Posts by Marc Sanchez

GRAS Loophole For more than two decades, the FDA’s “generally recognized as safe” (GRAS) framework has allowed food ingredients to enter the U.S. market either through FDA notification or through a company’s internal “self-GRAS” determination without notifying the agency. That flexibility is now under renewed scrutiny. Four separate bills introduced in the 118th and 119th…

The Hemp Provision in H.R. 5371: What the Shutdown-Ending Bill Means for Hemp, CBD, and Cannabinoid Products Congress quietly enacted one of the most sweeping federal cannabis and hemp restrictions in years—and it arrived tucked inside the same bill that ended the 43-day government shutdown. H.R. 5371, the legislation that restored funding for FDA and…

Reopening the FDA and USDA After 43 days, the longest government shutdown in U.S. history is officially over. On November 12, 2025, the President signed H.R. 5371, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, reopening the federal government and restoring funding across agencies. (Business Insider) The package…

Assuming Congress passes and the President signs the pending continuing resolution Backlog and Recovery Timeline: Even after funding is restored, both FDA and USDA face operational backlogs. Expect a staged recovery—FDA typically clears urgent submissions (recalls, safety-critical reviews) within the first week, while standard user-fee submissions and inspections may take two to four weeks to normalize.…

Day 35 Shutdown Update A Record-Breaking Shutdown—And No End in Sight Today marks Day 35 of the federal government shutdown—tying the longest in U.S. history. What began as a short-term funding dispute has evolved into a full-scale breakdown of regulatory continuity. Across FDA, USDA, and related agencies, internal coordination, submission review, and enforcement work are…

Day 33 Shutdown Update: A Second Month Without Movement The federal government shutdown has now reached Day 33, marking the start of its second month and solidifying its place as one of the longest funding lapses in U.S. history. As the shutdown enters this new phase, the implications for FDA, USDA, and related regulatory bodies…

Day 30 Shutdown Update Thirty days in, the shutdown has reached a threshold that few agencies were designed to withstand. What began as a temporary funding lapse has become an operational drought, and for several FDA centers—particularly the Center for Tobacco Products (CTP) and the Center for Veterinary Medicine (CVM)—the margin for continuity is disappearing. The broader government…

Day 29 Shutdown At Day 29, the shutdown has outlasted every modern benchmark for administrative endurance. While many agency websites still display the illusion of normalcy, beneath the surface the system is fractured: databases idle, renewal deadlines lapse unnoticed, and the flow of federal benefits—once a constant—is grinding to a halt. This week, the USDA’s…

Day 28 Shutdown Update: The federal shutdown reached Day 28 today, entering its fifth week with no funding resolution in sight. What began as a temporary budget impasse is now a slow-motion systems collapse across agencies responsible for food safety, public health, and regulatory oversight. While FDA and USDA have managed to preserve a skeleton…

Day 27 The shutdown has now reached Day 27, making it the longest lapse in FDA funding since the user-fee era began. While the visible symptoms—silent websites, frozen comment periods, suspended outreach—have persisted for weeks, a quieter crisis is now emerging: the slow depletion of review momentum and the near-total halt of new user-fee submissions. FDA:…

Day 23 Shutdown Update The shutdown has now entered Day 23, officially becoming one of the longest government funding lapses in U.S. history. What began as a stoppage of new appropriations has deepened into a systemic strain: critical agencies are still running on carryover funds, contingency staffing, and increasingly brittle infrastructure. This week’s updates illustrate…

FDA Shutdown Update As the shutdown stretches into its third full week, its effects are evolving from delay into erosion. Agencies like the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) remain officially operational, but the strain on review systems, registrant requirements, and workforce continuity is becoming more acute. Agency…