Food and Drug Administration Warns General Mills: Cheerios Is a Drug
The letter is here.
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.
And, General Mills responded that it’s flap with the FDA is a miscommunication on their packaging.
The science is not in question … the clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong. The FDA is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website. We look forward to discussing this with FDA and to reaching a resolution.â€
Ok, you would think the FDA would work with General Mills (which is a large food corporation) in formulating better language in compliance with the law rather than issuing a caustic legal missive which demands a fifteen day response.
Wouldn’t cooperation and compliance be better for the American people than confrontation and gotcha?
Technorati Tags: Cheerios, General Mills, Food and Drug Administration
6 Comments
Annapolis Cosmetic Dentist
Amazing! So Cheerios may be considered a “drug” now, huh?
What’s next, are they going to take them out of the cereal aisle and put them in the pharmacy?
Sarah
Thank you so much for posting this. I am researching this topic for a private matter and this is very helpful and informative.
Marissa
This is really nice post. My kids are eating Cheerios multi and the one with honey.
Norm Howe
My experience tells me that FDA’s letter was preceded by multiple less formal communications.
Flap
@4
If you have any evidence, I would like to see it.
Norm Howe
I don’t have any inside knowledge of this instance. But I do have decades of experience in similar situations and these letters are rarely a surprise.