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US FDA food regulations

FDA mandatory GRAS notification rule 2026 food ingredient safety filing.

FDA Mandatory GRAS Notification Proposed Rule 2026: What Companies Need to Know

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On 11 August 2026 the FDA proposed making GRAS notification mandatory, ending the ability to keep self-determined GRAS conclusions private. The rule (docket FDA-2025-N-3262) is open for comment until 9 December 2026 and offers a time-limited streamlined path for substances already on the market. This guide sets out who is bound, the deadlines, and the actions food and ingredient companies should take now.

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FDA dietary supplement health claims

Legal Challenge to FDA’s Evidentiary Standard for Dietary Supplement Health Claims: Regulatory Implications for Industry

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The FDA dietary supplement health claims framework requires that disease-related claims meet the Significant Scientific Agreement (SSA) standard under 21 CFR 101.14. A recent legal challenge questions whether the SSA threshold is overly restrictive, potentially impacting dietary supplement compliance and claim substantiation requirements.

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US FDA Updates Food Labeling Compliance Program: What Manufacturers Need to Know

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FDA Updates Food Labeling Compliance Program: What Manufacturers Need to Know The U.S. Food and Drug Administration (FDA) has released major revisions to its Compliance Program 7321.005, now titled “General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import.” This update, issued on June 24 2025, replaces the previous 2010 version and marks

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Life After “De Minimis”: What Importers of Cosmetics, Food, and Supplements Must Know

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Life After “De Minimis”: What Importers of Cosmetics, Food, and Supplements Must Know Introduction The elimination of de minimis import rules 2025 marks a turning point for global trade. The change rescinds previous rules allowing sub-$800. Shipments that once bypassed duties and simplified entry now require full customs clearance and compliance. For businesses importing cosmetics,

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How U.S. Tariffs Affect Imports of FDA-Regulated Products: What Importers Need to Know

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How U.S. Tariffs Affect Imports of FDA-Regulated Products: What Importers Need to Know Introduction Importing FDA-regulated products into the U.S. involves more than just regulatory compliance. Rising U.S. tariffs on specific goods can significantly affect your business strategy, especially if you’re importing cosmetics, dietary supplements, food, or medical devices. This article explores how tariffs and

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Export Food & Dietary Supplements to the USA | FDA Registration & US Agent Service

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How to Export Food and Dietary Supplements to the USA: Understanding FDA Facility Registration and the Role of a US Agent The Importance of Facility Registration and a US Agent Exporting food and dietary supplements to the United States is a significant opportunity for international businesses, given the high demand for quality food and health

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Adverse Event Reporting for Cosmetics | MOCRA Compliance with Cosmereg

Adverse Event Reporting for Cosmetics | MOCRA Compliance with Cosmereg

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What is Adverse Event Reporting for Cosmetic Products? | MOCRA Compliance with Cosmereg With the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), the U.S. FDA has strengthened regulatory requirements for cosmetic products, bringing them closer to the standards seen in food and drug industries. One of the most significant changes is the mandatory reporting

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U.S. Agent vs. FSVP Agent: Key Differences for FDA Compliance

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U.S. Agent vs. FSVP Agent: Key Differences for FDA Compliance When it comes to compliance in the U.S. food and dietary supplement industries, it’s crucial to understand the distinct roles of a U.S. Agent and an FSVP Agent. Both play key roles in regulatory compliance for foreign entities operating in the U.S., but they serve

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Common Challenges in FSVP Compliance and How to overcome them

Common Challenges in FSVP Compliance and How to Overcome Them

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Common Challenges in FSVP Compliance and How to overcome them   Compliance with the Foreign Supplier Verification Program (FSVP) can present several challenges for food importers and foreign exporters selling directly to U.S. consumers. Understanding these challenges and knowing how to address them is crucial for ensuring your food imports meet FDA standards. Here, we

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