For the first time, the Food and Drug Administration quietly exercised its authority in February to begin procedures to force a company to recall product.
FDA spokesman Siobhan DeLance confirmed the agency sent a letter to a pet treat company, marking the first instance of FDA beginning procedures to use new mandatory recall authority under the Food Safety Modernization Act.
The agency’s authority to mandate a recall has been in place since FSMA became law in January 2011. It applies to all products regulated by FDA, including fresh produce.
“We really expect it would be very infrequent that FDA would have to use its mandatory recall authority with produce companies because our industry works with the agency in a spirit of informed cooperation,” said Ray Gilmer, vice president of issues management and communication at United Fresh Produce Association, Washington D.C.
Gilmer Gilmer said United Fresh encourages members to know and protect their rights under FSMA, but also believes protecting the public health must be a top priority for fresh produce companies.
“The FDA always had the power to issue their own notices to the public, even if they couldn’t force a recall,” Gilmer said. “The potential damage to a company’s reputation that such a notice can cause has always been an influential tool for FDA.”
The FDA’s Feb. 13 letter to Kasel Associates Industries Inc., Denver, gave the company two business days after receipt of the letter to respond. The agency cited dozens samples of finished product and environmental swab tests at the Kasel manufacturing facility that tested positive for salmonella as the reason for its recall request.
On Feb. 20 Kasel voluntarily recalled all products made at its Denver facility from April 20, 2012, through Sept. 19, 2012.