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 …
In a dense, multi-part opinion, the Supreme Court affirmed 5-4 the lower courts’ dismissal of a challenge to California’s Proposition 12. That law bans the knowing sale of eggs, uncooked pork, or veal derived from farm animals that are housed under conditions that do not …
For those readers unfamiliar with the regulation of animal food ingredients in the United States, below is a brief background. In the United States, animal food (feed) regulations are enforced by state and federal regulatory officials. At the federal level, the Center of Veterinary Medicine (CVM) …
Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be moderating a panel on “The Use of Bioactive Substances in Food and Dietary Supplements” during the Food and Drug Law Institute (FDLI) Food and Dietary Supplement Safety and Regulation Conference. The conference will be held live in Washington …
Chocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. Though not …
