Foods

The latest issue of FDLI Update features an article by Hyman, Phelps & McNamara, P.C.’s Diane B. McColl and Susan J. Matthees.  The article, titled “Nutrition Labeling: A Look at FDA’s Proposed Requirements,” provides an overview of FDA’s November 2, 2007 Advance Notice of Proposed …

On February 4, 2008, FDA announced that the Bush Administration is requesting nearly $2.4 billion ($1.77 billion in budget authority and $628 million in user fees) for the Agency as part of the Fiscal Year 2009 budget.  Of particular interest in the proposed FY2009 budget …

Over the past few weeks, Congress has taken an acute interest in a broad range of FDA issues and FDA-regulated products, penning several letters and holding or expressing intent to hold hearings and investigations on various matters.  Below is a list of recent congressional activity: On …

North Dakota-based food and dietary supplement manufacturer Swanson Health Products, Inc. (“Swanson”) filed a Citizen Petition with FDA dated January 18, 2008, requesting the Agency to “take all appropriate steps to prevent California’s Safe Drinking Water and toxic Enforcement Act (‘Proposition 65’) from being applied …

The Food and Drug Law Institute is scheduled to hold its 6th Annual Conference on Enforcement and Litigation on February 19-20, 2008.  Among other topics of discussion slated for the conference are the U.S. Sentencing Commission’s proposed guidelines that would greatly enhance the criminal penalties …

On November 2, 2007, FDA published an Advance Notice of Proposed Rulemaking (“ANPR”) to revise nutrition labeling requirements for foods and dietary supplements.  FDA’s ANPR commences perhaps the most sweeping food labeling modification effort since 1993, when FDA issued the nutrition labeling rules mandated by …

On Nov. 27, 2007, FDA published a proposed rule to restrict the use of nutrient content claims for the omega-3-fatty acids, alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA). The Agency proposes to prohibit notified nutrient content claims for EPA and DHA and …

Earlier this year, President Bush signed Executive Order 13439 establishing the Interagency Working Group on Import Safety (“Working Group”).  The Working Group, chaired by Department of Health and Human Services Secretary Mike Leavitt, was charged with conducting a comprehensive review of current import safety practices …

Title VI of the recently-enacted FDA Amendments Act (“FDAAA”) amended the FDC Act to establish a non-profit corporation whose purpose is to advance FDA’s Critical Path Initiative to “modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”  (The …

Last week we reported on an influx of food safety bills that have been and that are planned for introduction in both the U.S. House of Representatives and the U.S. Senate.  The already crowded field became a little more congested when Representative Rosa DeLauro (D-CT), …

Earlier today, Hyman, Phelps & McNamara, P.C. issued its detailed summary and analysis of the recently-enacted FDA Amendments Act (“FDAAA”).  A copy of the summary and analysis is available here.  FDAAA reauthorizes several user fee and pediatric-related laws, and includes a host of new provisions, …

In response to recent scares over tainted food imports and E.coli outbreaks in produce, several members of the U.S. House of Representatives and Senate have introduced (and plan to introduce) a variety of bills aimed at improving food safety and security.  In late September alone, …

Late today, the U.S. Senate passed FDA reform legislation by unanimous consent.  The Senate vote follows the House’s action yesterday when it passed H.R. 3580, the FDA Amendments Act of 2007.  Earlier in the day there was some concern that the Senate vote on the …

Last month we reported on a highly anticipated ruling in a case concerning whether a New York City health code regulation requiring restaurants to post calorie content values on menus and menu boards is preempted by the Nutrition Labeling and Education Act of 1990 (“NLEA”).  …

The U.S. District Court for the Southern District of New York is expected to decide soon whether a New York City regulation requiring restaurants to post calorie content values on menus and menu boards is preempted by the Nutrition Labeling and Education Act of 1990 …