A California appeals court has affirmed a lower court’s ruling dismissing a putative class action alleging that Safeway misbranded its Lucerne-brand of Greek yogurt because U.S. Food and Drug Administration (FDA) regulations prohibit the use of “milk protein concentrate” (MPC) in foods labeled as yogurt. Tamas v. Safeway, Inc., No. RIC1206341 (Cal. Ct. App., 4th Dist., Div. 3, order entered February 23, 2015). The plaintiff argued that a 1981 FDA regulation determining yogurt’s “Standard of Identity” (SOI) dictated what ingredients are allowable in products sold as yogurt despite the agency’s stay of the regulation soon after it was issued. FDA promised to schedule a public hearing on the regulation but, as of January 2009, “due to competing priorities and limited resources, FDA has not held a public hearing to resolve these issues and the effective date for these provisions remains stayed. Therefore, these provisions were never in effect. Consequently, cultured milk…
Category Archives Food and Drug Administration
In a recent article for Law360, Shook, Hardy & Bacon Class Actions & Complex Litigation Co-Chair Jim Muehlberger and Agribusiness & Food Safety Associate Jeff Lingwall discuss the new wave of putative class action litigation against food and nutraceutical companies brought by plaintiffs bearing product test results that allegedly indicate deviations from labeled amounts. They explain U.S. Food and Drug Administration (FDA) standards for evaluating nutrition labeling and attendant provisions of the Federal Food, Drug, and Cosmetic Act/Nutrition Labeling and Education Act, advocating anticipatory measures by companies, given the advent of product testing websites, crowdfunded research and the increased scrutiny of the dietary supplement industry. Such measures, they say, include ensuring that (i) production processes (and those of any contract manufacturers) produce FDA-compliant test results and (ii) performing regular product testing to assure compliance with nutrition labeling per FDA-testing procedures. Issue 557
U.S. Sens. Barbara Boxer (D-Calif.), Richard Blumenthal (D-Conn.) and Rep. Peter DeFazio (D-Ore.) have reintroduced a proposed bill that would require the Food and Drug Administration to initiate labeling rules for foods that contain genetically engineered (GE) ingredients. “Some in the food and chemical industry say adding this very small piece of information to food labels will confuse people, will alarm people,” Boxer said. “Well, that argument is a familiar one. It’s been raised by almost every single industry when they want to avoid giving consumers basic facts about the product they’re buying.” The Genetically Engineered Food Right-to-Know Act reportedly has wide-ranging support from more than 120 public health, consumer and environmental organizations. The congressional lawmakers introduced similar legislation in the 113th Congress. See The Hill and Press Release of Congressman Peter DeFazio, February 12, 2015. Issue 555
The U.S. Food and Drug Administration (FDA) has issued the results of a study finding that dark chocolate products may contain milk that is not declared on other labels. According to a February 11, 2015, consumer update, the agency tested dark chocolate bars for the presence of milk after dividing them into categories based on their labeling: (i) those that included precautionary statements such as “may contain milk” or “may contain traces of milk”; (ii) those labeled “dairy-free” or “allergen-free”; (iii) those that made no mention of milk on the label; and (iv) those with inconsistent labels—for example, a “vegan” product with a label indicating the possible presence of milk traces. The results evidently identified milk in (i) two of the 17 dark chocolates labeled “dairy-free” or “allergen-free”; (ii) 55 of the 93 products that gave no clear indication of the presence of milk in the products; and (iii) all…
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…
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
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
The U.S. Food and Drug Administration (FDA) has published a draft environmental impact statement (EIS) for a proposed rule establishing science-based standards for the growing, harvesting, packing and holding of produce for human consumption. The draft EIS reportedly identifies the following rule provisions as potentially significant to the human environment and offers alternatives for consideration: (i) standards directed to agricultural water, (ii) standards directed to biological soil amendments (BSA) of animal origin, (iii) standards directed to domesticated and wild animals, and (iv) general provisions. The agency has also announced a February 10, 2015, public meeting in College Park, Maryland, to discuss the draft EIS. See Federal Register, January 14, 2015. Issue 551
Responding to objections submitted by the Natural Resources Defense Council (NRDC), the U.S. Food and Drug Administration (FDA) has confirmed its decision to allow the use of advantame as a non-nutritive sweetener and flavor enhancer in foods intended for human consumption. FDA apparently received 12 responses to its May 21, 2014, final rule on advantame, but only NRDC’s submission met the requirements for agency consideration. In particular, NRDC cited five animal studies allegedly showing that aspartame affects the hypothalamus, arguing that aspartame and advantame are “structurally related.” But FDA disagreed with this reasoning, noting that although advantame is structurally related to aspartame, the two substances are “chemically different and metabolized differently in the human body.” As a result, the agency did not consider the health effects of aspartame when reviewing the toxicological data for advantame. As the agency concluded, “NRDC’s objection to the advantame final rule does not provide any…
