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The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter to General Mills, Inc. objecting to claims the company makes on its Cheerios® Toasted Whole Grain Oat Cereal. The letter objects to General Mills’ use of claims about the ability of Cheerios to lower cholesterol levels, which the FDA views as impermissible drug claims. As discussed below, the Warning Letter is noteworthy for a variety of reasons, including the effect that it may have on claims made by both the food and dietary supplement industries. In addition, the letter reaffirms the FDA’s position that statements made on product and company Web sites, an area typically regulated by the Federal Trade Commission (FTC) as advertising, can be regulated by the FDA as labeling if the product’s label includes the Web address to the site where the claims are made.
Claims at Issue
The FDA’s Warning Letter principally objects to two cholesterol-reduction claims made on Cheerios labels that the agency believes suggest Cheerios is intended for use in lowering cholesterol. The particular claims at issue are:
- “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 1½ cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”
The FDA argues that these claims imply that Cheerios is intended for use in the prevention, mitigation, and treatment of the disease hypercholesterolemia as well as coronary heart disease (CHD) through lowering total and “bad” low-density lipoprotein (LDL) cholesterol. Claims that a product is intended for use in the prevention, mitigation, and treatment of a disease may appear only on drug products. Thus, the FDA argues that because Cheerios has not been approved for use as a drug bearing that particular claim, the product is misbranded as an unapproved new drug.
The FDA acknowledges that, pursuant to the health claim it has authorized associating the consumption of soluble fiber from whole grain oats with a reduced risk of CHD, an optional statement that the soluble fiber reduces the risk of CHD through the intermediate link of lowering blood total and LDL cholesterol is permitted. See 21 C.F.R. 101.81(d)(2)-(3). However, the FDA argues that General Mills does not use the optional cholesterol-lowering statements as part of the prescribed health claim, but rather, presents them as standalone claims in violation of the regulation. Moreover, the FDA notes that, even if the cholesterol-lowering claims were used as part of an otherwise permissible health claim, the resulting language of the claim would still violate the soluble fiber health claim regulation.
The Warning Letter also raises other objections concerning the claims used in connection with Cheerios labeling. For instance, the FDA argues that the health claim “Heart-healthy diets rich in whole grain foods can reduce the risk of heart disease,” which appears on the product’s Web site at www.wholegrainnation.com, causes the food product label itself to be misbranded because the Web site address appears on the product label. The FDA indicates that General Mills’ use of this health claim causes Cheerios to be a misbranded food because it has not been authorized by either regulation or the Federal Food, Drug and Cosmetic Act (FDCA) to bear such a claim. While the FTC has traditionally regulated Web content and promotional materials as “advertising,” in recent years, the FDA has asserted jurisdiction over statements made on product and company Web sites as “labeling” when the product label provides the Web site address.
Potential Implications
The FDA’s Warning Letter to General Mills concerning the Cheerios claims could have implications for the food and dietary supplement industries for several reasons. First, the letter has the potential to raise free speech issues that the FDA has struggled with in the past regarding the balance between the public’s right to access truthful, non-misleading, and substantiated information about the products they purchase as compared with the agency’s right to regulate the release of that information. The ruling of the United States Court of Appeals for the District of Columbia Circuit in Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), which addressed health claims on dietary supplements, generally supports the proposition that truthful and non-misleading label statements are entitled to First Amendment protection. The Pearson ruling could be viewed as supporting General Mills’ use of its cholesterol-reduction claims, even though they may not technically comply with the FDA’s regulations, because they can be argued to be truthful, non-misleading, and adequately substantiated by sound scientific support.
Second, the letter demonstrates that, notwithstanding the enormous focus on food safety issues in recent years, the FDA is diligently monitoring the use of potentially impermissible claims on food products. As a result, both the food and dietary supplement industries can no longer take comfort in the belief that the FDA is so busy addressing food safety that it is not concerned with labeling claims.
Finally, the letter raises questions as to whether the agency will begin to more actively police the use of potentially impermissible claims on food products as part of a new policy under the Obama administration that will lead to a regulatory environment in which food processors feel less comfortable venturing beyond what is clearly permissible under the regulations governing the claims they make on products.
For its part, General Mills has responded to the letter by saying that the science behind the claims is not in question and that the letter is simply a result of a dispute between the company and the FDA over the permissible wording of its claims. However, while food processors have become increasingly comfortable in recent years with venturing beyond the strict wording of health claims and other claims permitted by the FDA, largely without regulatory repercussions, the agency has now demonstrated an intent to hold manufacturers to a strict compliance standard, even if only in one very high-profile instance.
For further discussion on the claims at issue in the FDA’s Warning Letter as well as other topics related to false and misleading claims surrounding food and dietary supplement products such as trademark and intellectual property protection, please stay tuned for an invitation to Foley’s next installment of its quarterly Food Industry Team Web Conference in June.
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Michael D. Flanagan
Milwaukee, Wisconsin
414.297.5834
[email protected]
Jeffrey H. Greene
New York, New York
212.338.3519
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Sarah A. Key
Washington, D.C.
202.295.4720
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Richard J. McKenna
Milwaukee, Wisconsin
414.297.5723
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David L. Rosen
Washington, D.C.
202.672.5430
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