What FDA compliance steps must a Turkish manufacturer take to export dietary supplements to the United States?

Question

I'm a Turkish manufacturer planning to export dietary supplements to the U.S. market. What FDA requirements apply, such as labeling rules, CGMPs, NDIs where relevant, and import documentation, and what are the typical steps, timelines, and costs? Do I need a U.S.-based representative or agent to interact with FDA?

Lexin Legal · Accepted Answer

Hello. To export dietary supplements to the U.S., you need to complete FDA Facility Registration. Additionally, your product labeling must strictly comply with U.S. regulations. Since non-compliance can lead to detention of goods, professional legal assistance is recommended to navigate these steps correctly.

What FDA compliance steps must a Turkish manufacturer take to export dietary supplements to the United States?

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