January 5, 2010
by Justin J. Prochnow
As 2010 dawns, it is more apparent than ever FDA is determined to further expand its enforcement capabilities. Last years major recallsfrom peanut butter to instant milkwere among the most costly in U.S. history and generated an avalanche of negative publicity that FDA is trying to overcome by bolstering its public image as a stronger and swifter FDA. One component of that endeavor is the activation of the Reportable Food Registry (RFR). While the electronic portal went live on Sept. 8, 2009, many companies remain largely unaware of their obligations with respect to this mandatory online reporting database for companies that manufacture, process, pack or hold food, excluding dietary supplements, which could potentially cause serious adverse health issues. As FDAs enforcement discretion deadline expired on Dec. 8, 2009, food companies must familiarize themselves with the obligations of the RFR or they could find themselves subject to fines (and even jail time) for violations of federal law.
The authority behind FDAs creation of the RFR actually stems from legislation that was enacted more than two years ago, namely the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amended the Federal Food, Drug and Cosmetic Act (FDCA) by creating a new section 417 entitled the Reportable Food Registry. Pursuant to section 417, a responsible party is required to submit a report through the RFR portal within 24 hours of determining a food product is a reportable food. Subsection (a) of section 417 provides the definitions for these two key terms, responsible party and reportable food. A responsible party is defined as any person or entity required to be registered with FDA as a food establishment, including manufacturers, processors, packers or holders of food for sale in the United States. A reportable food is any article of food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals, with two exceptions; dietary supplements and infant formula are specifically excluded from the definitions of reportable food. Animal feed and pet food are subject to the reporting requirements if they meet the definition of reportable food.
It is no coincidence that serious adverse health consequences or death tracks closely with the definition for a Class I recall set forth in 21 CFR §7.3(m)(1), a point emphasized by FDA in its Guidance for Industry regarding the RFR. There can be no doubt that the multiple attacks on FDA for its failure to respond timely to recent food-borne illnesses during the last several years influenced the enactment of FDAAA and the formation of the RFR. FDA sees the RFR as a vehicle to enhance the agencys ability to act quickly to prevent food-borne illness and swiftly remove contaminated products from consumers hands.
Once a company determines it is a responsible party and there is a reportable food issue, it must submit an initial report through the RFR electronic portal (RFR.fda.gov). The initial report consists of certain data elements that must be entered, including, but not limited to, the food registration number of the responsible party, the date on which the product was determined to be a reportable food, the location of the product and information about the problems with the product. Once the initial report has been submitted, FDA may follow up and require the responsible party to file an amended report to provide additional information. The agency may also require the responsible party to provide notification to the immediate previous sources of the reportable food or the immediate subsequent recipients of the reportable food.
The timing requirement for submitting the report through the RFR is another critical element of this safety program of which companies must be cognizant. Subsection (d) of section 417 requires a report be submitted as soon as practicable, but in no case later than 24 hours after a responsible party determines an article of food is a reportable food.
There is one notable exception to the reporting requirements for cases in which there is a reasonable probability that use of or exposure to a food product will cause serious adverse health consequences or death. Section 417 provides that if (a) the food issue originated with the responsible party, (b) the issue is detected prior to any transfer to another person, and (c) the responsible party either corrects the issue or destroys the product; there is no requirement to submit a report through the RFR. Accordingly, if a company is able to take care of the issue before the product goes out to other entities or to the general public, no reporting is required.
Finally, companies should know section 417 imposes some record-keeping requirements on responsible parties as well. Each responsible party is required to maintain records related to each report received, each notification made and each report submitted to FDA under section 417 for a period of two years. Additionally, the responsible party must allow FDA, upon request, to inspect such records.
What happens to an individual or company that fails to comply with the reporting requirements of section 417? The failure to submit a report through the RFR or to provide a notification required pursuant to section 417 results is considered a prohibited act pursuant to section 301 of the FDCA, similar to the adulteration or misbranding of any food, drug, device or cosmetic in interstate commerce. Violations of section 301 can subject a responsible party to possible penalties, including costly fines and even jail time in egregious circumstances, as well as other enforcement remedies available to FDA.
As the RFR is still in its infancy and the period of enforcement discretion just ended, it is unclear how tightly FDA will be enforcing the RFR. The agency issued Guidance for Industry with respect to the RFR. This affords companies an opportunity to review the FDAs interpretation of section 417, including certain aspects such as the circumstances under which food might be reportable or what transfer to another person actually means. While the Guidance for Industry reflects the agencys current thinking on this issue, it is nonbinding and represents only FDAs recommendations for complying with the applicable statutes and regulations. Companies should become intimately familiar with the requirements of section 417 and consult a knowledgeable person regarding the RFR with any questions, as the consequences for failure to comply could be severe. If FDAs recent activities are any indication, companies should expect the agency will be looking to strictly enforce the obligations set forth in section 417 in an effort to underline its continued emphasis on food safety.
Justin J. Prochnow is a senior associate in the Denver office of the international law firm of Greenberg Traurig LLP. His practice concentrates on legal issues affecting the dietary supplement and natural products industries. He can be reached at (303) 572-6562 or [email protected] .
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