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. …
On July 7, 2025, President Trump, via Executive Order (“EO”), issued a presidential memorandum and accompanying fact sheet directing major changes in federal civilian hiring, including extending the federal civilian hiring freeze through October 15, 2025. Under the titular theme “Ensuring Accountability and Prioritizing Public …
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 …
Last Friday, the Supreme Court delivered a trio of decisions making it easier to litigate against the federal government. The facts and law in each case matter, and as is often the case when the Supreme Court “decides” an issue, much remains to be seen. …
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 …
Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institute’s Annual Conference, continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own. Now firmly in the chair after the agency’s controversial RIFs—which he …
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 …
The American Conference Institute’s popular “FDA Boot Camp” – now in its 43rd iteration – is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY . The conference is billed as the premier event to provide folks …
The government is currently funded through March 14th, 2025. Come Monday March 17th, if Congress does not pass a budget or continuing resolution, the FDA will enter a shutdown and shutter many offices and programs while Congress works out their inter-party squabbles on national priorities. …
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 …
