US Food and Drug Administration (FDA) Regulations

U.S. Food and Drug Administration (FDA) Regulations

INTRODUCTION

Malaysian exporters of food and beverage (F&B) must comply with

U.S. Food and Drug Administration (FDA) regulations to ensure the

goods are neither adulterated nor misbranded.

MATRADE, as the National Trade Promotion Agency, had

collaborated with Registrar Corp who provides assistance with U.S.

FDA Regulations to give a talk on the U.S. FDA requirements for

F&B exports to US.

Following the talk, this booklet is published as a guide for the

Malaysian exporters using the presentation material provided by

Registrar Corp. The information provided in the booklet is intended

as a general guidance for your reference only and is not intended

to represent necessarily all the rules and regulation required by the

U.S. FDA.

If you are unfamiliar with any terms used throughout this document

or have further question, please refer to Registrar Corp (

www.

or other U.S. Agents.

REGISTRATION WITH U.S. FDA

Malaysian manufacturer of Food and Beverage (F&B) and intended

to export their product to the US need to register their food facilities

with the U.S. FDA. This is in accordance to the Bioterrorism Act of

2002.

Facilities that manufacture, process, pack or store food (including

beverages and dietary supplements) must not only register but

must also designate a U.S. Agent for FDA communications. The

U.S. Agent must be based in the United States and available to

receive communications from the U.S. FDA 24/7.