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    • After Five Years, FDA Takes Initial Steps to Use Sanitary Food Transport AuthorityMay 6th, 2010

      By Riëtte van Laack – In 2005, the Sanitary Food Transportation Act of 2005 (“SFTA”) was enacted.  This law shifted responsibility for safe transportation of food from the U.S. Department of Transportation to FDA.  Among other things, the SFTA amended the FDCA to include section …

    • Voluntary Front-of-Pack Food Labeling: A Way to Combat the Obesity Epidemic?April 27th, 2010

      By Cassandra A. Soltis – That’s what the Food and Drug Administration (“FDA”) is hoping anyway.  In a notice expected to be published in the Federal Register on Thursday, April 29, 2010, FDA will announce that it is requesting data and information from “all interested parties,” …

    • NAD Takes a Crack at BioavailabilityApril 26th, 2010

      By Cassandra A. Soltis – In an advertising challenge brought by the Perrigo Company (“Perrigo”), the National Advertising Division (“NAD”) of the Better Business Bureau recommended that Pharmavite, LLC (Pharmavite) refrain from making several claims for its Nature Made® Prenatal + DHA Liquid Softgel Vitamins …

    • OIG Calls for Increased FDA Food Inspections and Expanded PenaltiesApril 8th, 2010

      By Ricardo Carvajal – The Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services released a report that finds fault with FDA’s inspection activities for food facilities and recommends several changes, including an expansion of FDA’s statutory authority.  OIG reviewed FDA's food …

    • FSIS Proposes Rule Concerning Recall ProceduresMarch 30th, 2010

      By Riëtte van Laack – On March 25, 2010, the Food Safety and Inspection Service (“FSIS”) of the USDA published a proposed rule requiring poultry and meat establishments subject to FSIS inspection to promptly notify the authorities when an adulterated or misbranded meat or poultry …

    • In Health Care Reform, a Nod to the Role of NutritionMarch 29th, 2010

      By Ricardo Carvajal – Earlier we blogged on the provisions of the Patient Protection and Affordable Care Act (“PPACA”) that most directly affect pharmaceutical and device manufacturers.  The PPACA also contains a number of provisions that will directly and indirectly affect the food industry.  Most …

    • Proposed Food Labeling Changes May be Hard for Pharmaceuticals to SwallowMarch 28th, 2010

      By Peter M. Jaensch – On March 23, 2010, Congressman Jason Chaffetz (R-UT) introduced H.R. 4913 – the Free Speech About Science Act of 2010.  The bill proposes several amendments to FDC Act § 403(r) concerning the misbranding of foods, which would have the effect …

    • FDA Tweaks Reportable Food Registry Reporting for Companies with Multiple FacilitiesMarch 25th, 2010

      By Ricardo Carvajal – In a recently issued guidance document, FDA makes clear that a company with a reportable food located in multiple facilities can submit a single report to the Reportable Food Registry (RFR) instead of individual reports for each facility (a reportable food …

    • Consumers Union and Organic Consumers Association Petition the FTC To Do What the USDA Says It CannotMarch 16th, 2010

      By Riëtte van Laack – For several years, the Consumers Union and the Organic Consumers Association (“Petitioners”) have urged the U.S. Department of Agriculture (“USDA”) to require that personal care products that use the term “organic” in product labeling comply with the requirements of the Organic …

    • GAO Report Criticizes FDA’s Oversight of GRAS Substances (Including Nanomaterials) and Points to Potential Legislative FixesMarch 9th, 2010

      By Nisha P. Shah and Ricardo Carvajal – The title of a report issued by the U.S. Government Accountability Office (“GAO”) neatly sums up that agency’s perspective: “FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS).”  The report …

    • HVP – The Next Peanut Butter?March 5th, 2010

      By Ricardo Carvajal – The ongoing recall of a widely used flavor enhancer known as hydrolyzed vegetable protein ("HVP") for possible contamination with Salmonella could mushroom to affect thousands of products.  Although no illnesses have been reported thus far and FDA judges the risk to …

    • Cracking Down on Claims: FDA Sends Warning to 16 Food Manufacturers, Issues an Open Letter to IndustryMarch 3rd, 2010

      By Cassandra A. Soltis – Think twice before putting that claim on your food label – or on your website.  Just last month, FDA issued 16 Warning Letters to food manufacturers regarding unauthorized nutrient content and health claims appearing in food labeling.  In addition, some …

    • FDA Lays Out Ambitious Agenda in the Latest Draft of its Framework of the Animal Feed Safety SystemJanuary 27th, 2010

      By Ricardo Carvajal & Diane B. McColl – In the fourth and most recent draft of the framework of its Animal Feed Safety System (“AFSS”), FDA provides a comprehensive overview of the system and of the significant gaps in that system that FDA intends to …

    • HPM Attorney to Speak at Food and Drug Law Institute (FDLI) Conference on Food Law and RegulationJanuary 20th, 2010

      Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be speaking at FDLI’s upcoming Introduction to Food Law and Regulation: A Program on Understanding How the Government Regulates the Food Industry.  Mr. Carvajal will be presenting on food safety and unintended components/contaminants in food.  The conference …

    • FDA Seeks to “Strengthen its Oversight of BPA”January 19th, 2010

      By Ricardo Carvajal – While calling for further research on bisphenol A ("BPA"), a chemical used in the manufacture of some plastics, FDA has acknowledged that it has "some concern about the safety of BPA:"  At this interim stage, FDA shares the perspective of the …