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.  

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?

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.  

 

Comments

[John Mack]

Mark,

I agree that there is a problem when charlatans are free to claim cures in search engine ads with impunity.

However, you should clarify that the FDA by no means "declared the years' long practice of Search Engine advertising off limits to companies" as you stated. It declared a "certain" tactic -- using the brand name in conjunction with the indiaction without including side effect info.

Pharma companies can still do effective search engine advertising without violating FDA regulations.

For example, when I searched Google on "diabetes treatments," the paid ad at the very top of the page was:

Diabetes Treatment
OnceDailyInsulin.com Blood Sugar Levels Matter. Find An Effective Treatment That May Help

This ad brings me to Lantus.com, a medicine provided by Sanofi-Aventis.

The second paid ad brought me to Januvia.com.

The third was the charlatan!

Two out three is not a bad score for the pharmaceutical industry!

[Mark Senak]

Excellent point John. However, it would be easier for consumers/patients if the name of the compound were present.

[John Mack]

Why would it be easier if consumers knew the brand name? I can only think that it would be beneficial to the drug company -- not the patient -- for building brand recognition. It then is not about educating the patient about treatment, it's about gaining market share of mind, which is a marketer's focus. If drug companies really wish to be patient-centric, they need to shift their thinking about brands and truly put patient needs first. I think the two drug ads I cited do that very well.

[fred]

But people really do eat oatmeal (and Cheerios) thinking it is a substitute for more effective LDL-lowering agents. People just see the claim that it lowers cholesterol and believe that eating oatmeal is as good as generic simvastatin. So yes, it could be a problem for the public's health.

[Mark Senak]

Fred - I appreciate your comment, but I seriously doubt that people eat oatmeal to lower cholesterol 4% and only get 3% lower and that this is a public health problem, particularly one that merits a Warning Letter over an untitled letter.

[Kate W]

I agree with John. While it does seem that the FDA is putting energey into areas that may not be severe, ever since I saw the Cheerios commercial, I thought - they are going to have problems. Since they have tapped into the world of healthcare by bringing the claim of "lowering of cholesterol" into the brand's benefits, they then need to take responsiblity, like the pharma companies do, by saying that Cheerios is not a substitue for rx medications.