FDA recently issued guidance announcing its intent to exercise enforcement discretion for several specific provisions in the agency’s regulations implementing the FDA Food Safety Modernization Act (FSMA). The guidance is...more
The Office of Management and Budget (OMB) recently released the Fall 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
The U.S. Food and Drug Administration (FDA) recently issued a final rule regarding Laboratory Accreditation for Analyses of Foods (LAAF). This memorandum summarizes the regulation. The U.S. Food and Drug Administration...more
The U.S. Food and Drug Administration (FDA) recently held a public meeting as a part of its Closer to Zero: Action Plan for Baby Foods initiative. This plan identifies steps the agency will take over the next three years...more
The U.S. Food and Drug Administration (FDA) recently hosted a three-day virtual summit on e-commerce, which focused on food safety for foods ordered online and delivered directly to consumers. Because of the increasing...more
11/16/2021
/ B2C ,
E-Commerce ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
FSMA ,
Public Comment ,
Regulatory Oversight ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) recently issued a review of work done over the last year in advancing its New Era of Smarter Food Safety (New Era) Blueprint, which was released in July 2020. In a corresponding FDA...more
For the past several years, the U.S. Food and Drug Administration (FDA) has used a “Systems Recognition” approach with its foreign regulatory counterparts, through which the FDA evaluates whether its foreign counterpart...more
The Office of Management and Budget (OMB) recently released the Spring 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This article...more
7/8/2021
/ APHIS ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
OMB ,
Regulatory Agencies ,
Regulatory Agenda ,
Regulatory Oversight ,
Rulemaking Process ,
USDA
The Food and Drug Administration (FDA or the agency) recently released a report entitled Resiliency Roadmap for FDA Inspectional Oversight (Report) recapping the inspectional activities across all parts of the agency during...more
The U.S. Food and Drug Administration (FDA) has issued a report on its recent investigation into a Fall 2020 outbreak associated with leafy greens and announced its next steps to address the safety of leafy greens. ...more
The U.S. Food and Drug Administration recently announced a new initiative called Closer to Zero, which is an action plan that identifies steps the agency will take over the next three years (and beyond) to reduce exposure to...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) released a guidance document on 1 December 2020 announcing an enforcement policy related to submission of a facility’s Unique Facility Identifier (UFI) as part of the 2020 biennial...more
The Food and Drug Administration (FDA) recently announced a pilot program to evaluate whether third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls for Human Food (PCHF) and...more
10/30/2020
/ Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
FSMA ,
FSVP ,
Regulatory Oversight ,
Regulatory Standards ,
Supply Chain ,
Third-Party Risk
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
For the first time, FDA entered into a consent decree against a firm or grower for violations of the Produce Safety Rule.
For the first time, the U.S. Food and Drug Administration (FDA) has entered into consent decree of...more
9/18/2020
/ CGMP ,
Farms ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Safety ,
Food Supply ,
Permanent Injunctions ,
Produce Safety Rule ,
Regulatory Requirements ,
Risk Mitigation ,
Supply Chain
On September 1, 2020, the Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) held a joint webinar to discuss the jointly-issued Employee Health and Food Safety Checklist for Human and...more
9/4/2020
/ Animal Food ,
CGMP ,
Coronavirus/COVID-19 ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Health and Safety ,
Infectious Diseases ,
OSHA ,
Safety Inspections ,
Social Distancing ,
Workplace Safety
The U.S. Food and Drug Administration (FDA) recently announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will...more
The U.S. Food and Drug Administration (FDA) recently released its “Blueprint for the Future” (Blueprint) as part of the New Era of Smarter Food Safety initiative. Launched in April 2019, this effort seeks to build upon FDA’s...more
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
The U.S. Food and Drug Administration (FDA) recently provided an update from FDA Commissioner Stephen Hahn M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas on the forthcoming New Era of Smarter Food...more
On May 27, 2020, the U.S. Food and Drug Administration (FDA) issued new guidance for human food establishments on voluntarily reporting to FDA temporary closures or significantly reduced production due to the COVID-19 public...more
5/28/2020
/ Animal Food ,
Business Closures ,
Coronavirus/COVID-19 ,
Farms ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Supply ,
Manufacturing Facilities ,
Restaurant Industry ,
Retailers ,
Self-Reporting
The U.S. Food and Drug Administration (FDA) recently provided an update regarding its plans for conducting routine surveillance inspections of domestic and foreign facilities during the COVID-19 pandemic. FDA announced in...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