Last week’s issuance of a request for information (RFI) in the Federal Register by the FDA and the US Department of Agriculture (USDA) marks the first step in the administration’s effort to address health concerns associated...more
In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This program guides FDA inspectors...more
On June 18, 2025, FDA announced for public comment a Post-market Assessment Prioritization Tool (Prioritization Tool) as an enhanced systematic process for post-market scientific assessment of chemicals in food, including...more
The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more systematic review process”...more
Both state and federal government authorities have recently turned their attention toward artificial coloring in foods. The Food and Drug Administration (FDA) announced a series of measures in April 2025 to phase out all...more
The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more
The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more
With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more
Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more
3/25/2025
/ Department of Health and Human Services (HHS) ,
Dietary Supplements ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Public Health ,
Regulatory Agenda ,
Regulatory Requirements ,
State and Local Government
FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food industry change in 2024 was the overhaul of how FDA structures itself to regulate foods generally....more
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question how this political shift...more
On October 1, 2024, the US Food and Drug Administration (FDA) announced the implementation of its long-promised reorganization, with the establishment of the unified Human Foods Program (HFP). The HFP now oversees all FDA...more
The Association of American Feed Control Officials (AAFCO) and the US Food and Drug Administration (FDA) announced on August 2, 2024 that their long-standing Memorandum of Understanding (MOU) governing the development and...more
The US Food and Drug Administration (FDA) issued final guidance titled Foods Derived from Plants Produced Using Genome Editing (Genome-Edited Plants Guidance), describing the agency’s approach for evaluating the safety of...more
The US Food and Drug Administration (FDA) recently announced that manufacturers have completed the voluntarily phase-out of the use of certain per- and polyfluoroalkyl substances (PFAS) in grease-proofing agents for food...more
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials...more
The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and reduced risk of type two...more
The US Food and Drug Administration (FDA) was busy in 2023 with significant, and even bullish, developments occurring across several areas, from drug and biologic development and manufacturing to labeling, advertising, and...more
The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify...more
After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet...more
In a sizable step toward reorganizing the Human Foods Program (HFP or Program) to rehaul the US Food and Drug Administration’s (FDA’s) current food infrastructure to better coordinate the agency’s regulation of food products,...more
The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product listing under the...more
In a historic decision, the United States Department of Agriculture (USDA) has approved two companies, Upside Foods and GOOD Meat, to market lab-grown chicken in the United States....more
FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft guidance is to modernize...more