Adjust Font Size :

An Abuse Of Power:
A Portrait Of The FDA As Bully

What is the difference between living as a free man or woman and living under tyranny? The answer is not living without laws and regulations — that is just anarchy. The answer is living under the rule of law.

People are entitled to know, in advance, what is legal and what is not legal; they are entitled to know what the consequences are for various behaviors and to trust that the laws will be uniformly applied to all. The government can take no action against a person for exercising his lawful rights. If a person is punished, he or she is entitled to know when the punishment is over and what is required to get back in the good graces of the law.

It is increasingly evident that the saga of the cantaloupes from Honduras that we addressed in our piece, FDA Fumbles Again On Cantaloupe ‘Alert’, has little to do with food safety and a lot to do with an FDA anxious to be seen as “doing something” in regard to food safety and “being tough” on imported food. So anxious that it is prepared to bend the law to garner the “tough cop” reputation it covets.

It is also clear that the arrogance of the FDA — a feeling that it has no obligation to explain itself or to provide evidence for its decisions or to articulate consistent policies — is undercutting the moral basis of the case for increased funding for the FDA and will eventually undermine consumer faith in the agency and its edicts.

We were, of course, pleased that important consumer media outlets, including “The Lede” from The New York Times, picked up on our point about how odd the FDA’s announcement was. After all, FDA mentioned only a company in Honduras and not any brand that the melons were marketed under.

Of greater concern, though, are seven important issues:

1) The company in Honduras has been very open, and it has explained that in its meetings with the FDA, it was told there were two tracebacks that implicate the company.

The first traceback comes from a casino in Washington State. The implicated delivery, however, contained product from three separate sources — the majority of which were not from Agropecuaria Montelibano.

The second traceback comes from a buffet-style restaurant in Salt Lake City, Utah.

Considering the fragility of memories and the food safety issues of buffet-style restaurants, this seems like pretty thin gruel to stop a whole industry. If the FDA has more than this, it is incumbent on it to present to the public its evidence and make its case. Yet the FDA feels no obligation to prove its case at all. The FDA rules, in the midst of our democracy, as some relic of the divine rights of Kings — “L’État, c’est moi”.

2) The CDC has said that the last report of an illness was made on March 5, 2008. With an incubation period of 12 to 72 hours for salmonella and the FDA having told us that the illnesses reported in accordance with a bell curve that peaked several weeks earlier, what is the basis for believing that there is ANY current health risk? Much less one so substantial as to destroy a company, crush an industry, a country and impoverish countless people. Consumers, after all, can hardly be expected to distinguish between producers or countries of origin; they are more likely to just avoid cantaloupe — or all melons.

3) Spokespeople for the FDA have told us that even if there is no current health risk, they had to issue the “import alert” because until it is determined what caused the last outbreak, consumption must be stopped since we are at risk that it could occur again. Even assuming that the outbreak had something to do with Agropecuaria Montelibano — a “fact” FDA has certainly not established — this is a standard that FDA just made up.

To this day, we do not know the cause of the spinach outbreak of 2006; the causes of most outbreaks are never determined. All these people now get to ship their product.

4) If a restriction is necessary, on what basis is all the product of a company banned? Agropecuaria Montelibano has multiple packing houses and multiple farms. Restrictions, when imposed, are typically imposed against the field, the farm, the packing house that is implicated — not the whole company. Why is this being treated differently?

5) Precisely where does the FDA get the authority to impose “import alerts” that are actually defacto nationwide recalls? The answer is that the FDA lies. It takes these alerts, which are actually binding instructions on FDA personnel, and declares them to be “guidance.” This distinction is crucial: If the alerts were binding, the FDA would have to post proposed rules and get comments on them before adopting them. By declaring them “guidance” when they clearly are not, it just shows contempt of the law and the due process of law that the Constitution requires.

