On June 4, 2015, FDA published draft guidance on the Food and Drug Administration’s (FDA) Voluntary Qualified Importer Program (VQIP).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 [...]
On May 6, 2015, FDA released draft guidance relating to its authority under the Food Safety Modernization Act (FSMA) to order mandatory recalls for foods. Comments on the draft guidance should be submitted by July 6, 2015. For more information please see this regulatory alert summarizing the key points in the guidance. Please contact Erik [...]
On April 9, 2015, FDA published a proposed rule in the Federal Register (the “Proposed Rule”) to amend and update its existing regulation on food facility registration. The Proposed Rule would implement provisions of FSMA that require food facility reregistration and changes to the definition of retail food establishments. The Proposed Rule makes additional changes [...]
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 [...]
Foreign government employees can play a number of roles under the Food Safety Modernization Act (“FSMA”) to conduct audits or inspections that exporters of food to the U.S. can provide to their U.S. importers to allow the importers to satisfy Foreign Supplier Verification Program (“FSVP”) food safety on-site audit requirements. FDA issued a proposed FSVP [...]
Today the U.S. Food and Drug Administration announced that it is hosting a public meeting on the supplemental proposed FSMA rules published on September 19. The meeting will be held on November 13, 2014, from 8:30-5:30 pm. The Agency published supplemental proposed rules on the Preventive Controls for Human Food Rule, Preventive Controls for Animal [...]
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 [...]
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. [...]
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 [...]
