By Ricardo Carvajal – The Notification of Opportunity to Initiate a Voluntary Recall that FDA recently issued to a pet treat manufacturer gives a good indication of the type of evidence and circumstances that can prompt the agency to exercise its new mandatory recall authority. Before …
By Ricardo Carvajal & JP Ellison – The U.S. Department of Justice ("DOJ") announced the indictment of former officials of the Peanut Corporation of America ("PCA") for their alleged role in the distribution of peanut products that were implicated in a 2008-2009 national outbreak of …
By Riëtte van Laack – On February 13, the Center for Science in the Public Interest (“CSPI”) together with a coalition of 10 public health departments, 20 national health organizations, and 41 health and nutrition experts, submitted a 55-page petition to FDA requesting that FDA review …
On January 31, 2013, Hyman, Phelps & McNamara, P.C. presented a webinar addressing the real-world implications from the Second Circuit decision in United States v. Caronia. Panelists addressed the potential impacts to the pharmaceutical, devices, dietary supplements, and tobacco industries. HP&M was quite pleased that …
By Ricardo Carvajal – FDA announced a somewhat unusual consent decree for permanent injunction in which a manufacturer of fruit and juice products agreed to retain a labeling expert (among other experts) to ensure compliance with applicable FDA regulations. In part, the government alleged that the …
By Ricardo Carvajal – FDA announced that it will host a series of public meetings on the recently issued proposed rules on preventive controls for human food and standards for produce safety. Fact sheets on the proposed rules are available here and here. The first meeting …
Hyman, Phelps & McNamara, P.C. is participating in the Food and Drug Law Institute's Food Week 2013 being held February 5 – 8 in Washington, D.C. This program provides an opportunity for food law, regulation and policy stakeholders to gather practical guidance on cutting-edge issues …
Hyman, Phelps & McNamara, P.C. will hold a complimentary webinar on Thursday, January 31, 2013, from 12:00 – 2:00 PM (Eastern) on the Second Circuit's recent and long-awaited decision in United States v. Caronia. This webinar is not just another summary of the Second Circuit's decision. Nor …
By Ricardo Carvajal – FDA released two long-awaited proposed rules to implement key provisions of the Food Safety Modernization Act ("FSMA"): Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Standards for the Growing, Harvesting, Packing, and Holding of Produce …
By Ricardo Carvajal – Signaling potential movement on an issue that has bedeviled industry, FDA published a notice requesting comments “relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens.” Undeclared major food allergens continue to be one of the two principal …
By Riëtte van Laack – District Judge Susan Nelson of the District of Minnesota recently concluded that FDA is best qualified and has been authorized by Congress to decide whether Milk Protein Concentrate (“MPC”) is a “proper, permitted ingredient in yogurt.” Earlier this year, on March …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Diane B. McColl has been elected to serve as the new President of the International Society of Regulatory Toxicology and Pharmacology (“ISRTP”). ISRTP’s mission is to provide an open public forum for policy makers and …
By Ricardo Carvajal – FDA announced that it executed a Food Safety Systems Recognition Arrangement ("RA") with its counterpart in New Zealand, the Ministry for Primary Indsutries ("PMI"). The RA is the culmination of an assessment that began in 2010 and included both paper and on-site …
By Etan Yeshua – Manufacturers of foods, drugs and cosmetics might possibly be able to label their products as “Carcinogen-Free” with federal approval. In November, Rep. Theodore Deutch (D-FL) and Rep. Sue Myrick (R-NC) introduced the "Carcinogen-Free Label Act of 2012" (H.R. 6601), which would …
As we promised in an earlier post, we provide here a deeper analysis of the Second Circuit’s holding in United States v. Caronia and the context in which it should be viewed by industry. Since the 2004 Warner-Lambert settlement, the federal government has investigated hundreds …
