US FDA Dietary Supplements

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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Key Developments in EU and UK Regulations: Early 2023 Updates

Amazon Dietary Supplements Requirements USA

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Navigating Amazon Dietary Supplements Requirements: A 2025 Compliance Guide Selling dietary supplements on Amazon USA can be highly profitable, but it also involves strict compliance with both Amazon’s internal policies and U.S. federal regulations. In recent years, Amazon has significantly tightened its oversight on supplement listings, making it critical for sellers—both domestic and international—to understand

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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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Understanding FDA Structure/Function Claims Notification (SFCN): Why and When It Is Necessary

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Understanding FDA Structure/Function Claims Notification (SFCN): Why and When It Is Necessary   The U.S. Food and Drug Administration (FDA) regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994. This legislation grants manufacturers the right to make certain types of claims about their products, provided these claims are truthful and

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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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Import Alert 99-32: What Happens If I Refuse FDA Inspection?

Import Alert 99-32: What Happens If I Refuse FDA Inspection?

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Import Alert 99-32: What Happens If I Refuse FDA Inspection?   FDA inspections of food establishments, both domestic and foreign, are vital for identifying food safety issues. Under section 704 of the FD&C Act, FDA representatives are authorized to conduct inspections, including those of foreign establishments whose products are imported into the U.S. The FDA

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