• where experts go to learn about FDA
  • Foods and Dietary Supplements

    • GMO Labeling And The ANPRM That Wasn’tJune 29th, 2017

      Earlier this week, USDA/AMS posted “Proposed Rule Questions Under Consideration” on its web page dedicated to the establishment of a National Bioengineered Food Disclosure Standard.  The posting asks for comment on 30 questions relating to different aspects of what such a standard might entail.  Most of …

    • FDA Grants 30-Day Extension for Comments to Menu Labeling RuleJune 29th, 2017

      Last month we reported that FDA decided to delay the compliance date for restaurant menu labeling from May 5, 2017 to May 7, 2018 while it reconsiders certain aspects of the final menu labeling rule. The Agency requested comments from industry and other stakeholder about …

    • Another Request for a Stay and Reconsideration of the Final Nutrition Labeling RuleJune 22nd, 2017

      As readers of this blog know, in May 2016, FDA issued a final rule amending the nutrition labeling regulations for food and dietary supplements. Major amendments include a new requirement to declare “added sugar,” the setting of a daily value for added sugars (but not …

    • FDA Sued Over its Delay of the Menu Labeling Compliance Date and Reconsideration of the RegulationsJune 14th, 2017

      As we previously reported, FDA recently extended the compliance date for its restaurant menu labeling regulations to May 8, 2018. Just one day before the previous (May 5, 2017) compliance date, FDA published an interim final rule (IFR) that delayed compliance for one year and …

    • FDA Announces Intent to Extend Compliance Date for Nutrition LabelingJune 13th, 2017

      On June 13th, FDA’s Office of Nutrition and Food Labeling “announced” that it intends to extend the compliance date for the new Nutrition Facts requirements.  As we previously reported, FDA received several citizen petitions requesting an extension of the compliance date. In addition, some in …

    • Colgate Asks Court to Stay Action until FDA Defines “Natural”June 12th, 2017

      As readers of this blog know, natural claims have been and continue to be a frequent basis for consumer class actions. Initially, lawsuits appeared to focus on natural claims for foods (and dietary supplements). However, natural claims for personal care products also have become a …

    • Coalition of Consumer Advocates Challenges FDA’s GRAS Notification Final RuleMay 26th, 2017

      A coalition of consumer advocates filed a lawsuit challenging FDA’s final rule that formally established the GRAS notification system.  The complaint alleges that the rule “unlawfully subdelegates statutory authority to private parties,” that the “secret GRAS system is contrary to the FDCA,” and that the “criteria for …

    • For the Love of Money: The Trump Administration’s Fiscal Year 2018 FDA Budget PlanMay 23rd, 2017

      Cue up “For The Love of Money” by The O’Jays (and theme song of The Apprentice) . . . The Trump Administration’s Fiscal Year 2018 Budget Proposal is out! On May 23, 2017, The White House Office of Management and Budget released President Trump’s Fiscal Year …

    • To Reduce Regulatory Burdens, Citizen Petition Asks FDA to Permit Interstate Sales of Raw MilkMay 10th, 2017

      A citizen petition (Docket No. FDA-2017-P-2626) recently submitted to FDA asks the agency to exercise enforcement discretion with respect to the regulatory prohibition on interstate shipments of milk products that have not been pasteurized (21 CFR 1240.61).  There have been previous petitions asking FDA to allow the …

    • FDA Postpones and Reconsiders Menu Labeling Regulation; Comments Due July 3, 2017May 2nd, 2017

      FDA has again decided to delay the compliance date for its regulations governing calorie labeling for menus and menu boards at restaurants and similar retail food establishments. In an unpublished Interim Final Rule (IFR) released on May 1 (and scheduled to be published in the …

    • American Bakers Association Petitions FDA to Revoke or Revise the New Dietary Fiber DefinitionApril 27th, 2017

      On April 10, 2017, the American Bakers Association (ABA) submitted a Citizen Petition and a Petition for Stay of Action on FDA’s new definition of dietary fiber in 21 C.F.R. § 101.9(c)(6)(i), and the accompanying recordkeeping requirement in 21 C.F.R. § 101.9(g)(10) and (11). By way …

    • Court Applies First Amendment Protections to FDA-Related ClaimsApril 25th, 2017

      Although the First Amendment has been more often discussed in the context of drug and medical device promotion, the Eleventh Circuit recently evaluated whether claims for a food also deserve similar constitutional scrutiny. In Ocheesee Creamery LLC v. Putnam, the Eleventh Circuit considered whether the …

    • Interagency Food Safety Analytics Collaboration Issues New Strategic PlanMarch 31st, 2017

      The Interagency Food Safety Analytics Collaboration (IFSAC) has issued a strategic plan for the 5-year period beginning in 2017.  This is the second such plan issued by IFSAC, a collaboration between FDA, USDA/FSIS, and CDC that aims “to improve coordination of federal food safety analytic efforts …

    • How to Name that Food: The Good Food Institute Petitions FDA for ClarityMarch 8th, 2017

      With the expanding market for plant-based foods, often developed as an alternative to the animal-based food products which consumers avoid for various reasons (allergies, health concerns, ethical concerns, environmental concerns, or taste preference), the naming of plant-based foods has become a major issue. Although the issue …

    • FDA Meeting to Discuss the Meaning and Use of the Term “Healthy” for FoodsFebruary 27th, 2017

      On February 15, FDA announced a public meeting to give interested persons an opportunity to discuss the use of the term “healthy” in the labeling of human food. As described in previous blog posts, since FDA’s issuance of a warning letter to Kind LLC in March of …