Cheerio crackdown

May 13, 2009 – 5:17 pm by Michael Christel

It’s a rare thing when amusing news comes out of FDA, but, in my opinion, the Great Cheerios Caper of 2009 qualifies as an exception.

As you may have heard by now, FDA recently sent an official warning letter to General Mills claiming that the labeling on Cheerios boxes is in “serious violation” of federal rules because it states that the cereal is “clinically proven to lower cholesterol,” thus implying, in the agency’s opinion, that Cheerios is a drug. Such clinical boastings, FDA says, may not be legally marketed without an approved new drug application for the popular breakfast food. Would an orphan cereal designation be good enough?

“Based on claims made on your product’s label, we have determined that your Cheerios Toasted Whole Grain Oat 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,” FDA’s letter states.

And to think when my stepdaughter and I hit the Acme the other night to pick up a few things, including some Cheerios, we went straight for the cereal isle, instead of the pharmacy. Silly us.

Now this issue is not totally a laughing matter. General Mills, obviously not amused, fired off a statement defending Cheerios’ cholesterol-lowering abilities, saying a “scientific body of evidence” supports its heart-healthy claim.

“The science is not in question,” the company says. “The clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong.”

General Mills notes that Cheerios’ “lower your cholesterol 4% in 6 weeks” message has been featured on its boxes for more than two years.

FDA also has the right to strictly enforce its policies on advertising, no matter how nitpicky this case may seem.

Said one reader comment on Wall Street Journal’s Heath Blog: “It’s about time that General Mills gets called out on this. Don’t get me wrong, I’m all for using proper diet and exercise to lead and maintain a healthy lifestyle, but if the FDA (Food AND Drug) is going to be so harsh on drugmakers for their marketing tactics, they should also require food producers.”

Said another: “More accurate and explicit product labeling is exactly where the FDA should be putting their efforts. Hope to see more like this!”

Maybe so, but to me that’s a discussion for another day. Right now, I still can’t get over the fact that FDA is targeting breakfast cereal, especially those soggy, nondescript, bland little Os I used to scarf down as a kid. You would think there are more important issues at hand for the agency and likely next commissioner Margaret Hamburg.

Anyway, gotta go. Need to call in a prescription for Lucky Charms, “They’re clinically delicious!”