Regulation Intelligence
Plain-language analysis of FDA regulations — what changed, who is affected, and what companies need to do next.
Food Dye Phase-Out: Federal & State Bans on Synthetic Color Additives
The U.S. is converging on the elimination of synthetic food dyes through a combination of the FDA's Red No. 3 ban (effective January 2027), a voluntary federal phase-out of six remaining petroleum-based dyes by end of 2026, and enacted state laws in California, West Virginia, and Utah. With 37+ states introducing food dye legislation in 2025 and major manufacturers pledging reformulation, the regulatory landscape is shifting faster than at any point in the past three decades.
Read more →GRAS Reform: FDA's Generally Recognized as Safe Review & Proposed Changes
The FDA is preparing a proposed rule to make GRAS notification mandatory, ending decades of industry self-determination. With the Better Food Disclosure Act advancing in Congress and targeted reassessments of BHA and other substances underway, companies relying on self-affirmed GRAS face a compliance reckoning in 2026-2027.
Read more →FSMA 204: FDA Food Traceability Rule — Compliance Deadlines & Requirements
The FDA's Food Traceability Rule requires standardized farm-to-fork recordkeeping for high-risk foods including leafy greens, seafood, soft cheeses, and shell eggs. Originally due January 2026, the compliance deadline was extended 30 months to July 20, 2028. A complete guide to the Food Traceability List, Critical Tracking Events, technology requirements, and what companies should do now.
Read more →Ultra-Processed Food: FDA Request for Information & Regulatory Outlook
The FDA and USDA published a joint Request for Information in July 2025 seeking public input on a federal definition of ultra-processed food — the first formal step toward regulating a category that constitutes an estimated 57-60% of American caloric intake. Backed by the MAHA Commission and former FDA Commissioner Kessler's petition to revoke GRAS status of key UPF ingredients, the regulatory trajectory is clear even as the timeline remains uncertain.
Read more →Section 781 Hemp & CBD: FDA Regulatory Framework & Enforcement
Section 781 of the FD&C Act, enacted November 2025, rewrites the federal definition of hemp with a total THC standard and a 0.4 mg per container cap -- threatening 95% of existing hemp-derived cannabinoid products by November 2026. FDA missed its February 2026 guidance deadline, leaving the $30B industry in regulatory limbo.
Read more →Red No. 3 Ban: FDA Revokes FD&C Red No. 3 for Food & Drugs
The FDA revoked color additive listings for FD&C Red No. 3 under the Delaney Clause. Food deadline January 15, 2027. Drug deadline January 18, 2028. Complete timeline, state bans, and reformulation guide.
Read more →PFAS in Food Contact Materials: FDA Phase-Out & State Bans
The FDA completed its voluntary phase-out of PFAS grease-proofing agents in February 2024 and revoked 35 food contact notifications in January 2025. At least 12 states have enacted their own PFAS food packaging bans, with compliance deadlines ranging from 2023 to 2032. This page tracks the full federal, state, and international regulatory landscape for PFAS in food contact materials, seafood, cosmetics, and drinking water.
Read more →Front-of-Pack Labeling: FDA's Proposed Nutrition Information Rule
The FDA has proposed mandatory front-of-package nutrition labels requiring a 'Nutrition Info box' displaying Low, Med, or High interpretive ratings for saturated fat, sodium, and added sugars on most packaged foods. Published January 16, 2025, the rule received 11,000+ comments and could be finalized in spring 2026 — though the Trump administration's MAHA initiative may reshape the final design.
Read more →Dietary Supplement GMP: 21 CFR 111 Compliance & FDA Enforcement
21 CFR Part 111 requires all dietary supplement manufacturers to follow current good manufacturing practices for identity testing, specifications, and documentation. With 34 CGMP-related enforcement actions in our database and nearly half of inspected facilities receiving FDA citations, supplement GMP compliance remains the industry's most persistent regulatory challenge.
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