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US FDA Dietary Supplements

Adverse Event Reporting for Cosmetics | MOCRA Compliance with Cosmereg

Adverse Event Reporting for Cosmetics | MOCRA Compliance with Cosmereg

Leave a Comment / US FDA Dietary Supplements, US FDA food regulations, US FDA Medical Devices, US FDA OTC regulations, USA Cosmetic Regulations /

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

US FDA Dietary Supplements /

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 not

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

US FDA Dietary Supplements, US FDA food regulations /

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

US FDA Dietary Supplements, US FDA food regulations /

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?

US FDA Dietary Supplements, US FDA food regulations /

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

US FDA Dietary Supplements, US FDA food regulations /

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. Understanding FSVP 1.1 What is FSVP? The FSVP is a program targeting

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Importing Food to the USA: A Comprehensive Guide

Importing Food to the USA: A Comprehensive Guide

US FDA Dietary Supplements, US FDA food regulations /

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

US FDA Dietary Supplements, US FDA food regulations, US FDA OTC regulations, USA Cosmetic Regulations /

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

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What’s the Difference Between Food and Dietary Supplement Labeling in the United States and Canada?

Canada Dietary Supplement NHP NPN, US FDA Dietary Supplements, US FDA food regulations /

What’s the Difference Between Food and Dietary Supplement Labeling in the United States and Canada?   What’s the Difference Between Food and Supplement Labeling in the United States and Canada? Food and supplement companies must follow the labeling requirements in each jurisdiction they intend to sell their products in the U.S. and Canada. However, there

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