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  • Foods and Dietary Supplements

    • ACI’s Advanced Summit on Food Law Regulation, Compliance, and LitigationJanuary 27th, 2026

      The American Conference Institute’s (“ACI”) milestone 10th Anniversary edition of its Advanced Summit on Food Law, Compliance and Regulation is scheduled to take place from April 28–29, 2026 at the Hilton Chicago/Magnificent Mile Suites in Chicago, IL. Since ACI’s last summit, the food industry continues to …

    • California’s New Allergen-Disclosure Law: A Sign of Things to Come?October 31st, 2025

      On October 13, 2025, Governor Gavin Newsom signed into law SB 68, titled “Allergen Disclosure for Dining Experiences Act,” officially creating a statewide requirement for certain restaurants to disclose major food allergens on their menus. What SB 68 Requires SB 68: Requires disclosure of the nine major food …

    • Kessler Petition Seeks Revocation of GRAS Status for Processed Refined CarbohydratesAugust 13th, 2025

      News coverage of the citizen petition submitted by Dr. David Kessler has been somewhat breathless, so it was nice to read the document first hand when it was posted yesterday in the docket at regulations.gov – and you should do the same. Spoiler alert! In …

    • Defining “Ultra-Processed” Food: FDA Wants Your InputAugust 4th, 2025

      Since 2009, the term ultra-processed food (“UPF”) has gained recognition as there have been studies that suggest a relationship between consumption of UPFs and chronic diseases.  The term frequently focuses on processing and composition without consideration of food groups and nutritional composition.  At this time, …

    • Color Food Beautiful: FDA Approves Gardenia Blue and Continues Push to Phase OutJuly 24th, 2025

      On July 14, 2025, the U.S. Food and Drug Administration (FDA) approved Gardenia Blue, a plant-based color additive, while simultaneously making clear to industry that the Agency encourages food manufacturers to accelerate their phasing out of the use of the synthetic dye FD&C Red No. …

    • State-Led Food Transparency: Texas and Louisiana Lead the ChargeJuly 10th, 2025

      Two southern states are taking bold steps to change the way they approach food labeling—and they’re not mincing words.  In a growing movement aligned with the “Make America Healthy Again” (MAHA) agenda, Texas and Louisiana have each passed sweeping new laws requiring clearer warnings and …

    • It’s a Bird, It’s a Plane, It’s an UPDATE on Operation Stork SpeedMay 19th, 2025

      Operation Stork Speed is a go! 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 …

    • More on the Impact of the FDA RIFs: How Information Disclosure will Start FOIA-lling BehindApril 10th, 2025

      The recent and drastic Reduction In Force (RIF) at the U. S. Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. While much of the focus has …

    • While FDA Suffers Staffing Cuts, Nondelegation Case in SCOTUS Is Latest Legal Challenge to Curb Agency PowersApril 4th, 2025

      Last June, the United States Supreme Court issued four landmark decisions that curbed executive agency powers. Those decisions are changing the way agencies, including FDA, exercise their rulemaking and enforcement authorities. Regardless of your position on the correctness of the holdings or the reasoning behind …

    • Governmentally Recognized as SafeApril 3rd, 2025

      That’s a play on an old acronym, in service of a point. A few weeks ago, HHS released a press release stating that FDA had been directed “to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance …

    • More Uncertainty and Less Advice from FDA Means Companies will Need to Even More Carefully Chart their own Course to Achieve their GoalsApril 2nd, 2025

      Trade and national press have reported that recent changes in FDA staffing levels have already led to  slower responses to calls and emails.  According to reports, which were published before the most recent reports of HHS staff level reductions and tumultuous changes in leadership, FDA …

    • 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, …