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FDA: Are Cheerios a drug or a breakfast cereal?

By Dan Haugen | 05/12/09

Are Cheerios a drug or a breakfast cereal?

That's what General Mills will have to decide, following a warning letter from the U.S. Food and Drug Administration accusing the company of misbranding the health benefits of eating Cheerios.

Cheerios packaging claims that eating Cheerios "can Lower Your Cholesterol 4% in 6 weeks." In order to make that type of claim, the cereal-maker will have to apply for approval as a new drug.

Food companies are not allowed to quantify the health benefits of their foods in marketing, the Associated Press reports.

The FDA letter also says the company's claim about whole-grain foods lowering the risk of heart disease is deceptive without the full, legally required context. Food packages must state that a diet with whole grains and fruits and vegetables and low in saturated fat and cholesterol may reduce the risk of heart disease.

A spokesman for General Mills tells the Associated Press that the science behind its Cheerios claims "is not in question" and that it will work with the FDA to make the language compliant. (More: Reuters, Star Tribune, Wall Street Journal)

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Comments (5)

Submitted by Todd Pitman on May 12, 2009 - 1:30pm.

This is how I felt when Subway started marketing their sandwiches as a weight-loss method. Eh?

Submitted by Justin Dessonville on May 12, 2009 - 1:52pm.

cheerios.com is now running a promotion that says "Cheerios helps lower cholesterol 10% in one month".

Submitted by Mike Richardson on May 12, 2009 - 2:38pm.

...but Todd, the problem comes when they make specific claims, like that it helps lower cholesterol 10% in one month. Did Subway do that? I don't think so...they definitely didn't here in Germany.

Submitted by Erica Mauter on May 12, 2009 - 2:42pm.

There are a bunch of different issues here.

1. If the Mills failed to respond to new legislation or regulations or even guidelines reflective of evolving industry practice, that's one thing. But they've been making similar claims about Cheerios forever. It could just be that a slight change in wording pushed the envelope a little too far. That's what I'm thinking happened here.

(1.5 Tangentially related: You'll note that baking soda has both Drug Facts and Nutrition Facts labeling on the box.)

2. There's an increasingly fuzzy line between food and pharmaceuticals. I'm not sure the regulatory environment has really caught up to it.

3. It could just be that the FDA is just finally getting around to it on their long to-do list and their chronically understaffed state.

A warning letter is the lowest level of regulatory action from the FDA, but it's no joke. They're not messing around.

I wonder if or how claims on the box differ from claims in advertising (e.g., a tv commercial).

As far as that whole grain thing, the legal definitions are appallingly lax. So, yeah, your whole grains in any puffed cereal are more likely "whole grains."

I take issue with this tossed in at the end of that Strib story: "The scientific claims are widely discussed in the blogosphere, with some writers ridiculing General Mills. Cheerios 'brings world peace in three months, too,' one wrote." How is that helpful or substantive? He just wanted to rip off the punchline.

(BTW, I used to work at General Mills and now work at a pharma company.)

Submitted by Dan Haugen on May 12, 2009 - 4:52pm.

Erica, your second point is a great one, and timely. Next week Dr. Ann Bode of the Hormel Institute will be giving a speech at the 2009 BIO International conference in Atlanta called "Finding the Cure for Cancer in the Foods You Eat Everyday." Thanks for the comments.