On May 6, 2015, FDA released draft guidance relating to its authority under the Food Safety Modernization Act (FSMA) to order mandatory recalls for foods. Comments on the draft guidance should be submitted by July 6, 2015.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 [...]
The U.S. Food and Drug Administration (FDA) has announced that they will be holding a national meeting regarding the beginning of their implementation of the Food Safety Modernization Act (FSMA). The meeting will be held in Washington, DC, from April 23-24, 2015. More details on the meeting may be found here. Please contact Erik Lieberman [...]
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 [...]
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 [...]
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 [...]
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 [...]
