• where experts go to learn about FDA
  • Foods

    • FDA’s First Substantiation Guidance for a Conventional FoodSeptember 19th, 2016

      By Ricardo Carvajal – FDA’s issuance of a draft guidance for industry titled Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling marks the first issuance of a guidance that addresses structure/function (SF) claim substantiation for a conventional food.  As FDA explains in the guidance, …

    • FDA Tries New Approach to Removing Marketed Dietary Ingredients; Prepares About-Face on Dietary Ingredient Status of VinpocetineSeptember 7th, 2016

      By Wes Siegner – After 20 years of marketing vinpocetine, and accepting without objection the filing of 5 new dietary ingredient notifications (NDINs), FDA has “tentatively concluded” that vinpocetine is an illegal dietary ingredient for two reasons: 1) it does not fit within the statutory list …

    • ACI’s Food Law Regulation Boot CampSeptember 6th, 2016

      The American Conference Institute’s (“ACI’s”) Food Law Regulation Boot Camp is slated to take place at the InterContinental Chicago Magnificent Mile in Chicago, Illinois from November 15-16, 2016. The conference is billed as a way to “[c]onnect the dots of food regulatory law and gain …

    • Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to StaySeptember 5th, 2016

      Over the course of roughly the last year, gene editing has gone from being a topic limited to scientific conferences to being featured in the New York Times and on the cover of TIME magazine.  Most of the attention has been due to a molecular …

    • FDA Finalizes Regulations for Voluntary GRAS Notifications; Few SurprisesAugust 31st, 2016

      By Riëtte van Laack – On August 17, FDA published in the Federal Register the long awaited final rule, “Substances Generally Recognized as Safe.” The final rule is based on the proposed rule from 1997, and a reopening of the comment period with supplemental questions in …

    • FSIS Now Allows Use of the Term GMO in “Negative Claims”August 29th, 2016

      By Riëtte van Laack – On August 24, 2016, the Food Safety Inspection Service (FSIS) of the U.S. Department of Agriculture announced the availability of its compliance guidance regarding “Statements That Bioengineered or Genetically Modified (GM) Ingredients or Animal Feed Were Not Used in the Production …

    • FDA Issues Calorie Labeling Guidance Documents for Vending Machine OperatorsAugust 21st, 2016

      By Riëtte van Laack – On August 15, 2016 FDA simultaneously issued two guidance documents, the Draft Guidance, Calorie Labeling of Articles of Food in Vending Machines and the Final Guidance, Small Entity Compliance Guide (SECG), Calorie Labeling of Articles of Food in Vending Machines, to help …

    • FDA Issues Long-Awaited Revised Dietary Supplement NDI Draft GuidanceAugust 14th, 2016

      By Etan J. Yeshua – Last week, FDA issued for the dietary supplement industry a draft guidance document that largely doubles-down on controversial positions the Agency has previously taken. The draft guidance – “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” – replaces the draft …

    • FDA Publishes Industry Resources re the New Nutrition Labeling Requirements; Many Questions Remain UnansweredAugust 4th, 2016

      By Riëtte van Laack – Yesterday, FDA announced the availability of a webpage providing information to industry regarding the requirements of the recently finalized Nutrition Facts and serving size regulations.  FDA clarifies that until the compliance date of July 26, 2018 (or July 26, 2019 for companies …

    • HHS OIG’s Odd Take on Food RecallsJune 22nd, 2016

      By Ricardo Carvajal – In an unusual “Early Alert,” the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) publicly took FDA to task for allegedly lacking “an efficient and effective food recall initiation process that helps ensure the safety of …

    • FSIS Receives Petition to Amend Safe Handling Statement on Meat and PoultryJune 13th, 2016

      By Riëtte van Laack – On May 31, 2016, the Food Safety Coalition submitted a Petition to the Food Safety Inspection Service (FSIS) to amend regulations requiring safe food handling instructions (SHI) on certain meat and poultry products. The Federal Meat Inspection Act (FMIA) and the Poultry …

    • Health Science Funding Case – A Lesson in How Not to Address Marketing Uncertainty Surrounding Medical FoodsJune 12th, 2016

      By Riëtte van Laack As we reported previously, in 2013, Health Science Funding, LLC (HSF) filed what might be the first medical food lawsuit against FDA.  Plaintiff markets a medical food for women with lupus, Prastera® DHEA.  Medical foods may be marketed without pre-market approval by …

    • FDA Rolls Out Sodium Reduction Initiative, and Salt Remains GRASJune 7th, 2016

      By Jenifer R. Stach & Ricardo Carvajal – Carrying through on what had been designated as a high priority item, FDA rolled out its sodium reduction initiative with several actions, all on the same day.  On June 1, 2016, FDA published a Federal Register notice to announce …

    • And Then There Were Seven: FDA Issues the Final Rule on Intentional Adulteration of Food; the Last Required by FSMAMay 31st, 2016

      By Riëtte van Laack – On May 27, 2016, FDA published the final rule, required under FSMA, regarding “the Mitigation Strategies to Protect Food against Intentional Adulteration.”  Food defense has been on the agenda ever since the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 …

    • FDA Announces Final Regulations on Nutrition and Supplement Facts Labels and on Serving SizesMay 25th, 2016

      By Riëtte van Laack – On Friday the 20th of May, FDA announced the availability of the final regulations for nutrition labeling and serving sizes (in prepublication format).  The final regulations will be published in the Federal Register on May 27, 2016.  That date will be used …