On May 27, 2016, the U.S. Food and Drug Administration (FDA) published the final Food Defense Rule pursuant to the Food Safety Modernization Act (FSMA). The rule requires certain U.S. and foreign facilities that process and pack food to write and implement a written food defense plan, including a vulnerability assessment. Please see this Lieberman [...]
Lieberman PLLC has released an updated comprehensive timeline of U.S. Food and Drug Administration (FDA) actions to implement the Food Safety Modernization Act (FSMA) dated May 18, 2016. The timeline is available for download here. The timeline contains both past actions of FDA and future actions required of the Agency by FSMA. All of the major [...]
On May 13, 2016, the U.S. Food and Drug Administration (FDA) released draft guidance for industry on Qualified Facilities under the Food Safety Modernization Act (FSMA) Preventive Controls Rules for Human and Animal Food (“Preventive Controls Rules”). Qualified Facilities enjoy less stringent regulatory obligations under the Preventive Controls Rules. Certain Qualified Facilities however are subject [...]
On April 16, Erik Lieberman of Lieberman PLLC conducted a webinar reviewing the final rule implementing the Sanitary Food Transportation Act. The final rule has been issued pursuant to the Food Safety Modernization Act (FSMA). The Rule will have significant impacts on shippers, carriers, loaders and receivers. The replay may be viewed here. For more [...]
On October 6, 2015, the U.S. Food and Drug Administration (FDA) published a document entitled “FDA’s Strategy for FSMA Training-Who Will Provide Training for the Food Industry? Public and Private Partners Working Together” which summarizes the major components of FDA’s training strategy pertaining to implementation of the Food Safety Modernization Act (FSMA). Please see this [...]
Learn the details of the most signficant new food regulations in generations and how they impact your business. On August 30, 2015, FDA released the final rule on Preventive Controls for Human Food. The rule imposes sweeping new requirements on food facilities, including manufacturing plants and distribution centers. Compliance is required starting in 2016. Join [...]
On September 10, 2015, the U.S. Food and Drug Administration (FDA) released the final Preventive Controls for Human and Animal Food Rules. These historic rules impose sweeping new requirements—and liabilities—on the food industry. The rules apply to U.S. and foreign food facilities the produce food for consumption in the U.S. The Preventive Controls for Human Food [...]
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 [...]
On July 23, 2015, the U.S. Food and Drug Administration (FDA) released draft Model Accreditation Standards for Third-Party Auditor /Certification Body Accreditation pursuant to the Food Safety Modernization Act (FSMA). FDA also released a proposed rule on user fees for participation in the program. Please see this Lieberman PLLC Regulatory Alert which summarizes the key [...]
Lieberman PLLC is pleased to announce that Erik Lieberman, principal of Lieberman PLLC and president of U.S. Food Imports LLC has been named to the Food Safety Preventive Controls Alliance (FSPCA) International Subcommittee. The FSPCA is a public-private partnership created by the U. S. Food and Drug Administration (FDA), and the Illinois Institute of Technology’s Institute for [...]
