The new bi-annual Food and Drug Administration (FDA) registration requirement for foreign and domestic food facilities imposed by the Food Safety Modernization Act (FSMA) took effect on 1 October 2012. This new requirement will catch the domestic and international food industries completely off guard according to former FDA regulatory counsel, Benjamin England.
“No one is prepared for this,” said Mr England, who is currently founder and chief executive officer of FDA consulting firm, FDAImports.com.
“With the summer ending, the elections looming and a total lack of other FSMA headliners, no one is talking about this going into effect. It’s going to be a shocker.”
FSMA amended the Food, Drug and Cosmetic Act (FDCA) Section 415 by requiring foreign and domestic food producers to register their facility every two years with FDA, rather than just once for all time. Under the FDCA, the FDA now has the authority to suspend the registration of a food facility that produces or exports food products to the United States.
“The impact of a food facility registration suspension becomes more severe when you consider how many different food products are manufactured in any one food facility,” said Mr England.
“Under this new authority, if any one product causes a reasonable health risk in the eyes of FDA, then FDA can prevent the import of any food product from that facility’s entire product line.”
According to Mr England, foreign companies probably do not know that they are required to renew their registration this year.
“If foreign food companies fail to renew, FDA will automatically suspend their registrations and they will not be able to ship to the USA,” said Mr England.
He further stated that if FDA finds a reason to recall food that was made in a foreign facility, FDA can suspend that foreign facility's registration and the facility could be put out of business if it does not respond rapidly to the problem. FDA could also go after other companies along the supply chain as well.
“If you are the domestic importer and distributor of a foreign processed food and you packed, received or held such food knowing of the risks of adverse health consequences associated with that food, FDA may go after your registration as well,” said Mr England.
“The time to register under the new FSMA requirements is right now.”
His company, FDAImports.com, assists international and domestic companies in FDA-regulated industries with all forms of FDA compliance including registration, listing, labeling and facilities.
For more information:
Visit: www.fda.gov/Food/FoodSafety/FSMA/ucm247559.htm
