Category Archives Legislation, Regulations and Standards

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The U.S. Food and Drug Administration (FDA) has issued draft guidance on how it will evaluate the public health importance of a food allergen not listed as a major food allergen.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.

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. Department of Agriculture has announced a public meeting scheduled for April 19, 2022, to discuss U.S. positions for the meeting of the Codex Committee on Contaminants in Foods of the Codex Alimentarius Commission. Issues to be discussed include: "Maximum level for cadmium in cocoa powder (100% total cocoa solids on a dry matter basis)"; "Code of practice for the prevention and reduction of cadmium contamination in cocoa beans"; "Maximum levels for lead in certain food categories"; "Maximum levels for total aflatoxins in certain cereals and cereal-based products including foods for infants and young children"; "Sampling plans and performance criteria for total aflatoxins in certain cereals and cereal-based products including foods for infants and young children"; "Maximum level for total aflatoxins in ready-to-eat peanuts and associated sampling plan"; "Maximum levels for total aflatoxins and ochratoxin A in nutmeg, dried chili and paprika, ginger, pepper and turmeric and associated sampling…

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.

Regulations governing the use of per- and polyfluoroalkyl substances (PFAS) continue to evolve. In California, the Office of Environmental Health Hazard Assessment (OEHHA) announced the addition of perfluorooctanoic acid (PFOA), one type of PFAS, to the list of chemicals established under the state's Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65). The U.S. Food and Drug Administration (FDA) issued a constituent update about the results of tests for PFAS in food. The study purportedly found that 89 of 92 food samples "had no detectable levels of PFAS"; the three that contained the substance were seafood—tilapia, cod and shrimp. "To date, there have been 10 samples with detectable PFAS out of 532 [Total Diet Study (TDS)] samples the FDA has tested since 2019," the update notes. "Based on the best available current science, the FDA has no scientific evidence that the levels of PFAS found in the TDS…

The European Food Safety Authority (EFSA) has completed a "comprehensive safety assessment of sugars in the diet and their potential links to health problems." The assessment aimed to set a tolerable upper intake level for dietary sugars, but the panel was unable to reach a conclusion. According to the assessment's plain language summary, "the risk of adverse health effects (responses) increased across the whole range of observed intake levels (doses) in a constant (linear) manner, i.e. the higher the intake, the greater the risk of adverse effects." The announcement indicated that the wide-ranging assessment may allow researchers to set a tolerable upper intake level following future studies. One panelists reportedly stated, "We screened over 30,000 publications so we have identified several areas to target for researchers and technicians. The pooling and reuse of individual human data from research studies would be a valuable source of information. Research should focus both…

The U.S. Food and Drug Administration has announced that it has "made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring." The agency determined that the product does not raise any safety concerns and that the product developer is not expected to pursue FDA approval before marketing the product, which is produced from cattle with an intentional genomic alteration (IGA) ensuring a short-hair coat. "To date, the FDA has made low-risk determinations for enforcement discretion for many other IGAs in animals for non-food uses and also has approved applications for five IGAs: in groups of goat, chicken, salmon, rabbit and, most recently, in a line of pigs," the announcement notes. “Today’s decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat…

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