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FDA Compliance

A New Era in Food Safety Oversight

The FDA wields its FSMA authority against Sunland Inc.

Published: Wednesday, January 9, 2013 - 10:39

Last December, Sunland Inc. entered into a court-ordered agreement imposing requirements that must be complied with if the company is to operate. This consent decree follows the Food and Drug Administration’s (FDA) suspension of Sunland’s food facility registration in November 2012. The suspension came as a result of evidence linking Sunland to an outbreak of Salmonella Bredeney that sickened 42 people in 20 states, as well as the company’s history of violations. The company was barred from distributing food in intrastate or interstate commerce while its registration was suspended.

The consent decree may be seen by some as a final step in the process, but at the FDA we see it as a beginning. Certainly, it is a new beginning for Sunland, which must correct the problems identified during recent FDA inspections before being allowed to market its nut butter products. More broadly, though, it is the beginning of a new chapter in FDA history.

With the suspension of Sunland’s food facility registration, for the first time the FDA was, in effect, able to independently prevent a company from distributing food that could have caused harm to consumers. This was our first use of this new authority granted by the FDA Food Safety Modernization Act (FSMA), and it will be an important tool for the FDA to use in the future to ensure the accountability of companies for the safety of the food they produce.

Under the decree, Sunland must hire an independent sanitation expert to develop a program to ensure products are produced in a sanitary way and according to good manufacturing practices. The company must also conduct environmental testing to ensure that disease-causing bacteria aren’t present in its facility or in its final food products. The FDA will evaluate the programs Sunland sets up and will not allow the company to operate its peanut butter plant until we determine that its products can be safely produced.

Paving the way for this new beginning of food-safety accountability was the work of the many employees from the FDA and the Centers for Disease Control (CDC), as well as state and local governments, who responded to and investigated this outbreak. The work done on this investigation was outstanding. Within days of being notified of the outbreak, the FDA’s Coordinated Outbreak Response and Evaluation (CORE) network was making headway in the investigation. A link was made between the illnesses and the product and its manufacturer, and our investigators in the field ramped up their ongoing investigation of Sunland’s facility to find the source of the outbreak.

I also think that the FDA’s first use of the suspension authority provided by FSMA demonstrates the promise that FSMA itself holds in all its aspects. The suspension of Sunland’s registration demonstrates the FDA’s new enforcement tools, but we are also working on other new preventive tools as well.

As I said earlier, we are writing new chapters in the history not just of the FDA, but of food safety. Our response to the recent Salmonella Bredeney outbreak related to peanut butter was a fine example of our newest innovations, like CORE, and using our authority to suspend a registration. But there is still more to come.

Blog post by Michael R. Taylor. First published Dec. 22, 2012, in FDAVoice.

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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.