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Does the FDA Need an "Instant Replay" Rule?

According to the rules of the National Football League, if a coach believes that a referee has erred in making a ruling on a play, the coach may throw a red handkerchief on the ground, signaling his desire to exercise his right for an instant replay.

Perhaps the U.S. Food and Drug Administration should consider handing out red handkerchiefs.

The recent media frenzy over the salmonella scare (allegedly) associated with tomatoes got me to start thinking about a conversation I had with a senior executive of a major consumer products company.  Some of the points we discussed then -- the growing power of the internet, consumer uncertainty about the concepts of safety and risk, the hyper-sensitive nature of regulators, the uncertainty of science, the hovering presence of trial lawyers, etc. -- all seem to be at play here. 

And even for communications managers whose companies are not in the business of selling fruits and vegetables, this is a cautionary tale for anybody involved in the messy business of managing communication and reputation.

As everyone in the Western Hemisphere surely knows by now, an outbreak of salmonella in the U.S. prompted food safety experts (including the FDA and the Centers for Disease Control) to issue a warning in June to consumers about eating certain types of tomatoes.  The issue quickly became a national news story.

Saturday's (July 5) Wall Street Journal caught my attention.  "Jalapenos Probed in Outbreak --- Tomatoes No Longer Seen as Prime Suspect for Salmonella," said the headline of the top story, above the fold, on page 1.

After reading this report, I went back to the transcript of the joint FDA/CDC conference call with media on July 1, when the agencies conceded that the source may not be tomatoes at all.  Specifically the comments of Dr. Robert Tauxe, CDC's Deputy Director, Division of Foodborne, Bacterial and Mycotic Diseases:

I'd like to say that the process of investigation is complex and often difficult and when CDC and the states conduct a foodborne outbreak investigation, it's like a - a detective trying to solve a case. We often have to rely on peoples' memory about things that are not very memorable such as what they ate last week or the week before or the week before that. People may remember many things but they may not remember everything they ate and they may not realize or remember that many of the things that they ate have many different ingredients. So our information is gathered through interviews with people who got sick as well as other people who did not get sick. It might be family members or neighbors or other people that are in the area. And then we compare that information....

Hardly what one would consider a sound scientific investigation.  Now contrast that to what the FDA said in its June 7 news release (emphasis added):

The Food and Drug Administration (FDA) is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, raw red Roma, raw red round tomatoes, and products containing these tomatoes.

Certainly no sense of uncertainty in this declaration.

If there is one thing crystal clear as I write this blog entry, is that there is absolutely no clarity as to the source of the salmonella outbreak.  Yet almost a month ago the FDA and CDC were speaking as if they had every confidence that the source of the salmonella was tomatoes.  The response provided by Dr. David Acheson, the FDA's Associate Commissioner for Foods to a question from CNN's Amy Burkholder during the June 16 FDA/CDC media conference call is telling, particularly in light of the new revelations about a possible alternative source of the outbreak:

Amy Burkholder: We had one other quick question. We are getting a lot of questions about salsa. Can you help us give the proper message regarding fresh salsa or even jarred salsa?

David Acheson: I think with regarding the question to ask is what kind of tomatoes was the salsa made from and where did they come from? And if the place that's selling the salsa can - has information to say that they come from one of the areas where we don't have concern, then fine. If they - if they're from an area where we still have concern, then that's not fine and it shouldn't be consumed. The salsa shouldn't be consumed.  If the salsa obviously made with grape, cherry, or tomatoes that are still on the vine, which is probably unlikely, then that's okay too. But it's the usual message that if a consumer is in doubt, it's better to play on the side of safety and not eat the salsa. I - but that's one of the reasons why we're emphasizing to retailers and restaurateurs -- know where your tomatoes are coming from and tell your consumers. Tell your customers, because you're' right -- it's about an information flow and how's a customer going to know.

Dr. Acheson's response focused solely on the tomatoes in the salsa.  Never once was there discussion about the potential that other ingredients may be the culprit.

In fact, in a review of the FDA's special website (which includes the title, "Salmonella Saintpaul Outbreak" over a photo of tomatoes) I was hard pressed to find any discussion of alternatives to tomatoes as a possible or likely source of the contamination.  Bottom line:  If one were to solely rely on the FDA website, one would draw the conclusion that tomatoes were the definitive culprit.

So, in light of the growing uncertainty and confusion, one has to wonder...

  • Were the regulators acting solely based on scientific evidence and investigation, or did the politics of fear (including the fear of Congressional and media criticism) creep into their decision process?
  • Did the FDA move too fast without solid conclusions because it feared criticism that it was moving too slow?
  • Did the media know enough to ask the right questions, or were they willing (if not enthusiastic) participants in the hype?
  • Was the speed and breadth of the internet a force for good or not?
  • How does industry expect to keep the conversation focused around reason and facts in the face of this strong headwind?

I excerpt two passages from a NY Times article from April 25 that tell us a lot about the mood of the consumer and the dogma of NGOs and consumer activists.  While these individuals were speaking specifically on the bisphenol-A controversy, these comments have equal relevance to the tomato commotion, or any similar episodes of market reaction (or overreaction):

"...There is a an extraordinary fear level right now, whether or not it is justified on the scientific side," said Carol Schreitmueller, director of research and development for Pacific Market International, the maker of Aladdin food containers and water bottles, based in Seattle. "It is going to change what happens to materials. We have to decide if people will trust this material anymore."

"...This may be a completely safe product, but we don't have the information we need to make that assessment," said Aaron Freeman, the policy director at Environmental Defense..."

In short, fear trumps reason, and industry is guilty until proven innocent. 

A July 6 column from the Tulsa World points to a Deloitte study which captures the potential consequence of such fear:

"After more than 300 food recalls last year is it any wonder that a recent survey by the consultancy arm of Deloitte showed that three-quarters of those polled were more concerned about the food they eat than five years ago, and 57 percent said they had stopped eating certain foods following a food scare. Fear creates harm in the marketplace. Consumers avoiding certain foods can put producers out of business and that can affect state economies."

Perhaps when all is said and done, scientists and regulators will conclude that tomatoes were the source of the salmonella outbreak.  But for the time being, confusion reigns supreme, and the reputation of both industry and regulators suffers.

Where are those red handkerchiefs?

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Published 07 July 2008 20:00 by Chris Gidez

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