FDA Issues First New Rules Under Food Safety Modernization Act

FDA announced yesterday two new regulations designed to help ensure the safety and security of food in the U.S. The rules are the first to be issued by FDA under the new authorities granted the agency by the Food Safety Modernization Act (FSMA). Both rules will take effect July 3, 2011.

The first rule strengthens FDA’s ability to prevent potentially unsafe food from entering commerce. It allows the FDA to administratively detain food the agency believes has been produced under insanitary or unsafe conditions, according to a press release. Previously, 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 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.

“This authority strengthens significantly the FDA’s ability to keep potentially harmful food from reaching U.S. consumers,” said FDA Deputy Commissioner for Foods Mike Taylor. “It is a prime example of how the new food safety law allows FDA to build prevention into our food safety system.”

The second rule requires anyone importing food into the U.S. to inform FDA if any country has refused entry to the same product, including food for animals. This new requirement will provide the agency with more information about foods that are being imported, which improves FDA’s ability to target foods that may pose a significant risk to public health. This new reporting requirement will be administered through 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.

Source: FDA News Release

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6 comments on “FDA Issues First New Rules Under Food Safety Modernization Act

  1. I would like to know what criteria it will use for assessing a “reason to believe”. It may be something as simple as an anonymous phone call and your facility could be shut down for up to 30 days.
    This is what you get when you look to the govt for assistance.
    Scares me to think so many people wanted the govt this involved.

  2. I agree with the first commentor. There needs to be a legitmate reason for the FDA to hold product. This reason must be clearly stated in the event of a hold situation. In conjunction they also need to come up with a system that determines the amount of time they have to ispect a particular product catergory based on perishability; ex fresh produce they must have an answer within 4-7 days and dry goods could be up to 30 days.

  3. I would like to know what criteria it will use for assessing a “reason to believe”. It may be something as simple as an anonymous phone call and your facility could be shut down for up to 30 days.
    This is what you get when you look to the govt for assistance.
    Scares me to think so many people wanted the govt this involved.

  4. I agree with the first commentor. There needs to be a legitmate reason for the FDA to hold product. This reason must be clearly stated in the event of a hold situation. In conjunction they also need to come up with a system that determines the amount of time they have to ispect a particular product catergory based on perishability; ex fresh produce they must have an answer within 4-7 days and dry goods could be up to 30 days.

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