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Jeni's Balked At FDA Records Requests In 2013, 2014

jenisicecream.jpg
Jeni's Splendid Ice Creams
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FDA records show Jeni's declined to provide documents in voluntary records requests.

Jeni's Splendid Ice Creams has shut down twice, this year. Each time, the company has been transparent about finding listeria in its production kitchen. But FDA records reveal Jeni's was not as open with inspectors, last year -- nine months before this spring's recall. 

For food manufacturers, FDA inspections are a fairly common occurrence. So it wasn't out of the ordinary, last August, when Jeni's got a visit from the FDA.

According to FDA records we received through a Freedom of Information request, an inspector toured the site where Jeni's makes its baked goods, such as cookies and candies, for its ice creams and yogurts.

During the review, the FDA asked Jeni's to provide more than a dozen documents. The agency wanted to see paperwork on cleaning procedures, its floor plan and training records.  

The FDA report states, "after repeated requests, [Jeni's CEO John Lowe] declined to provide [the inspector] with any of this information."

It wasn't the first time Jeni's declined the FDA's requests for records. During a four-day inspection in 2013, the company would not show the FDA its sanitation procedures, lab test analyses and a number of other records without a written request as the law requires.

And that's key. Jeni's did nothing legally wrong. It did not have to turn over the documents. Both FDA reports indicate Jeni's did not refuse any records to which the agency was entitled.

And Jeni's refusal is not unusual.

An expert in food inspections, Kansas State University food services manager Bryan Severns said Jeni's position is common among food manufacturers. 

"Unfortunately, whether they're good or bad, that seems to be standard operating procedure," Severns said. "They just went by the rule of law on not releasing those."

We asked the FDA, why then did it repeatedly request those documents?

In an email, the FDA clarifies that even though it did not have the authority to review the records it requested, it "routinely asks firms to voluntarily provide records that [it] uses to access compliance" of the law.

Oklahoma State University food engineering professor Tim Bowser is an FDA inspection consultant for food manufacturers. Bowser said he recommends his clients cooperate with the FDA during voluntary records requests, especially involving sanitation procedures.

"A lot of plants are proud of their record; they're proud of their procedures. And that's an open book to anybody that walks in because it's so important for business. And food safety is obviously the paramount concern in most every plant I've ever been to," Bowser  said. "Yeah, they want to make a profit. They want to stay alive. But they know they can't do that at the expense of anybody's health. And so I think it would have been good to see more compliance from Jeni's."

And Severns added, "If I am open with the inspectors and open with the government, it makes things go a lot earlier and catch a before a problem arises."

Jeni's declined interview requests. But in a statement, CEO John Lowe said he felt that some inquiries during the 2014 FDA inspection, "had nothing to do with food safety or helping us better run our facilities."

Lowe wrote, "As a result, we made the decision to fully cooperate with the FDA, and to provide every piece of information to which the FDA was entitled, but to not go above and beyond in providing information as we normally would."

The 2014 inspection came nine months before testing found listeria in pints of Jeni's ice cream. Some of the documents the FDA requested involved areas Jeni's was found deficient in the post-listeria inspection.

An OSU food safety expert we talked with said the listeria was probably there in 2014. But no one can say for sure. The FDA would not speculate whether a release of the records would have caught gaps in Jeni's sanitation procedures that inspectors found after the listeria contamination.

Inspection expert Tim Bowser said, "It may have exposed something. It's possible. But to me, and with my experience, the real proof is in the watching, the doing, the seeing," by inspectors. 

Bowser said the FDA is stretched thin and often doesn't get enough time at facilities. He added that many companies don't get to know inspectors enough to develop a rapport, which Boswer said can lead to uncooperative food manufacturers.

"Some people see the FDA as an enemy, and that's really discouraged, and I think it's wrong. But in some cases where you have an adversarial type agent that comes into your plant, it can be like that," Bowser said. "You don't feel like you want to give them anything beyond what's absolutely required. They're playing around with your livelihood and your paycheck."

Records show another squabble between the FDA and Jeni's. They disagreed over a former sorbet name that the FDA said made drug claims. Jeni's disagreed but ultimately changed the name. But from the report, some contention appeared to remain about the issue.