The U.S. Food and Drug Administration (FDA) has released draft options for a new voluntary “healthy” symbol for packaged foods to depict the nutrient content claim. As previously noted, on 7 May 2021 the FDA issued a notice...more
The U.S. Food and Drug Administration (FDA) has recently signaled its continued interest in developing a voluntary “healthy” symbol for packaged foods as a representation of the nutrient content claim....more
5/10/2021
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Nutrition Facts Labels ,
Product Labels ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Standards ,
Rulemaking Process
The U.S. Food and Drug Administration (FDA) recently issued updated guidance that extends agency enforcement discretion over compliance with the requirement that domestic and foreign food facilities provide a unique facility...more
On 5 March 2021, the U.S. Food and Drug Administration (FDA) issued a letter to baby and toddler food manufacturers and processors covered by the preventive control provisions of the Current Good Manufacturing Practice,...more
3/9/2021
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Children's Products ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
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Hazardous Substances ,
Public Health ,
Regulatory Agenda ,
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Regulatory Requirements ,
Toxic Chemicals
On May 1, 2020, Blue Bell Creameries L.P. (Blue Bell) and the U.S. Department of Justice (DOJ) entered into two separate agreements related to the 2015 listeriosis outbreak linked to Blue Bell ice cream. This memorandum...more
As we face huge challenges from COVID-19, I am reminded daily of the parallels we faced in the 9/11 aftermath and related Anthrax incident nearly 20 years ago when I was Director of FDA’s Center for Food Safety and Applied...more
This post summarizes the U.S. Food and Drug Administration (FDA) Compliance Program Guidance Manual (CPGM) for food facilities subject to preventive controls and sanitary human food operation requirements. As an overview,...more
The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”)....more
2/20/2020
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Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
FSMA ,
Public Health ,
Recordkeeping Requirements ,
Regulatory Oversight ,
Regulatory Requirements ,
Rulemaking Process ,
Verification Requirements
The Office of Management and Budget (OMB) recently released the Fall 2019 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
12/19/2019
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APHIS ,
Farms ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
Food Supply ,
FSMA ,
Imports ,
OMB ,
Regulatory Agenda ,
Regulatory Oversight ,
Rulemaking Process ,
USDA
On November 6, 2019, the Food and Drug Administration (FDA) announced in a Constituent Update that it will continue to exercise enforcement discretion with respect to certain supply-chain program requirements applicable to...more
11/18/2019
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Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
FSMA ,
Hazardous Substances ,
Public Health ,
Regulatory Oversight ,
Risk Management ,
Suppliers ,
Supply Chain ,
Verification Requirements
The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization Act (FSMA)....more
11/14/2019
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Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
FSMA ,
FSVP ,
Imports ,
Laboratory Developed Tests ,
Proposed Rules ,
Public Health ,
Regulatory Oversight ,
Regulatory Requirements ,
Rulemaking Process ,
Test Guidelines
The Food and Drug Administration (FDA) issued a final rule to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to comply with the vending machine calorie labeling requirements. The...more
10/29/2019
/ Disclosure Requirements ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Nutrition Facts Labels ,
Public Health ,
Regulatory Oversight ,
Regulatory Requirements ,
Rulemaking Process ,
Vending Machines
On October 21, 2019, the U.S. Food and Drug Administration (FDA) held a public meeting to engage stakeholders on the agency’s initiative, “A New Era of Smarter Food Safety,” to build on the advances that have been and are...more
10/25/2019
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Food Contamination ,
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Health and Safety ,
Innovative Technology ,
Public Health ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management
The U.S. Food and Drug Administration (FDA) has launched two new online dashboards that track key metrics reflecting the impacts from the FDA Food Safety Modernization Act (FSMA) regulations. The dashboards are part of...more
10/11/2019
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Food and Drug Administration (FDA) ,
Food Contamination ,
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Food Recalls ,
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Regulatory Oversight ,
Regulatory Requirements
The Food and Drug Administration (FDA) recently announced the launch of an updated version of the Food Defense Plan Builder Version 2.0 (FDPB) to help companies meet the requirements of the final rule “Mitigation Strategies...more
The Food and Drug Administration (FDA) recently announced it will hold a full-day public meeting on October 21, 2019, regarding “A New Era of Smarter Food Safety.” As explained in more detail in this memorandum, as part of...more
Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the laboratory accreditation provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the...more
8/27/2019
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Clinical Laboratory Testing ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Foreign Suppliers ,
FSMA ,
Regulatory Oversight ,
Regulatory Requirements
FDA recently released a Draft Guidance for Industry entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” (“Draft Guidance”). The Draft Guidance addresses the growing, harvesting,...more
7/3/2019
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Draft Guidance ,
Farms ,
Food and Drug Administration (FDA) ,
Food Borne Bacteria ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
FSMA ,
Public Health ,
Regulatory Oversight ,
Rulemaking Process ,
Seeds
The Office of Management and Budget (OMB) recently released the Spring 2019 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand...more
3/29/2019
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Biotechnology ,
Cooperative Agreements ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
FSMA ,
GMO ,
Imports ,
Public Health ,
Regulatory Standards ,
Safety Inspections ,
Safety Precautions
The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of...more
The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was...more
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently issued a statement affirming that Produce Safety Rule inspections will begin this spring. Last year FDA chose to delay routine inspections to allow...more
2/14/2019
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Farms ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Inspection Rights ,
Produce Safety Rule ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Standards ,
Safety Precautions
What are the 3 letters that should strike fear into the heart of every food executive? No, the 3 letters are not F-D-A. Although the Food and Drug Administration is quite powerful, the agency can only wield that power...more
As previously reported, the Food and Drug Administration (FDA) and the U.S Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) are operating under significantly reduced functions since funding for the...more
1/14/2019
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Federal Funding ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Recalls ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
Government Shutdown ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Safety Inspections ,
Trump Administration ,
US-Mexico Border Wall