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 Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements, on January 6, …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 …
This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these “lessons” will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. Although FDA has long taken the …
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 …
The word unprecedented has been used a lot in the past two weeks. Perhaps appropriately. Below is some precedent that’s been on this blogger’s mind recently and that may be relevant in the coming days, weeks, and months: Tummino v. Hamburg. Why? The HHS Secretary …
The Supreme Court’s recent decision in Loper Bright v. Raimondo has done away with Chevron deference to federal agencies’ interpretation of ambiguous statutes, including the FDA. The decision commands that federal judges must make their own decisions in suits against FDA, considering—but not deferring to—the …
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 …
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 …
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 …
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 …
WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, …
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 …
