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Alicia Lee

Alicia Lee is an associate in the firm’s Food, Drug, and Device Practice Group. She advises food and biotechnology companies on a wide range of regulatory and compliance matters. 

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On November 8, 2024, the Food and Drug Administration (FDA) issued a notice of request for information (RFI) regarding the agency’s current approach to providing export certification in the form of lists (export lists) for human food products. The RFI seeks to learn more about U.S. exporters’ experiences and the challenges they face related to meeting export listing requirements of other countries and FDA’s certification processes for export lists. FDA will use this information to inform the continuing development of its export list program for human foods.

Background

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a “certification” for products FDA regulates. In many cases, a foreign government may be seeking official assurance that the product can be marketed in the U.S. or otherwise meets specific U.S. requirements. A foreign government also may require export certification as part of the process to register or import a product into that country. For the importation of certain products, some countries require export certification in the form of inclusion on a list of establishments that the competent authority in the exporting country has certified as complying with applicable food safety requirements.

Under FDA’s Export Certification Program for FDA-regulated human food products, the agency provides an “export certification” in the form of an export certificate or export list.[1] FDA’s export certification provides the agency’s official attestation concerning a product’s regulatory status, based upon available information at the time FDA issues the certification. In addition, as of August 2024, FDA has established export lists that cover 19 categories of food products for Chile, China, the European Union, Saudi Arabia, Taiwan, and the United Kingdom.

FDA is authorized under section 801(e)(4)(B) of the FD&C Act to charge a fee of up to $175 for each written export certification that the agency issues within 20 days of receipt of the request for certification. The agency does not currently charge fees for food export lists, but is considering implementing fees to offset the associated operational costs.Continue Reading FDA Seeks Public Input on Process for Human Food Export Certification Lists

June 27, 2024, Covington Alert

On June 25, 2024, the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced that it has finalized Guidance for Industry (GFI) #276, Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs (Final Guidance). The Final Guidance replaces CVM’s draft guidance issued in November 2022. While CVM’s core recommendations remain the same, the Final Guidance clarifies the discussion and recommendations related to geographic locations from which Dirofilaria immitis (D. immitis) larvae used in trials should be sourced, laboratory dose confirmation studies, and field effectiveness studies for products intended to prevent heartworm disease. CVM’s stated overarching goal in making the revisions is to better align GFI #276 with current technology and veterinary epidemiology, including available diagnostic methodology. Drug sponsors who deviate from these recommendations are encouraged to discuss the deviations with CVM.

Background

On May 24, 2018, FDA published a Federal Register Notice requesting public input on possible alternative approaches for evaluating the effectiveness of heartworm disease prevention products for dogs. On its webpage announcing the final guidance, FDA explained that it asked for public input because of reports of lack of effectiveness and certain limitations of the effectiveness studies conducted to support product approval. FDA’s then-current recommendation for demonstrating the effectiveness of a new animal drug intended to prevent heartworm disease was for sponsors to conduct two laboratory dose confirmation studies and one multi-site field effectiveness study under the principles of Good Clinical Practice. FDA specifically requested input on the population level effectiveness endpoint, exposure to infective D. immitis larvae in field studies, outcome assessment in field studies, and laboratory study designs.Continue Reading FDA Issues Final Guidance on Demonstrating Effectiveness of Anthelmintics in Dogs