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  • Foods and Dietary Supplements

    • Dietary Supplement GMPs: Repeat Offenders BewareDecember 5th, 2011

      By Ricardo Carvajal -  Recent FDA actions suggest that dietary supplement firms who fail to correct deficiencies in their GMP’s do so at their peril.  For example, FDA recently filed a complaint for permanent injunction against ATF Fitness Products, Inc. et al. ("ATF"), a manufacturer and …

    • When “All Natural” Isn’tDecember 1st, 2011

      By Ricardo Carvajal – FDA issued a warning letter to a food manufacturer for labeling as “all natural” a product that contains disodium dihydrogen pyrophosphate, purportedly a synthetic chemical preservative.  The letter cites an alleged violation of FDC Act § 403(a)(1), under which a food is …

    • In Sugar v. HFCS (aka “Corn Sugar”), A Message For Trade Association MembersNovember 20th, 2011

      By Ricardo Carvajal – Late last month, a district court issued a ruling of interest in a Lanham Act case brought by sugar producers and trade associations against corn refiners and the Corn Refiners Association ("CRA") over their marketing of high fructose corn syrup ("HFCS").  The …

    • Congress Asks GAO to Examine Adverse Event Reporting for Dietary SupplementsNovember 15th, 2011

      By Riëtte van Laack – On November 8, 2011, Senator Durbin and Representative Waxman requested that the U.S. Government Accountability Office ("GAO") determine how the adverse event reporting ("AER") for dietary supplements system is working.  Since December 22, 2007, pursuant to the Dietary Supplement and Nonprescription …

    • Burton Proposes New Grandfathered Dietary Ingredient Date of January 1, 2007November 9th, 2011

      By Riëtte van Laack – Last week, Rep. Dan Burton (R-IN) introduced the “Dietary Supplement Protection Act of 2011.”  Referencing the exemplary safety record of dietary supplements, the bill proposes to amend section 413(d) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to significantly …

    • New Citizen Petition Asks FDA to Revoke Notice of FSMA User FeesNovember 4th, 2011

      By Susan J. Matthees – The American Council of Independent Laboratories (“ACIL”), the Association of Food Industries, and the Cheese Importers Association of America, Inc. recently petitioned FDA to revoke or partially revoke its Federal Register notice announcing Food Safety Modernization Act (“FSMA”) user fees amounts …

    • IOM Recommends a Single, Standard FOP Symbol System for FoodsNovember 3rd, 2011

      By Cassandra A. Soltis – The Institute of Medicine (“IOM”) recently issued its Phase II report on consumer use and understanding of front-of-package (“FOP”) labeling systems for foods, recommending that both the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”) “consider …

    • Nanotech Roundup: Foods v. Drugs, the EC Definition, and NNI’s EHS Research StrategyOctober 30th, 2011

      By Ricardo Carvajal –  NIH and USDA announced a joint workshop on Using Nanotechnology To Improve Nutrition Through Enhanced Bioavailability and Efficacy.  Among the goals of the workshop are to “identify knowledge gaps in the use of nutrients (and bioactive food components) for disease prevention,” and to …

    • FDA Updates Guidance on Administrative Detention of FoodOctober 27th, 2011

      By Ricardo Carvajal –  FDA updated its guidance on administrative detention of food to reflect the expansion of the agency’s authority under the Food Safety Modernization Act ("FSMA").   As we noted in a prior blog posting, the FSMA made it easier for FDA to administratively …

    • 7th Circuit Affirms Dismissal of Fiber Case, With Prejudice, Largely On Preemption GroundsOctober 24th, 2011

      By Ricardo Carvajal – The 7th Circuit Court of Appeals affirmed a district court’s dismissal of an action alleging consumer fraud in food labeling claims for fiber.  As we noted in a prior posting, Plaintiff alleged that Defendants violated state consumer fraud laws by failing to …

    • Kidvid Flashbacks? FTC Considers Curtailing Proposed Voluntary Principles for Marketing Food to ChildrenOctober 18th, 2011

      By Cassandra A. Soltis – Earlier this year, we reported on the Interagency Working Group’s (“IWG’s”) proposed voluntary principles for marketing food to children.  The IWG includes representatives from the Federal Trade Commission (“FTC”), the Centers for Disease Control and Prevention, the Food and Drug Administration, …

    • 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 …