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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, http://www.fda.gov/foi/warning_letters/s7188c.htm, accessed May 13, 2009.

Since Cheerios(R) "is not generally recognized, among experts . . .as safe and effective for use . . . suggested in the labeling . . ." it qualifies as a "new drug" under the Act. 21 U.S.C. section 321(P)(1). Unfortunately for General Mills, the Act requires agency approval of a new drug application prior to the introduction of a "new drug" into interstate commerce. 21 U.S.C. section 355(a).

When a drug is also food

Although the FDA clearly views Cheerios(R) as a "drug" by virtue of its intended use as described on the label, the Agency also analyzed the product claims pursuant to the regulatory authority governing health claims in food substances. Specifically, the agency refers to the permissible soluble fiber health claim and the requirements set forth in the applicable regulations. The FDA determined that General Foods failed to conform to the specific requirements of the soluble fiber health claim to the extent that they attributed a degree of risk reduction (4% in 6 weeks) for coronary heart disease to diets that include foods eligible to bear the claim.

In addition, the FDA found that General Foods misbranded Cheerios(R) by including unauthorized health claims in its labeling. The claim referenced by the FDA was as follows: "Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease." http://www.fda.gov/foi/warning_letters/s7188c.htm, page 3, accessed May 13, 2009).

Interestingly, the claim referenced above did not appear on the Cheerios(R) box, but rather appeared on a General Mills website located at www.wholegrainnation.com. According to the Act, "[t]he term 'labeling' means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. Because the above-referenced claim appeared on a website, the address for which was located on the Cheerios(R) box, the FDA considered the content on the website as part of the product labeling.

Historically, the FDA and Federal courts have taken an expansive view of what is included in a product's labeling. The term "labeling" has been broadly interpreted and is not restricted to information that accompanies the product. In fact, "labeling" has been broadly defined to include any literature that "supplements or explains" a drug, including "advertising or descriptive matter"-"[n]o physical attachment one to the other is necessary." See, Kordel v. United States, 335 U.S. 345, 348-50, 69 S.Ct. 106, 93 L.Ed. 52 (1948) (affirming broad definition of "Labeling" under the Food, Drug, and Cosmetic Act). For example, the FDA has taken the position that the mailing of a re-print of a scientific journal article constitutes product "labeling" to the extent the article makes a claim about the manufacturer's product. FDA, Letter of T. E. Byers to Sterling Drug Co. regarding distribution of medical journal reprint to 80,000 physicians, Regulatory Letter 78-HFD-312-6 (Nov. 21, 1978). See also, U.S. v. Articles of Drug Consisting of Following: 5,906 Boxes, 745 F.2d 105, 39 Fed. R. Serv. 2d 1481 (1st Cir. 1984) (Index cards delivered to physicians); FDA Reg Ltr 80-PHI-03, to Y. L. Johnson, Clifton Pharmacal (Nov. 1979) (Flyers delivered to pharmacists); Dickinson, Oraflex--No Wrongdoing?, 7 Pharmaceutical Technology 23 (Feb. 1983) (Press kit materials for briefings to journalists).

Conclusions

The FDA Warning Letter to General Mills serves as a reminder of the expansive definition of a "drug" under the Act and the unintended consequences which may occur from seemingly innocuous product claims. In addition, the Warning Letter serves as a reminder with regard to the expansive nature of product "labeling" under the Act. When formulating marketing pieces that include product/drug claims, marketers and their agents should consider the broad definition of "labeling" under the Act and the ramifications of a misbranding claim.

If you would like to continue to receive periodic updates on regulatory developments from the FDA and State and Federal authorities, please email us at info@millennium-mis.com to subscribe to the Millennium Medical Information Services, Inc. Regulatory Newsletter.


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SOURCE Millennium Medical Information Services, Inc.
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