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.
Category Archives Food and Drug Administration
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 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…
U.S. Representative Rosa DeLauro (D-Conn.) has written a letter to the Office of the Inspector General seeking "assistance in investigating whether the Food and Drug Administration (FDA) took prompt, appropriate, and effective action leading up to the recent recall involving powdered infant formula produced by Abbott Nutrition's Sturgis, Michigan plant." DeLauro indicates she is "concerned the agency acted too slowly in pulling potentially dangerous infant formula off store shelves, which may have resulted in additional illnesses and death." The letter notes that FDA alerted the public to a potential link between formula produced at the Sturgis location and Cronobacter sakazakii four months after the agency learned of the possible link. "The delay between the September inspection and the recall raises serious questions about the FDA's ability to adequately regulate the infant formula industry," the letter asserts. "It seems evident that the FDA could have acted sooner to prevent additional illnesses and deaths…
The Center for Food Safety and International Center for Technology Assessment have filed a rulemaking petition urging the U.S. Food and Drug Administration to regulate the use of nanotechnology in infant formula. "These new materials can have fundamentally different properties from their bulk material counterparts—properties that also create unique human health and environmental risks—which create new oversight challenges for the regulatory agencies charged with protecting public health and the environment," the petition states. "Of unique concern is the use of engineered nanomaterials in infant formulas sold throughout the United States." The actions the groups request include "rigorous screening or safety testing" of infant formula for "nanomaterials or other potentially toxic synthetic ingredients," a required delineation of all nanoparticle ingredients on the label of an infant formula product, and a declaration that any infant formula currently available that contains nanomaterials is adulterated and misbranded.
Following the Environmental Protection Agency's 2021 final rule revoking tolerances for residues of the pesticide chlorpyrifos in food, the U.S. Food and Drug Administration's (FDA's) Center for Food Safety and Applied Nutrition has issued guidance for industry on how the agency will enforce the rule, which sets the expiration date for the tolerances as February 28, 2022. The guidance document is issued in the form of questions and answers; questions include "After the tolerances expire, is food containing residues of chlorpyrifos considered adulterated under the [federal Food, Drug and Cosmetic Act]?," "As an example, how would FDA respond to rutabagas with chlorpyrifos residues before and after the showing date?" and "As an example, how would FDA respond to canned rutabagas with chlorpyrifos residues before and after the showing date?" "There are two stages to our enforcement approach after February 27, 2022: (1) in Stage 1, we generally intend to exercise…
The U.S. Food and Drug Administration (FDA) has released a list of the draft and final guidance topics that the agency is prioritizing for 2022. The list includes guidance on allergens, cell-cultured foods, heavy metals in juice and labeling of plant-based alternatives to milk and animal-derived foods. According to a caveat in the constituent update, "Although the FDA's intent is to publish all draft and final guidance topics on the list, modifications in plans may be needed to support emerging issues and Administration priorities."
Several advocacy groups, including the Environmental Defense Fund, Consumer Reports and Environmental Working Group, have filed a petition with the U.S. Food and Drug Administration (FDA) "requesting that the agency remove its approvals of the use of bisphenol A [BPA] . . . because recently published scientific studies show that the exposure from those food additive uses is not safe." The groups cite a reevaluation of BPA effects conducted by the European Food Safety Authority (EFSA) and published in December 2021 that "unanimously concluded that 'there is a health concern from dietary BPA exposure for all age groups.'" "Given the magnitude of the overexposure, we request an expedited review by FDA of the food additive petition because the proposed amendments to the agency’s rule are intended to significantly increase the safety of the food supply," the petition asserts. "Not only will it dramatically decrease exposure to a toxin – BPA –…
The U.S. Food and Drug Administration (FDA) has revoked the standard of identity for French dressing following a citizen petition filed by the Association for Dressings and Sauces. The revocation finalizes a December 2020 rule that "will allow for greater innovation and more flexibility of products on the market," according to an FDA Constituent Update. "The standard of identity for French dressing characterized it as containing oil, acidifying and seasoning ingredients, and allowed additional safe and suitable ingredients," the update notes. "However, based on information submitted to the FDA, consumers appear to expect French dressing to have certain characteristics not required by the standard, such as containing tomatoes or tomato-derived ingredients."
The U.S. Food and Drug Administration (FDA) has released guidance on limiting sodium in processed and packaged foods. "Limiting certain nutrients, such as sodium, in our diets plays a crucial role in preventing diseases like hypertension and cardiovascular disease that disproportionately impact racial and ethnic minority groups; these diseases often result in hundreds of thousands of lives lost and billions in annual health care costs," the agency stated in a press release. The statement notes that "people consume 50% more sodium than recommended," and "about 70% of the sodium we eat comes from packaged, processed and restaurant foods." "[W]e recognize that most of the food consumption in the U.S. comes from a relatively small number of products and menu items in the marketplace that are produced by a limited number of food manufacturers," the guidance states. "It is possible that reformulation by these food manufacturers could lead to increased demand…
