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  • Foods and Dietary Supplements

    • 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 …

    • Ricardo Carvajal to Moderate Panel at FDLI’s Food and Dietary Supplement Safety and Regulation ConferenceMarch 16th, 2023

      Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be moderating a panel on “The Use of Bioactive Substances in Food and Dietary Supplements” during the Food and Drug Law Institute (FDLI) Food and Dietary Supplement Safety and Regulation Conference. The conference will be held live in Washington …

    • Be Still, My Beating Heart: FDA Announces Qualified Health Claims for Cocoa Flavanols and Reduced Risk of Cardiovascular DiseaseFebruary 14th, 2023

      Chocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. Though not …

    • A Holiday Surprise; FTC Published Its Health Products Compliance GuidanceJanuary 11th, 2023

      On Dec. 20, 2022, FTC announced the publication of its Health Products Compliance Guidance (“new Guidance”). FTC staff  prepared the new Guidance to update and replace Dietary Supplements:  An Advertising Guide for Industry, issued in 1998 (“1998 Guidance”).  The new Guidance provides the first update …

    • FDA Issues Two Guidance Documents on Food Allergen Labeling RequirementsDecember 9th, 2022

      Last week, the U.S. Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. The draft guidance, “Questions and Answers Regarding Food Allergen Labeling (Edition 5),” replaces the 16-year-old Edition 4 of the final guidance with new …

    • This Thanksgiving, Be Thankful for Family and Food(borne Illness Prevention)November 23rd, 2022

      At the risk of ruining our readers’ appetite for America’s most food-focused holiday, foodborne illnesses have been a feature of Thanksgiving for some time now.  Some of us might still recall the 2017 salmonella outbreak linked to raw turkey products that caused over 279 infections, …

    • FDA Completes First Consultation for an Animal Cell-Cultured FoodNovember 17th, 2022

      FDA announced that it has completed the first pre-market consultation for an animal cell-cultured food, based on a safety assessment submitted by UPSIDE Foods. In an indication of the significance of this development, FDA Commissioner Robert Califf and CFSAN Director Susan Mayne issued a statement …