FDA Issues First New Rules of Food Safety Modernization Act

The U.S. Food and Drug Administration has announced two new regulations—the first to be issued by the FDA under the Food Safety Modernization Act (FSMA). Both rules will take effect July 3, 2011.

1. The first rule allows the FDA to administratively detain food the agency believes has been produced under insanitary or unsafe conditions. Previously, the FDA's ability to detain food products applied only when the agency had credible evidence that a food product presented was contaminated or mislabeled in a way that presented a threat of serious adverse health consequences or death to humans or animals. Beginning in July, the FDA will be able to detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed, to ensure they are kept out of the marketplace. The products will be kept out of the marketplace while the agency determines whether an enforcement action such as seizure or federal injunction against distribution of the product in commerce is necessary. Before this new rule, the FDA would often work with state agencies to embargo a food product under the state's legal authority until federal enforcement action could be initiated in federal court. In keeping with other provisions in the FSMA, FDA will continue to work with state agencies on food safety and build stronger ties with those agencies.
2. The second rule requires anyone importing food into the United States to inform the FDA if any country has refused entry to the same product, including food for animals. This will provide the agency with more information about foods that are being imported, which improves the FDA's ability to target foods that may pose a significant risk to public health. It will be administered through the FDA's prior notice system for incoming shipments of imported food established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

The issuance of these rules is the latest accomplishment of FDA in implementing the new food safety law. In April, the FDA launched a consumer-friendly web search engine for recall information and issued the first annual report to Congress describing FDA's activities in protecting the U.S. food supply. FDA also released a guidance document to the seafood industry on ways to reduce or eliminate food safety hazards.

More information is available at FDA.