What are U.S. FDA Import Alerts?

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New changes are being made to the FDA import alerts every day. Registrar Corp, an FDA consulting company, explains to industry the meaning and impact of U.S. FDA Import Alerts.

Registrar Corp Assists Companies with U.S. FDA Regulations
"There are procedures by which companies may petition FDA to be removed from a Red List or added to a Green List."

The mission of the U.S. Food and Drug Administration (FDA) is to keep unsafe foods, drugs, devices and other products from reaching consumers in the United States. One way that FDA keeps potentially dangerous products from foreign countries from entering United States commerce is by issuing "Import Alerts."

An Import Alert allows FDA to detain, without physically examining, products that either have or potentially could violate the Food, Drug, and Cosmetic Act. The Alert allows FDA’s field staff know that the Agency has enough evidence or other information to refuse admission of future shipments of an imported article.

U.S. Importers should always verify that their foreign suppliers are in good compliance standing before importing products into the United States. The challenge is that currently there are approximately 265 FDA Import Alerts, but the number of Import Alerts and information in each may change daily.

For example, on July 21 2014, FDA changed the following Import Alerts:

FDA added a company from Mexico to the import alerts due to uneviscerated dried fish.

Import Alert: 16-74
Detention without physical Examination of Uneviscerated Fish Or Partially Eviscerated Fish that are either Salt-Cured, Dried, Smoked, Pickled, Fermented or Brined (i.e., excluding LACF and Acidified Products Filed Under 21 CFR 108/113 or 114) for Fish, N.E.C. (FDA Product Code: 16A--99) Description: Dried Charal.
Notes: Uneviscerated dried fish; less than 5 inches in length. No documentation such as HACCP plan was submitted with the package to show that proper controls were taken by the manufacturer during the processing of the product to ensure the safety of the uneviscerated fish from the hazard of C. botulinum and toxin formation.

FDA added a company from China to the import alerts because of its nutrition facts label.

Import Alert: 99-20
Detention Without Physical Examination of Imported Food Products Due to NLEA Violations for Cookie, Biscuit, Wafer Dough, N.E.C. (FDA Product Code: 03M--99) Description: Sesame Cracker (Cookie).
Notes: Charge; 403(q) The product label fails to properly declare the serving size in a common household measured as specified in 21 CFR 101.9(b). The product label fails to declare the serving size based on the appropriate reference amount customarily consumed (RACC). The product label declares the serving size as 100g; however the established RACC for "Snacks" is 30g as specified in 21 CFR 101.9(b)(2) and 21 CFR 101.12. The product label declares a percent daily value for trans-fat. Charge; 403(i)(2) The label declares Vegetable Oil; however; it fails to list each individual fat and/or oil ingredient as required by 21 CFR 101.4(b)(14)). The label declares sucrose; however it fails to list the common or usual name sugar as required by 21 CFR 101.4(b)(20).

FDA Import Alerts generally fall into one of two categories: "Red Lists" and "Green Lists” (although there are a few “Yellow Lists” as well). Companies with a history of violations may cause FDA to add that company to an Import Alert Red List for a particular issue, such as salmonella or pesticide contamination, or the presence of illegal color additives.

Alternatively, FDA may determine that problems with a specific type of product, either from a certain country or worldwide, are so widespread that all shipments of that product should be detained, regardless of manufacturer. For those cases, FDA may establish a Green List of manufacturers which have proven to be free of the identified problem.

There are procedures by which companies may petition FDA to be removed from a Red List or added to a Green List. Registrar Corp provides assistance with this complicated petition process. Receive assistance with FDA Import Alerts.

With 17 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company comply with U.S. FDA Regulations. For more information on U.S. FDA Import Alerts or any other FDA regulation, go to http://www.registrarcorp.com.

About Registrar Corp: Registrar Corp is an FDA Compliance Consulting Firm that helps companies with U.S. FDA Regulations, including Food Facility Registrations and Food label reviews. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 17 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations.

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David Lennarz

Liviana Callahan
since: 08/2010
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