Cheerios FDA Warning Letter Signals Narrow Interpretation of Authorized Health Claims

Signaling a new focus on food health-related claims, the FDA has issued a Warning Letter to General Mills with respect to the labeling of Cheerios® Toasted Whole Grain Oat Cereal. The FDA accused General Mills of being marketed as an unapproved new drug because the product is promoted as being intended for use in the prevention, mitigation, and treatment of disease. The FDA also found that the product was a misbranded food because it bears unauthorized health claims in its labeling and on its referenced website.

The FDA took the position that labeling is not just the packaging of the product, but also includes that the website www.wholegrainnation.com is labeling because the url appears on the product label. Specifically, the FDA focused on the claims of intended for use in lowering cholesterol, i.e., "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?" The FDA also focused on the health claims of "Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease" and "Including whole grain as part of a healthy diet may ... [h]elp reduce the risk of certain types of cancers. Regular consumption of whole grains as part of, a low-fat diet reduces the risk for some cancers, especially cancers of the stomach and colon."

The FDA found that although the lower left corner of the Cheerios® front label contains a soluble fiber/coronary heart disease health claim authorized under 21 CFR 101.81, the two claims about lowering cholesterol were not made as part of that claim but rather were presented as separate, stand-alone claims through their location on the package and other label design features. The FDA also took that position that even if the cholesterol-lowering claims were part of an otherwise permissible claim, the claim language still would not qualify for the use of the soluble fiber health claim because to use the soluble fiber health claim, a product must comply with the claim specific requirements that the claim not attribute any degree of risk reduction for coronary heart disease to diets that include foods eligible to bear the claim.

The FDA found although FDA has issued a regulation authorizing a health claim associating fiber-containing grain products with a reduced risk of coronary heart disease that the health claim misbranded the product because was not authorized either by regulation or under authority of the health claim notification provision of the Act because it omits important diet restriction clarifications.

A Warning Letter is a serious notification from the FDA. While there is some question as to why the FDA waited to send the letter after the campaign has been running for several years, the impact of the Warning Letter is that manufacturers who are making health claims that are related to permissible health claims need to be sure that the claims are consistent with the authorized claims. While it would appear that there are First Amendment issues that arise with truthfully promoting a product consistent with the authorized language, the FDA is reading the scope of its authorized claims narrowly. Moreover, the FDA's assertion that a reference on a label to a website triggers labeling jurisdiction may result in the FDA asserting greater jurisdiction over advertising of OTC drugs, foods, and cosmetics.

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