Tom Jones

It’s not unusual for this column to kick a little sand at the FDA. It’s not unusual for Food Safety News reporters and editors to grill the FDA’s staff and administrators. And, at the risk of sounding like Tom Jones, it’s not unusual for our publisher to cut to the chase when he opines about the agency.

That’s what the big guy did Thursday night when he got word that online retailers were still selling a contaminated peanut butter substitute — marketed as I.M. Healthy soy nut butter and recalled more than seven months ago when a multistate E. coli outbreak was traced to it.

“What the Hell?” was the headline on the Publisher’s Platform, quickly and passionately penned by Bill Marler. He posed a more specific question in the column: “So, FDA, companies, what are you doing?”

In less than 24 hours the agency responded, not to Marler, but to us all.

A public reminder telling consumers to double check their pantries and to not buy any of the flavors of I.M. Healthy branded soy nut butter or granola went live on FDA’s website yesterday afternoon. The notice included a reminder for retailers, in cyberspace and down the street from your home, that it is against federal law to sell recalled food.

It might seem like the least the agency could do, especially to the 32 outbreak victims across a dozen states who were sickened by E. coli O157:H7.

I might agree with that sentiment.

However, credit is due to the crew at the Food and Drug Administration, “crew” being the operative word there. I’ve no doubt that the FDA’s communications and outbreak investigation staffs spent many of the hours between Thursday night and Friday afternoon trying to persuade higher ups to do something. After all, they were grilled in early September after a food safety researcher in California reported she had ordered and received some of the poison non-peanut butter from Amazon.com during the Labor Day holiday weekend.

Then, in late September, there was a report from the mother of one of the outbreak victims, an 8-year-old California boy who ate the contaminated I.M. Healthy soy butter. He spent 25 days in the hospital as the infection ravaged his entire body and sent him into kidney failure. They don’t know yet if he has permanent kidney damage. What they do know is that he has several symptoms of post-traumatic stress disorder (PTSD), including attacks of anxiety and fear at mealtimes.

Erin Simmons said a friend of the family let her know during the last week of September the product that had sent her son to ICU was still on grocery store shelves in the Bay Area.

She couldn’t believe it.

Neither could I.

We were both just as stunned at the FDA’s generic comment that suggested the bad guys were the businesses, not the government.

“Thanks for bringing this to our attention,” an FDA spokeswoman said in an email response to questions from Food Safety News in late September.

“The FDA is investigating and can confirm product has been removed. We continue to follow up with online retailers and businesses as we become aware of recalled products being offered for sale. It is the responsibility of a recalling firm to ensure that a recall is effective.”

If it looks like a pile, and it smells like a pile …
Given that recent pile of steaming evidence, demonstrating the less-than-effective recall policies and procedures in place, I’m betting the FDA serfs had a relatively easy time getting the bureaucrats to OK the detailed public reminder posted yesterday afternoon.

I commend the government workers who championed the public reminder through the red tape, blue suits and legal eagles.

I condemn the money-grubbing individuals and business entities that haven’t pulled the poison from the stream of commerce and destroyed it.

I condemn the appointed and elected officials who continue to put profit above the public. Their trickle down approach has never worked for the greater good. We all know what trickles down: See above reference to steaming piles. These officials, who wrap themselves in the flag while helping to unravel the fabric of America with so-called deregulation they claim will give us safer and higher-quality goods and services, need to get a clue. An unregulated free market rewards business for providing the least and charging the most at the expense of the public.

I commiserate with the rank and file and middle managers at FDA. Their behind-the-scenes efforts through these kinds of episodes reminds me of one of a handful of quotes I retained from Western Civ 101. Actually, it’s the misquote of Voltaire’s original French thought that applies in this instance. I hope it gives the agency serfs some comfort. Their efforts are good more often than not:

Don’t let the perfect be the enemy of the good.

How you can help FDA help all of us
Just as I believe business and government have obligations to operate with the greater good as a guiding principle, so do I believe individuals have the same obligation.

There are a couple of questions that I pose repeatedly to FDA employees. It doesn’t matter what they are. The answer is the important part. Unfortunately, because of the fear of reprisal, the answer has been off the record; until yesterday.

If you’ve got a question or concern about something under FDA’s umbrella, file a consumer complaint. That bears repeating.

If you’ve got a question or concern about something under FDA’s umbrella, file a consumer complaint.

All those people from the agency who have endured my repeated questions have told me the FDA’s policy of investigating and responding to consumer complaints is strictly enforced — and the best way of getting action in motion at the agency.

The public reminder about the recalled I.M. Healthy brand soy nut butter reinforces that message.

“The FDA will continue to monitor this situation closely and follow up with retailers as we become aware of recalled products being offered for sale. Additionally, the public is urged to report any product being offered for sale to the FDA Consumer Complaint Coordinator in their region,” according to the reminder.

Editor’s note: Seattle attorney Bill Marler is managing partner of Marler Clark LLP, a law firm that focuses on civil cases involving victims of foodborne illnesses. The firm is representing victims of the I.M. Healthy soy nut butter E. coli outbreak.

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