How FDA and State Regulators Have Turned into “Bouncers”

by David Gumpert
The Complete Patient

If you’ve ever been in a restaurant or club patrolled by bouncers, you know the system of justice is uneven. If you somehow violate the club rules–maybe are a little unruly, or try to converse with the entertainers–the punishment usually varies according to where you stand in the club’s pecking order. If you know the club’s owner, you’ll be given a second chance, and a third chance. But if you don’t know anyone, and the club’s bouncer doesn’t like your attitude, or the way you’re dressed, or the sound of your voice, out you go, on your rear end.

Or it could be that the bouncer knows you, or knows of you, and doesn’t like your type, doesn’t approve of your choice of friends or cars…or food.

Bouncers, after all, are generally bullies, with some authority.

That’s kind of what it’s like in the world of food production and so-called food safety in these days of hyper-fear-mongering.

Consider two recent cases of producers who knew the bouncers’ boss.

Dole, the global fruit and veggie producer, just announced it is “voluntarily” recalling lots of bagged salad because the Ohio inspectors found listeria in one bag of the stuff. That’s it, just put out a recall notice and go about your business. Dole stays in the night club.

And the U.S. Food and Drug Administration announced earlier this month that its inspectors (er, bouncers) have now on two occasions, last January and February, found listeria “from direct food-contact surfaces” in cookie-producing facilities at Kellogg, the worldwide producer of cereal and other foods.

The penalty in this situation? A slap on the wrist, if you want to call warning letters a slap on the wrist. It seems as if Kellogg has received two warning letters, and has had at least a couple of in-person meetings with FDA officials, and provided any number of cleanup plans. Just keep rocking and rolling.

Here’s what the FDA bouncers said to in their second warning letter to Kellogg: “In addition to the March 09, 2011, response discussed above and the Augusta Hygienic Reset document discussed above, we acknowledge receipt of your firm’s response letters dated February 23, 2011, and March 02, 2011. Furthermore, on March 03, 2011, management representatives from Kellogg met with representatives of the Atlanta District Office and provided an overview of the corrective actions outlined in the March 02 response letter. FDA officials again met with representatives from your firm on May 02, 2011, at FDA’s White Oak campus in Silver Spring, Maryland to discuss food safety issues, and actions your firm has taken since FDA’s inspection in February 2011. We have evaluated your written responses and will verify the adequacy and implementation of these steps during our next inspection.”

I ordinarily don’t dwell on the ongoing government minuteae of inspection, recall, and warning letters–there are any numbers of roving product liability law firms to bombard us with this info in their quest for new clients–but these two incidents stood out to me because both involved the presence of listeria monocytogenes in and around food…and both companies were allowed to go their merry ways.

For two other companies that didn’t know the bouncers’ bosses, or more likely, irritated the bouncers because of the kind of food they produce, life hasn’t been nearly as simple as it’s been for Dole and Kellogg.

Morningland Dairy had pretty much the same situation as Dole–listeria monocytogenes found in two samples of its product shipped to California last spring. Unfortunately, the bouncers didn’t allow the company to continue shipping and selling product after implementing a recall, as Dole can do. No, Morningland not only had to do the recall, but was ordered to destroy its entire inventory, representing essentially all its working capital.

When Morningland began asking questions, raising objections, well, the bouncers did the equivalent of breaking the owners’ arms, kicking them in the groin, and throwing them out into the street–that’s what the Missouri suit filed against the company represented.

Estrella Family Creamery in Washington had pretty much identical circumstances to Kellogg. Listeria monocytogenes found in the production facilities. But unlike Kellogg, Estrella wasn’t allowed to do endless back-and-forth. It improved on a second inspection, but that wasn’t good enough. When it tried to do what Kellogg has done–sell product to stay in business–boom, a court order shut it down.

I’m thinking the titles for the FDA inspectors and their state underlings should be changed, to something like “Bouncer 1”, “Bouncer 2” and so forth, till you reach the top of the bureaucratic pile: “Bouncer Supreme”. With the Food Safety Modernization Act taking effect, giving the FDA bouncers ever more authority, and food producers fewer options for court appeals, small producers will do well to avoid the bouncers.

Read the Full Article Here: http://www.thecompletepatient.com/journal/2011/6/26/how-fda-and-state-regulators-have-turned-into-bouncers-just.html

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