OUR EVER VIGILANT FDA AT WORK TO SHOW NEW ADMINISTRATION EFFECTIVENESS

Am I dreaming? Is this surreal?

Because "Cheerios is a food not a drug," the claims that it "lowers cholesterol and reduces the risk of heart disease and cancer violates federal law," says the FDA in a letter to General Mills.

The FDA appears to have just wakened to the fact that Cheerios’ cholesterol-lowering claim has been featured on the Cheerios box for more than two years and the heart health claim was approved by the FDA 12 years ago. "The science is not in question, admits the FDA. "The scientific body of evidence supporting the heart health claim was the basis for FDA's approval of the heart health claim, and the clinical study supporting Cheerios' cholesterol-lowering benefits is very strong,"

“But,” says the FDA “Cheerios marketing of health benefits fails to include language the FDA requires about other foods that help reduce risks. According to the agency the information on the box leaves out any reference to fruits, vegetables, and fiber,” the FDA letter said. The FDA states that while the agency allows a health claim linking soluble fiber from whole grain oats to a reduced risk of heart disease by means of lowering cholesterol, Cheerios boxes have cholesterol as a prominent, stand-alone claim, the FDA pointed out in its 5/5/09 letter.

“Your claim does not convey that all these factors together help to reduce the risk of heart disease and does not enable the public to understand the significance of the claim in the context of the total daily diet.” "[Therefore] 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," the FDA said in a letter to General Mills which was posted on the federal agency's website.

This is the first attack against a “mainstream food product” in more than nine years and showed the agency is exerting its new authority under a new President Barack Obama.

Thus the advertising by Cheerios on its box [that gives me such happy reassurance at breakfast about lowering cholesterol] don't "convey that it’s not just soluble fiber but all these factors together [ i.e. fruits and vegetables] help to reduce the risk of heart disease."
It does not "enable the public to understand the significance of the claim in the context of the total daily diet,” says the FDA. For instance, recommends the FDA “a company should say on its box that “a diet low in saturated fat and high in fiber-rich foods such as fruit, vegetables and whole grains may reduce the risk of heart disease.”

What’s more says the FDA, the claim about lowering cholesterol "qualifies Cheerios under US regulations as an unapproved new drug."

In its warning letter, the FDA said that unless the cereal maker takes action to "correct the violations" on its labels, "boxes of Cheerios could disappear from supermarket and wholesaler shelves around the United States and the company could face legal action." Thus, claims that the 68-year-old whole-grain oat cereal lowers cholesterol and reduces the risk of heart disease and cancer violates federal law, the agency said. As a result General Mills faces seizure of products or an injunction against making and distributing Cheerios.

HELLO! Do you think that maybe the FDA is going too far? Does the FDA think we’re all idiots?

The FDA is threatening to consider Cheerios as a new drug because it has not been "recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease." That means General Mills may not legally market Cheerios unless it applies for approval as a new drug or changes the way it labels the small, doughnut-shaped cereal, the FDA said.

I hope this is not a sign of worse things to come. I don’t know what I’d do if I had to obtain a prescription on my next doctor’s visit to get my favorite cereal. This would more than double the price of a box of cereal.

And what about the reassuring reading on the box? Does that mean I’ll have to mix some spinach and broccoli over the cereal before I pour the milk?


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