According to the Food and Drug Administration, Cheerios have been declared a drug (not kidding):

Unapproved New Drug

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. 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."

These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act U.S.C. § 321 (g)P)(B). The product is also a new drug under section 201(p) of the Act 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 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.

Also, the product has been labeled as "Misbranded Food":

Your Cheerios ® product is misbranded within the meaning of section 403(r)(1)(B) of the Act U.S.C. § 343(r)(1)(B) because it bears unauthorized health claims in its labeling. We have determined that your website www.wholegrainnation.com is labeling for your Cheerios® product under section 201(m) of the Act U.S.C. § 321 (m) because the website address appears on the product label. This website bears the following unauthorized health claims:

• "Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease."

This health claims misbrands your product because it has not been authorized either by regulation section 343(r)(3)(A)-(B) of the Act] or under authority of the health claim notificati6n provision of the Act section'343(r)(3)(C) of the Act]. Although FDA has issued a regulation authorizing a health claim associating fiber-containing grain products with a reduced risk of coronary heart disease (21 CFR 101.77), the claim on your website does not meet the requirements for this claim. For example, under section 101.77(c)(2), the claim must state that diets low in saturated fat and cholesterol and high in fiber-containing fruit, vegetable, and grain products may reduce the risk of heart disease. The claim on your website leaves out any reference to fruits and vegetables, to fiber content, and to keeping the levels of saturated fat and cholesterol in the diet low. Therefore, 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 (see section 343(r)(3)(B)(iii) of the Act U.S.C.§ 343(r)(3)(B)(iiill.
Source(s):
http://www.fda.gov/foi/warning_letters/s7188c.htm
http://www.allgov.com/ViewNews/FDA_Says_Cheerios_Health_Claims_Unsubstantia...
http://www.examiner.com/x-4559-Denver-Weight-Loss-Examiner~y2009m5d14-FDA-s...


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