Glen Burnie, MD (PRWEB) September 16, 2012
If a labor dispute between U.S. seaport workers and port managers is not resolved before an impending September 30th deadline, then October 1 will represent more than the start of a new Federal Government Fiscal Year. It will also mark the start of a new import/export trade crisis that will make the last 12 months of U.S. economic problems pale in comparison, according to FDAImports.com. The looming shut down of many Eastern Seaboard and Gulf Coast ports will not only raise the costs of holiday merchandise but also gridlock imports of all goods regulated by the U.S. Food and Drug Administration. Benjamin England, Founder and CEO of FDA consulting firm, FDAImports.com, stated that the effects of a shutdown would expand farther than a simple increase in holiday gift prices to a total lack of holiday items. “If these U.S. seaports shut down then all importers are going to switch to other ports and new supply chains,” said England. “This is no small task either from a logistical or an FDA compliance perspective.” Mr. England stated that along with any major change of ports, companies could expect a variety of unexpected costs, delays and compliance issues with the FDA and USDA.
“Importers trying to supply retail store shelves for the Christmas season are going to have to rapidly choose new partners,” said England. “The new foreign exporters and suppliers will catch the attention of FDA’s PREDICT system resulting in High Risk holds, delays and exams.” According to England, the ripple effects multiply with each modification along the supply chain. FDA will require new exporters to produce product and registration information that they won’t have. Ports that remain open will be backlogged with shipments diverted from the now-striking ports. Ports and FDA/Customs officials who are used to handling a few specific commodities will become overwhelmed with new commodities that are out of their wheelhouses of experience. FDA compliance officers will be flooded with shipments and products that they’re not familiar with. “Add to this the fact that everyone will be in a rush and cutting corners in the vetting process and you have a supply chain catastrophe on your hands that could have extraordinary impact for importers, exporters, foreign suppliers and you and me – the consumers,” said England.
“With PREDICT on line at FDA, foreign suppliers and U.S. importers of FDA-regulated products must begin developing contingency plans now to mitigate the effect of these striking ports,” said England. “You can’t just switch ports and you can’t just jump to a new supply chain. You need to make sure that your prospective partners are fully aligned with your compliance strategy before signing anything- especially when it comes to FDA documentation.”
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.com.