Tag Archives FDA

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…

Politico has published a report on the U.S. Food and Drug Administration (FDA) based on more than 50 interviews with current and former employees of the agency, including former FDA commissioners. "There is a remarkable level of consensus that the agency is simply not working," states the report. "Current and former officials and industry professionals used terms like 'ridiculous,' 'impossible,' 'broken,' 'byzantine' and 'a joke' to describe the state of food regulation at FDA." Subjects examined by the investigation include leadership issues within the food division of the agency, a lack of action on foodborne illnesses, the issue of heavy metals in baby food and delays on nutrition targets. Sen. Patty Murray (D-Wash.) sent a letter to Commissioner Robert Califf expressing concern over the findings of Politico's investigation. "This report highlighted several delays in regulatory action that have endangered the public health. Over a decade after the Food Safety Modernization…

The U.S. Food and Drug Administration (FDA) has issued draft guidance on how it will evaluate the public health importance of a food allergen not listed as a major food allergen. Topics in the guidance include (i) scientific factors FDA will consider; (ii) what types of information will be relevant to the labeling and production of food containing the allergen; and (iii) recommendations for identifying and analyzing evidence for the evaluation of a non-listed food allergen.

Shook Of Counsel John Johnson III will co-present "Food and Dietary Supplement Regulation Year-in-Review" on Wednesday, March 30, 2022, at the Food and Dietary Supplement Safety and Regulation Conference. The conference, which takes place March 30-31, will be presented virtually by the Food and Drug Law Institute. "This session will recap the most significant recent developments in food and dietary supplement regulation and enforcement, including updates on FDA and United States Department of Agriculture (USDA) inspections, FDA and Federal Trade Commission (FTC) warning letters and enforcement, and compliance challenges faced by manufacturers and retailers," according to the conference agenda. "Panelists will also discuss the extent to which federal regulation and enforcement may have impacted private litigation over the past year."

The U.S. Food and Drug Administration (FDA) has announced that it will conduct quantitative consumer research on the use of "voluntary symbols that could be used in the future to convey the nutrient content claim 'healthy.'" The agency is simultaneously "developing a proposed rule that would update when manufacturers may use the 'healthy' nutrient content claim on food packages." "Updating labeling and making it more accessible helps empower consumers," the constituent update states. "In particular, claims and symbols can help consumers better understand nutrition information and identify foods that contribute to a healthy eating pattern. Manufacturers may also reformulate products to improve their nutritional value so they can use the claim."

The U.S. Food and Drug Administration (FDA) has issued a final rule amending the acceptable qualities of food labeled as yogurt. Under the rule, the standards of identity for lowfat and nonfat yogurt will be combined with the general definition; in addition, the list of allowable ingredients has expanded to include additional substances such as agave. "Additionally, the final rule supports the many innovations that have already been made in the yogurt marketplace, including continuing to allow manufacturers to fortify yogurts, such as adding vitamins A and D, as long as they meet fortification requirements," according to the constituent update. "The rule also allows various styles or textures of yogurt as long as they meet requirements in the standard of identity."

The U.S. Food and Drug Administration (FDA) has issued guidance indicating that it will not enforce particular provisions implementing the Food Safety Modernization Act (FSMA). "In certain situations the FDA has determined it is appropriate to take time to consider options, including rulemaking, to address concerns raised by stakeholders, while continuing to protect public health," the constituent update states. "As we work on solutions, the agency does not intend to enforce these provisions as they currently apply to entities or activities addressed in the guidance." Affected rules include: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Animal Food; Foreign Supplier Verification Program; Produce Safety; and Intentional Adulteration.

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