Posts by Marc Sanchez

The landscape of food ingredient safety is entering a period of significant transition in 2026. For decades, the “Generally Recognized as Safe” (GRAS) pathway has allowed companies to bring new ingredients to market based on their own scientific determinations of safety. However, as the FDA implements a major restructuring of its Human Foods Program, the…

The medical device industry is currently navigating one of its most significant regulatory shifts in decades. For nearly thirty years, the Food and Drug Administration (FDA) relied on the Quality System Regulation (QSR) found in 21 CFR Part 820 to ensure the safety and efficacy of devices. However, the landscape has changed. To foster innovation…

The U.S. Food and Drug Administration has announced a new enforcement approach to products labeled “no artificial colors,” signaling heightened scrutiny for food and beverage companies that rely on clean-label marketing. While the phrase may appear straightforward, the regulatory analysis behind it is far more nuanced. As outlined in the FDA’s official press announcement, the…

Compounding pharmacies play a critical role in patient care, especially when commercially available drugs cannot meet specific clinical needs. However, the regulatory distinction between traditional compounding and large-scale outsourcing remains one of the most common sources of enforcement exposure in the pharmaceutical space. Misunderstanding where that line is drawn can create compliance risks under 503a…

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 Congresses would…

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…

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 combines full-year FY 2026 appropriations…

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.…

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 running on fumes. User-fee…

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 are no longer temporary—they…

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 remains without appropriations, and…

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 announcement that November…