Life Science Compliance Update

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May 31, 2009

FDA: Pharmaceutical Cheerios?

I did not realize there were negative side effects or addiction problems with Cheerios but apparently the FDA thinks Cheerios are drugs.

With all of the health care reform legislation coming close to an initial framework, and with numerous federal agencies working with the Obama Administration and Congress to present these outline to the public one would suspect that agencies such as the Food and Drug Administration (FDA) were using their resources and time wisely.

Not these guys, instead of focusing on the safety of the food supply or developing a swine flu vaccine, the FDA recently felt the need to attack one of America’s favorite foods: Cheerios.

As disclosure for this article my kids love Cheerios, one of my daughters is allergic to gluten and this is one of the only cereals she can eat along with Rice Krispies. w\We even have a song that we sing in the morning cheer-e-o-o-o-o-oos. But there is a down side, I end up stepping on them pretty regularly, and hearing the cheerios crunch, the end up all over the car, behind the seats in crevasse. Last Saturday I spent an hour cleaning Cheerios up in our van.

The FDA’s mission to cleanse society of those annoying little O’s began in early in May, when the FDA issued a letter to Ken Powell, Chairman of the Board and CEO of General Mills. According to the letter:

“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).”

Moreover, the FDA determined based on claims that on the product's label, that 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, the FDA asserted that the Cheerios® product bears the following claims on 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."

As a result, the FDA claims that Cheerios® is considered a “new drug” because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease, and therefore, it may not be legally marketed with the above claims in the United States without an approved new drug application.

The FDA further argues that 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 backgrounds, and other text effects, clearly distinguish it from the health claim in the lower left corner. Consequently, this allowed the FDA to call Cheerios ® a misbranded product because it bears unauthorized health claims in its labeling, and because the website bears the following unauthorized health claims:

"Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease."

Apparently, the claim leaves out any reference to fruits and vegetables, to fiber content, and to keeping the levels of saturated fat and cholesterol in the diet low, and thus 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.

Ultimately, General Mills, Inc. was told to advise the FDA in writing within 15 days regarding the specific steps they will take to correct the violations noted above.

General Mills though is not rolling over in a statement earlier this month stated:

Cheerios’ soluble fiber heart health claim has been FDA-approved for 12 years, and Cheerios’ ‘lower your cholesterol 4% in 6 weeks’ message has been featured on the box for more than two years.  The science is not in question.  The scientific body of evidence supporting the heart health claim was the basis for FDA’s approval of the claim, and 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 are in dialog with FDA, and we look forward to reaching a resolution."

As shocking and ridiculous as this letter is, what is even more frustrating is that Cheerios® is trying to help people become healthier. Instead of acknowledging the significance this cereal can have in making people healthy, (the FDA must want us all eating sugary cereals such as Captain Crunch with Crunch Berries, or Sugar Smacks) the FDA chose to classify a cereal as a ‘drug.’

Moreover, this is a miss allocation of resources the FDA could be out figuring out ways to stop childhood obesity where foods actually could be considered drugs (such as candy and soda), and helping the Health and Human Services Department figure out new ways to educate people, the FDA is actually going after the good guys.

Where does the FDA find the time to . The FDA needs to get their priorities straight soon. Healthy eating is one of the core missions of this organization, and attacking a brand like Cheerios ® is not only wrong, but sets a bad example for other companies not to produce healthy foods because of the risk (unnecessarily) associated with their product. Cheerios as a drug (does this now mean I should ban them from my house) – give me a break!! What’s next, fruit, fiber?

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