“It’s not unusual for FDA to not agree with the comments it has received and just dismiss them,” Bethany Kennedy, an attorney with law firm Emord and Associates, told NutraIngredients-USA. “The rule itself that they are publishing pretty closely mirrors what FSMA says.”
The rule, which became effective in its interim form in July 2011, permits FDA to administratively detain food it believes is adulterated or misbranded.
FDA lacked this authority before FSMA. At that time, food products could only be detained by the agency when it credible evidence that the posed a threat of serious adverse health consequences or death to humans or animals. Under the final rule, the agency can keep the products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure.
FDA wanted new authority
Duffy MacKay, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, said he too was not surprised that FDA chose not to amend its interim ruling. The authority granted by FSMA to the agency was something agency staff had wanted to better policy food safety.
“This is about their authority to detain food. When we look FSMA and the increased authorities FDA was given, this was one of the sticks they were given and I think they don’t want to water it down,” he said.
“Remember this is all coming on the heels of things like melamine. In some of those cases FDA did not feel as if it had the tools to act swiftly.”
CRN’s comment on the interim rule was among several that requested that FDA clarify what is meant by the phrase that said the agency could administratively detain a food (or dietary supplement) shipment if it had “a reason to believe that an article of human or animal food was adulterated or misbranded.”
“They came back and said that it’s fact specific and case specific so they feel like they need to amend the regulation to clarify it,” MacKay said. “Down the line will they need to issue a guidance document? Possibly.”
Other comments expressed concern about how the agency would use its new found authority, and urged it to restrict it to cases of true food safety risks.
Judicious application
The agency responded that “FDA intends to use administrative detention in a manner that is consistent with and furthers the prevention-based goals of FSMA and the Agency's public health mission. The Agency also is aware that the new criteria provide FDA with more flexibility in its use of administrative detention and intends to use this tool as appropriate.”
But the agency also said that it will continue to rely on administrative tools such as Warning Letters and untitled letters to enforce compliance. Thus administrative detention becomes another arrow in the agency’s quiver, but does not supplant other enforcement mechanisms.
MacKay said the implementation of the rule won’t necessarily constitute a headache for industry, but it remains to be seen how it will play out.
“It’s my hope and expectation that FDA will use this authority judiciously. I think the agency is well aware that if they use this authority they will get themselves in a tangle,” he said.