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  • Foods and Dietary Supplements

    • 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  Critics allege that, among other things, GRAS determinations employ outdated science; GRAS determinations are rife with conflicts of interest; the safety of food …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 …

    • FDA Releases Updated Total Diet Study Results (and Advises Consumers to Keep Eating)July 13th, 2014

      By Ricardo Carvajal – FDA released data for its Total Diet Study (TDS) covering the period from 2006 to 2011.  Under the TDS, FDA collects data on levels of pesticide residues, industrial chemicals, toxins, and nutrients present in foods to monitor changes in the levels of …

    • Zarbee’s Honey-Based Cough Claims Choked by FDAJuly 8th, 2014

      By Wes Siegner – Just in time for the windup to ad campaigns for the fall/winter cold/flu season, FDA has sent Zarbee’s, Inc. a Warning Letter alerting the company that its dietary supplement products are in fact illegal drugs, some prescription drugs, given the claims that the …

    • FDA Refines Its Thinking on NanotechnologyJuly 6th, 2014

      By Ricardo Carvajal – FDA finalized three guidance documents that address various aspects of the use of nanotechnology in products regulated by the agency: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Safety of Nanomaterials in Cosmetic Products, and Assessing the Effects of Significant …

    • Vermont, GMOs, and Compelled SpeechJune 24th, 2014

      By Ricardo Carvajal – As widely reported in the press, several food industry trade associations sued the state of Vermont to overturn its recently enacted law requiring that a food “entirely or partially produced with genetic engineering” be labeled with the “clear and conspicuous words ‘produced …