FDA’s New Take on Imports
June 20, 2011
WASHINGTON—FDA is stepping up enforcement on imported foods, supplements and ingredients with a new strategy designed to meet the regulatory challenges posed by the increased number of products imported to the United States. A report released by FDA, titled "Pathway to Global Product Safety and Quality," calls for coalitions of and increased data sharing among international regulators.
“In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "There has been a perfect storm–more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented."
The FDA report calls for the agency to transform the way it conducts business and to act globally. Four key changes highlighted in the report include:
- FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.
- The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.
- FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.
- FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.
Hamburg said FDA-regulated imports have quadrupled since 2000, adding “The FDA must further collaborate and leverage in order to close the gap between our import levels and our regulatory resources. This report is an important step in ensuring we are able to fulfill our critical public health mission."
FDA said it expects the upcoming years to see several import trends, including:
- Western economies will increase their productivity to compete with emerging markets and economies, leading to more imports and increased pressure to reinvent manufacturing processes.
- Money, goods, data and people will increasingly and more quickly cross borders. Today, a typical U.S. manufacturing company relies on more than 35 different contract manufacturers around the world, according to FDA.
- Manufacturers will adopt new manufacturing processes and emerging technologies in response to growing demand, constrained supply, and increased regulatory and social scrutiny.
- Governments worldwide will increasingly be called upon to mitigate the sometimes negative impacts of globalization on their citizens, making the operating environment for companies more complex.
The new strategy coincides with FDA broadening its food safety efforts under the FDA Food Safety Modernization Act (FSMA). This new law creates a new foods safety system, in which FDA has a legislative mandate to require preventive controls across the food supply chain and has new tools to hold players in the supply chain responsible. There are also new inspection mandates, including a mandate leading to the inspection of more than 19,000 foreign food facilities in the year 2016.
Under FSMA, food importers now have an affirmative obligation to verify the safety of the food they bring into the United States. In addition, FDA will establish a program for qualified third parties to certify that foreign food facilities are in compliance with U.S. requirements and can require certification as a condition of entry into the United States. And, FSMA explicitly encourages arrangements with foreign governments to leverage resources.