Background

Filing Entries of Hand Sanitizer

The Food and Drug Administration states that it has recently become aware that some entries of hand sanitizers have been disclaimed to the FDA and the full message set was not filed for FDA review. Additionally, some entries of hand sanitizers have been transmitted as cosmetics instead of drugs.

In response, the FDA is reiterating that hand sanitizers are drugs regulated by the agency and are generally considered as over-the-counter drug products. As such, entries of hand sanitizers must be filed with the FDA upon importation with the appropriate PG message set data for OTC drug products, and importers and entry filers should not disclaim entries of hand sanitizers. In addition, foreign manufacturers whose drugs (including OTC drugs) are imported into the U.S. must register with the FDA and submit a listing of drugs in commercial distribution before the drugs are imported. 

Foreign Supplier Program Violations

The FDA continues to issue warning letters to importers concerning noncompliance with requirements under the Foreign Supplier Verification Program. The FSVP requires importers to perform certain risk-based activities to verify that the human and/or animal food they import has been produced in a manner that meets applicable U.S. food safety standards.

Most recently, FDA inspections of the facilities of three separate importers found that they did not develop, maintain, and follow the required plans for (1) carbonated mineral water and cornmeal, (2) tahini, sesame seeds, and semolina, and (3) boiled rice and cake rusk. In each case, the FDA states that within 15 working days the importer should provide information on the specific things it is doing to correct these violations; e.g., documentation of changes made and records to demonstrate implementation of an FSVP. If the importer does not act promptly the FDA may take further action, such as refusing admission of violative products and subjecting them to detention without physical examination.

For more information on the FSVP, please contact FDA consultant Domenic Veneziano at (202) 734-3939.

Import Alerts on Foods, Drugs, and Medical Devices That May be Detained

FDA import alerts on the following have been modified in the past week.

- products from firms refusing FDA foreign establishment inspection

- raw agricultural products

- foods containing illegal and/or undeclared colors

- guanabana (soursop)

- fresh produce that appears to have been prepared, packed, or held under insanitary conditions

- cheese

- animal feeds and feed ingredients that may contain ingredients of animal origin

For more information on import alerts and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939.

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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