And if it doesn’t, the FDA threatens to seize the cereal.
An FDA review of Cheerios’ labeling “found serious violations of the Federal Food, Drug, and Cosmetic Act” and suggests Cheerios could be considered an “unapproved new drug,” the warning letter says.
Here’s an excerpt from the warning letter:
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. … These claims indicate that Cheerios is intended for use in lowering cholesterol … . 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.
… Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
General Mills responded to the FDA letter with an online statement that noted its heart-health claim has been approved by the FDA for more than a decade. Here’s the cereal-maker’s statement:
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 2 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 heart health 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 look forward to discussing this with FDA and to reaching a resolution.
There are serious issues involved here, to be sure, but can you envision federal agents raiding a Cheerios plant and seizing boxes of cereal?