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    • With or Without FSEA, FDA Will Establish Standards to Prevent Microbial Hazards in Fresh ProduceAugust 11th, 2009

      By Jamie K. Wolszon & Ricardo Carvajal – FDA has published three draft guidances that instruct growers, packers, processors, transporters, retailers and others on the prevention of microbial hazards in tomatoes, melons, and leafy greens.  According to FDA’s press release, Dr. Hamburg stated that the …

    • House Passes Food Safety Enhancement Act of 2009July 30th, 2009

      By Ricardo Carvajal – The U.S. House of Representatives has passed the Food Safety Enhancement Act of 2009, which would substantially strengthen FDA’s regulatory authority over foods.  The bill would grant FDA mandatory recall authority, expanded access to records, stronger seizure and administrative detention authorities, …

    • False Advertising Claim under Lanham Act Not Precluded or Barred by the FDC ActJuly 28th, 2009

      By Cassandra A. Soltis – In Pom Wonderful LLC v. Ocean Spray Cranberries, Inc., 2009 WL 2151355 (C.D. Cal. 2009), the U.S. District Court for the Central District of California determined that Pom Wonderful LLC’s (Pom’s) false advertising claim against Ocean Spray Cranberries, Inc. (Ocean …

    • So What Does “Reasonable Probability of Serious Adverse Health Consequences or Death” Really Mean?July 24th, 2009

      By Ricardo Carvajal –       On July 23, FDA held the first of three public workshops to explain the Reportable Food Registry requirements that will take effect on September 8, 2009.  One thing was made clear: the agency has no plans to offer a definition of …

    • IFT Publishes Expert Report on Making Decisions About the Risks of Chemicals in Foods with Limited Scientific InformationJuly 17th, 2009

      By Ricardo Carvajal – The Institute of Food Technologists (“IFT”) has published an expert report that addresses the challenge of responding to food contamination events in the face of limited scientific information.  The report describes the U.S. legal framework that governs substances intentionally or inadvertently …

    • CIFOR Publishes Guidelines for Foodborne Disease Outbreak ResponseJuly 17th, 2009

      By Ricardo Carvajal – The Council to Improve Foodborne Outbreak Response (“CIFOR”) has published guidelines intended to help local, state and federal agencies improve their response to foodborne disease outbreaks. The guidelines address planning and preparation, surveillance and outbreak detection, investigation of clusters and outbreaks, …

    • FDA Shows That It’s Serious About Food Allergen GMPsJuly 15th, 2009

      By Ricardo Carvajal –       In a complaint filed on July 1, the government is asking a federal district court to enjoin certain manufacturers of protein powder mixes and dietary supplements from further marketing of products alleged to be adulterated under FDC Act section 402(a)(4) due to the …

    • Becoming a Dietary Ingredient the Hard WayJuly 12th, 2009

      By Diane B. McColl & Riëtte van Laack – On June 25, 2009, Ovos Natural Health Inc. ("Ovos") filed a citizen petition asking FDA to promulgate a regulation allowing use of homotaurine, a new dietary ingredient, in dietary supplements under sections 201(ff)(3)(B)(ii) and 301(ll)(2) of …

    • FDA Firms Up Implementation Date for the Reportable Food RegistryJune 29th, 2009

      By Ricardo Carvajal – FDA has announced public workshops on the Reportable Food Registry intended to “explain the purpose of the Registry, how it will work, and the responsibilities of persons required to submit a report regarding instances of reportable food to FDA through the …

    • Pet Food Business Owners Plea to FDC Act Misdemeanors in Connection with Pet Food ScandalJune 17th, 2009

      JP Ellison – The U.S. Attorney's Office for the Western District of Missouri announced three guilty pleas to misdemeanor violations of the FDC Act in connection with the "nationwide recall of pet food and the death and serious illness of countless pets across the United States …

    • Reportable Food Registry Will be Operational in September 2009June 17th, 2009

      By Riëtte van Laack – The FDA Amendments Act (“FDAAA”) amended the Food, Drug, and Cosmetic Act (“FDC Act”) to create section 417, which directs FDA to establish a Reportable Food Registry (“Registry”).  The purpose of the Registry is to provide a “reliable mechanism to …

    • FDA Takes Canned Pet Food Processor Off-LineJune 15th, 2009

      By Ricardo Carvajal – In an increasingly common exercise of the agency’s authority under FDC Act § 404, FDA announced that is has it has suspended the temporary Emergency Permit issued to Evanger's Dog & Cat Food Co., Inc. in April 2008.  Under § 404 …

    • With Draft Food Safety Legislation, Heavy Burdens All AroundJune 11th, 2009

      By Ricardo Carvajal – Much ink has already been spilled detailing the burdens that draft federal food safety legislation would impose on industry (click here for the latest version of the  Food Safety Enhancement Act of 2009 (“FSEA”)).  Little has yet been said about the burdens …

    • Obama Food Safety Working Group Launches WebsiteMay 29th, 2009

      By Ricardo Carvajal – The Obama administration’s Food Safety Working Group has launched a website through which it intends to keep the public informed of its activities (to date, the only activity listed on the website is a listening session and breakout discussion among stakeholders …

    • President Obama Sets New Criteria for Preemption in Federal Agency Rules and Orders Sweeping Review of Existing RulesMay 22nd, 2009

      By JP Ellison – In a Memorandum to the heads of Executive Departments and Agencies dated May 20, 2009, with the Subject Line “Preemption” (the “May 20, 2009 Memorandum”), President Obama stated that “executive departments and agencies have sometimes announced that their regulations preempt State …