Donnelly McDowell on Food Safety

In Wake of COVID-19, FDA Scales Back Food Facility Inspections and Takes Other Steps to Reassure Americans and Protect the Food...

This week, the Food & Drug Administration (FDA) made a series of announcements in connection with its efforts to address the outbreak of COVID-19. The Agency sought to reassure the American public that the U.S. food supply...more

3/23/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Food Safety , Food Supply , Infectious Diseases

FDA Releases First in Series of Draft Guidances Regarding Mitigation Strategies to Protect Against Intentional Adulteration

On June 20, 2018, the Food and Drug Administration (“FDA”) released draft guidance for companies required to comply with the FDA’s final rule, “Mitigation Strategies to Protect Food Against Intentional Adulteration” (“IA...more

7/3/2018 / Administrative Agencies , Draft Guidance , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , FSMA , Vulnerability Assessments

FDA Releases Guidance Regarding Strategies to Protect Against Food Adulteration

On June 20, 2018, the FDA released draft guidance regarding the FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration Rule (IA Rule). This is the first of three installments of guidance the FDA plans...more

7/2/2018 / Administrative Agencies , Draft Guidance , Food and Drug Administration (FDA) , Food Safety

FDA to Hold Public Meeting on Foods Produced Using Animal Cell Culture Technology

The FDA recently announced that it will hold a public meeting entitled, “Foods Produced Using Animal Cell Culture Technology,” on July 12, 2018 to provide the public with an opportunity to offer feedback related to the...more

6/21/2018 / Comment Period , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Public Meetings

“Challenges Remain” for FDA’s Inspections of Food Facilities, According to Inspector General Report

While FDA is on track to meet the initial inspection timeframes specified under the Food Safety Modernization Act (FSMA), questions remain about the effectiveness of those inspections and the capacity for FDA to meet future...more

10/3/2017 / Food and Drug Administration (FDA) , Food Safety , FSMA , Inspections , Inspector General

Senate Hearing on FDA Commissioner Nominee Scott Gottlieb Provides Insights on the Future of Food Safety and Labeling

Last Wednesday, April 5, the Senate Committee on Health, Education, Labor, & Pensions held a hearing on the nomination of Scott Gottlieb, MD, as Commissioner of the Food and Drug Administration. As part of the hearing,...more

4/13/2017 / Antibiotic Resistance , Food and Drug Administration (FDA) , Food Labeling , Food Safety , FSMA , GMO

FDA Continues FSMA Implementation, Finalizes Guidance on Voluntary Qualified Importer Program to Expedite Food Imports

The Food & Drug Administration (FDA) released last week a final version of its guidance for industry on the Voluntary Qualified Importer Program (VQIP), which will provide a mechanism for eligible food importers to expedite...more

11/21/2016 / Audits , Food and Drug Administration (FDA) , Food Safety , Foreign Suppliers , FSMA , FSVP , Imports

FDA Releases Draft Guidance on Determining What Constitutes a “Qualified Facility” under FSMA Preventive Controls Rules

On Friday, the FDA announced the availability of a draft guidance describing its current thinking on how to determine whether a business is a “qualified facility” that is subject to modified requirements under its previously...more

5/17/2016 / Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , FSMA

FDA Partially Stays Controversial Policy of Requiring INDs for Clinical Studies Evaluating Food, Dietary Supplements and Cosmetics

On Friday, October 30, 2015, FDA issued a Federal Register notice announcing a partial stay of the agency’s controversial Final IND Guidance entitled, “Investigational New Drug Applications—Determining Whether Human Research...more

11/11/2015 / Administrative Stay , Clinical Trials , Cosmetics , Dietary Supplements , Draft Guidance , Food and Drug Administration (FDA) , Food Safety , Investigational New Drug Application (IND)

FDA Releases Draft Guidance on Voluntary Qualified Importer Program

The FDA announced last week the release of a draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act (FSMA). The draft guidance...more

6/10/2015 / Draft Guidance , Food and Drug Administration (FDA) , Food Safety , Foreign Suppliers , FSMA , Importers

Donnelly McDowell

Kelley Drye & Warren LLP

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