FDA Requiring Firms to Report Dangerous Food

In an effort to stave off potential cases of <"http://www.yourlawyer.com/practice_areas/food_poisoning">food borne illnesses, some of which have hammered the United States in recent years, the U.S. Food and Drug Administration (FDA) has implemented the Reportable Food Registry (RFR), which food industry officials must use to alert the agency quickly, via an electronic portal when they discover that their products might sicken or kill people or animals. The requirement, a result of legislation, took effect with the launch of the portal.

Facilities that manufacture, process, or hold food for consumption in the United States now must tell the FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal.

The reporting requirement applies to all foods and animal feed regulated by the FDA—except infant formula and dietary supplements—which are covered by other regulatory requirements. Some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling, or elevated levels of certain chemical components.

According to the FDA, the opening of the RFR electronic portal reflects a fundamental principle of the President’s Food Safety Working Group that “preventing harm to consumers is our first priority.” Commissioner of Food and Drugs Margaret A. Hamburg, M.D., added: “President Obama has pledged to strengthen food safety. The opening of the Reportable Food Registry electronic portal represents a significant step toward that pledge.”

“By fostering real-time submission to the FDA of information on food safety hazards, the registry enhances FDA’s ability to act quickly to prevent food borne illness,” said Michael R. Taylor, senior advisor to the commissioner. “Working with the food industry, we can swiftly remove contaminated products from commerce and keep them out of consumers’ hands,” he added, said the FDA.

The new requirements apply to any person required to submit registration information to the FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States. These people are termed responsible parties and must:

Investigate the cause of the adulteration, if the adulteration of food may have originated with the responsible party;

Submit initial information; followed by supplemental report; and

Work with the FDA authorities to follow up as needed;

A responsible party is not required to report if it found the problem before the food was shipped, and corrected the problem or destroyed the food.

The agency issued draft guidance on the RFR in June and sought comment. The FDA also held three public workshops across the country in which FDA representatives explained the RFR requirements and how the portal will work. A Federal Register notice was issued today announcing the opening of the RFR electronic portal and the availability of final guidance to assist the food industry in complying with the requirements of the RFR. Additional information on the RFR can be accessed here.

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