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  • Foods and Dietary Supplements

    • GMA Presents Webinar on GRAS Self-DeterminationOctober 24th, 2013

      The Grocery Manufacturers Association ("GMA") is presenting a webinar on GRAS self-determinations for food ingredients next Tuesday, October 29 from 1:30 to 3:00 p.m. EST.  The webinar is intended to help food businesses understand applicable requirements and avoid missteps in ingredient safety assessments, and will …

    • At EFLA’s Third EU-US Food Law Conference, An Invigorating Discussion of International RecallsOctober 22nd, 2013

      By Ricardo Carvajal – This past Monday, the European Food Law Association held its third conference on developments in food law in the EU and US.  The conference was devoted entirely to the subject of food recalls and related public alerts, and the significant impact that …

    • Jensen Farms Sues Auditor PrimusLabsOctober 21st, 2013

      By Riëtte van Laack – Jensen Farms, (the Jensens), the growers facing criminal charges related to the deadly 2011 listeria outbreak linked to their cantaloupes, are suing Primus Group, Inc. d/b/a/ Primus Labs (Primus) alleging that the food safety consultants who audited the Jensens’ facilities shortly …

    • AMI Appeals District Court’s Denial of Preliminary Injunction against COOL RegulationsOctober 16th, 2013

      By Riëtte van Laack – As previously reported, the American Meat Institute (“AMI”) and several international meat industry organizations filed a lawsuit in an effort to stop the Agricultural Marketing Service ("AMS") of the USDA from implementing the Country of Origin Labeling ("COOL") rule.  On …

    • Move Over, Cricket! Lickets: Edible Insects are On the MarchOctober 13th, 2013

      By Ricardo Carvajal – People have been eating insects for thousands of years, and the practice certainly has its devotees in the U.S.  Notwithstanding that history of consumption, industrial production of insects for food use has remained a rarity.  Now there are signs of a …

    • California Court Decides that the Organic Food Production Act Does Not Apply to Personal Care ProductsOctober 10th, 2013

      By Riëtte van Laack – In May of 2012, Plaintiff Matthew Dronkers filed a complaint in the United States District Court for the Southern District of California, on behalf of himself and other class members against Kiss My Face, LLC (“KMF”) claiming that KMF’s marketing …

    • $5 Million Later, Truvia® is Still “Natural”October 4th, 2013

      By Riëtte van Laack & Ricardo Carvajal – On September 19, 2013, Cargill entered into a $5 million settlement agreement to dispose of a class action lawsuit regarding its advertising for Truvia® products as “natural.”  Plaintiffs charged that the products are not natural because they …

    • As Partial Government Shutdown Kicks In, FDA’s Foods Program Is Hardest HitOctober 1st, 2013

      By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …

    • Medical Food Mumbo Jumbo: Confusing FDA Guidance Documents Will Discourage Medical Food DevelopmentSeptember 19th, 2013

      By Wes Siegner & Paul M. Hyman –  The term “medical food” was first defined by statute in the Orphan Drug Act Amendments of 1988.   The medical food category is closely related to the already existing category of “foods for special dietary use,” authorized by …

    • District Court Denies Request for Preliminary Injunction Against COOL RegulationsSeptember 17th, 2013

      By Riëtte van Laack – As previously reported here, in July, the American Meat Institute and several international meat industry organizations filed a lawsuit in an effort to stop the Agricultural Marketing Service ("AMS") of the USDA from implementing the Country of Origin Labeling ("COOL") rule, …

    • CFSAN Priorities for 2013-2014 Include FSMA, Food Labeling, NDIs, Energy Drinks, and Cosmetic SafetySeptember 16th, 2013

      By Etan J. Yeshua – Three months after announcing a strategic research plan to support its regulatory agenda, FDA's Center for Food Safety and Applied Nutrition ("CFSAN") this week announced its regulatory priorities for 2013 and 2014, giving those in the food, dietary supplement, and cosmetic …

    • Are Foods that Contain GMOs “All Natural”? Some Courts Won’t Wait for FDA’s ViewSeptember 3rd, 2013

      By Ricardo Carvajal – In a number of recent class actions, a central allegation has been that a marketer misled consumers by labeling as “all natural” a food that contains a genetically modified organism ("GMO").  Defendants usually invoke the doctrine of primary jurisdiction in an …

    • State Actions Grounded in “Source” Claims: Preempted or Not?August 30th, 2013

      By Ricardo Carvajal – Is the word “source” (just “source” – not “good source” or “excellent source”) a nutrient content claim?  FDA seems to think so, as reflected in a paragraph in this warning letter that escaped our attention when it issued in March 2011.  FDA …

    • FSMA and Third-Party Audits: What is a “Serious Risk to the Public Health?”August 21st, 2013

      By Ricardo Carvajal – In poring over FDA’s recently issued proposed rule on Accreditation of Third Party Auditors (see our prior post here), one thing that caught our eye is FDA’s discussion of FSMA’s notification requirement for auditors.  That requirement is embedded in new § 808(c)(4) …

    • New Dietary Ingredients Revisited – Let’s Not Forget There’s a LawAugust 16th, 2013

       By Wes Siegner – In response to a history of FDA illegal restriction of the marketing of dietary supplements in the 1980s and early 1990s, Congress amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”), passing by unanimous consent the Dietary Supplement Health and Education …