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, …
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. …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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, …
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 …
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 …
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 …
