Background

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

Drug Entry Review Pilot Ends

The FDA’s 90-day drug entry review pilot project concluded June 11. During this pilot the FDA conducted entry admissibility reviews on a national basis (instead of the usual port-by-port approach) and utilized entry review staff over multiple time zones to expand drug entry review coverage times.

The FDA will now assess data from the pilot to determine any benefits gained from a national drug entry review approach, the potential to automate portions of the entry review process, allowing entry reviewers more time to focus on potentially higher violation products, and efficiencies gained from timely receipt of associated documentation.

Import Alerts: Cosmetics, Fruits, Lentils

FDA import alerts affecting the following have been newly issued or modified in the past week.

- butterfly lentils from Kenya

- cocktail fruit nectar from Egypt

- cosmetics from China

- dessert biscuits from Russia

- figs from Turkey

- green onions from Mexico

- parsley from Mexico

- sesame seed from India

- skin whitening cream from the Dominican Republic

- tahini from Canada

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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