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
/ Baby Products ,
Children's Products ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Hazardous Substances ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Toxic Chemicals
On 18 December 2020 the Interagency Food Safety Analytics Collaboration (IFSAC) announced the release of its 2018 annual report on the sources of foodborne illness involving the pathogens Salmonella, Escherichia coli (E....more
12/23/2020
/ Annual Reports ,
Centers for Disease Control and Prevention (CDC) ,
E-Coli ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
Listeria ,
Public Health ,
Salmonella ,
USDA
Dr. Stephen M. Hahn, the Commissioner of Food and Drugs for the Food and Drug Administration (FDA) issued a statement on July 10, 2020, describing the agency’s intentions and approach to resuming domestic inspections in light...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
Late yesterday, the U.S. Food and Drug Administration (FDA) announced that due to the COVID-19 pandemic the agency has temporarily postponed all domestic routine surveillance facility inspections. This announcement is not...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The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”)....more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
/ Corrective Actions ,
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
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
/ Enforcement Guidance ,
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
/ Accreditation ,
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
/ Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
FSMA ,
Health and Safety ,
Innovative Technology ,
Public Health ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management
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 U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act...more
8/16/2019
/ Enforcement Actions ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Safety ,
Foreign Suppliers ,
FSMA ,
FSVP ,
Imports ,
Public Health ,
Regulatory Violations ,
Salmonella ,
Supply Chain ,
Verification Requirements ,
Warning Letters
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
/ Agribusiness ,
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
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
/ Agribusiness ,
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) 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
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
/ Federal Budget ,
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
The U.S. Food and Drug Administration (FDA) recently released its Plant and Animal Biotechnology Innovation Action Plan (“Action Plan”). The Action Plan provides an overview of the key priorities FDA expects to pursue through...more
On September 26, 2018, the Food and Drug Administration issued a statement by FDA Commissioner Scott Gottlieb, M.D. on FDA’s commitment to disclose retailer information for certain food recalls to improve consumer safety....more
The Food and Drug Administration (FDA) has released an Excel file that lists all general inspection citations included on every FDA Form 483 (Inspectional Observations) issued for almost the past ten years, from October 2008...more