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    • It’s a Bird, It’s a Plane, It’s Operation Stork SpeedMarch 31st, 2025

      On March 18, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched a significant initiative called Operation Stork Speed to bolster the availability and safety of infant formula in the United States (link, link).  This initiative …

    • Adios to Synthetic Colors in Food?March 27th, 2025

      Our good friends Virginia and West Virginia have become the first states in the nation to restrict the availability of foods containing certain synthetic colors (or in FDA parlance, certain colors subject to certification). You can read more about the particulars here and here. Although …

    • HPM Director to Moderate at FDLI’s Food and Dietary Supplement Safety and Regulation ConferenceMarch 10th, 2025

      Hyman, Phelps & McNamara, P.C. Director Ricardo Carvajal will be moderating a session at the Food and Drug Law Institute’s (“FDLI’s”) upcoming 1-day conference on Food and Dietary Supplement Safety and Regulation, scheduled to take place on March 25. Join us for timely, in-depth discussions …

    • FDA Recommends Disclosure of Plant Source in Draft Guidance on Labeling Plant-Based AlternativesJanuary 21st, 2025

      Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here, here, and here). Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements, on January 6, …

    • To Be or Coco-Not To Be: That’s One Question Answered in FDA’s Final Guidance Documents on Food AllergensJanuary 14th, 2025

      On January 6, 2025, FDA released two final guidance documents on food allergens: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), and Evaluating the Public Health Importance of Food Allergens Other …

    • FDA’s Final Rule on the Implied Nutrient Content Claim “Healthy” Maintains Focus on Foods Rather than on NutrientsJanuary 3rd, 2025

      As we previously reported in 2022, FDA published a proposed rule defining  the nutrient content claim “healthy.”  The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients.  In contrast, the 2022 proposed …

    • MAHA, Nutrition, and the FDANovember 14th, 2024

      Among the more interesting developments in the recent election was the emergence of Robert Kennedy as a prominent figure in the MAGA movement – and the collateral emergence of the MAHA movement (Make America Healthy Again). As crisply laid out in short YouTube video, MAHA …

    • Traditional Meat Industry’s Beef With Alternative Protein Continues with the FAIR on Labels ActMarch 6th, 2024

      As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products.  The animal product industry, particularly the beef industry and the dairy industry, has challenged naming …

    • FDA Proposes to Ban Brominated Vegetable Oil in FoodNovember 23rd, 2023

      For any of our readers seeking recommendations on which drinks pair well with turkey this Thanksgiving, certain fruit-flavored beverages may be off the table.  Earlier this month, FDA issued a proposed rule that would revoke 21 C.F.R. § 180.30, its interim authorization of the use of …

    • HP&M Recognized by Best Law Firms® as National Tier 1 – FDA Law and Regional Washington, DC Tier 1 – FDA Law (2024 Edition)November 15th, 2023

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce the firm has been selected to the 2024 edition of Best Law Firms.  Firms included in the 2024 Best Law Firms ranking are recognized for professional excellence with persistently impressive ratings from clients and peers. To …

    • It’s About Time: FDA’s Proposed Rule to Amend Prior Notice RegulationsNovember 10th, 2023

      On October 31, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines.  More specifically, the proposed rule, if finalized, would: Amend 21 C.F.R. § 1.281(b)(10) to require that prior …

    • FDA Releases Draft CPG on Major Food Allergen Labeling and Cross-ContactMay 24th, 2023

      On May 16, the U.S. Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact.  The draft CPG reflects the three major laws and regulations that …

    • By the Thinnest of Margins, State-Based Animal Welfare Requirements Move ForwardMay 22nd, 2023

      In a dense, multi-part opinion, the Supreme Court affirmed 5-4 the lower courts’ dismissal of a challenge to California’s Proposition 12. That law bans the knowing sale of eggs, uncooked pork, or veal derived from farm animals that are housed under conditions that do not …

    • AAFCO Publishes Proposed Common Food Index of 72 Foods; Requesting FeedbackMay 15th, 2023

      For those readers unfamiliar with the regulation of animal food ingredients in the United States, below is a brief background. In the United States, animal food (feed) regulations are enforced by state and federal regulatory officials.  At the federal level, the Center of Veterinary Medicine (CVM) …

    • The FTC Asserts Its Penalty Offense Authority (Again)April 18th, 2023

      On April 13, the Federal Trade Commission (“FTC” or “Commission”) issued a press release that it had sent letters to “almost 700 marketing companies that they could face civil penalties if they can’t back up their product claims.” FTC indicates that the notices were sent to companies …