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The U.S. Food and Drug Administration (FDA or Agency) recently announced the availability of a new draft guidance titled “Conducting Remote Regulatory Assessments: Questions and Answers” (RRA Draft Guidance). Remote...more
This week, the U.S. Food and Drug Administration (FDA) issued final guidance concerning regulatory oversight of food imported from Systems Recognition Arrangement (SRA) countries. FDA employs a Systems Recognition (SR)...more
The US Food and Drug Administration (FDA) has changed its policy of allowing import entries to declare the identity of the Foreign Supplier Verification Program (FSVP) importer as “unknown.” Effective July 24, 2022, food...more
FDA announced on February 2 that it would be resuming domestic surveillance inspections across all product types, beginning on February 7, in light of declining COVID-19 rates. This announcement follows a series of inspection...more
Warning Letter Provides Insight on FDA’s Priorities - The U.S. Food and Drug Administration’s (FDA) Warning Letter to Maribel’s Sweets, Inc., provides an important look into how FDA is implementing the Food Safety...more
Shook Attorneys Present Webinar on Minimizing FDA Enforcement Risk on Food Importers - In spring 2020, the U.S. Food and Drug Administration (FDA) started regulating food importers under the Foreign Supplier Verification...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
Importing dietary supplements and dietary supplement components can present many challenges. Not the least of which are those required to stay in compliance with aspects of the Food Safety and Modernization Act (FSMA)....more
What the FDA Requires for Food Safety During the COVID-19 Pandemic - The U.S. Food and Drug Administration’s (FDA) regulatory requirements for food companies, including manufacturers and importers, remain largely unchanged...more
On April 3, 2020, the Food and Drug Administration (FDA) issued a Constituent Update notifying the public that for Foreign Supplier Verification Program (FSVP) inspections, FDA requests importers electronically send records...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
The spread of COVID-19 has led to questions for the food industry regarding the food supply chain, FDA’s role in protecting it, and changes to FDA operational procedures during the public health emergency. In response, FDA...more
On March 17, 2020, in light of the ongoing global public health emergency and associated travel restrictions, the FDA announced a temporary policy adjustment for food facilities with certain supplier verification obligations...more
The Food and Drug Administration’s (FDA) “express lane” for food importers, the Voluntary Qualified Importer Program (VQIP), is now accepting applications for the period between October 1, 2020 and September 30, 2021,...more
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
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). The document contains a...more
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
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
In a signal to industry that the period for education and enforcement discretion related to the Foreign Supplier Verification Programs (FSVP) may be concluding, the Food and Drug Administration (FDA) recently issued its first...more
The Food Safety Modernization Act (“FSMA”) ushered in a sea change in the government’s regulation of food safety. Pursuant to FSMA, the FDA has promulgated a series of rules, including a 2015 rule related to the Foreign...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
On July 30, 2019, the U.S. Food and Drug Administration (FDA) issued its first Warning Letter to an importer for violations of the Foreign Supplier Verification Program (FSVP) requirements at 21 C.F.R. Part 1, Subpart L (21...more
There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA). The below post summarizes the following topics: - Guidance on application of the Foreign Supplier...more
The Food and Drug Administration (FDA) recently posted a document on its website that lists all importers that have been identified at entry in connection with the Foreign Supplier Verification Programs (FSVP) regulation....more