Glen Burnie, MD (PRWEB) September 06, 2012
The new bi-annual FDA registration requirement for foreign and domestic food facilities imposed by the Food Safety Modernization Act (FSMA) takes effect October 1, 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 England, who is currently Founder and CEO 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.”
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 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. “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 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 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 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 England. “The time to register under the new FSMA requirements is right now.”
FDAImports.com is an FDA consulting firm helping U.S. and foreign companies navigate through and meet complex FDA regulations for marketing and importing foods, dietary supplements, drugs, cosmetics and medical devices. Benjamin L. England, Founder and CEO, is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Contact: Jon Barnes, (410) 220-2800 or pr(at)fdaimports(dot)com.
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