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    • Indiana Joins NYC’s Efforts to Combat Obesity; House Passes Menu Labeling BillMarch 6th, 2009

      By Cassandra A. Soltis –       The Indiana Senate is currently reviewing House Bill No. 1207, passed by the House on February 25, 2009, which would require food establishments having 20 or more locations in Indiana to post both calorie and carbohydrate information “in a manner that …

    • A Pig is a Pig Even if it Has Only Three Legs, is Laying Down or is FatiguedMarch 3rd, 2009

      By Riëtte van Laack – The Eastern District Court of California enjoined California from enforcing California's Penal Code Section 599f against federally inspected swine slaughterhouses on the ground that section 599f is expressly preempted by the Federal Meat Inspection Act (“FMIA”).  Section 599f prohibits a slaughterhouse …

    • States Take Action to Limit Enviga Green Tea Beverage Weight Loss ClaimsMarch 3rd, 2009

      By Cassandra A. Soltis – A settlement agreement reached between numerous state attorneys general and Coke, Nestle, and Beverage Partnership Worldwide makes clear that it is not just the Federal Trade Commission that is scrutinizing weight loss claims.  The target of the attorneys general action …

    • Guilty Pleas Announced in Adulterated Tomato Products CaseFebruary 26th, 2009

      By John R. Fleder, Douglas B. Farquhar & Ricardo Carvajal – The U.S. Attorney for the Eastern District of California  (Sacramento) has announced guilty pleas by two individuals for fraudulent activities in connection with their distribution of tomato products.  Allegedly at the direction of her superiors …

    • FDA Can’t Always Get What it Wants In Seafood HACCP CaseFebruary 26th, 2009

      By John R. Fleder, Douglas B. Farquhar & Ricardo Carvajal – FDA has obtained summary judgment and an order of permanent injunction against a Minnesota seafood supplier that was found to have had an inadequate HACCP plan for more than three years, in violation of FDC …

    • Second Circuit Upholds NYC Regulation Mandating Calorie Disclosure in RestaurantsFebruary 18th, 2009

      By Ricardo Carvajal The Second Circuit Court of Appeals has rejected  the New York State Restaurant Association’s (NYSRA’s) challenge to a New York City Board of Health (NYC) regulation requiring all menu boards and menus in chain restaurants with 15 or more establishments nationally to bear …

    • California District Court Rules Against FDA Preemption of “Natural” ClaimFebruary 10th, 2009

      By Ricardo Carvajal –       Disagreeing with an earlier New Jersey district court decision, a California district court has ruled that there is no federal preemption of an unfair competition claim against the manufacturer of a food that contains high fructose corn syrup ("HFCS") and is labeled …

    • FDA Approves First Biological Product Derived From Genetically Engineered AnimalsFebruary 9th, 2009

      By Ricardo Carvajal –       FDA has approved the biological product ATryn, an anticoagulant derived from the milk of genetically engineered ("GE") goats.  The approval follows on the heels of the agency’s issuance of long-awaited guidance on its regulatory approach to GE animals, which we discussed …

    • A Bigger, Bolder FDAGAFebruary 8th, 2009

      By Ricardo Carvajal & Susan J. Matthees –       The FDA Globalization Act (“FDAGA”) of 2008 was “meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure safety” of products over which the agency has jurisdiction.  When we commented on …

    • USDA Acts Against Peanut Corporation of America; FDA Testifies Before CongressFebruary 6th, 2009

      By Ricardo Carvajal –       USDA has suspended, and proposes to debar, Peanut Corporation of America ("PCA") from “participating in government contracts or subcontracts, as well as federal non procurement programs,” among other activities.  The suspension is for one year and is effective immediately.  The proposed debarment …

    • Latest FDLI Update Magazine Features Two Articles Written by HPM AttorneysJanuary 30th, 2009

      The latest issue of the Food and Drug Law Institute’s “Update” magazine features articles written by four Hyman, Phelps & McNamara, P.C. attorneys.  The first article, titled “Imported Products – FDA Is Not Fooling Around,”  was written by Dara Katcher Levy and John R. Fleder.  It …

    • FDA Found Lead in Vitamins; California Files SuitJanuary 29th, 2009

      By Wes Siegner & Ricardo Carvajal –  Last August, FDA published data that the Agency had gathered on the content of lead in 324 vitamin products labeled for use by women or children. FDA made clear that its estimates of lead exposures for all of …

    • Memo to Food and Feed Ingredient Suppliers: Would Your Auditor Pass Muster with FDA?January 27th, 2009

      By Diane B. McColl & Ricardo Carvajal –       In an attempt to improve import safety and further implement its Food Protection Plan, FDA has issued a Guidance for Industry titled “Voluntary Third-Party Certification Programs for Foods and Feeds.”  The guidance recognizes that independent certification of …

    • Is the Obama Administration Poised to Undo FDA’s Preemption Stance?January 26th, 2009

      By Kurt R. Karst –       Those following the subject of preemption of conflicting state laws have speculated for months whether the Obama Administration might undo the position FDA has advanced in Federal Register announcements and in court filings in which the Agency has generally staked …

    • FDA Determines That Pyridoxamine Is Excluded From the Definition of Dietary Supplement Under FDC Act § 201(ff)(3)(B); Implications for FDA’s Interpretation of § 301(ll) Could Be SignificantJanuary 25th, 2009

      By Diane B. McColl & Ricardo Carvajal – In response to a citizen petition filed on behalf of a pharmaceutical company, FDA has determined that products containing pyridoxamine (a form of vitamin B6) are not dietary supplements within the meaning of FDC Act § 201(ff) and …