fda (8)

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The FDA (Food and Drug Administration) is proposing additional record keeping requirements for a list of "high risk" foods under the US Food Safety Modernization Act (FSMA), which is intended to make it easier to rapidly and effectively track the movement of a food to prevent or mitigate a foodborne illness outbreak. The Food Traceability List (FTL) identifies the foods which would be covered by the new rule. The additional recordkeeping requirements would apply not only to foods specifically listed on the FTL, but also to foods that contain foods on the list as ingredients.

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The FDA (US Food and Drug Administration) is allowing temporary flexibility in food labelling requirements for manufacturers experiencing difficulty sourcing some ingredients during the COVID-19 pandemic. It has published temporary guidance to allow for minor formulation changes without updating labels, in order to help minimise the impact of supply chain disruptions associated with the current COVID-19 pandemic on product availability.

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The US agencies have issued letters to seven companies, and removed online listings from others, whose products falsely claim to prevent or treat coronavirus.

The US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued warning letters to seven companies for selling fraudulent COVID-19 products that claim to treat or prevent the virus. At current there is no approved prevention or therapy for coronavirus.

According to the agencies, the products being sold are unapproved and pose a significant risk to patient health, as they may be unsafe for consumption and/or stop or delay patients getting necessary medical diagnoses and treatments.

The companies selling these products are violating federal law and may be subject to legal action, including but not limited to seizure or injunction, emphasise the organisations.

 

 

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3885569532?profile=RESIZE_710xThe US Food and Drug Administration (FDA) has issued for consultation its third draft guidance to help the food industry defend against intentional adulteration, including by acts of terrorism as required under the Food Safety Modernization Act (FSMA). This supplemental draft guidance document, when finalised, will help the food sector that manufacture, process, pack, or hold food,to comply with the requirements of the subsidiary Regulation “Mitigation Strategies to Protect Food Against Intentional Adulteration.” The latest draft guidance has chapters covering “food defence corrective actions, food defence verification, re-analysis, and recordkeeping.” The first four chapters of the guidance were published in June 2018 and addressed how to set up a food defence plan and carry out vulnerability assessments, with preliminary guidance on mitigation. A second document published in March 2019 extended the information on vulnerability assessment and other topics including staff training. The consultation ends in June 2020.

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3820997074?profile=RESIZE_710xThe FDA has launched its Food Defense Plan Builder (FDPB) Version 2.0 software programme, which is a user-friendly tool, designed to help owners and operators of food facilities create a detailed food defence plan specific to their facility and products. It is designed to assist food operators with meeting the requirements of the Mitigation Strategies to Prevent Food Against Intentional Adulteration regulation (21 CFR Part 121) (IA rule). The software provides a simple-to-use, fill-in-the-blanks system that—when finished—can generate a complete report that is consistent with FDA’s existing regulations and guidance on food defence. While the finished report that the software generates does not constitute FDA approval of a food defence plan, the tool certainly goes a long way in helping a processor organise, create and document a detailed food defence program and strategy.

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The FDA has issued its second installment of how companies should take measures and mitigation strategies to protect themselves against intentional adulteration (IA rule), which is a requirement of the recent Food Safety Modernization Act (FSMA). The draft document is out for consultation, which closes on 5 July 2019. The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the USA. There are some exceptions including farms, except farms producing milk. Companies are required to develop/implement a food defence plan identifying vulnerabilities, and how to deal with them, and ensure they are working. The FSMA covers attacks intended to cause wide scale public health harm to humans including acts of terrorism focused on the food supply, and these are ranked as the highest risk. There is also intentional adulteration for economic gain with or without any safety implications; acts of disgruntled employees, consumers, or competitors. The IA rule is focused on addressing only acts causing wide scale public health harm, and not acts of disgruntled employees, consumers, or competitors, or acts of economic gain without public health implications. 

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The new guidance from the U.S. Food and Drug Administration aims to help food businesses understand and comply with the new Intentional Adulteration Rule, which comes into effect in July 2019. The IA Rule requires businesses to implement strategies to reduce the risk of intentional adulteration at food facilities that are particularly vulnerable.

The 94-page draft guidance, which is the first of three installments, includes chapters on the Food Defense Plan, vulnerability assessment, and mitigation strategies. The other installments will be released later in the year.

Read the full guidance here.

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The FDA is responsible for food safety enforcement of all food production except any product with a meat or poultry ingredient. This often leads to duplication of inspection by the two agencies for many producers manufacturing a range of foods. A new formal agreement between the FDA and USDA will lead to better coordination and collaboration between the two agencies in food safety inspections, the update of biotechnology regulations and the implementation of new preventative safety inspections on produce farms.

 

Read the full article at: USDA FDA Coordination

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