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    • “Carcinogen-Free” Label Program Proposed in House BillDecember 12th, 2012

      By Etan Yeshua – Manufacturers of foods, drugs and cosmetics might possibly be able to label their products as “Carcinogen-Free” with federal approval.  In November, Rep. Theodore Deutch (D-FL) and Rep. Sue Myrick (R-NC) introduced the "Carcinogen-Free Label Act of 2012" (H.R. 6601), which would …

    • A Deep Dive Into the Second Circuit’s Caronia Decision, Potential Next Steps, and Potential Enforcement FalloutDecember 12th, 2012

      As we promised in an earlier post, we provide here a deeper analysis of the Second Circuit’s holding in United States v. Caronia and the context in which it should be viewed by industry. Since the 2004 Warner-Lambert settlement, the federal government has investigated hundreds …

    • In Litigation, FDA Explains and Defends FSMA EffortsDecember 11th, 2012

      By Ricardo Carvajal – We previously reported on a lawsuit that seeks to compel OMB and FDA to accelerate the implementation of FSMA.  Now the government has filed a motion to dismiss the case and for summary judgment.  The motion provides a full accounting of …

    • In a FSMA First, FDA Suspends a Food Facility’s RegistrationNovember 29th, 2012

      By Ricardo Carvajal & John R. Fleder – On November 26th, Commissioner Hamburg issued an order suspending the registration of the Sunland Inc. food manufacturing facility alleged to be at the heart of the ongoing recall of peanut products potentially contaminated with Salmonella.  Until the order …

    • No Preemption of California Class Action Targeting Nutrient Content ClaimsNovember 22nd, 2012

      By Riëtte van Laack – In April 2012, a California consumer filed a class action lawsuit against The Hershey Company alleging that Defendant’s Special Dark Chocolate Bars, Special Dark Kisses, Special Dark Cocoa and Cocoa were misbranded because they carried impermissible nutrient content claims, including nutrient …

    • CSPI Jacks Up Scrutiny of Caffeination and FortificationNovember 19th, 2012

      By Ricardo Carvajal – The Center for Science in the Public Interest (“CSPI”) is taking on caffeination and fortification of foods with renewed vigor.  In a letter to FDA/CFSAN’s Office of Compliance, CSPI alleges that certain foods to which caffeine is added “appear to violate [FDA’s] …

    • The Toxin in Ackee: Naturally Occurring? Added? Does It Matter?November 13th, 2012

      By Ricardo Carvajal – FDA published a draft Compliance Policy Guide ("CPG") that sets out enforcement criteria for ackee fruit products that contain hypoglycin A, a toxin that is naturally present in the fruit.  Adverse effects of consuming the toxin can range from none to vomiting, …

    • Expedited Entry of Imported Foods Remains a Gleam in Importers’ EyesNovember 5th, 2012

      By Ricardo Carvajal – The Government Accountability Office ("GAO") published a report that examines FDA’s progress in implementing provisions of the Food Safety Modernization Act ("FSMA") that direct the agency to establish a third-party certification system for imported foods.  Among other things, that system is a …

    • California Proposition 37’s Take On “Natural”October 23rd, 2012

      By Ricardo Carvajal – As the November 6 election draws near, debate over California’s Proposition 37 is heating up.  If the measure passes, genetically engineered ("GE") foods sold at retail in the state would have to be labeled as such – a requirement that would have …

    • USP Recognizes Work of Food Ingredients Expert CommitteeOctober 11th, 2012

      The U.S. Pharmacopeial Convention (“USP”) recently announced at an Awards and Recognition Program for USP Expert Volunteers that the 2012 USP Award for an Innovative Response to Public Health Challenges went to the Food Ingredients Expert Committee.  Hyman, Phelps & McNamara, P.C. Director Diane B. …

    • Suit Targeting Benecol Dismissed on Preemption GroundsSeptember 25th, 2012

      By Ricardo Carvajal – A federal district court dismissed a class action that took issue with a number of allegedly false and misleading claims made on the label of Benecol, a butter/margarine alternative.  The claims at issue include “each serving contains .85g of plant stanol …

    • In Florida, Watch How You Use “Honey”September 17th, 2012

      By Ricardo Carvajal – A federal court has ruled that the express preemption provisions added to the Federal Food, Drug, and Cosmetic Act (“the Act”) by the Nutrition Labeling and Education Act (“NLEA”) do not preempt Florida’s standard of identity for honey.  Plaintiffs in the case, …

    • Hold the Fructose: FDA Petitioned to Act Against Certain High Fructose Corn SyrupsSeptember 5th, 2012

       By Ricardo Carvajal – A consumer group, Citizens for Health, submitted a citizen petition (Docket No. FDA-2012-P-0904) to FDA asking the agency to “take action to protect the public from the illegal, mislabeled use of high fructose corn syrup (‘HFCS’) that is above 55 percent fructose” and …

    • FDA and OMB Sued Over Delays in FSMA ImplementationAugust 31st, 2012

      By Ricardo Carvajal – The Center for Food Safety and the Center for Environmental Health filed suit in the Northern District of California to compel FDA and the Office of Management and Budget (“OMB”) to implement several major provisions of the Food Safety Modernization Act (“FSMA”). …

    • HP&M Attorneys to Present at Upcoming Conferences on Food LawAugust 20th, 2012

      Hyman, Phelps & McNamara, P.C.’s Diane McColl will present at USP’s 2012 Science & Standards Symposium, which is dedicated to functional foods and dietary supplements.  The conference will address scientific and regulatory issues from an international perspective, and will feature speakers from USP and NIH’s …