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FDA Announces FSMA Fees for Fiscal Year 2016

FDA is announcing the Domestic and Foreign Facility Reinspections, Failure to Comply with Recall Orders, and Certain Importer Reinspections User Fee Rates for Fiscal Year 2015.  The fees are $221 per hour if domestic travel is required and $315 per hour if foreign travel is required.  More information may be found in the FY 2016 Fee [...]

FDA Releases Voluntary Qualified Importer Guidance

On June 4, 2015, FDA published draft guidance on the Food and Drug Administration’s (FDA) Voluntary Qualified Importer Program (VQIP).  Please see this Lieberman PLLC Regulatory Alert for additional information.  The Food Safety Modernization Act (FSMA) required FDA to establish VQIP.  VQIP is a voluntary, fee-based program that provides for expedited review and importation of [...]

By |2016-10-30T01:15:05-04:00June 12th, 2015|FDA, FSMA, Imports, VQIP|0 Comments

Webinar–FSMA: Opportunities for Foreign Governments

On November 20, 2014, Erik Lieberman held a webinar on opportunities for foreign governments under the Food Safety Modernization Act (FSMA).  FSMA provides for a number of specific roles foreign governments can play in assisting their food exporters to the U.S. in complying with the law.  The webinar reviewed the proactive steps governments of foreign countries [...]

WTO COOL Ruling: What does it mean for the food industry?

On October 20, 2014, a World Trade Organization (WTO) Dispute Settlement Panel (DSP) issued a report which ruled that the revised Country of Origin Labeling (COOL) regulation finalized by USDA in May 2013 (2013 Final Rule) did not make the COOL laws and regulations as applied to beef and pork compliant with the Technical Barriers to [...]

FSMA Update Webinar

On October 2, 2014, Erik R. Lieberman of Lieberman PLLC conducted a webinar on the Food Safety Modernization Act (FSMA) which reviewed the regulations issued to date by the U.S. and Food and Drug Administration (FDA), and provided a look ahead to the future regulations FDA is required to issue under the law.  A replay of [...]

FSMA Food Facility Reregistration Period Begins Oct. 1

The Food Safety Modernization Act (FSMA) requires facilities that are required to register under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Sec. 415 of the Federal Food, Drug and Cosmetic Act) to reregister with the U.s> Food and Drug Administration (FDA) on every even-numbered year.  This requirement applies to both U.S. [...]

Webinar on FSMA Supplemental Proposed Rules

On September 25, 2014, Erik Lieberman held a webinar to review the supplemental proposed rules released by the U.S. Food and Drug Administration (FDA) on September 19 to implement the Food Safety Modernization Act (FSMA).  The revisions apply to the following rules: Preventive Controls for Human Food, Preventive Controls for Animal Food, Foreign Supplier Verification [...]

Criminal Prosecutions of Corporate Officers Under FD&C Act Highlight Importance of FSMA Compliance

On September 19, 2014, Stewart Parnell, the former owner and president and CEO of Peanut Corporation of America was found by a twelve member jury guilty of 67 federal felony counts associated with a massive Salmonella outbreak in 2008. His brother, Michael Parnell, who served as vice president of the company, was found guilty on [...]

By |2014-09-23T10:07:37-04:00September 23rd, 2014|FDA, Food, Food Safety, Food Safety Modernization Act, Imports, Park Doctrine|0 Comments

FDA Releases Revised Proposed FSMA Rules

On September 19, 2014, the Food and Drug Administration released four revised proposed rules to implement the Food Safety Modernization Act (FSMA).  The revisions apply to the following rules: Preventive Controls for Human Food, Preventive Controls for Animal Food, Foreign Supplier Verification Program, and Produce Safety.  The revisions address some of the key—and most controversial—aspects [...]

FDA Announces FSMA Fees for Fiscal Year 2015

FDA is announcing the Domestic and Foreign Facility Reinspections, Failure to Comply with Recall Orders, and Certain Importer Reinspections User Fee Rates for Fiscal Year 2015.  The fees are $217 per hour if domestic travel is required and $305 per hour if foreign travel is required.  More information may be found in the FY 2015 Fee [...]

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