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FDA: Packaged Foods' Health Claims Make Them Drugs

FDA: Packaged Foods' Health Claims Make Them Drugs


Could the breakfast staple, Cheerios, be classified as a drug? That's what the Food and Drug Administration is claiming, based on the product's labeling that it's "clinically proven to help lower cholesterol." On May 5, the FDA sent a warning letter to General Mills, the maker of Cheerios, charging that the cereal's cholesterol-lowering health claims violate federal law. It stated:

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.

According to The Wall Street Journal, if General Mills wishes to keep the statements on the Cheerios box as is, the company has to file a new-drug application for the cereal. In a statement issued this morning, General Mills expressed that it will "look forward to discussing this with the FDA and to reaching a resolution."

While I agree that the FDA should be closely involved with health claims in consumer products, I can't help but wonder whether this is taking resources away from a larger problem in the FDA's hands: improving food safety in our country. Should packaged foods be able to make health claims, or does that render them drugs?

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