When I was ten years old, I used to grind up Cheerios in a plastic bowl and eat the dusty paste that remained. I would bring my bowl into the TV room and watch National Geographic documentaries about lions and tigers and bears. Little did I know that I was engaging in drug trafficking activity from the kitchen to the TV room.
Fortunately, the federal government stepped in to inform my of my misdeeds. The Food and Drug Administration recently classified General Mills’ Cheerios as a drug, because the consumption of Cheerios can mitigate health problems.
Just about every healthy food mitigates health problems. For example, bread mitigates starvation. And orange juice, which contains vitamin C, mitigates vitamin C deficiency (scurvy).
In a letter to General Mills chairman and CEO Ken Powell, Director of the FDA’s Minneapolis District, W. Charles Becoat, threatened “seizure of violative products” if General Mills did not remove the offending statments on its website and products within 15 days.
But the offending statements are hardly false. The FDA takes issue with the following claim on the Cheerios website:
“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.”
. . . but the FDA’s problem is not that this claim is false or inaccurate. The problem is that that the claim does not include enough oversantized fluff language to destroy any trace of meaning. Specifically, Director Becoat writes:
“The claim on your website leaves out any reference to fruits, vegetables, and fiber content. Therefore, your claim does not convey that all these factors together help to reduce the risk of heart disease and does not enable the public to understand the significance of the claim in the context of the total daily diet.”
The FDA bemoans the fact that General Mills did not transform their whole-grain cereal into an advertising billboard for competing products. Director Becoat warns General Mills against using the following phrase:
“Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease”
But again, this phrase is accurate, and the FDA admits as such. In fact, because this claim is accurate, the FDA then tries to classify Cheerios as a drug.
“However, the label of your Cheerios® cereal claims a degree of risk reduction for coronary heart disease by stating that Cheerios® can lower cholesterol by four percent in six weeks. High blood total and LDL cholesterol levels are a surrogate endpoint for coronary heart disease; therefore, the cholesterol-lowering claims on the Cheerios® label attribute a degree of risk reduction for coronary heart disease because if total and LDL cholesterol levels decline, the risk of coronary heart disease declines as well.”
What does this mean? Well, this means that Cheerios, like OxyContin and Tylenol and Advil and anabolic steroids, is a drug.
“These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, 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.”
To prevent the seizure of its products, General Mills has to comply with an FDA demand to tag on “and other plant foods” to “regular consumption of whole grains.” General Mills must be free to publish accurate information without being strong-armed into including irrelevant and already-obvious information on its product packaging. Cheerios is neither a fruit, nor a vegetable, nor a drug. Grab a bowl of Cheerios, pour on some milk, and lament the fact that the federal government wastes other peoples’ money trying to tell us otherwise.