The U.S. Food and Drug Administration (FDA) recently issued a new food allergen-focused chapter of its Hazard Analysis and Risk-Based Preventive Controls for Human Food draft guidance. The new chapter addresses allergen...more
FDA published a final rule “Requirements for Additional Traceability Records for Certain Foods” designed to improve the agency's ability to rapidly track and trace food through the supply chain. The final rule maintains the...more
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 U.S. Department of Agriculture (USDA or the department) recently announced plans to invest more than US$4 billion to strengthen critical supply chains under President Biden’s “Build Back Better” initiative....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
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
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
The United States Department of Agriculture (USDA) recently updated its Frequently Asked Questions (FAQs) webpage regarding COVID-19 to include a section on President Trump’s Executive Order (EO) invoking the Defense...more
This week, President Donald Trump issued an Executive Order invoking the Defense Production Act (DPA) to protect the meat and poultry production supply chain. In the Executive Order, entitled, Delegating Authority Under The...more
Yesterday, the U.S. Food and Drug Administration (FDA) posted on its website a conversation with FDA Deputy Commissioner for Food and Policy Response Frank Yiannas that addresses common questions concerning food availability...more
The Department of Homeland Security’s (DHS’s) Cybersecurity & Infrastructure Security Agency (CISA) has issued recommendations to address hand sanitizer shortages. CISA has identified that the problem of hand sanitizer...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
As the novel coronavirus crisis continues to escalate, state and local governments have begun implementing increasingly aggressive measures, including restrictions on when and which businesses may operate, quarantines,...more
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 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
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
The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule...more