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When Your Breakfast is Considered a 'Drug'
Date:5/21/2009

CHICAGO, May 21 /PRNewswire/ -- Millennium Medical Information Services, Inc. reports that the Food and Drug Administration (FDA) recently issued a Warning Letter to General Mills for illegally marketing their new "drug," commonly known as Cheerios(R) Toasted Whole Grain Oat Cereal (Cheerios(R)). The FDA Warning Letter serves as a healthy reminder as to the unintended consequences that may arise when navigating the comprehensive regulatory scheme governing the marketing and promotion of food and drugs in the United States. The FDA Warning Letter gives rise to the fundamental question: Are Cheerios(R) a food or a drug?

The Cheerios(R) box reviewed by the FDA included the following statements:

  • "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."

According to the Federal Food, Drug, and Cosmetic Act, a "drug" includes "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. . ." 21 U.S.C. section 321(g)(1)(B). Based on the claims set forth on the Cheerios(R) label, the FDA opined "that Cheerios(R) is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios(R) is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol." General Mills, Inc., Warning Letter, '/>"/>

SOURCE Millennium Medical Information Services, Inc.
Copyright©2009 PR Newswire.
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