2024 is poised to be a big year for food regulation, particularly as federal agencies work to implement their regulatory agendas in preparation for a possible change in administration after the 2024 election. Here are the key...more
The U.S. Food and Drug Administration (FDA) recently announced the results of its pilot program evaluating whether several third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls...more
The U.S. Food and Drug Administration (FDA) issued a draft guidance for industry on Action Levels for Lead in Food Intended for Babies and Young Children (Draft Guidance). The proposed action levels would apply to processed...more
On December 6, 2022, the Reagan-Udall Foundation for the FDA (“RUF”) issued a highly anticipated report on FDA’s Human Foods Program (the Program) capturing the findings and recommendations of a months-long independent review...more
The U.S. Food and Drug Administration (FDA) recently released its Congressional Justification for the fiscal year (FY) 2023 budget. The agency is requesting $1.2 billion for its Foods Program to be allocated to initiatives...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 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 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 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 29 March 2021 the United States District Court for the Eastern District of California entered a significant ruling temporarily halting the filing of new lawsuits by the California Attorney General and anyone else related...more
4/2/2021
/ Beverage Manufacturers ,
Chamber of Commerce ,
Commercial Speech ,
Constitutional Challenges ,
Consumer Product Companies ,
Corporate Counsel ,
First Amendment ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
OEHHA ,
Preliminary Injunctions ,
Proposition 65 ,
Retail Market ,
Toxic Chemicals ,
Warning Labels
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
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 22, 2020, the U.S. Food and Drug Administration (FDA) announced two policies to provide temporary flexibility with respect to packaged foods formulation and labeling requirements during the COVID-19 pandemic. The...more
This post summarizes two recent documents the U.S. Food and Drug Administration (FDA) issued for the Food and Agriculture Sector in response to the COVID-19 outbreak. The first, “Use of Respirators, Facemasks, and Cloth Face...more
5/1/2020
/ Agribusiness ,
Agricultural Workers ,
Coronavirus/COVID-19 ,
Farms ,
Food and Drug Administration (FDA) ,
Food Safety ,
Food Supply ,
Health & Safety Standard ,
OSHA ,
Personal Protective Equipment ,
Regulatory Requirements
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
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has issued a revised compliance guideline for substantiating animal raising claims on labels for meat and poultry products. This updated...more
1/10/2020
/ Agribusiness ,
Animal Health ,
Claim Procedures ,
Consumer Protection Laws ,
Farm Animals ,
Farms ,
Food Labeling ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
New Guidance ,
Regulatory Oversight ,
Regulatory Requirements ,
Retail Market ,
Rulemaking Process ,
Strict Compliance ,
Third-Party Service Provider ,
USDA
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
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
U.S. Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless, M.D., and Deputy Commissioner for Food Policy and Response Frank Yiannas recently issued a public statement on steps to usher the U.S. into a new era...more
Last week, the Centers for Disease Control and Prevention (CDC) released a report entitled, “Preliminary Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food – Foodborne Diseases Active...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
/ 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) 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
On Friday, November 16, 2018, the U.S. Department of Agriculture (USDA) Secretary Perdue and U.S. Food and Drug Administration (FDA) Commissioner Gottlieb announced a joint regulatory framework to oversee cell cultured...more