On July 7th, 2011, FDA’s office of global regulatory operations and policy published a special report entitled the pathway to global product safety and quality. This report can be found on the FDA website. Please follow the link at the bottom of the report. This report should be read by food manufacturer and also by every food consumer, as the consequences for the future are equally broad and disconcerting. This report speaks to food, drug safety and medical device safety. I’ll consider only food safety. FDA cites US-GAO statistics, which state that now, 10% to 15% of Food consumed by U.S. families is imported. Significantly, nearly two-thirds of those fruits and vegetables and 80 percent of the seafood eaten domestically already come from outside the country.
FDA points out that between 2004 and 2011 food imports have increased by an average of 10% each year. FDA anticipates the dependence upon imported food to accelerate, with complications because of its regulatory mission. Historically, FDA’s primary tools for product safety and quality have been review of manufacturing facilities and ports of entry. In the face of the anticipated onslaught of imports, this report comprises the admission that: FDA doesn’t – nor will it have the tools to keep pace with the pressures of globalization. Indeed, the present rate where imports are actually scrutinized has shrunk lately at about 3 percent or less. Nevertheless, it is FDA’s expectation that: Over the next decade, FDA will transform itself from a national agency working in a globalized world to a truly global agency fully ready for a regulatory environment where product safety and quality know no boundaries.
Brave words, but FDA already appears fully aware that it will never be able to satisfy the expectations of the newly passed FDA Food Safety Modernization Act (FDA-FSMA) which anticipated FDA to have inspected at least 600 foreign cong bo thuc pham chuc nang within the first year of the law’s passage and rapidly ramp up to 19,200 inspections at the sixth year after the law’s passage. FDA hopes to unite creative global coalitions with cutting edge investigative tools collectively and these are expected to obviate the need for immediate FDA inspection. Unfortunately, virtually nothing is said about what cutting-edge investigative tools FDA has in mind. Apparently, the global coalitions are there to give sufficient information to enable the assessment of risk carried over to the last product from all the components used by each subcontractor involved in the final formula of a certain product.