Guidance for Industry and Food and Drug Administration: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile; Availability

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The Food and Drug Administration (FDA or agency) is announcing the availability of a revised guidance document entitled "Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile." The guidance explains that FDA has established a list that is provided to the government of Chile and posted on FDA's Internet site, which identifies U.S. dairy product manufacturers that have expressed interest to FDA in exporting dairy products to Chile, are subject to FDA jurisdiction, and are not the subject of a pending judicial enforcement action (e.g., injunction or seizure) or a pending warning letter. Application for inclusion on the list is voluntary. However, Chile has advised that dairy products from firms not on this list could be delayed or prevented by Chilean authorities from entering commerce in Chile. The revised guidance document describes the recommended process for U.S. manufacturers to follow to be included on the list and explains FDA's request, on Chile's behalf, that this information be updated every 2 years.