The FDA Classifies Cheerios as a Drug

This bit of news has been making its round around the Internet for a few weeks now, but it you haven’t heard, the Food and Drug Administration is classifying the cholesterol-lowering cereal as a drug.

In a letter to General Mills from the FDA, a passage states:

“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,”

Since the marketing of the cereal focuses on the claim of lowering of cholesterol by 4 percent in 6 weeks, that classifies it as a drug, and not a food item.  With that being said, that means Cheerios is a “new” drug, and since it isn’t approved as a drug, it’s not “recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease.”  The claim on the box has been around for two years, and it has taken the FDA that long to realize this?  Either they work very slow, or that they’re looking for something to do, it’s not like they’re really doing much in food safety.  If General Mills does not retract the claim, the FDA is threatening to take Cheerios off of supermarket and wholesaler shelves.  I can see a long legal battle coming down the line.

While it does seem logical why the FDA is pursuing the matter so aggressively, there might be another reason behind this.  While it’s rather simple minded, I think there might be some validity to it.

Marketing Cheerios with the stated claim of lowering cholesterol might take away sales of cholesterol-lowering drugs.  Even though it’s a bit of a stretch, think about the impact on the pharmaceutical companies that manufacture and sell the drugs.  Pharmaceutical companies are in business to make money, and like other businesses, it’s about the bottom line.  Since Cheerios has been clinically proven to lower cholesterol, that would mean it’s an alternative to taking cholesterol-lowering drugs.  Sales of Cheerios goes up, sales of cholesterol-lowering drugs go down or remain stable.

Will we be seeing Cheerios being sold in the over-the-counter drug aisles?  Let’s hope not.

~ Kin