Cheerios: A sign of the times? FDA has sent out a warning letter to General Mills, which makes the ubiquitous O-shaped cereal, saying that it might as well be a drug. That's because Cheerios boxes are labeled with claims that it can lower cholesterol. (And advertised that way, too; you know those "give us six weeks" ads.)
"Based on claims made on your product's label we have determined that your Cheerios ... is promoted for conditions that cause it to be a drug," the FDA wrote, "because the product is intended for use in the prevention, mitigation and treatment of disease." So, General Mills, if you want to promote your cereal as a cholesterol fighter, then you'd better file an NDA.
No, this isn't April Fool's Day, and it's no joke. And General Mills didn't take it as such. The company vociferously defended Cheerios' cholesterol-lowering abilities, saying a "scientific body of evidence" supports its heart-healthy claim. The "clinical study supporting" that claim is "very strong," the company said in a statement. But if FDA wants us to change our wording, well, we'll talk.
Is this a harbinger of new scrutiny for so-called nutraceuticals, a.k.a. foods that are marketed as beneficial to one health issue or another? Is it simply a sign that FDA is going to be more active overall, now that Obama's leadership team is almost in place? After all, if the agency is going after breakfast cereal, then we'd expect it to aggressively attack a host of problems -- not just in the marketplace, but inside the agency's own four walls.
- see the General Mills statement [1]
- read the letter from FDA
[2]- check out the Health Blog post [3]
Links:
[1] http://www.fiercebiotech.com/press-releases/general-mills-issues-statement-today-response-u-s-fda-warning-letter-regarding-choles
[2] http://www.fiercebiotech.com/press-releases/fda-warning-letter-general-mills
[3] http://blogs.wsj.com/health/2009/05/12/fda-warns-general-mills-cheerios-is-a-drug/