FDA Issues Warning Letter on Cheerios – Priorities Askew

This is not a joke -at least they didn't intend it to be.  You can decide.  

J0438664 On May 5, the FDA issued a Warning Letter to General Mills because of the promotional claims on a box of Cheerios.  Here is what the FDA said – "Based on claims made on your product's label (the box), we have determined that your Cheerios Toasted Whole Wheat Grain Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation and treatment of disease."  (emphasis my own) I bet you didn't know that if you ate Cheerios.

What sparked the FDA's ire was this.  The breakfast cereal box, apparently the product label, stated that you can lower your cholesterol 4% in six weeks.  In actuality you can probably lower your cholesterol that much in six minutes by using a different test, but that is neither here nor there.  The point is, did this claim on the box lead to such a dire situation that, with all of the other health concerns that the FDA faces in product regulation right now, that the Cheerios box was problem for public health?

When issuing a regulatory letter, the FDA has a choice – either issue a Warning Letter which suggests a violation is so serious that it creates a public health threat – or an untitled letter or notice of violation which suggests something annoying but less severe.  Here, the FDA issued a Warning Letter.  For Cheerios.  Hello?

J0386036 Yet, when FDA's DDMAC issued its infamous 14 letters on April 2 which suddenly declared the years' long practice of Search Engine advertising off limits to companies, the FDA removed from the search engine scene notices about drug treatments when a user is doing a health search about a particular condition.  That means now, if you search on a term like "diabetes treatments" as I did this morning, and you may see an ad that suggests that you can cure your diabetes naturally without drugs.  Bear in mind, according to the Pew Internet & American Life Project, people with chronic conditions like diabetes are much more inclined to search for and act upon information they get on the Internet.  I'm not sure there is a statistic on how many people flock to buy cereal to lower their cholesterol, but I bet the number doesn't stack up.

And who suffers the greater harm?  The diabetes patient who clicks on the ad promising a natural cure for diabetes, or the couch potato innocently munching on breakfast cereal?

By taking the drug ads out of the search equation, when it comes right down to it, what poses a bigger public health threat?  An ad from a pharmaceutical company about a real, FDA approved diabetes treatment that used to be there, or now an ad that promises a cure without drugs?  Did the FDA's action alleviate a public health threat, or create one?

And if your answer is the former, that leads to the next question.  Who deserves the Warning Letter, Cheerios or DDMAC?  You decide.  

And speaking for myself, I don't think this type of action helps re-establish FDA's credibility.  

 

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