5/14/09

This is your brain on cereal

A box of Cheerios breakfast cereal.

Apparently General Mills has overstepped their bounds when promoting Cheerios as a cholesterol-lowering agent. The FDA (US Food and Drug Administration) sent a warning letter to General Mills telling 'em that the packaging of the tasty O's is misleading.

What's the problem? The FDA believes that the big-G company is marketing Cheerios as a drug:
...the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. 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.

They also say the website www.wholegrainnation.com is considered part of the label since the URL shows up on the Cheerios packaging. The site claims "Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease," but the FDA contends that Cheerios are not officially approved for this statement.
Although FDA has issued a regulation authorizing a health claim associating fiber-containing grain products with a reduced risk of coronary heart disease (21 CFR 101.77), the claim on your website does not meet the requirements for this claim

The FDA goes on to say that such health claims are reserved for drugs and that products approved as drugs cannot use them. You can read the whole letter here.

The Slow Food site has an interesting take on this:
The letter has triggered criticism against both the FDA and the Obama Administration, with conservative groups seeing it as yet another authoritarian step to restrict company rights. What all critics fail to do is address the FDA’s argument. The ongoing controversy cannot take away the fact that this is the first time in nine years that the agency has taken action against a “mainstream food product”.

Meanwhile, I'll continue to eat Cheerios, despite the drug-related influences. To make up for it maybe I'll eat some Cap'n Crunch on the weekends.




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