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    • FTC Dives into the “Natural” FrayApril 14th, 2016

      By Riëtte van Laack – As we have reported on several occasions, “natural claims,” particularly when used in the advertising of food and dietary supplements, are frequently challenged by competitors and consumers.  Neither the Federal Food, Drug, and Cosmetic Act (FDC Act), nor FDA regulations, nor …

    • FDA’s New Sanitary Transportation Regulations Focus on SafetyApril 12th, 2016

      By Riëtte van Laack – Last week, FDA issued the sixth of the seven major rules expected to issue under the authority of the Food Safety Modernization Act (FSMA), namely the final rule for Sanitary Transportation of Human and Animal Food. Although FSMA directed FDA to …

    • 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 – …

    • 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 …

    • DOJ Makes History: On a Single Day It Files a Criminal Prosecution, a Consent Decree and a Criminal Forfeiture of Foods Involved in the Same IncidentJanuary 26th, 2016

      By Riëtte van Laack & John R. Fleder – In hockey parlance, a player gets a “hat trick” when the player scores three goals in one game. In the FDA enforcement world, a “hat trick” – and perhaps a “Gordie Howe hat trick” – would be 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 …