Government Audit of FDA Food Oversight Not Pretty

July 26th, 2011. By Hunter West

The Obama Administration has tried to beef up the FDA (US Food and Drug Administration). Give it more authority, and more autonomy.

But it’s too little, too late. And the law that the President signed in January, giving the FDA the power to mandate food recalls (it didn’t in the past???) has yet to be implemented and can’t be enforced until they figure out how.

Sorry, but I always thought the FDA was the prescription drug police, the overseer of our food chain and the watchdog over medical devices. Cross that watchdog and look out. Pushing the envelope and dissing the regulator might get you a warning if you’re lucky. Chances are, if you’re a pharmaceutical company, or a food supplier and you screw up—you WILL find yourself in the FDA slammer.

In our dreams…

It comes as no surprise that a recent government review of serious food recalls reveals that the FDA is dropping the ball on its responsibility for protecting the nation’s food supply.

And in so doing, protecting us. 

According to a CNN report last week, the Department of Health and Human Safety Services (HHS) reviewed 17 Class 1 food recalls from July 1, 2007 through June 30^th, 2008. That’s a period of one year, if you’re counting. And of the three classes of recalls, the Class 1 is the most serious. A Class 1 recall is issued when a product could kill, or cause serious and irreversible harm if consumed.

There were 17 Class 1 recalls that year. And the HHS is not happy with the FDA, noting in its findings that the Food and Drug Administration failed to conduct extensive reviews of product recalls, and failed to supervise how food producers disposed of their contaminated products.

And for heaven’s sake, the FDA was found to have not even followed its own guidelines to properly handle recalls.

Why is that? What is the basis for a government agency to fail to follow through on its own guidelines? Lack of staff? Lack of resources? Conflict of interest? Probably, all of the above. The FDA has long been criticized for not only being ineffective, but without the capacity to truly work at arm’s length from the food, drug and medical device suppliers it is mandated to police.

Supervise appears to be the more correct term. The FDA is attempting to watch out for us in a supervisory role, but lacks the clout or mandate to actually bring the hammer down on suppliers. There is too much lobbying, too much process and too few resources.

That’s slowly changing—and perhaps the Obama Administration’s Food Safety Modernization Act will improve things over time.

But there remains a lot wrong with the system. The 17 food recalls pigeon holed for HHS scrutiny involved imported products tainted with Salmonella, Listeria and Botulism. To be fair, HHS didn’t just slam the FDA. The audit also chastised food companies for not getting it right. In one example, a supplier of mussels imported from New Zealand contaminated with Listeria failed to recall the product until three months after the FDA learned about the problem.

Yes, shame on the importer. But questions remain. How long was the contamination a factor BEFORE the FDA learned of the problem? And why could the FDA not force a recall upon learning of the contamination? The agency should have demanded that the recall be implemented by the importer immediately, or mandate the recall itself.

But the FDA doesn’t have the authority to do that—yet. And when it does, will the agency be given the proper resources to properly carry out that mandate? 

Probably not. There’s too much money being spent on the US war machine, and too much focus on the spiraling debt, to consider pouring the billions of dollars needed into the FDA to truly reform the agency, and provide the tools it needs. 

That’s a shame, because we are really on our own here. There’s no shortage of lip service. But the next time you open that can of sardines, bear in mind that this is America, thank you, and no one is really minding the store. 

The Centers for Disease Control and Prevention notes that one in 6 Americans will become sick from food related diseases this year. That’s 48 million people. 

Of those, 3,000 will die.  

Every year. 

George Nedder, a spokesperson for the Office of the Inspector General for HHS, put it best. 

“We’re very concerned about the findings of our audit,” he said. 

You should be, too.

Tags: FDA, FDA Authority, FDA Recall, food safety, Government FDA Audit

This was posted on Tuesday, July 26th, 2011 at 8:08 am and is filed under Drugs/Medical, Food Illness . Feel free to respond, or trackback. Read our comments policy.