6) There is no domestic counterpart to an “import alert.” FDA personnel at the border can refuse entry to product, but FDA can’t station officers around a domestic cantaloupe farm and prohibit sale of the cantaloupes. This seems very much like a trade barrier prohibited under the WTO.

7) Why is there no communication? The FDA chose to do this with FDA personnel over Easter weekend, when people couldn’t get in touch with lawyers. It was a catastrophe. Executives were traveling. Why behave this way? Why not be decent and call the folks and say this is what is happening, get your ducks in a row, call your executive team back from vacation. Why make the situation more difficult than it has to be? Even better why not put eveything in writing so people won’t have to speculate on what the FDA meant when its staff spoke to them?

As best we can determine, the answer to all these questions is that the FDA is indulging in an irrational absolutism. That it has forgotten it is an agency leashed by the Constitution and that food safety is important, but is not the only interest the Constitution protects.

There has been an ongoing debate about whether the FDA should have the authority, and under what conditions, to order a mandatory recall. In produce, FDA does not have that authority. For good reason… under the law, producers are liable for any harm their product may cause — recall or not.

It is very easy for the FDA, which doesn’t have to pay the bill, to order recalls, justified or not. In fact, since FDA is likely to get blamed for any sickness, but there are zero consequences for the FDA if it orders a recall that was not necessary, we can expect the incentives to lead FDA to order many superfluous recalls.

That is, in any case, a discussion for another day. For now, despite much discussion, Congress has elected not to give the FDA authority to order a mandatory recall.

This means that, under the law, FDA should go and seek a recall. It should have to persuade the importers of record that their product was at fault. It should not use some form of sleight of hand to impose a recall, which it currently has no legal authority to impose.

Yet this seems to be precisely what happened here.

Even though the evidence is marginal at best, the threat infinitesimal and the FDA made no effort to seek a voluntary recall, the FDA just decided to show those Hondurans who the boss is.

Normally if there is a recall, it is narrowly tailored: specific farms, specific production lines, specific brands, and production during a specific time frame, perhaps specific lot numbers.

This time, the FDA didn’t even ask. It made no effort, zero, to find out which packing line, which farm, to do anything to mitigate the impact of its planned alert. The FDA simply decided it wouldn’t respect the importer’s rights not to recall and would force a defacto recall upon them. After all, if the FDA issues a statement saying that consumers ought to “throw away the cantaloupe,” no reputable retailer will stock it.

In effect, instead of respecting the legal rights of the importers, the FDA looked for a way to evade the law and thus usurp a power — to order recalls of fresh produce — that Congress has not elected to grant the FDA.

Under normal circumstances, the FDA would get away with it. Some farmer — not willing or able to fight city hall — would apologize, admit guilt, do anything to get back in the good graces of the FDA so he can start shipping. In fact, in good conscious we have to urge the good people of Honduras to do just that so they can get shipping before the season is over.

It is only because Agropecuaria Montelibano had the ear of the president of Honduras and because produce is such an important industry — and because the FDA without strong cause insulted the integrity of the produce of this proud nation — that the FDA may be pressured to “reexamine the evidence”.

Early in the morning of March 27, several officials from Honduras — The Minister of Agriculture, The Minister of Commerce and The Minister of Health — met with Mr. Michael O. Leavitt, the US Secretary of Health and Human Services, to request an immediate lifting of the FDA’s import alert based on the fact that there is no hard evidence and little in the way of circumstantial evidence to tie this particular farm to this outbreak.

They also surely made the case that with the last illness being identified on March 5, 2008, there is no ongoing threat to the health of the US population.

We hope Secretary Leavitt listened. We know that FDA and CDC personnel are now in Honduras; hopefully a deal will be struck and the “alert” will be lifted. We also hope, though, that when this is over, the Secretary will launch an investigation of how the FDA could behave in a manner so offensive to American ideals of fairness, justice and due process of law.

Print Friendly, PDF & Email

The Latest from Jim Prevor's Perishable Pundit