US FDA Adds 85 Firms to Import Alert for Use of Illegal Colors in Food: Many New Non-US Firms Affected Since January 2010 -- According to, LLC

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Since January 2010, US FDA has added 85 new firms to Import Alert #45-02 for importing foods containing illegal, unapproved, or undeclared color additives. FDA has regulatory authority over color additives for foods, drugs and cosmetics. Hundreds of shipments with illegal, unapproved or undeclared color additives are being automatically detained without examination at the port of entry. Benjamin England of, LLC, adds that, “Because the problem is with the formulation, there is often no way to correct it without exporting or destroying the shipment.”

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Because the problem is with the formulation, there is often no way to correct it without exporting or destroying the shipment.

As of May 17, 2010, the U.S. Food & Drug Administration (FDA) has added 85 Firms to Import Alert #45-02, “Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors” (IA 45-02). These 85 new firms have been added to the alert since January of this year -- less than a 5 month period. FDA regulates color additives in food, drugs and cosmetics. Under FDA’s regulation, all color additives must be from FDA certified lots or must be expressly exempted from the certification requirements. This applies to both imported and domestic products. According to Benjamin L. England, of, LLC, “…unapproved colors can be a big issue for food and cosmetics importers. Colors are usually the least prominent ingredient in a food, but if a firm uses the wrong color, their product is not going to make it to the U.S. market. Because the problem is with the formulation, there is often no way to correct it without exporting or destroying the shipment.”

Under the 2010 Fiscal Year budget, FDA’s appropriation increased 20%, with a significant portion of that budget being devoted to food safety, including domestic enforcement and enforcement upon importers at the ports of entry. Congressional concern regarding imported food safety continues to drive legislative proposals, designed to increase the regulatory and administrative burdens foreign food manufacturers face when exporting to the USA. It is, therefore, even more important to make certain exported food meets FDA requirements before the product is shipped.

Hundreds of manufacturers have been placed on Import Alert #45-02 for using illegal or undeclared food color additives. Once a firm is placed on IA 45-02’s Red List, they are subject to detention without physical examination (DWPE). Firms subject to DWPE under the Alert have their shipments detained automatically at the Customs Port of Entry, even without a physical examination of the product. According to IA 45-02, FDA has instructed its field inspectors to report violations they find, so that FDA can place the violating importer on the import alert and ensure nationwide coverage of that foreign manufacturer’s shipments.

Being placed on an Import Alert will result in expensive delays, storage and shipping charges for the importer. In addition, Import Alerts are always released to the public. “I used to be an FDA agent, so I know how this process works,” stated Mr. England. “Now that I am in the private sector, I see how being on an Import Alert can be devastating to a business. Having your business or firm placed on an Import Alert not only costs a lot of money; it can hurt your firm’s business reputation.”

If you have been placed on IA 45-02, currently have entries subject to detention for alleged use of unapproved or unsafe food, drug, or cosmetic colors, or are concerned about your firm’s FDA compliance, let, LLC show you "the way through.”, LLC is a consulting firm that can help you avoid placement on Import Alerts, as well as offer advice on correcting violations that already occurred and help you get your products back on the market. urges manufacturers who are in one of the above mentioned situations, or who desire to avoid such expensive business problems, to contact them promptly for advice tailored to your situation. Don’t let your firm get Red Listed on Import Alert #45-02.


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