When Are Food Companies Required To Report Potentially Dangerous Foods Under The FDA Reportable Food Registry?
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The FDA's Reportable Food Registry ("RFR") first went online in September 2009.
Since its inception, numerous questions have been asked regarding the specific circumstances under which a food company is required to inform the FDA about a potentially dangerous food product.
Generally speaking, under the RFR, any food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if the company learns that it has manufactured, received or distributed a potentially implicated food product.
Because the FDA reporting requirements are only triggered under certain defined circumstances, however, a food company uncertain about its reporting obligations under the registry should consider contacting legal counsel to determine the extent and scope of any potential reporting requirements triggered by the FDA rules.
In their current form, the FDA rules extend to any company that is required to submit registration information to the FDA as a manufacturer, processor, packer, or distributor of food. In turn, the rules apply to any food product regulated by the FDA, with the exception of infant formula and dietary supplements which are covered by other regulatory requirements.
Under existing FDA rules, a food company is required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. As explained by the FDA, some examples of reasons a food may become reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.
In turn, once a food company discovers a problem with a product it has received, manufactured or shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and contain any potentially affected products. In addition, responsible parties will be required to notify their relevant suppliers, distributors and customers of any potential food safety issues, be ready to submit further data and analysis to the FDA, and initiate their own investigation if the problem is thought to have originated internally.
Notably, however, in addition to other exceptions, the FDA’s reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it was the sole manufacturer of the food product, it discovered the problem internally before the food product was distributed, and it then corrected the problem or destroyed the implicated food.
For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry.
