FDAImports.com’s success rate continues to increase, as it successfully petitions FDA to remove yet another client from Import Alert—this time, Import Alert #45-02, “Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.”
FDA placed a Mexican manufacturer of flavoring concentrates and extracts for use in beverages on Import Alert #45-02 in 2002, because one of its concentrates was found to contain Brilliant Blue FCF (certifiable as FD&C Blue No.1), which the company failed to declare on the product’s label. FDA also found that the concentrate contained Azorubine, (formerly D&C Red No. 10), which is an unapproved color additive.
Further investigation of the violation showed that the company did not fail to disclose the presence of colors altogether, but simply listed “artificial colors” in its ingredient declaration. At the time, the declaration “artificial colors” was sufficient under Mexican law to reflect the presence of color additives in the products and the company’s printers mistakenly printed the same statement of ingredients for its U.S. labeled products.
The Mexican company ceased production of the noncompliant concentrate in 2002. In fact, the single shipment that FDA tested and resulted in the company being placed on Import Alert was produced and shipped as a product sample and was not for retail sale. Later the company discontinued the product altogether. However, because the company was listed on import alert the economic damages and interruptions to the company’s import operations continued. Even though one specific concentrate was placed on Import Alert #45-02, FDA began automatically detaining shipments of a different concentrate with a similar name but different formulation. As a result of this mistaken identity, the Mexican company sought help from FDAImports.com to convince FDA to remove them from Import Alert.
By proving to FDA that the company no longer manufactures or ships the concentrate of concern, convincing FDA that the company had resolved the conditions that gave rise to the violation and demonstrating that the company implemented the necessary control steps to prevent its recurrence, FDAImports.com succeeded in removing the Mexican company from Import Alert #45-02.
There is a lesson here regarding FDA’s Import Alert listings: Once on, you may never come off – unless you petition for your right to come off! Another way to say this is that in FDA’s mind, an Import Alert never goes stale, even after 10 years of not shipping the listed product to the U.S. There are many Import Alert listings that have been active for 10 or 20 or even 25 years. Those companies are probably not even in business anymore, but FDA maintains the Import Alert anyway. There is one way, and only one way, to successfully be removed from an Import Alert – by presenting good, solid evidence to FDA justifying removal in a strong, well-reasoned legal petition. “Five clean shipments” just does not work anymore.
