparency of foreign food safety audits on which many food companies and importers currently rely to help manage the safety of their global food supply chains.” In particular, the rules establishing foreign supplier verification programs would hold U.S. importers responsible for ensuring that human and animal food produced abroad meets the safety standards set forth in the Federal Food, Drug, and Cosmetic Act and is neither adulterated nor misbranded “with respect to food allergen labeling.” In addition, FDA has proposed creating…
Category Archives U.S. Government and Regulatory Agencies
The U.S. Food and Drug Administration (FDA) has issued a final rule defining the term “gluten-free” for voluntary food labeling. Among other things, the rule defines “gluten-free” to mean that a food does not contain (i) an ingredient that is a gluten-containing grain (e.g., spelt wheat); (ii) an ingredient derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or (iii) an ingredient derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch). In addition, a food must contain less than 20 parts per million of gluten to use the term “gluten-free” on its label. According to FDA, a food that bears the claim “no gluten,” “free of gluten” or “without gluten” on its label and fails to meet the requirements for a “gluten-free” claim will be deemed misbranded. The rule will take effect 30 days after its publication in…
A federal court in California has dismissed without prejudice a putative class action alleging that Wholesoy & Co. misleads consumers by (i) listing “organic evaporated cane juice” instead of “sugar” or “dried cane syrup” as an ingredient on its soy yogurt products in violation of Food and Drug Administration (FDA) labeling rules, and (ii) marketing its soy product as yogurt because it fails to comply with FDA’s standard of identity for “yogurt.” Hood v. Wholesoy & Co., No. 12-5550 (N.D. Cal., decided July 12, 2013). The court agreed with the company that the complaint must be dismissed under the primary jurisdiction doctrine because its resolution would require the court to decide an issue committed to the agency’s expertise “without a clear indication of how FDA would view the issue.” Specifically, the court found that the evaporated cane juice guidance document on which the plaintiff relied is expressly “not a ‘legally…
The Food and Drug Administration (FDA) has issued a request for comments, scientific data and information to use in risk assessment of human salmonellosis associated with the consumption of tree nuts, including almonds, cashews, pistachios, pine nuts, Brazil nuts, macadamia nuts, and walnuts. The risk assessment seeks to quantify the public health risk associated with eating tree nuts potentially contaminated with Salmonella and evaluate the impact of interventions to prevent contamination with the bacterium or to reduce contamination levels. FDA said an assessment is necessary in light of “outbreaks of human salmonellosis linked to tree nuts during the past decade, by product recalls, and by Salmonella isolation from tree nuts during surveys.” Comments will be accepted until October 16, 2013. See Federal Register, July 18, 2013.
The Food and Drug Administration (FDA) has published new guidance on Salmonella-contaminated food for animals. Titled “Compliance Policy Guide Sec. 690.800 Salmonella in Food for Animals” (CPG), the guidance finalizes the draft CPG that was announced in August 2010 and includes the following changes: (i) the title has changed from “Salmonella in Animal Feed” to “Salmonella in Food for Animals” to clarify that it covers all animal food, including pet food and animal feed, and (ii) the term “direct human contact animal feed” has been replaced with the term “pet food” and includes treats and chews. FDA has also announced (i) the removal of 21 CFR 500.35 “Animal feeds contaminated with Salmonella microorganisms,” and (ii) the withdrawal of “Compliance Policy Guide Sec. 690.700 Salmonella Contamination of Dry Dog Food.” See Federal Register, July 16, 2013.
A federal court has awarded $90.8 million to the attorneys who represented African-American farmers in litigation against the U.S. Department of Agriculture alleging discrimination in the loan application process. In re Black Farmers Discrimination Litig., No. 08-0511 (D.D.C., decided July 11, 2013). Additional details about class counsels’ request appear in Issue 405 of this Update. Explaining the challenges counsel faced, their extensive efforts to secure an award for the class of farmers in excess of $1 billion, the millions they incurred in unreimbursed expenses, as well as the hours devoted to assisting the Claims Administrator during the claims process, the court found an award representing 7.4 percent of the claims fund reasonable. According to the court, “Class counsel have undertaken the immense challenge presented by this action with the utmost professionalism and integrity, exhibiting skill, diligence, and efficiency in all aspects of their duties.”
A coalition of animal rights organizations has sued U.S. Department of Agriculture (USDA) Secretary Tom Vilsack under the National Environmental Protection Act (NEPA), claiming that the agency failed to conduct a required environmental review before granting the application of a “horse slaughter plant operator in New Mexico, bringing the nation closer to its first horse slaughter operation since federal courts and state lawmakers shuttered the last three U.S.-based plants in 2007.” Front Range Equine Rescue v. Vilsack, No. 13-3034 (N.D. Cal., San Francisco Div., filed July 2, 2013). The parties agreed to voluntarily transfer the suit to the District of New Mexico as a more appropriate venue, and the court entered an order granting the transfer on July 10, 2013. Because the defendants advised the plaintiffs that no federal inspections at horse slaughter facilities will take place before July 29, the court vacated its expedited scheduling order. In their complaint,…
Trade organizations representing the interests of cattle and pork producers and meat processors in Canada and the United States have filed a lawsuit against the U.S. Department of Agriculture (USDA), challenging country-of-origin (COOL) labeling regulations that took effect May 23, 2013. Am. Meat Inst. v. USDA, No. 13-1033 (D.D.C., filed July 8, 2013). They seek declaratory and injunctive relief, an order vacating the final rule, attorney’s fees, and costs. Explaining that meat producers and processors in the United States, Canada and Mexico have for years freely “commingled” livestock born, raised and processed across their borders, the plaintiffs allege that new requirements forcing them to “list separately, in sequence, the specific country where the animal was ‘born,’ the country where it was ‘raised,’ and the country where it was ‘slaughtered,’” will impose significant costs and entail extensive detail and paperwork for no health or safety reasons. They allege that the COOL regulations…
The National Marine Fisheries Service (NMFS) of the National Oceanic and Atmospheric Administration (NOAA) has published a final rule “to enhance the requirements for documentation to support labels on tuna products that represent the product as dolphin-safe.” According to NMFS, the rule “is intended to better ensure dolphin-safe labels comply with the requirements of the DPCIA [Dolphin Protection Consumer Identification Act] and to ensure that the United States satisfies its obligations as a member of the World Trade Organization (WTO).” Information about an adverse WTO ruling in a dispute with Mexico over U.S. dolphin-safe labeling provisions appears in Issue 424 of this Update. See Federal Register, July 9, 2013.
According to a news source, the U.S. Department of Agriculture (USDA) has granted permission for slaughterhouses in New Mexico and Iowa to convert their facilities into horse-processing plants, the first such facilities to be licensed since Congress banned the practice seven years ago. Other applications for horse-processing plants are reportedly being considered in Missouri, Oklahoma and Tennessee. Before horse slaughter can begin, however, plants must be inspected by USDA inspectors who have reportedly not yet been hired. “This is very far from over,” an attorney for the New Mexico plant was quoted as saying. “The company is going to plan to begin operating in July. But with the potential lawsuits and the USDA—they have been dragging their feet for a year—so to now believe they are going to start supplying inspectors, we’re not going to hold our breath.” See The Associated Press, June 28, 2013; Emporiagazette.com, July 11, 2013.
