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    • Have a Happy (And Safe) ThanksgivingNovember 24th, 2010

      By Ricardo Carvajal – It’s the time of year for holiday food safety alerts.  The home kitchen has long been recognized as a significant source of foodborne illness.  Reliable data are hard to come by, but a recent survey and study suggest that consumer awareness and …

    • FDA and FTC Target Caffeinated Alcoholic Malt BeveragesNovember 23rd, 2010

      By Ricardo Carvajal & Diane B. McColl – FDA issued warning letters to the manufacturers of certain caffeinated alcoholic malt beverages contending that the products are adulterated under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) because caffeine is not an approved food additive for …

    • Publish and Perish: A Disturbing Trend in the European Union’s Regulation of Nutrition Health Claims Made on FoodsNovember 19th, 2010

      By Ricardo Carvajal – An article in the current edition of the Food and Drug Law Institute’s Update discusses a recent development in the European Union's regulation on health claims used in food labeling that could have the effect of suppressing publication of scientific research on …

    • Trans Fat Labeling: Another Court Finds in Favor of PreemptionNovember 8th, 2010

      By Ricardo Carvajal – A California district court dismissed a class action lawsuit alleging that baked-goods products manufactured by Hostess Brands, Inc. are marketed in violation of California law because they are promoted as containing “0 grams of Trans Fat” despite containing partially hydrogenated oils.  The …

    • FDA Announces Meeting on Human MilkOctober 31st, 2010

      By Ricardo Carvajal – FDA announced that its Pediatric Advisory Committee will meet on December 6 to “obtain and discuss information and data that will provide the Agency with a better understanding of current practices, and potential benefits and risks associated with the donation and banking …

    • IOM Charts Narrow Course for FOP LabelingOctober 21st, 2010

      By Ricardo Carvajal – The Committee on Examination of Front-of-Package Nutrition Rating Systems and Symbols (part of the Food and Nutrition Board at the Institute of Medicine of the National Academies) recently released a report on the first phase of its study of front-of-package ("FOP") nutrition …

    • Of Fish, Milk, and Beets: Biotech Heats Up (Again)October 4th, 2010

      By Ricardo Carvajal – No sooner did FDA hold its advisory committee meeting and public hearing on bioengineered AquAdvantage salmon than Congressional representatives made their displeasure known with the prospect of FDA approval.  In addition to signing on to letters of protest to the Commissioner (here …

    • FDA Releases Draft Guidance on Acidified FoodSeptember 30th, 2010

      By Ricardo Carvajal – FDA announced the availability of a draft guidance on acidified food intended to help processors determine whether their products are subject to the current good manufacturing practice ("CGMP") requirements in 21 CFR part 114 and the “Specific Requirements and Conditions for Exemption …

    • Fiber Case Gets FlushedSeptember 15th, 2010

      By Ricardo Carvajal – A district court dismissed a complaint alleging consumer fraud in food labeling that highlights the presence of fiber.  Plaintiff alleged that defendants violated state consumer fraud laws by failing to disclose that their products contain alleged “non-natural” fibers that “have not …

    • Sen. Leahy Introduces the Food Safety Accountability Act of 2010September 14th, 2010

      By Kurt R. Karst –    Earlier this week, Senator Patrick Leahy (D-VT) introduced the Food Safety Accountability Act of 2010 (S. 3767).  The bill, which follows Sen. Leahy’s Food Safety Enforcement Act of 2010 (S. 3669) introduced earlier this year and the recent egg …

    • FDA Continues Clamp-down on Antioxidant ClaimsSeptember 9th, 2010

      By Ricardo Carvajal – In late August, FDA issued warning letters to Unilever and Dr. Pepper Snapple Group objecting to the use of unauthorized nutrient content claims for antioxidants in the labeling of certain products containing green tea.  Similar warning letters addressing other types of …

    • FDA Announces Public Hearing and Advisory Committee Meeting on Genetically Engineered SalmonAugust 29th, 2010

      By Riëtte van Laack – In anticipation of the possible approval of the New Animal Drug Application (“NADA”) for genetically engineered AquAdvantage Salmon (“GE salmon”), FDA announced a public hearing on September 21, 2010, concerning the labeling of food made from such salmon.  This is …

    • Judges Ask FDA: What is “Natural”?August 26th, 2010

      By Ricardo Carvajal – In several cases that challenge food marketers’ use of the term “natural” in labeling and advertising, the presiding judges have recently opted to suspend proceedings and seek an administrative determination from FDA as to whether high fructose corn syrup ("HFCS") qualifies …

    • FDA Announces Availability of Two New Draft Guidance Documents on Implementation of PPACA Section 4205August 26th, 2010

      By Susan J. Matthees – FDA announced yesterday the availability of two new draft guidance documents regarding implementation of the menu labeling provisions of section 4205 of the Patient Protection and Affordable Care Act (“PPACA”).  As we reported last month, FDA requested comments on how …

    • CVM Shifts Focus on Feed IngredientsAugust 19th, 2010

      By Diane B. McColl – According to Sharon Benz, Ph.D., Director of the Division of Animal Feeds in FDA's Center for Veterinary Medicine ("CVM"), CVM is moving away from enforcement discretion for new animal feed/pet food ingredients.  In a conversation with HP&M's Diane McColl, Dr. …