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    • The Other Shoe Drops on Just MayoSeptember 2nd, 2015

      By Ricardo Carvajal – FDA issued a warning letter to Hampton Creek alleging that its Just Mayo products are misbranded, in part because they purport to be a food governed by a standard of identity – namely, mayonnaise – that the products fail to meet.  This alleged …

    • FSMA Accreditation of Third-Party Auditors/Certification Bodies: A Look at FDA’s Proposed User Fee Rule and Model Accreditation Standards GuidanceAugust 20th, 2015

      By Jenifer R. Stach* & Ricardo Carvajal – On July 24, 2015, FDA issued a proposed rule amending the Agency’s previously issue proposed rule on Accreditation of Third-Party Auditors/Certification Bodies (see our prior posts here and here) and establishing user fees for the Agency’s proposed accreditation …

    • The Government Seeks an Unprecedented Life Sentence for Former Peanut Corporation of America Executive, Stewart ParnellAugust 11th, 2015

      By Jenifer R. Stach* – After Stewart Parnell’s conviction for selling salmonella-tainted peanut products, causing many deaths and illnesses, he could be facing life in prison.  Attorneys on both sides called the recommendation for a life sentence “unprecedented” for a food-poisoning case.    We wrote about the convictions …

    • FDA Finalizes Guidance on Use of Nanomaterials in Animal FeedAugust 10th, 2015

      By Riëtte van Laack – On August 5, 2015, FDA announced the availability of a guidance document regarding nanomaterials in food for animals.  The guidance contains no surprises as it is virtually identical to the draft guidance (based on the docket, it appears that FDA did not …

    • FDA Guidance Regarding Nutrition Labeling Regulations for Small Amount of Nutrients and Dietary IngredientsAugust 3rd, 2015

      By Riëtte van Laack – On July 30, FDA announced the publication of a draft guidance titled “FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels”.  The draft guidance addresses an apparent conflict between FDA’s compliance guidelines and FDA’s rounding rules for nutrition …

    • FDA Proposes Daily Value for Added SugarsJuly 27th, 2015

      By Riëtte van Laack – Last week, FDA announced a supplemental proposal to amend the nutrition labeling regulation for food and dietary supplements, and the availability of consumer studies related to FDA’s proposed changes to the format of the Nutrition Facts box. Undoubtedly, the proprosal to establish …

    • “Natural” vs. “Made With Natural Ingredients”July 27th, 2015

      By Ricardo Carvajal -  The distinction between the claims “natural” and “made with natural ingredients” is among the issues addressed in a recent NAD decision involving advertising for ASPIRE, a brand of sports drinks promoted as “all natural” and “natural sports drinks.”  The drinks include vitamins and citric …

    • Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations BillsJuly 24th, 2015

      By Kurt R. Karst –       Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016.  Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and …

    • House Agriculture Committee Approves The Safe and Accurate Food Labeling Act to Address GMO Labeling IssuesJuly 19th, 2015

      By Riëtte van Laack – On July 14, the House Agriculture Committee approved The Safe and Accurate Food Labeling Act (H.R. 1599), advancing the legislation another step in the long legislative process.   The Act is an amended version of legislation introduced in March by Representative Mike Pompeo (R-KS).   (a copy …

    • FDA Extends Menu Labeling Compliance Date and Announces Forthcoming GuidanceJuly 12th, 2015

      By Etan J. Yeshua – Last week, FDA announced that it will be extending by one year the compliance date for its menu labeling rule.  This means that restaurants and other establishments covered by the rule, and by the menu labeling provisions of the Affordable Care …

    • White House Freshens Up Federal Regulation of BiotechnologyJuly 8th, 2015

      By Ricardo Carvajal –   The White House Office of Science and Technology Policy (OSTP) directed the three federal agencies charged with ensuring the safety of biotechnology products (FDA, USDA, and EPA) to undertake a review intended to “improve the transparency, predictability, coordination, and, ultimately, efficiency of …

    • FSMA Food Import Fast Lane Anticipated in October 2018 – But How Many Importers Will Take It?June 30th, 2015

      By Ricardo Carvajal – As directed under FSMA, FDA issued draft guidance on its approach to implementation of the Voluntary Qualified Importer Program (VQIP).  In exchange for voluntarily subjecting themselves to an initial round of heightened scrutiny, importers who are approved for participation in the program …

    • FDA Issues Declaratory Order Revoking GRAS Status of PHOsJune 17th, 2015

      By Ricardo Carvajal, Diane B. McColl & Jenifer R. Stach – FDA issued a declaratory order revoking the GRAS status of partially hydrogenated oils (PHOs), thereby finalizing its November 2013 tentative determination that there is no longer consensus among qualified experts that PHOs are safe for use in …

    • Where’s the Beef? USDA FSIS Issues Final Rule for Labeling of Mechanically Tenderized Beef ProductsMay 22nd, 2015

      By Riëtte van Laack – Where’s the beef?  It’s in a recent announcement from the USDA Food Safety and Inspection Service (“FSIS”) concerning finalized labeling requirements for mechanically, blade- or needle-tenderized beef.   Under the new rule, published on May 18, 2015, raw or partially cooked mechanically tenderized …

    • Non-GMO Claims Get a Boost From USDAMay 15th, 2015

      By Ricardo Carvajal -  The AP reports that USDA has developed a Process Verified Program (PVP) claim for non-GMO corn and soybeans, at the request of “a leading global company.”  The PVP claim was approved under a program operated by USDA’s Agricultural Marketing Service.  The program provides …