FDA registration service

Mekong Counsel(*) is the only company in Mekong Delta which provides services on FDA (Food and Drugs Administratrion) registration for food intended for humans and animals consumption imported into the United States. Together with the cooperation of a law office specialized in foods and beverages, Mekong Counsel provides the following services on FDA registration :

  •    Registering FDA registration and selection of the United States agent :

According to Public Health Security and Bioterrorism Preparedness and Response Act of 2002 of the US (the Bioterrorism Act), any facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. are required to register the facility with the United State Food and Drug Administration (“FDA”) to be issued FDA Registration number.

According to the Bioterrorism Act, foreign facilities are required to have a U.S. agent which resides or maintains a place of business in the U.S. and is physically present in the U.S.

  •     Making Prior Notice to FDA :

Under Final Rule - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (68 FR 58975) which comes into effects since May 6, 2009, FDA must be given notice before food is imported or offered for import into the United States. If food is from a foreign facility that fails to give notice in advance, it is subject to being placed under hold under section 801(l) of the act.

  •    FCE (Food Canning Establishment) and SID (Submission Identifier) filings :

Federal Regulations require commercial processors of acidified foods and low-acid canned foods to be sold in the United States to register with FDA each establishment a FCE (Food Canning Establishment member) and file scheduled processes SID (Submission Identifier) with FDA.

(*)Mekong Counsel is a consultancy company and not affiliated with U.S. FDA.



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