Background

Food and Drug Administration import alerts affecting the following have been newly issued or modified in the past week.

- apple juice concentrate from Turkey

- beauty products from China

- black olives from Egypt

- carrots from Mexico

- cilantro from Mexico

- dietary conventional foods from Indonesia

- electronic nicotine delivery systems from China

- flavor enhancers from Canada

- ginger root from Nicaragua

- herbals and botanicals from Canada, India, Indonesia, and Taiwan

- juice from India and Taiwan

- mackerel from Guyana

- medical devices from China and Pakistan

- medicines from India, Indonesia, and the United Kingdom

- mushrooms from China

- patient examination gloves from China

- pineapple (dried or paste) from Canada

- prickle pears from Mexico

- rice from India

- sea cucumbers from Dominican Republic

- saffron from Spain

- salmon from the Netherlands

- scallions from Mexico

- sesame seed from Thailand

- shampoo from India

- shrimp and prawns from Guyana and India

- soft drinks and water from Canada

- spices and seasoning from Canada

- swordfish and tuna from Mozambique

- vitamins from Canada, Indonesia, and Taiwan

- watermelon from Mexico

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.

For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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