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US Food Facility Registration Renewal required

If you are one of the 5000 Australian food facilities registered with the US Food and Drug Administration (FDA) you have between 1 October and 31 December 2014 to renew that registration. Failure to renew will result in cancellation of your registration and limit your ability to export foods to the US.


Written by

Russell Wiese,

Lynne Grant,
Special Counsel

Fran Smyth,



Since 2003 Australian businesses that manufacture/process, pack or hold food for human or animal consumption in the United States are required to register with the FDA.  Registration is part of the FDA taking steps to protect the US public from a threatened or actual terrorist attack on the US food supply.  Registration requires the Australian business to nominate a US resident agent that will act as a communications link between the FDA and the business.


Since 2012, renewal of registration has been required every second year.  For a registrant where there has been no change in details, an abbreviated renewal process is available.  If registration is not renewed by 31 December 2014 the registration will be considered expired and the account removed from the FDA's system. 
Registration renewal can be completed online at


It is crucial that your renewal be performed prior to 31 December 2014 as a failure to be registered when required can result in prosecution by US authorities.  Further, food that is exported to the US from a facility that is not registered is likely to be held at the US port of entry.


It is important to remember that on top of what we might ordinarily think of as food, the registration requirement extends to dietary supplements, infant formula, beverages, raw agriculture commodities, live food animals and animal feed and pet food.
If you are unsure whether you need to be registered with the FDA or have questions about the renewal process, please feel free to contact us.

Disclaimer: The information contained in this e-alert/update is not advice and should not be relied upon as legal advice. Hunt & Hunt recommends that if you have a matter that is legal, or has legal implications, you consult with your legal adviser.


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