For more information on these and other FDA issues, please contact Domenic Veneziano at (202) 734-3939.
Import Data for Veterinary Devices
The Food and Drug Administration is proposing to make the data elements currently required to be submitted in the Automated Commercial Environment at the time of entry for imports of other FDA-regulated products (e.g., food contact substances, drugs, biological products, medical devices for human use, cosmetics, etc.) also mandatory for the electronic filing of entries containing a veterinary device. These data elements include FDA country of production, complete FDA product code, full intended use code, and phone number and email address of the importer of record. Comments on this proposed rule are due no later than Oct. 19.
Dairy Exports to China
The FDA has announced changes to its export listing procedures for dairy and infant formula firms seeking to export their products to China, effective for all applications received on or after July 1.
Under the U.S.-China phase one trade agreement, China agreed to recognize the U.S. dairy safety system as providing at least the same level of protection as China’s system. As a result, firms seeking to be listed as eligible to export such goods to China should no longer provide to the FDA, and the FDA will no longer provide to China, confirmation that a third-party auditor has found them to be in compliance with the relevant standards, laws, and regulations of China for dairy and infant formula firms. In addition, as of July 1 the Department of Agriculture eliminated plant audits for dairy and infant formula firms seeking to export to China.
The FDA notes that it will include firms on export lists only if they are in substantial compliance with applicable FDA regulations.
Face Masks, Dietary Supplements Among Items on Import Alerts
FDA import alerts on the following have been modified in the past week.
- drugs (based on analytic test results)
- uneviscerated fish or partially eviscerated fish that are salt-cured, dried, smoked, pickled, fermented, or brined
- filtering facepiece respirators
- human and animal foods imported by importers not in compliance with requirements of the foreign supplier verification program
- dietary supplement products from firms that have not met dietary supplement good manufacturing practices
- products from firms refusing FDA foreign establishment inspection
- raw and cooked shrimp from India
- low-acid canned foods or acidified foods
- papaya from Mexico
- foods containing illegal and/or undeclared colors
- food products that appear to be misbranded
- foods containing undeclared major food allergens or that fail to properly label major food allergens
- active pharmaceutical ingredients that appear to be misbranded
- aquaculture seafood products
- food products containing sulfites
- honey and blended syrup
Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Before shipping into the U.S., importers should be aware of whether or not their product is listed on an import alert.
Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers.
Firms and/or products on the “red list” of an import alert are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.
If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.
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