By Lisa Suennen

First Posted at Venture Valkyrie on 9/15/2013

Lisa Suennen, The Venture Valkyrie
Lisa Suennen, The Venture Valkyrie

A few days ago Dan Munro, a Forbes columnist, got out ahead of me on a Princess Bride metaphor I intended to use for this story for one of his own, a really good column on healthcare disruption.   I was going to use some of the same quotes from my all-time favorite movie and call this article, “I do not think that word means what you think it means!”  This is what Mandy Patinkin’s character, Inigo Montoya, says to Wally Shawn’s character, Vizzini, in response to Vizzini’s constant use of the word “Inconceivable!”  Every time he says, “Inconceivable!” the thing he is referring too suddenly becomes quite conceivable, thus provoking Inigo’s response.

And the reason I wanted to say, “I do not think that that word means what you think it means,” is because I was in a meeting last week where I learned that the FDA’s own food-labeling regulations allow food manufacturers to publish nutrition labels that have a 20% margin for error.  In other words, as long as a food manufacturer reports their food’s calories or sodium or fat levels, and as long as they are only 20% wrong, they are compliant with the law.  Thus, “Calories?  I do not think that word means what you think it means.”

imagesMaybe I am the last to know this, but I don’t think so.  I have been dropping the statistic casually in conversation this week here and there and the uniform reaction is, “Crap, I wish you hadn’t told me that.”

Ronald Reagan once famously said, “The nine most terrifying words in the English language are: ‘I’m from the government and I’m here to help.’” And right now I couldn’t agree more with the sarcasm of this sentiment.

You know how hard we all work to eat well and be healthy?  You know how the government is always out there hand-waving and telling us that we have too much diabetes and heart disease and encouraging the healthcare industry to do something about it?  You know how some people find that no matter how hard they try, they still keep getting fatter?  Well this labeling slush fund seems to me to be a potentially very real contributing factor.  If you are trying very hard to maintain a 2000 calorie-a-day diet and in fact you are eating 2500 calories a day (which isn’t even in the fine print), you are on the path to gain an extra pound every week.   Worse yet, if you are one of those people who is supposed to be on a restricted sodium or fat diet due to medical reasons, the FDA has turned a blind eye to what could be a very serious situation.

Guilty as charged

Guilty as charged

Not only does the FDA not even mention this in passing to us regular idiots, but apparently they really don’t enforce aggressive violations of the rules anyway.  The US Government Accountability Office (GAO), which functions as the government’s conscience (yeah, right), did a study in 2011 which showed that about 24% of food products tested had nutrition labels with an even greater than 20% variance from what was printed on the page.   A few examples from a study Good Morning America did when they got wind of this whole thing:  David’s Sunflower Seeds had 23% more saturated fat than reported, Ritz Crackers had 36% more sodium than reported, and Wonderbread had 70% more total fat than reported. The FDA’s action/reaction: Nada.

In the healthcare world, as more and more FitBits and related devices show up, there is much debate about how accurate they are.  With a wide variation in step counts, for instance, the general response is, “oh well, it’s the trend that matters.”  But when you are talking about calories or sodium or fat in a medically-restricted diet, that doesn’t cut the high sodium mustard.

Eh, close enough...let's go to lunch!

Eh, close enough…let’s go to lunch!

I do understand that the FDA doesn’t exactly have the labs to test and verify every food item, but their usual approach is to lean on industry til it squeaks.  This has definitely been the approach with medical device and pharma/biotech companies of late.  While there are some similar lazy approaches in medical product enforcement (e.g., blood glucose meters are also allowed to have a 20% swing from actual results—god help us), can you imagine if the FDA gave guidance to pharmacists that anything within 20% of the recommended dose of a drug was A-OK?  Yeah, me neither.

And while we are at it, I am wondering what the world would be like if this 20% rule applied to other government-consumer interactions.  For instance, imagine the IRS told you that you had to pay taxes at a rate that was 20% more than what you really owed? I’m guessing you would not be too happy about that, nor would the IRS be thrilled if you paid 20% less than you actually owed and enclosed a little note that said, “Close enough, suckers.”

How about if the US Post Office delivered your mail to a house 80% of the way to your actual house?  Now I realize that happens sometimes, but that is not really the target they are supposed to shoot for.  And while we’re on the topic, if I put 80% of the required postage on a letter, it won’t even get 0% of the way there.



And given our propensity to pursue the opportunity to blow up other nations, I am guessing that those in nearby proximity would be fairly bent out of shape if the US Air Force bombers were able to set their target for “distance to bad guy plus or minus 20%.” If we do end up bombing Syria, which I personally think to be a very bad idea, I think the Israelis are going to be pretty pissed off if we overshoot the border by 20%.  “Uh, sorry, Israel, but we were within allowable regulatory error.”  Or as the saying goes, “Good enough for government work.”

With the cost of health and public health hot on the minds of regulators, and Obamacare the subject of every story (my favorite story recently was one by humorist Andy Borowitzreporting that the best way to solve the Syria crisis would be by repealing Obamacare), you would think that the FDA might want to tighten down on this 20% thing a bit, or at least undertake a public awareness campaign that says a little more than, “Psych!”

Ready, fire, aim!

Ready, fire, aim!

It is hard to create a nation of quantified selfers or even data-driven healthcare consumers when the data itself is garbage in, garbage out.  Dieters everywhere are stepping on their scales and seeing the numbers still rising and screaming to themselves, “Inconceivable!” It is said that Hell hath no fury like a women scorned, but I think millions of hungry, cranky weight loss patients feeling deceived by regulators about calorie counts might be the basis for an actual revolution.  Prepare the donut launcher!


TechTonics coverIf you like what you read on this blog, you might like this newly published book: Tech Tonics: Can Passionate Entrepreneurs Heal Healthcare With Technology?
by David Shaywitz & Lisa Suennen ~ Available from Amazon by clicking here.