Tag Archives FDA

A New Jersey federal court has dismissed claims filed against Plum PBC and Campbell Soup Co. alleging the companies sold baby food products containing high levels of heavy metals. In re Plum Baby Food Litig., No. 21-2417 (D.N.J., entered October 31, 2022). In finding that the plaintiffs lacked standing, the court echoed the reasoning followed by a Virginia federal court in a decision dismissing a lawsuit against Gerber with similar claims. "Plaintiffs purchased the baby food products from Defendants to feed their children, and these products were fully used for their intended purposes. [] Plaintiffs do not allege that their children have suffered physical harm: the children did not starve or become nutrient deficient. [] Imparting nutrition is ostensibly what Defendants advertised regarding its baby food products," the court found. "Moreover, the [U.S. Food and Drug Administration's (FDA's)] opinion that parents should not throw out their supply of packaged baby foods or…

The U.S. Food and Drug Administration (FDA) has announced the release of the Interagency Food Safety Analytics Collaboration's annual report, which provides data on source attribution estimates for 2020 for Salmonella, E. coli and Listeria monocytogenes. The findings include that (i) "Salmonella illnesses came from a wide variety of foods"; (ii) "E. coli O157 illnesses were most often linked to Vegetable Row Crops (such as leafy greens) and beef"; and (iii) "Listeria monocytogenes illnesses were most often linked to Dairy products, Fruits, and Vegetable Row Crops."

The U.S. Department of Agriculture has announced a November 15, 2022, public meeting to discuss and vote on adopting measures related to controlling Salmonella in poultry products. The meeting will also include an update on actions related to Cyclospora cayetanensis as well as an additional work charge on Cronobacter in powdered infant formula. Parties interested in expressing comments during the meeting must register by November 8, 2022.

The U.S. Food and Drug Administration (FDA) has announced a proposed update to guidance on how the term "healthy" can be used in marketing and labeling food products. The announcement notes that current limitations on usage of the term are out of step with the dietary guidelines—for example, salmon is excluded from permitted use due to fat levels despite being considered part of the "key elements of a healthy dietary pattern." "The existing 'healthy' claim has become inconsistent with the longstanding purpose of this type of implied claim to indicate that the nutrient levels in a food may help consumers maintain healthy dietary practices," the document notes. "The proposed framework for the updated definition of 'healthy' uses a food group-based approach in addition to nutrients to limit (based on the understanding that each food group contributes an array of important nutrients to the diet). The proposed, updated 'healthy' criteria would…

The U.S. Food and Drug Administration (FDA) has released an activities document outlining how the agency is working to enhance the safety of fresh produce imported into the United States. The Activities to Enhance the Safety of Imported Produce, announced September 27, builds on the FDA’s Strategy for the Safety of Imported Food, which began in February 2019. The 2019 import strategy outlined the agency’s comprehensive approach to ensuring the safety of food imported into the United States. The new activities document details how the strategy for safeguarding imported food applies specifically to produce. “The success of FDA’s imported food safety efforts relies in large part on the safety of produce since fresh fruit and vegetables represent a significant volume of imported food,” the agency said in the activities document. “About 15% of the U.S. food supply is imported, including nearly 55% of fresh fruit and 32% of fresh vegetables.”…

The White House has released the "Biden-Harris National Strategy on Hunger, Nutrition and Health," which lays out the Biden administration's policy goals on a number of food-related subjects. The third pillar of the strategy includes the administration's intention to (i) "develop a front-of-package (FOP) labeling system to quickly and easily communicate nutrition information"; (ii) "make sure that foods labeled as 'healthy' align with current nutrition science and the Dietary Guidelines for Americans"; (iii) "adequately fund [the U.S. Food and Drug Administration (FDA)]'s Center for Food Safety and Applied Nutrition (CFSAN) to prioritize its nutrition and labeling work"; and (iv) "facilitate making nutrition information easily available when grocery shopping online." The strategy also notes the policy goals of "lowering the sodium content of food" beyond FDA's voluntary short-term reduction targets and "lowering added sugar consumption" by further researching strategies for reducing American's sugar intake. The document further promises "regular updates to…

The Center for Science in the Public Interest (CSPI) has filed a regulatory petition asking the U.S. Food and Drug Administration (FDA) "to require on the principal display panel of a food an easy-to-understand, standardized system that is 1) mandatory, 2) nutrient-specific, 3) includes calories, and is 4) interpretative with respect to the levels of added sugars, sodium, and saturated fat per serving." The petition argues that current food labeling requirements and voluntary industry initiatives are "insufficient to promote healthy diets" because the Nutrition Facts label "has low utilization." "Dozens of countries have implemented [front-of-package nutrition labeling (FOPNL)], and over one hundred experimental and real-world studies have tested the effects of different FOPNL systems," the petition asserts. "These studies find that well-designed interpretive FOPNL can significantly improve the healthfulness of foods selected by consumers and prompt product reformulation. The U.S. should learn from experiences abroad and follow the science to…

The U.S. Government Accountability Office (GAO) has issued a report suggesting that federal agencies can better coordinate guidance on healthy eating. The report found that GAO's previous recommendations had not been implemented, including a 2021 recommendation that Congress "consider identifying and directing a federal entity to lead a strategy on diet-related efforts." The agency also recommended in 2017 that the presidential administration develop a strategy for federal food oversight. "We have long reported on the fragmented federal food safety oversight system. We added federal oversight of food safety to our high-risk list in 2007; federal government operations on this list either need broad reform or are vulnerable to fraud, waste, abuse, and mismanagement. We added this issue to the list because of inconsistent oversight, ineffective coordination, and inefficient use of resources. For example, the U.S. Department of Agriculture (USDA) had critical information on contaminated eggs that ultimately sickened more than…

The attorneys general of 22 states have submitted a letter to the U.S. Food and Drug Administration (FDA) and Department of Agriculture (USDA) asserting that the agencies "are not sufficiently prioritizing a public health problem long overdue for robust action: children’s exposure to neurotoxic heavy metals (lead, arsenic, cadmium, and mercury) through foods specifically designed and marketed for babies and young children." Led by New York Attorney General Letitia James, the group argues that the existing plan to set limits on heavy metals, the Closer to Zero Plan, has "lengthy and vague timelines, which now extend to mid-2024 and beyond," and is "already behind schedule." "As a result of this and other agency delays, U.S. baby food manufacturers continue to largely self-regulate the amount of lead (and other toxic elements) that is contained within their products. Indeed, it remains up to the manufacturers to decide whether even to test their…

The attorneys general of 21 states have filed a petition for reconsideration for a citizen petition denied May 2, 2022, that urged the U.S. Food and Drug Administration (FDA) "to adopt a series of interim guidance measures intended to complement the long-term approach of the Closer to Zero Plan," which aims to reduce the amount of contaminants in baby foods. The attorneys general sought interim guidance to (i) set action levels for inorganic arsenic, lead, cadmium and mercury; (ii) set an action level for inorganic arsenic in infant rice cereal that is lower than the existing action level of 100 parts per billion; and (iii) issue guidance to industry that testing for heavy metals is a "preventive control" manufacturers should perform. The reconsideration petition takes issue with multiple points in the denial, including the argument that FDA did not consider relevant information as to its own authority. The attorneys general…

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