Del Monte Fresh Produce has filed suit against the Food and Drug Administration (FDA) in U.S. District Court for the District of Maryland to seek an injunction that would lift an FDA rule restricting the importation of wholesome fresh cantaloupes into the United States.
Del Monte Fresh’s claims are based on the FDA’s (and several other state health agency officials’) “erroneous speculation,” unsupported by scientific evidence, that cantaloupes previously imported by Del Monte Fresh from a Guatemalan farm and packing facility were contaminated with the pathogen Salmonella.
Neither the FDA nor any state health agency in the U.S. has offered evidence or data to support the FDA action.
Dennis Christou, Vice President Marketing, of Del Monte Fresh states:
“We require all of our suppliers to comply with all FDA recommended food safety procedures, including the FDA’s Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, as well as the FDA’s Sanitary Standard Operating Procedures. The farm and packing facility at issue in this case was in full compliance with these food safety procedures. The restrictions imposed by the FDA on Del Monte Fresh Produce’s ability to import cantaloupes are unnecessary and not supported by the facts.”
In March 2011, the company issued a recall with the help of the FDA of 4,992 cartons, each containing four sleeves of their three-pack of cantaloupes, as they may have possibly been contaminated with Salmonella Panama.
Collaborative investigative efforts of state, local, and federal public health and regulatory agencies had linked this outbreak to eating cantaloupe. Eleven of 12 ill persons reported eating cantaloupe in the week before illness. Ten of these 11 ill persons ate cantaloupes purchased at seven different locations of a national warehouse club.
Information gathered with patient permission from membership card records helped determine that ill persons purchased cantaloupes sourced from a single farm. Product trace back information indicates these cantaloupes were harvested from single farm in Guatemala. FDA began working closely with the CDC’s authorities in states where illnesses have occurred and the firms involved to investigate the source of the contamination.
Del Monte Fresh is one the largest importers of cantaloupes into the U.S. and is well known for selling fruit of the highest quality. The melons are farmed, processed, transported, and stored under state-of-the-art food safety controls that far exceed FDA regulatory requirements.
Most persons infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most persons recover without treatment. However, in some persons, the diarrhea may be so severe that the patient needs to be hospitalized. Salmonella infection may spread from the intestines to the bloodstream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics. The elderly, infants, and those with impaired immune systems are more likely to have a severe illness from Salmonella infection.
The FDA’s actions adversely affect Del Monte Fresh’s ability to receive perishable fresh produce for sale to its customers in the U.S., as the import alert threatens the viability of a major import source for cantaloupes.
Since significant resources and commitments must be finalized immediately to ensure cantaloupes will be ready for harvest in the near future, Del Monte Fresh is seeking immediate injunctive relief from the court system.
Written by Sy Kraft