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FDA

FDA Compliance

Foreign Exporters Study U.S. Food Safety Law

Importer accountability and third-party certification are new challenges

Published: Monday, October 3, 2011 - 11:27

The Food and Drug Administration’s (FDA) international program has logged nearly 75,000 hits to its web pages on the new food safety law, as foreign companies that export food to the United States scramble to learn how the law affects them.

“A lot of our foreign offices are being deluged with questions,” says Mary Lou Valdez, FDA’s associate commissioner for international programs. “The China office has done significant outreach with Chinese officials and exporters” and translations of the law into 11 languages are popular downloads.

Valdez says FDA translated the Food Safety and Modernization Act, which became law earlier this year, into 11 languages using eight different alphabets. Excluding English, they include the five other, official United Nations languages—Arabic, Chinese, French, Russian, and Spanish—and six languages that represent the top countries from which the United States imports food—Italian, Japanese, Korean, Portuguese, Thai, and Hindi.

President Obama signed the food safety act into law on Jan. 4, 2011. It enables the FDA to more effectively guard against foodborne illness by focusing on prevention, as opposed to reacting to contamination and other food-safety problems after they happen.

“For imported foods, the primary difference under the new law is that, for the first time, importers will be specifically required to have a program to verify that the food products they are bringing into this country are safe,” says David Elder, director of FDA’s Office of Regulatory Operations.

Increased authority

Because a high percentage of some foods—such as seafood and fresh fruit—served in U.S. households and restaurants are imported, the law gives FDA important new authority to hold imported foods to the same standards as domestic foods. This authority includes:

Importer accountability—For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate controls in place to ensure that the food they produce is safe.

Third-party certification—It establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports.

Certification for high-risk foods—The FDA has the authority to require imported foods that are at high risk of contamination have a credible third-party certification or other assurance of compliance as a condition of entry into the United States. The “third party” could be a private company or a governmental entity.

Voluntary qualified importer program—The FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from program-certified facilities.

Authority to deny entry—The FDA can refuse entry into the United States of food from a foreign facility if the agency is denied inspection access by the facility or the country in which the facility is located.

Inspections abroad

The law also directs the FDA to develop a plan to expand the technical, scientific, and regulatory food-safety capabilities of foreign governments and their industries. Part of the plan includes training foreign governments and food producers on U.S. food-safety requirements.

Elder says resident investigators in the FDA’s foreign offices have already gotten a jump on the requirements. “FDA’s foreign offices have already exceeded our operational expectations,” Elder says. “Investigative staff in-country have conducted many routine and directed inspections to support FDA’s foreign inspection program. They have already been working closely with the host country inspectors to help them better understand what our requirements are.”

And the foreign inspection program is bearing fruit, Elder says. Last year, a food producer in China—the site of the FDA’s first foreign office—refused to allow an FDA investigator to perform an inspection.

“That resulted in FDA'’ first-ever import alert based on a foreign firm’s refusal to permit an FDA inspection,” Elder says.

In addition, Elder says investigators in FDA’s 11 foreign offices have obtained and shared local information that resulted in better identifying the products coming into the United States that might not meet strict FDA standards.

“Their efforts to build productive working relationships with, and provide training and technical assistance to, regulatory officials in foreign countries will serve us well in the long term by supporting awareness, collaboration, and product safety,” Elder says.

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FDA

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.