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  • Foods and Dietary Supplements

    • FTC to Food Marketers: Don’t Forget the “Q” in QHCOctober 31st, 2014

      By Ricardo Carvajal & Riëtte van Laack –  FTC filed a complaint in the district court of New Jersey alleging that certain of Gerber’s advertising claims for its hydrolyzed-whey-based infant formula constitute deceptive acts or practices and the making of false advertisements, in violation of the FTC Act.  …

    • FDA Makes Educational Push on Mislabeling of SeafoodOctober 27th, 2014

      By Ricardo Carvajal -  FDA released an online learning module intended “to help the seafood industry, retailers, and state regulators ensure the proper labeling of seafood products offered for sale in the U.S. marketplace.”  The learning module consists of three videos that provide an overview of applicable …

    • FDA Agrees to Deadline for Issuance of GRAS Final RuleOctober 22nd, 2014

      By Ricardo Carvajal –  FDA and the Center for Food Safety (CFS) entered into a consent decree that calls for FDA “to submit a final rule regarding ‘Substances Generally Recognized as Safe’ to the Federal Register for publication no later than August 31, 2016.”  As we reported in …

    • Beyond Drinking the WormOctober 19th, 2014

      By Ricardo Carvajal – That’s the clever title of a symposium on entomophagy being delivered at the next annual meeting of the Entomological Society of America (ESA), scheduled for the week of November 16 in Portland, Oregon.  As we noted in a prior posting, the market for insect-derived …

    • ISRTP Workshop on GRAS DeterminationsOctober 9th, 2014

      The International Society of Regulatory Toxicology and Pharmacology (“ISRTP”) will be holding a Workshop on GRAS Determinations from October 13-14, 2014 at the ASEA Conference Center in Washington, DC.  The workshop provides a forum for leading scientific experts to contribute to the ongoing debate prompted …

    • Setting the Record Straight on GRAS: Part 2October 6th, 2014

      By Ricardo Carvajal & Diane B. McColl – In Part 1 of our effort to characterize the principal errors and mischaracterizations underpinning attacks on the GRAS exception, we focused on misrepresentations of the Food Additive Amendment’s legislative history and of the difficulties FDA allegedly faces in …

    • Bayer Case Highlights the Importance of Involving an Expert in SubstantiationSeptember 28th, 2014

      By Jennifer M. Thomas – For the past few days, industry has reacted with anxiety to the government’s decision to pursue an order to show cause why Bayer, Corp. should not be held in contempt of that company’s 2007 consent decree with FTC due to its …

    • Former Officials of Peanut Corporation of America Found Guilty; Coincidentally (?), FDA Proposes to Require Supplier Verification Under the FSMA Preventive Controls RuleSeptember 22nd, 2014

      By Ricardo Carvajal & JP Ellison – The U.S. Department of Justice recently announced the convictions of former officials and a broker of the Peanut Corporation of America (“PCA”) – the company at the heart an outbreak of salmonellosis five years ago that was traced to the …

    • GRAS Determinations: Fact vs. FictionSeptember 15th, 2014

      The integrity of Generally Recognized As Safe (“GRAS”) determinations, and FDA’s reliance on the voluntary GRAS notification process, has come under attack.  Critics allege that, among other things, GRAS determinations employ outdated science; GRAS determinations are rife with conflicts of interest; the safety of food …

    • Foodborne Illness and the Rise of Environmental Pathogen AnalysisSeptember 9th, 2014

      By Ricardo Carvajal – FDA has made no secret of its increasing investment in, and reliance on, databases of genetic information to investigate outbreaks of foodborne illness.  In public presentations, compliance officials have lauded the utility of PFGE and PulseNet, the Whole Genome Sequencing (WGS) Program, …

    • HP&M Attorneys to Present CLE Telephone Seminar on FSMASeptember 7th, 2014

      In conjunction with Virginia CLE, Hyman, Phelps & McNamara, P.C. Director Ricardo Carvajal and Senior Counsel Brian Donato are presenting a 2-hour CLE telephone seminar that will provide an overview of the Food Safety Modernization Act and its anticipated impact on food businesses.  The seminar is directed …

    • GMA Announces GRAS InitiativeAugust 29th, 2014

      By Ricardo Carvajal & Diane B. McColl – The Grocery Manufacturers Association ("GMA") announced an initiative designed to “improve the process and increase transparency for making Generally Recognized As Safe ("GRAS") determinations of ingredients added to food.”  The initiative includes the following five elements: Development by independent …

    • Who Would Benefit from a Federal Standard of Identity for Honey?August 25th, 2014

      By Riëtte van Laack – As previously discussed, since at least 2006, the U.S. honey bee industry has been trying to get FDA to adopt a standard of identity for honey.   In 2006, the American Beekeeping Federation and honey industry groups petitioned FDA for a standard …

    • FDLI Conference on Food Safety and FSMA Just a Couple of Weeks AwayAugust 22nd, 2014

      The Food and Drug Law Institute is sponsoring a conference titled "Food Safety: Latest FSMA Developments & Enforcement Actions in a Changing Business Climate," scheduled for September 9.  The conference will feature a regulatory update by Michael Landa (Director of FDA/CFSAN), an exploration of the …

    • Consumer Groups File Motion to Intervene in Vermont GE Labeling LitigationJuly 25th, 2014

      By Ricardo Carvajal & JP Ellison – The Vermont Public Interest Research Group ("VPIRG") and Center for Food Safety ("CFS") filed a motion to intervene in the lawsuit challenging Vermont’s new law requiring labeling for foods produced with genetic engineering (see our prior posting here).  VPIRG …