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
/ Comment Period ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Products . ,
Food Safety ,
Food Supply ,
Health Claims ,
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
/ 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 19 January 2021, the U.S. Department of Health and Human Services (the Department or HHS) published in the Federal Register Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The...more
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
Our team wanted to highlight a proposed rule issued by the U.S. Department of Health and Human Services (HHS) on 4 November 2020 - with only a 30-day comment period - that would establish sunset (expiration) dates for...more
The Office of Management and Budget (OMB) recently released the
Spring 2020 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
7/15/2020
/ Agribusiness ,
APHIS ,
Farms ,
Food and Drug Administration (FDA) ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
Food Supply ,
FSMA ,
Hemp ,
OMB ,
Regulatory Agenda ,
Regulatory Oversight ,
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
In March, the Food and Drug Administration (FDA) issued guidance documents, first revised on March 27, temporarily relaxing certain regulatory requirements for the production of alcohol-based hand sanitizers, to respond to...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
This memorandum summarizes recent actions the U.S. Food and Drug Administration (FDA) has taken in response to the COVID-19 outbreak. First, FDA Deputy Commissioner for Food Policy and Response Frank Yiannas issued a food...more
As the novel coronavirus crisis continues to escalate, the demand for hygienic products such as hand sanitizer has dramatically increased. In response, many businesses, such as food and industrial and beverage alcohol...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
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
/ Agribusiness ,
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
/ 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 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
/ CGMP ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Recalls ,
Food Safety ,
Food Supply ,
FSMA ,
FSVP ,
Regulatory Oversight ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP) regulation....more
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
The U.S. Food and Drug Administration (FDA) recently released an updated Fourth Edition of its Guidance for Industry entitled, “Fish and Fishery Products Hazards and Control Guidance, Fourth Edition – August 2019” (“the...more