Sorry, But the FDA Isn’t THAT Stupid
The health/fitness supplement industry has an uneasy relationship with the FDA – to say the least. Thus, it was no surprise to see a link to this news item getting passed around, so people could have a laugh at the agency’s expense…
Popular cereal is a drug, US food watchdog says
WASHINGTON (AFP) – 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.
So the FDA sez Cheerios is a drug! Stoopid, stoopid FDA – Ha. Ha. Ha.
There’s only one problem… this is a highly abridged version of what the FDA actually said. In reality, the agency’s action is quite consistent with its mandate and completely defensible. This is obvious from reading the actual warning letter – which comes across quite differently than the media version.
The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA’s review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA’s home page at http://www.fda.gov.
Unapproved New Drug
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 because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims ort 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. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”
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 make a long story short, the FDA isn’t really claiming Cheerios is a drug. The agency is saying that the label claims are consistent with the definition of a drug, as defined by the Federal Food, Drug, and Cosmetic Act. This is a horse of a somewhat different color. General Mills has violated legal limits by making unauthorized disease prevention claims for their product.
This is nothing new. The FDA has historically been tighter than a tick about approving such claims for food products…very few of these are allowed. Legally, the product is misbranded, and General Mills needs to bring the label into compliance with the regs.
Ho-hum.
So, can the tittering, kids. Lord knows, like many others in the fitness arena, I have my issues with the FDA. But this ain’t one of ’em…yes, perhaps they may be overly tight about food product claims, but I’m not particularly bothered by this – I’d just as soon they err on the side of caution here, to avoid consumer confusion.
