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US FDA food regulations

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

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

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

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

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?

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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Navigating FSVP Compliance: A Comprehensive Guide

Navigating FSVP Compliance: A Comprehensive Guide

Navigating FSVP Compliance: A Comprehensive Guide     In 2017, the FDA introduced the Foreign Supplier Verification (FSVP) Program, sparking concerns among many. To address these concerns, we’ve compiled an informative FSVP FAQ guide to help you understand and navigate the compliance process seamlessly. Read more : Dietary Supplement Labeling Guide: Understanding Claims, Labels and

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Importing Food to the USA: A Comprehensive Guide

Importing Food to the USA: A Comprehensive Guide

Importing Food to the USA: A Comprehensive Guide   If you’re planning to import food into the United States, understanding the regulatory process is crucial. The U.S. Food and Drug Administration (FDA) plays a central role in overseeing all foods and food ingredients introduced into or offered for sale in interstate commerce. Here’s a step-by-step

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How to get a DUNS number for food facility registration with the FDA

Step-by-Step Guide: Obtaining a DUNS Number for FDA Food Facility Registration

How to get a DUNS number for food facility registration with the FDA In the United States, both domestic and foreign facilities engaged in the manufacturing, processing, packing, or storage of food intended for human or animal consumption are required by law to register with the U.S. Food and Drug Administration (FDA). This registration process

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