Category Archives Food and Drug Administration

As part of a proposal to reorganize several federal agencies, the Trump administration has recommended that food-safety regulatory oversight be shifted to the U.S. Department of Agriculture (USDA), combining the agency's Food Safety and Inspection Service (FSIS) with the current food purview of the Food and Drug Administration (FDA). According to the proposal, the Government Accountability Office found that the existing approach "has caused inconsistent oversight, ineffective coordination, and inefficient use of resources" and recommends "merging Federal food safety functions as a potential solution to this fragmentation." For example, the administration suggests, "[W]hile FSIS has regulatory responsibility for the safety of liquid eggs, FDA has regulatory responsibility for the safety of eggs while they are inside of their shells; FDA regulates cheese pizza, but if there is pepperoni on top, it falls under the jurisdiction of FSIS; FDA regulates closed-faced meat sandwiches, while FSIS regulates open-faced meat sandwiches." The proposed USDA agency, the…

The U.S. Food and Drug Administration (FDA) has released draft guidance on intentional adulteration of the food supply. The guidance aims to help manufacturers develop and implement plans to protect their products by providing details on the components of a food defense plan, including vulnerability assessments, mitigation strategies and training requirements. Large businesses must have a plan by July 26, 2019, with enforcement dates in 2020 and 2021 for small or very small businesses. FDA also indicated that it will issue two further installments of draft guidance on intentional adulteration focusing on vulnerability assessments and corrective actions. "The likelihood of an incident at a particular facility is low, but the intentional adulteration of the U.S. food supply represents a very serious threat – one that could have devastating public health consequences," FDA Commissioner Scott Gottlieb said in a statement. "The goal of this draft guidance, in its entirety, is to…

The U.S. Food and Drug Administration will host a public meeting on cultured meat, poultry and seafood on July 12, 2018. In a press release, FDA Commissioner Scott Gottlieb asserted that the agency governs "both substances used in the manufacture of these products of animal cell culture technology and the products themselves that will be used for food" and grouped cultured meats with other "rapidly evolving areas of technological innovation" such as genetically engineered foods and microbial, algal and fungal cells generated and used as direct food ingredients. "The FDA remains committed to using our expertise in relevant scientific areas to evaluate the safety of emerging food technologies, such as foods generated by animal cell culture technology," according to Gottlieb's statement. "But as we mentioned, in addition to leveraging the existing expertise of our staff, we’re also investing in making sure we are considering all the unique attributes and challenges…

The U.S. Food and Drug Administration has released guidance identifying eight non-digestible carbohydrates that the agency intends to add to its list of dietary fibers—including mixed plant cell wall fibers, alginate, polydextrose and resistant maltodextrin/dextrin—because the agency has "tentatively determined that they have physiological effects that are beneficial to human health." These additions "provide industry with additional clarity to update their product labels and accurately declare dietary fiber content on the Nutrition Facts and Supplement Facts labels for consumers," according to a constituent update.

The U.S. Food and Drug Administration (FDA) has confirmed its 2015 decision removing partially hydrogenated oils (PHOs) from generally recognized as safe status by denying a food additive petition seeking approval for the use of PHOs in some foods. The agency also extended the June 2018 compliance date for removing PHOs from food, citing trade associations that "informed us that, due to shelf lives ranging from 3 to 24 months, a variety of products containing non-petitioned uses of PHOs will be in distribution on, and for some time after, the compliance date in the final order," according to the Federal Register announcement. For products manufactured before June 18, 2018, the enforcement date will be January 1, 2020. FDA has also extended the compliance date for the uses of PHOs in the food additive petition, including (i) use as a solvent or carrier for flavoring or coloring agents; (ii) use as a processing aid;…

The U.S. Food and Drug Administration (FDA) has announced the availability of "Menu Labeling: Supplemental Guidance for Industry," which includes an advisory of FDA's intent to exercise discretion regarding nutrient declarations for calories from fat. FDA has taken this position "because the current science supports a view that the type of fat is more relevant to the risk of chronic disease than the overall caloric fat intake." The guidance also addresses concerns about the implementation of nutrition labeling, includes "expanded and new examples of alternatives to aid in compliance" and details the criteria for considering natural variations in foods when determining nutritional labels.

The U.S. Food and Drug Administration (FDA) has extended the compliance date for its changes to food nutrition labels. The extension applies to rules on (i) providing updated nutrition labeling on food; (ii) defining a single-serving container; (iii) requiring dual-column labeling for certain containers; (iv) updating, modifying and establishing certain reference amounts customarily consumed; and (v) amending the label serving size for breath mints. The compliance date for manufacturers with $10 million or more in annual food sales is January 1, 2020, and the compliance date for manufacturers with less than $10 million in annual food sales is January 1, 2021.

The U.S. Food and Drug Administration (FDA) has announced a change to the common name "brown king crabmeat," derived from Lithodes aequispinus. Effective May 3, 2018, the common and usual name for crabmeat previously described as "brown king crabmeat" has been changed to “golden king crabmeat.” The compliance date for the changes is January 1, 2020.

The U.S. Government Accountability Office (GAO) has announced new food safety recommendations for managing the risk of arsenic in rice and efforts to reduce pathogens in meat and poultry products. Following a request to review issues related to arsenic in rice, GAO determined that the U.S. Food and Drug Administration (FDA) has not updated its risk assessment of the human health effects in two years and was unable to provide a timeline for either an update or final draft guidance. GAO has recommended that FDA develop such timelines, work with other agencies to coordinate risk assessments and work with the U.S. Department of Agriculture (USDA) to develop methods to detect contaminants in food. GAO also reviewed USDA’s approach to reduction of pathogens in meat and poultry, finding the agency has failed to develop standards for some products—including turkey breasts and pork chops—and has not fully documented its process for deciding…

The U.S. Food and Drug Administration (FDA) has announced a public advisory committee meeting of the Science Board, which advises the agency on complex scientific and technical issues and emerging issues within the scientific community. Written submissions on issues pending before the committee will be accepted until April 18, 2018, for the April 23 meeting.

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