A California importer who allegedly tried to re-import products previously refused by the Food and Drug Administration (FDA) may get off with a warning, specifically a warning letter.
The attempt to re-import refused product was carried out by Pomona, CA-based Rosy Trading Co., the importer, from Hong Kong’s SUN FUNG, the exporting shipper.
It all started with a shipment of Sweet Plait Biscuits containing the food coloring Rhodamine B, a suspected carcinogen formerly known as D&C Red 19. The product was detained and subsequently refused entry to the United States by FDA.
Now almost two years after that event, FDA issued a warning letter to the Roxy Trading Inc., to let the company know that it has the responsibility to see that anything it imports complies with the federal Food, Drug, and Cosmetic Act and its various regulations.
“As the importer of record, it is your responsibility to ensure that all imported products meet all requirements of the Federal Food Drug and Cosmetic Act and the regulations promulgated there under,” wrote Alonza E. Cruse, FDA’s Los Angles district director. “These responsibilities include but are not limited to introduction and distribution of products in U.S. commerce which are not adulterated and do not contain an FDA refusal stamp that demonstrates that the products were previously examined and refused entry by FDA.
“Your firm also has the ongoing responsibility to ensure that all shippers, import brokers, consignees and others working on your behalf follow all requirements of the Act and the regulations promulgated there under.
The March 28 warning letter to Roxy Trading was made public this week.
FDA said Roxy Trading imported 199 cartons of the Sweet Plait Biscuits on July 22, 2008. FDA discovered the non-permitted color additive for food on Aug. 21, 2008. The products were first detained and then on Dec. 11, 2008 they were stamped “REFUSED.”
Then the color additive was found in another shipment, this one involving 64 cartons of the biscuits, on April 2, 2009.
“On October 21, 2009, an FDA inspection was conducted to verify that all of the 64 cartons of “FDA Refused” Sweet Plain Biscuits for entry number 880-0073538-6 were held intact by the Importer, ” the warning letter continued.
A total of 64 cartons were presented to the FDA investigator. Fifteen were stamped as “REFUSED Dec 11, 2008, FDA LOS-DO appeared to be deliberately manipulated, with areas of the master carton packaging missing. The missing sections of the master cartons appear to be the size of the FDA “REFUSED” stamp. The shipper for this entry was SUN FUNG in Hong Kong which was the same consignee for entry number 880-0073743″2 which was witnessed by FDA to have been exported on December 11, 2008.
“Based on the above findings we have concluded that your company re-imported into the United States adulterated products that were initially refused entry by FDA.”
The warning letter says injunction and prosecution is possible for knowingly importing adulterated products. The 15-day period for Roxy Trading to respond to FDA’s warning has passed, but the government has not closed out the matter.