The FDA is going after General Mills for claiming that Cheerios is "clinically proven to lower cholesterol" without getting approved as a new drug. In a letter to General Mills, the FDA says that the labeling on the Cheerios boxes is "in serious violation" of federal rules and that Cheerios, " may not be legally marketed with the above claims in the United States without an approved new drug application." The letter further states, "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." The Cheerios box states the following : "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is the only leading cold cereal clinically proven to lower cholesterol. A clinical study showed that
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