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Home » Topics » Regulatory » FDA

FDA
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FDA Guidance for Food Importers on Inspection Refusals

October 20, 2022

The U.S. Food and Drug Administration has released a guidance for industry that describes the actions, behaviors, and statements made by a foreign food establishment or foreign government that the agency considers to be a refusal of an FDA inspection.


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FDA Small Entity Compliance Guide for LAAF Program

October 19, 2022

To help small entities participate in or comply with the Laboratory Accreditation for Analyses of Foods (LAAF) program, the U.S. Food and Drug Administration (FDA) has published the Small Entity Compliance Guide.


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Food Safety Matters

Hughes and McEntire: FDA’s Commodity-Specific Prevention Strategies for Produce

October 17, 2022

Part of Food Safety Magazine’s series with the U.S. Food and Drug Administration (FDA), titled, “Evolution of a New Era: Advancing Strategies for Smarter Food Safety,” this episode of Food Safety Matters discusses the agency’s commodity-specific strategies to prevent foodborne illness outbreaks through FDA's Foodborne Outbreak Response Improvement Plan under the New Era of Smarter Food Safety initiative. We are joined by Stephen Hughes, Prevention Coordinator in the Office of Food Safety at FDA's Center for Food Safety and Applied Nutrition, and Dr. Jennifer McEntire, Chief Food Safety and Regulatory Officer at the International Fresh Produce Association (IFPA).


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FDA Webinar Series on Infant Formula Enforcement Discretion Transition Plan

October 12, 2022

The U.S. Food and Drug Administration (FDA) will host a series of four webinars on the Infant Formula Transition Plan for Exercise of Enforcement Discretion.


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FDA Launches Retail Program Standards Reference System

October 12, 2022

The U.S. Food and Drug Administration (FDA) has launched its Retail Program Standards Reference System, a searchable database of current Voluntary National Retail Food Regulatory Program Standards interpretations.


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FDA Study Will Evaluate Children’s Exposure to Mercury from Seafood

October 11, 2022

As part of the Closer to Zero Action Plan, the U.S. Food and Drug Administration has asked the National Academies of Sciences, Engineering, and Medicine to conduct an independent study to assess young children’s exposure to mercury from consuming seafood.


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Food Processors

Evolving Relationships Between Food Processors and Regulatory Agencies

Processors speak out about how they are coping with regulatory demands now that FDA has resumed in-person inspections
Bob Ferguson
Bob Ferguson
October 11, 2022

We have been monitoring the relationships between food processors and regulators for a number of years. Our attention to this topic started with the implementation of FSMA to watch the evolution of the FDA's enforcement posture, as well as inspection and sampling procedures related to the new requirements. Now that the FDA has resumed its regular in-person inspections, we asked processors: (1) whether they have had an inspection so far in 2022 and, if so, did FDA collect any samples; (2) now that processors are seeing inspectors again, do they still agree that FDA "educates before it regulates"; and (3) with their experiences from recent and previous inspections, what do processors wish that regulators understood better? This column presents answers from more than 300 food processors in every category on these and related regulatory questions. 


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The Incident Command System and Foodborne Illness Outbreak Investigations

The Coordinated Outbreak Response and Evaluation (CORE) Network is the coordination focal point for all FDA resources during outbreak investigations
Stelios Viazis Ph.D. Sharon Seelman M.S., M.B.A. Kari Irvin M.S. Julia Mangia M.P.H.
October 11, 2022

During foodborne illness outbreak investigations, public health and regulatory authorities collect three types of data to determine a common food consumed by ill people: epidemiologic, traceback, and laboratory. State and local partners work with FDA to conduct traceback investigations and examine the food supply chain to determine the origin of the foods identified by the epidemiologic investigations. This article looks at the benefits of using incident command system (ICS) principles during emergency response coordination activities for foodborne illness outbreaks, with input from members of the FDA's CORE Network.


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Food Safety Matters

Ep. 130. Kim Livsey: Leading a Food Safety Incident Management Team

October 10, 2022

In this episode of Food Safety Matters, we talk with Kimberly (Kim) Livsey about the interworking of the U.S. Food and Drug Administration’s (FDA’s) investigations of and responses to food safety incidents and foodborne illness outbreaks through the Incident Command System and Incident Management Teams (IMTs). Kim is a Senior Emergency Response Coordinator in FDA's Office of Regulatory Affairs' Office of Human and Animal Food Operations who has led a number of IMTs, including for a recent, high-profile foodborne illness outbreak.


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FDA Webinar on the Laboratory Accreditation for Analyses of Foods Program

October 7, 2022

On October 27, 2022, the U.S. Food and Drug Administration will hold an informational webinar discussing the new Laboratory Accreditation for Analyses of Foods program.


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Benchmarking Foreign Material Contamination in 2026: What the Data Shows

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