Countdown to October 1, 2012: New FSMA Biennial FDA Registration for All Food Facilities
It’s almost here. The new biennial FDA registration requirement for foreign and domestic food facilities imposed by the Food Safety Modernization Act (FSMA) takes effect October 1, 2012.
FSMA amended 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 “one time for all time.” What does this mean for foreign food producers that export food to the United States? Turns out quite a lot.
Under the FDCA, the Food and Drug Administration (FDA) now has the authority to suspend the registration of a food facility that produces or exports food products to the United States. While this may not sound that severe, the significant impact of a food facility registration suspension becomes more apparent when you think about how much, and how many, different food products are manufactured in any one food facility. 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.
Benjamin England., Founder and CEO of FDAImports.com, is informing his clients of the consequences of this new registration requirement. “There are two big issues here for foreign food suppliers,” said England. “They probably do not know that they are required to renew their registration this year and if they fail to do so, FDA will automatically suspend their registrations and they will not be able to ship to the USA. Additionally, if FDA finds a reason to recall food that was made in a foreign facility, FDA can (and will) suspend that foreign facility’s registration and the facility could be put out of business if it does not respond rapidly to the problem. That’s where we come in.”
FDA’s newly minted authority impacts everyone involved. After FDA suspends the registration of a food facility that may have been the reasonable likely cause of adverse health effects to humans, FDA can then go after other facilities along the supply chain. FDA may suspend the registration of another facility that “(1) created, caused or was otherwise responsible for such reasonable probability, or (2) knew or had reason to know of such reasonable probability AND packed, received or held such food.” In other words, 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.
FDA allows an administrative hearing for a company that becomes subject to a food facility registration suspension, but who wants to wait months for a costly decision? Do not become victim to FDA’s new FSMA authorities. Be prepared and be compliant. FDAImports.com assists domestic and international companies every step of the way, from registration to distribution and everything in between.