Yesterday, the Senate confirmed Robert F. Kennedy, Jr. as the Secretary of the Department of Health and Human Services (HHS). Shortly after his confirmation, President Trump issued an Executive Order establishing the Make...more
On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a...more
On January 31, 2023, Commissioner Califf announced a new vision for the U.S. Food and Drug Administration (FDA)’s Human Foods Program. The Proposal calls for unifying the work currently done by the Center for Food Safety and...more
Last week, the U.S. Food and Drug Administration (FDA) released a systematic review of the scientific literature on food safety culture. The review was conducted as part of FDA’s New Era of Smarter Food Safety blueprint,...more
The U.S. Food and Drug Administration (FDA) recently published draft guidance that explains the approach the agency intends to take when evaluating the public health importance of food allergens that are not one of the nine...more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
/ 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
Following a series of Warning Letters issued throughout 2020 related to recalls due to allergen labelling errors, the U.S. Food and Drug Administration (FDA) recently issued a Constituent Update emphasizing the agency’s focus...more
The U.S. Food and Drug Administration (FDA) recently issued a fifth Warning Letter related to allergen labeling, continuing a series of Warning letters in the past six months that cite companies for failing to “identify and...more
10/16/2020
/ Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food Allergies ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Recalls ,
Food Safety ,
Food Supply ,
Public Health ,
Regulatory Requirements ,
Warning Letters
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
On April 21, 2020, Chipotle Mexican Grill, Inc. (Chipotle) and the U.S. Department of Justice (DOJ) entered into a three-year deferred prosecution agreement (DPA) in connection with norovirus and Clostridium perfringens...more
In response to the COVID-19 outbreak, the U.S. Food and Drug Administration (FDA) has announced it will begin requesting that importers send the agency records required under the Foreign Supplier Verification Programs (FSVP)...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
As the novel coronavirus (COVID-19) crisis has continued to escalate, both the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have taken additional action to provide industry, the...more
3/18/2020
/ China ,
Coronavirus/COVID-19 ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Recalls ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
Food Supply ,
Infectious Diseases ,
Public Health ,
Safety Inspections ,
USDA
As you likely know, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are closely monitoring the spread of the novel coronavirus (COVID-19), a respiratory disease that has...more
3/4/2020
/ Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Health and Safety ,
Infectious Diseases ,
Policies and Procedures ,
Public Health ,
Retail Market ,
Risk Management ,
Supply Chain ,
Workplace Safety
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
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 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
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