FDAImports.com Persuades Government to Remove Client from FDA Import Alert 72-03

By Rick Quinn

FDAImports.com Persuades Government to Remove Client from FDA Import Alert 72-03

The proven capability and dedication of the FDA attorneys and FDA consultants at FDAImports.com, LLC was recently evidenced by the removal of another represented client from a FDA Import Alert #72-03 Red List. Import Alert #72-03 is an FDA “automatic detention” or “detention without physical examination” of rawhide pet chews (such as pig ears and other pet treats) due to an alleged presence of Salmonella. On March 25, 2011, after convincing an obstinate and resistant FDA that this company complied with FDA current Good Manufacturing Practices (cGMP) and was importing safe products, FDA relented and removed the company from Import Alert #72-03.

FDA Import Alert #72-03 was originally published in 1999 when FDA learned of 30 cases of Salmonella cases in humans (mostly children) that were associated with rawhide pig ear dog treats in Canada. “Fear of encountering similar issues in the USA,” Benjamin England, Founder of FDAImports.com, LLC notes, “FDA was merely being cautious – and perhaps too cautious.” Even though the Red List on Import Alert #72-03 consists of over 60 firms world-wide, FDA’s internet-published Alert reveals that “FDA and CDC [Center for Disease Control] are not aware of any cases of Salmonella in the U.S. that have been linked to pig ear dog treats.”

FDAImports.com understands the negative impact that being placed on FDA Import Alert can have on a foreign manufacturer – both on the company’s reputation and image to consumers and on the business image to the government and trading companies. “It is a unique mix here.  We dedicate hours of researching and analyzing the company’s and FDA’s procedures and add that to my 17 years of direct, recent experience inside FDA to assist clients in complying with FDA laws and regulations.” says Mr. England. “But we also find ways to get FDA to comply with the federal laws and regulations as well, which is the harder task sometimes.”

In 2004, the affected company, a Mexican rawhide processor, was placed on Import Alert #72-03 because of a single shipment containing a small parcel with rawhide scrap that tested positive for Salmonella contamination. This particular shipment was not the typical product imported by this company. The affected product was originally manufactured by a third party contract manufacturer. The Import Alert should never have applied to the targeted company. Because this was not an ordinary shipment, the company was unaffected by FDA Import Alert for six years, until 2010 when FDA import field offices started automatically detaining finished, heat treated rawhide pet chews and treats under the import alert.  

“That was more than any company could tolerate,” says England, “because a relatively narrow and nominal Import Alert listing suddenly represented risk to the company’s major lines of product – and inappropriately so.  But this was a challenge because the company no longer shipped rawhide scraps – so we had to improvise to show FDA that the Import Alert was no longer needed, no longer appropriate and no longer justifiable.  That is our job.” On March 25, 2011, FDAImports.com persuaded FDA to remove the company from Import Alert #72-03 altogether – for rawhide scrap which was improperly affecting the company’s processed, finished and heat treated product.  

FDAImports.com, LLC is a regulatory food and drug consulting firm, founded by 17-year FDA veteran and former FDA attorney Benjamin England that regularly assists companies with successful and timely Import Alert petitions. FDAImports.com, LLC finds ‘the way through’ for its clients over and over, by overcoming the complex challenges involving compliance with FDA regulations and other federal and state laws.