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    • The Long Swim Continues As Groups Sue FDA Over GE SalmonApril 4th, 2016

      By Jay W. Cormier – Just a little more than four months after FDA approved AquAdvantage Salmon (AAS) – the first genetically engineered (GE) animal intended for food use – several organizations filed suit against FDA and the U.S. Fish and Wildlife Service (FWS) challenging that approval.  Plaintiffs …

    • Food Importers: Wake Up!March 23rd, 2016

      By Ricardo Carvajal – That’s our take-away from FDA’s recent public meeting on the implementation of FSMA’s import provisions and the associated regulations (FSVP, VQIP, and Accredited Third Party Certification).  Several comments made at the meeting suggest that many importers may still be unaware of the advent …

    • District Court Dismisses PHO Lawsuit on Preemption GroundsMarch 15th, 2016

      By Ricardo Carvajal & JP Ellison – In a decision of significance in the realm of food additive regulation, the U.S. District Court for the Northern District of California dismissed a lawsuit targeting coffee-creamer products containing partially hydrogenated oil (PHO) on preemption grounds.  The complaint – …

    • Attorney General Lynch Delivers a Public Service Announcement About DOJ’s Enforcement Actions for Unsafe Dietary SupplementsMarch 10th, 2016

      By Jenifer R. Stach & Wes Siegner – If you weren’t aware that the Department of Justice (DOJ) has unsafe dietary supplements on its list of enforcement priorities, you should take notice. On Tuesday March 8th, 2016 as part of National Consumer Protection Week, United States Attorney …

    • New York City Sodium Rule Caught in Litigation is One of Many State and Federal Food Labeling Requirements Currently in LimboMarch 9th, 2016

      By Etan J. Yeshua – A regulation requiring restaurants in New York City to warn customers about menu items with high levels of sodium was set to take effect last week, but it is now the latest in a string of food labeling laws and regulations …

    • Fixing Erroneous FDA Guidance Can Take a Decade – and PersistenceMarch 7th, 2016

      By Wes Siegner – In April 2005, FDA published guidance for industry on dietary supplement labeling, “A Dietary Supplement Labeling Guide.”  As we wrote in 2009, an error in this guidance, stating that the term “dietary supplement” was not an acceptable statement of identity on its …

    • 48 Hours in New Orleans: Food, Drugs, and – Oh, Right – LawFebruary 21st, 2016

      By Ricardo Carvajal – The prompt was an invitation to speak at the 21st Annual Tulane Environmental Law and Policy Summit on the pros and cons of genetically engineered food animals, in the wake of FDA’s approval of AquAdvantage salmon as a new animal drug (a topic we’ve …

    • Something Fishy in the Appropriations Act: With GE Salmon, A Side of Smoke and MirrorsFebruary 18th, 2016

      By Ricardo Carvajal & Jay W. Cormier – In response to a Congressional directive buried in the 2016 Consolidated Appropriations Act (“the Appropriations Act”), FDA issued an Import Alert targeting “[a]ny shipment of suspected or known GE salmon or product composed in whole or in part of GE …

    • Chipotle and FDA’s ReachFebruary 11th, 2016

      By Ricardo Carvajal & JP Ellison – According to public communications by the restaurant chain Chipotle, the company has been served with subpoenas in a federal criminal investigation apparently arising out of one or more outbreaks of foodborne illness that appear to implicate certain of the …

    • Soy Protein and Coronary Heart Disease Health Claim Stands – For NowJanuary 22nd, 2016

      By Ricardo Carvajal -  On January 4, FDA denied the Weston A. Price Foundation’s citizen petition seeking revocation of the health claim for soy protein and coronary heart disease (CHD).  As reported in a prior blog posting, the Foundation filed the citizen petition in 2008, and sued the …

    • NOP Clarifies What Substances Can Be Used in Post-Harvest Handling of Organic ProductsJanuary 20th, 2016

      By Riëtte van Laack – On January 15, 2016, the National Organic Program of USDA's Agricultural Marketing Service (NOP) announced the availability of guidance on substances that may be used in the post-harvest handling of organic products and in facility pest management. Under the Organic Food Production …

    • California Supreme Court Holds that the Organic Food Production Act of 1990 Does Not Preempt State Consumer Lawsuits Regarding Organic MislabelingDecember 17th, 2015

      By Riëtte van Laack – The Supreme Court of California recently concluded that federal law does not preempt claims against allegedly intentional misrepresentations of organic status of a food. According to the Court, the Organic Foods Production Act of 1990 (OFPA) only preempts state law on …

    • Question: What do Sodium Reduction, FOP Labeling, and Medical Foods Have in Common?December 16th, 2015

      By Ricardo Carvajal – Answer:  They were all designated as high priority items in a Nutrition Program Review (NRP) Report prepared by CFSAN staff for the Center Director in December 2014.  (We compiled the report and its attachments into a single PDF, which we repaginated for …

    • FSIS Finally Nets “Catfish”December 10th, 2015

      By Riëtte van Laack – Although it has taken some time, the Food Safety and Inspection Service (FSIS) of the USDA published a final rule establishing a mandatory inspection program for “catfish (“fish of the order Siluriformes and products derived from these fish.”) This rule implements …

    • Aloe Vera Extract and Goldenseal Root Powder Added to Proposition 65 List of “Known” CarcinogensDecember 7th, 2015

      By Riëtte van Laack – On December 4, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) added Aloe vera, non-decolorized whole leaf extract and Goldenseal root powder to the list of “chemicals known to the State of California to cause cancer for purposes of …