This third installment of our series analyzing the rider provisions in the fiscal year 2026 appropriations legislation continues our examination of key FDA policy directives embedded in congressional committee reports. This post focuses on provisions related to medical devices, pharmacy compounding, GLP-1 medications, and food-areas …
It gets repeated as an article of faith: The generally recognized as safe (GRAS) exception to the definition of “food additive” in section 201(s) of the FD&C Act was intended to encompass only common food ingredients such as vinegar and salt. Not so fast. Just a …
As we previously reported, in June 2025, Texas enacted a labeling law requiring a warning statement on any food and beverage containing one of 44 specified substances. We indicated that such state law initiatives might well be challenged by industry. So it did not come as …
As we previously reported, HHS Secretary Robert F. Kennedy, Jr. and FDA have highlighted the removal of petroleum-based synthetic dyes which remain approved for use in food as a focus of the MAHA campaign. These dyes include FD&C Green No. 3, FD&C Red No. 40, …
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 …
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 …
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 …
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 …
