Regulatory Analysis
FDA regulatory intelligence, warning letter breakdowns, and actionable analysis for brands across all FDA-regulated categories.
FDA Pharmaceutical Data Integrity Enforcement in 2026: Falsified Records, Destroyed Evidence, and the Import Alert That Follows
Five FDA warning letters in Q1 2026 cite deliberate falsification across drug manufacturers, contract labs, and CROs — including records destroyed while investigators were on-site. Here is what it means for US companies sourcing from overseas.
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FDA's Undeclared Prescription Drug Problem: Two Supplement Categories, One Accelerating Enforcement Pattern
Ten enforcement actions in ten weeks. That is the pace at which FDA has moved against dietary supplements containing undeclared prescription drug ingredients in 2026. Recalls, safety alerts, import holds — the activity spans two distinct product categories, involves a short list of recurring pharmaceutical compounds, and points toward continued escalation.
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FDA Inspections in 2026: DOGE Didn't Cut Inspectors — It Cut Everything Around Them
FDA is running 36% below pre-pandemic inspection levels. DOGE's 2025 cuts to support staff, lab scientists, and travel logistics made closing that gap harder.
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FDA's 30 GLP-1 Warning Letters: The Largest Compounding Crackdown in Over a Decade
On March 3, 2026, the FDA issued 30 warning letters to telehealth companies selling compounded GLP-1s. Here's what happened, why it matters, and what QA teams should do now.
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FDA Food Additive Regulations 2026: Red No. 3 Ban, Petroleum Dye Phase-Out, BHA Safety Review, and What Food Brands Must Do Now
FDA food additive regulations are seeing their biggest overhaul in decades. Here's the current state of the Red No. 3 ban, petroleum dye phase-out, BHA safety review, and GRAS reform — with deadlines and action items for food brands.
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FDA Supplement Regulations 2026: CGMP Violations, 483 Observations, and the New Enforcement Reality
Our analysis of 7,500+ FDA enforcement actions shows supplement enforcement at a decade-high intensity. Here are the CGMP violation patterns, top 483 observations, and substances driving the most regulatory heat in 2026.
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FDA Recall List 2026: What 1,000 Recalls Reveal About the Biggest Threats to Food Safety
Our analysis of 1,000 FDA recall actions reveals the pathogens, allergens, and contaminants driving a 9-year high in food recalls — and the three patterns every food brand needs to understand.
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MoCRA Compliance in 2026: The Registration Deadline Just Passed — Here's What Comes Next
MoCRA biennial registration renewals are underway, with all first renewals due by July 1, 2026. Here's what FDA's expanded authority means for beauty brands, what safety records you must keep, and the new NSF standard that's reshaping compliance.
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Nobody Monitors the FDA for Your Specific Products. We Built the Thing That Does.
MoCRA renewals, PFAS evaluations, warning letters up 73%. The information is public. The question is whether you know which of YOUR products any of it affects. That cross-reference step is where warning letters live — and nobody automates it. Until now.
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