FDA Goes After Cheerios: Says Cereal Claims Classify it as Drug

There’s a mini-drug war going on behind the scenes involving a favorite oat-based General Mills cereal, the long arm of the government, and the informant, a league that “protects and promotes social and economic justice for consumers and workers” in the U.S. and abroad.

According to the FDA, the secret “drug cartel” General Mills has been marketing the cereal Cheerios as a cholesterol lowering “drug”. Unless and until GM backs up their claim, the cereal has to be approved via a drug application and FDA testing before GM can continue to make such insidious claims.

GM countered that the soluble fiber in whole grain Cheerios has been approved by the FDA for 12 years as a method for lowering cholesterol.

The group responsible for tattling on Cheerios is the National Consumer’s League. Here’s the link to the letter they sent to the FDA.

The National Consumer’s League touts itself as the “promotional claims for food” police and it was the NCL that specifically stated in their letter that GM’s claim that the cereal lowers cholesterol “bears a drug-like claim”. The NCL goes on to state that Cheerios’ label “boldly entices consumers” to join the Cheerios challenge and “lower your cholesterol in 4-6 weeks”.

While the NCL states that it isn’t contesting General Mill’s claim that soluble fiber from oats lowers cholesterol–which, by the way, is exactly what Cheerios claims too–NCL protests that the Cheerios challenge doesn’t include advising cereal eaters to change their diet or make lifestyle changes.
The FDA agreed with NCL and warned GM to cease and desist.

And yet, I seem to recall the Cheerios ads stated that one “could” lower their cholesterol by eating Cheerios along with a diet low in saturated fat and cholesterol. In fact, they state it on the website:

A family favorite for decades – and with good reason. Made with whole grain, Cheerios is the only ready-to-eat cereal clinically proven to lower cholesterol when eaten as part of a diet low in saturated fat and cholesterol.

Which leads us back to the FDA and the comments posted on the original Denver Post story, comments which are worth their weight in gold:

“According to the posters at the health club, exercise will reduce your risk of heart disease. Does making the claim make exercise a drug too? Don’t these guys have anything better to do?

Our tax dollars at work.”

“Now all that is left is to make sure Cheerios ship in tamper/child proof containers . Funny, if it didn’t cost our tax money. As to false advertising: It’s a free country and my only request would be that all ingredients in food or drugs (or anything else we consume) should be more clearly labeled so we can make educated decisions.

My latest pet peeve: “biodegradable (except as defined by the State of California)” label on dog waste bags … how about all states agree on one designation at least? I bet only the California definition truly indicates biodegradability in a reasonable amount of time and without needed UV exposure, but the only bags available her that comply are made in Norway (and then shipped to the US), how environmentally friendly.

As for processed grain cereals: I would stay away from them altogether. Eating the box should be healthier (more fiber).”

“Cheerios? I need an RX to eat them now? Will that raise the price to $420/box?”

“No wonder the kids are wandering around in a daze…on drugs, oops, Cheerios. How many grams do you have to possess to get busted? Gotta go now…I need to flush mine down the commode.”

“A box of FDS regulated Cheerios will now cost $5698.67. Will my health insurance cover it?”

And then there’s this comment:

“The problem is not that General Mills claims Cheerios are part of a heart-healthy diet. There’s data to back that claim up. It’s that they claim a specific percentage reduction in LDL cholesterol with no data to back it up.

There may be people out there who need a 4% reduction to reach LDL goals and decide not to take medications, but instead eat Cheerios. General Mills has to prove that those people will benefit.

I know it seems trivial, but to the medical community (for which I am in training to become a part of), it’s potentially quite serious.”

While the last comment is essentially true, one can’t help but wonder if the FDA approved prescription drug Lipitor were to make a cereal such as “Lipitos”, what the ensuing commercial were to contain. Such ditties as “with Lipitos as part of your low-fat diet, you could lower your LDL levels a whopping 39-69%. Side effects include:

* Headache
* Constipation
* Diarrhea
* Gas
* Upset stomach and stomach pain
* Rash
* Muscle and joint pain

Or more serious side-effects as:

* Serious muscle problems that can lead to kidney problems, including kidney failure.

* Liver problems. LIPITOS can cause liver problems.

Of course, Lipitos would be approved for commercials because it contained a drug that was pre-approved by the FDA.

What will most likely to occur in the FDA-Cheerios “drug” melodrama, Cheerios will forfeit their claim that Cheerios lowers cholesterol a specific number of points, a hard fought victory for the FDA.

By LBG

Image – FDA Cartoon

Tags: CEREAL, Cheerios, Drug, FDA, General Mills