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Life and Times of an itinerant slacker in Sacramento. Thrills, Spills Galore coming soon. Not to mention lots of opinions.

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Wednesday, May 13, 2009

They'll Pry My Cheerios From My Cold Dead Hands

The FDA today has today sent a Warning Letter to General Mills claiming the labeling of Cheerios is in violation of Federal law. The FDA takes offence to claims of lowered cholesterol.

Although several respected media outlets have reported this, I only found one mainstream media report (Wall Street Journal's blog) that actually appears to have read the two page warning letter. That's really a shame,since this letter is a doozy. I tend to agree wiht the position the FDA is taking, but it seems strange anyway.

In the broadest sense, the FDA's compaint is that the claims made on the box of Cheerios make Cheerios a drug. The FDA made this call because,

"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. Specifically, your Cheerios® product bears the following claims ort its label:

• "you can Lower Your Cholesterol 4% in 6 weeks" "
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."


Now comes the fun stuff:

Since Cheerios labeling has made the stuff a drug, the fun starts now:

"The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application."

Yep, Cheerios as currently labeled is subhect to the FDA's drug approval process.

Now, here's where the hoarding comes in:

"Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products."

First go after my breakfast, next thing you know, they'll take my gun! I guess maybe those cranial anal inserted reactionaries was right all the time! Perhaps not.

That's my story and I'm sticking to it.

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I must enjoy shouting into a vacuum, but I think about getting my act together one of these days. My mom says I am very handsome and intelligent.

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