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  • Foods and Dietary Supplements

    • Philadelphia Petitions FDA for Exemption from Menu LabelingOctober 17th, 2011

      By Susan J. Matthees – We recently learned that on August 30, 2011, Philadelphia petitioned FDA pursuant to FDC Act § 403A(b) to request that FDA exempt Philadelphia from federal menu labeling requirements.  As far as we know, this is the first petition for an exemption …

    • In a First, FDA Seizes Administratively Detained FoodOctober 13th, 2011

      By Ricardo Carvajal – FDA announced its first seizure of a food that was administratively detained pursuant to FDA’s expanded authority under the Food Safety Modernization Act ("FSMA").  FSMA amended the FDC Act to make it easier for FDA to exercise the administrative detention authority that …

    • Biotech Opponents Argue that GE Foods are Materially Different from Conventional FoodOctober 12th, 2011

      By Riëtte van Laack – On October 4, 2011, the Center for Food Safety (“CFS”) announced the filing of what it touts as “a groundbreaking new legal petition” with FDA, demanding that FDA issue regulations that require the labeling of all food produced using genetic engineering.  …

    • Regulatory Science vs. Talk Show ScienceOctober 4th, 2011

      By Ricardo Carvajal -  It almost escaped our notice – a blog posting by FDA asserting that “there is currently no evidence to suggest a public health risk from fruit juices, including apple juice” (emphasis added).  The posting went up the same day as the airing …

    • A Very Full Plate: FDA’s 5-Year Plan for FoodsOctober 3rd, 2011

      By Ricardo Carvajal – FDA released an ambitious Draft Strategic Plan for 2012-2016 to guide the activities of its Foods and Veterinary Medicine ("FVM") Program (meaning the activities of CFSAN and CVM, as well as ORA’s food-related activities).  The Plan articulates priorities organized around the following …

    • Class Action Lawsuit Alleges Bear Naked Foods Not “Natural”September 28th, 2011

      By Cassandra A. Soltis – There is yet another lawsuit to add to the growing list of class actions against companies marketing foods bearing “natural” claims.  On September 21, 2011, a class action complaint was filed in California against Bear Naked, Inc. (“Bear Naked” or “the …

    • HPM Attorney to Present at Upcoming Conferences on Food Law and PolicySeptember 20th, 2011

      Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be presenting at the following upcoming conferences on food law and policy. The ASQ Food, Drug, and Cosmetic Division's 22nd West Coast Conference on Dietary Supplement Challenges will address cGMPs, analytical issues, the FSMA, and FDA’s draft guidance …

    • Court Sides With Government in Case Alleging Adulteration, But Deems Injunction Request OverbroadSeptember 15th, 2011

      By Wes Siegner, John R. Fleder & Ricardo Carvajal – In U.S. v. Scenic View Dairy, LLC, et. al., the government prevailed on summary judgment in an injunction action against dairy farms alleged to market cows bearing unlawful drug residues.  Although nominally a veterinary drug case, …

    • FDA and FSIS Request Information on Sodium ReductionSeptember 14th, 2011

      By Ricardo Carvajal – FDA and FSIS have published a notice seeking information on issues related to reduction of dietary sodium.  Last year, the CDC determined that the government’s recommendation to limit sodium to no more than 1,500 mg/day applied to nearly 70% of adults (those …

    • Another Reminder: Nutrition Labeling of Single Meat and Poultry Products is Coming SoonSeptember 12th, 2011

      By Riëtte van Laack – As we previously reported, on December 29, 2010, the Food Safety Inspection Service ("FSIS") published its final rule on nutrition labeling of single ingredient meat and poultry products and ground or chopped meat and poultry products. The new rule requires nutrition …

    • Is a Bioengineered Food “100% Natural”?September 11th, 2011

      By Ricardo Carvajal – That question is presented in class actions recently filed against ConAgra Foods, Inc. in California and New York.  The complaint in the California case alleges that ConAgra’s labeling and advertising of Wesson Oils as “100% natural” violates California law because the oils …

    • FDA Grants 60-Day Extension to Comment on NDI GuidanceSeptember 8th, 2011

      On September 9, 2011, FDA will publish in the Federal Register a notice granting a 60-day extension, until December 2, 2011, to file comments on the draft guidance on New Dietary Ingredient (“NDI”) notifications that the Agency issued on July 5, 2011 (see our previous …

    • New Twist In “Natural” LawsuitSeptember 7th, 2011

      By Riëtte van Laack – On August 24, 2011, another class action suit regarding “natural” food labeling claims was filed in the Southern District of California.  The defendants include Kashi Co. (“Kashi”) and its general manager, as well as Kashi’s parent Kellogg Co. and its President …

    • NRDC Doggedly Pursues Action on BPAAugust 29th, 2011

      By Ricardo Carvajal – In June, we reported that the DC Circuit Court of Appeals decided it lacked exclusive jurisdiction over a Natural Resources Defense Council (“NRDC”) citizen petition seeking FDA action against BPA.  Undeterred, NRDC has now filed its complaint in district court.  The complaint …

    • FDA Maintains That Preparation of an NDI Notification Takes 20 HoursAugust 25th, 2011

      By Riëtte van Laack – Under the law, a manufacturer of a new dietary ingredient ("NDI") or a dietary supplement containing an NDI must notify FDA of the basis for the manufacturer’s conclusion that its product “will reasonably be expected to be safe.”  FDA’s regulation, 21 …