FDA Says Cheerios Advertised as an Illegal Drug; Threatens to Seize Every Box in the U.S.
The FDA has accused General Mills of illegally marketing Cheerios as a drug because of advertising claims that the cereal can lower cholesterol. (Cheerios is handled by Saatchi & Saatchi.)
The move sounds bizarre until you read the FDA’s letter in the original. Then you get an idea of just how exaggerated “health” claims can get; and how the Obama administration is intent on cleaning up Dodge. (FTC chairman Jon Leibowitz recently went after Kellogg for false claims on attentiveness made by Frosted Mini Wheats.)
In a letter, the FDA accused GM of “serious violations of the Federal Food, Drug, and Cosmetic Act” in its Cheerios campaign:
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. Specifically, your Cheerios® product bears the following claims on its label:
• “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. …”
… the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease …
Because of these intended uses, the product is a drug …
Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application.
The FDA also didn’t like Cheerio’s website, alleging that it claims “diets rich in whole grain foods, can reduce the risk of heart disease” but fails to mention that in order to make that claim such a diet must also contain fruit, vegetables and other grain products.
The FDA has threatened to seize every box of Cheerios in the country if the violations are not cleaned up:
Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
Better eat them now, before they become illegal.
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
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