FDA update – May 9, 2011

FDA issues new rules under Food Safety Modernization Act

U.S. Food and Drug Administration today announced two new regulations that will help ensure the safety and security of foods in the United States. The rules are the first to be issued by the FDA under the new authorities granted the agency by the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in January. 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. 
  • 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 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.

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.

  • It 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.
  • With prior notice, in the event of a credible threat for a specific product or a specific manufacturer or processor, the FDA is able to mobilize and assist in the detention and removal of products that may pose a serious health threat to humans or animals.

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. 

 In addition, since the law was signed, the FDA has held two large public meetings with industry and consumer groups on the import and preventive control provisions of the law, and reached out extensively to partners in other federal, state, and foreign governments.

Any questions on this new FDA rules please email us at info@mdiconsultants.com  and Ref: new rules under FSMA. If you would like information on achieving ISO22000 and/or BRC certification please email us at info@mdiconsultants.com and Ref: ISO/BRC