WTF? FDA Says Cheerios Are a "Drug"

[Mr Wiggl3s]

Popular US breakfast cereal Cheerios is a drug, at least if the claims made on the label by its manufacturer General Mills are anything to go by, the US Food and Drug Administration (FDA) has said.

"Based on claims made on your product's label, we have determined that your Cheerios Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug," the FDA said in a letter to General Mills which was posted on the federal agency's website Tuesday.

Cheerios labels claim that eating the cereal can help lower bad cholesterol, a risk factor for coronary heart disease, by four percent in six weeks.

Citing a clinical study, the product labels also claim that eating two servings a day of Cheerios helps to reduce bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol, the FDA letter says.

Those claims indicate that Cheerios -- said by General Mills to be the best-selling cereal in the United States -- is intended to be used to lower cholesterol and prevent, lessen or treat the disease hypercholesterolemia, and to treat and prevent coronary heart disease.

"Because of these intended uses, the product is a drug," the FDA concluded in its letter.

Not only that, but Cheerios is a new drug because it has not been "recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease," the FDA said.

That means General Mills may not legally market Cheerios unless it applies for approval as a new drug or changes the way it labels the small, doughnut-shaped cereal, the FDA said.

General Mills defended the claims on Cheerios packaging, saying in a statement that Cheerios' soluble fiber heart health claim has been FDA-approved for 12 years, and that its "lower your cholesterol four percent in six weeks" message has been featured on the box for more than two years.

The FDA's quibble is not about whether Cheerios cereal is good for you but over "how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website," said General Mills.

"We look forward to discussing this with FDA and to reaching a resolution."

Meanwhile, the FDA warned in its letter that if General Mills fails to "correct the violations" on its labels, boxes of Cheerios could disappear from supermarket and wholesaler shelves around the United States and the company could face legal action.

According to General Mills, one in eight boxes of cereal sold in the United States is a box of Cheerios. The cereal debuted on the US market in 1941.

Hm.....

 

[Calabrio]

The issues is about how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website.

 

[luxuryrules]

Of course, wouldn't Special K also fall into this kind of classification as well? As I remember, they had a promotion of eating a bowl or two a day and losing a couple pounds after a few weeks...

 

[Calabrio]

Of course, wouldn't Special K also fall into this kind of classification as well? As I remember, they had a promotion of eating a bowl or two a day and losing a couple pounds after a few weeks...

I don't know, that's not as specific or medical as saying it'll lower your cholesterol by x points in so many weeks. Cutting calories isn't really "medical" just common sense.

This is actually an interesting story, but not outrageous. People want an aggressive FDA, so that means the decisions made have to go beyond common sense.

 

[SoonerLS]

Being overweight is not, in and of itself, a disease or medical condition, so claiming to help with weight loss is not claiming to treat a medical condition. The purveyors of such products usually include a note that their products are not intended to treat a disease or medical condition (usually in the fine print).

This is another one of those stories that seems absurd on the face of it, but isn't if you follow the facts. The problem is not in what General Mills is claiming, it's in the way they're claiming it:

FDA has issued a regulation authorizing a health claim associating soluble fiber from whole grain oats with a reduced risk of coronary heart disease (21 CFR 101.81). Like FDA's other regulations authorizing health Claims about a food substance and reduced risk of coronary heart disease, this regulation provides for the claim to include an optional statement, as part of the health claim, that the substance reduces the risk of coronary heart disease through the intermediate link of lowering blood total and LDL cholesterol. See 21 CFR 101.81(d)(2),-(3). 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 are not made as part of that claim but rather are presented as separate, stand-alone claims through their location on the package and other label design features. The cholesterol claim that mentions the clinical study is on the back of the Cheerios® box, completely separate from the health claim on the front label. Although the other cholesterol claim is on the same panel as the authorized health claim, its prominent placement on a banner in the center of the front label, together with its much larger font size, different background, and other text effects, clearly distinguish it from the health claim in the lower left corner.

Additionally, even if the cholesterol-lowering claims were part of an otherwise permissible claim, under 21 CFR 101.81, the resulting claim language still would not qualify for the use of the soluble fiber health claim. To use the soluble fiber health claim, a product must comply with the claim specific requirements in 21 CFR 101.81, including the requirement that the claim not attribute any degree of risk reduction for coronary heart disease to diets that include foods eligible to bear the claim. See 21 CFR 101.81(c)(2)(E). 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.

The complete letter can be found at http://www.fda.gov/foi/warning_letters/s7188c.htm .

 

[fossten]

First Obama goes after nasty big oil, then the greedy banks, then the evil car companies, then nationalizes healthcare, and finally he's attacking evil big food.

 

[Black87LSC]

First Obama goes after nasty big oil, then the greedy banks, then the evil car companies, then nationalizes healthcare, and finally he's attacking evil big food.

Hmmm... Who is the nasty, greedy, evil one now?

 

[n8bachelor]

If i market my dick as the cure to female sexual frustration can i get a "cease and desist" letter from the FDA too? LoL

 

[Calabrio]

If i market my dick as the cure to female sexual frustration can i get a "cease and desist" letter from the FDA too? LoL

I think you'd have to be able to sell it first.