When is a breakfast cereal not a breakfast cereal? Well, when it’s a drug.
General Mills has been rapped over the knuckles by the US Food and Drug Administration (FDA) for illegal health claims on its popular Cheerios-brand cereal. Rightfully so. The company’s flouting of the law gives health claims – and the food industry – a bad name.
Bloggers have been out in force over the issue, with one telling the FDA to ‘grow up’, and another saying the decision demonstrates the Obama administration is ‘authoritarian’.
What they are frothing about is the FDA taking issue with claims on Cheerios packs that the cereal is “clinically proven to lower cholesterol” and “you can Lower Your Cholesterol 4% in 6 weeks".
It said that this classifies Cheerios as a drug, as it is intended for use in the prevention, mitigation and treatment of a disease. In order to continue making the claim, the FDA said General Mills can not market the cereal without an approved new drug application.
“It is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease,” the FDA said in a warning letter to the company.
Nit-picking? I don’t think so.
The rules are clear: If you are marketing a food as something that can resolve a medical issue, you are, by definition, selling a drug.
Functional vs. medicinal
Of course, functional foods do exist, but companies can only claim that foods reduce the risk of a disease. In fact, the FDA has approved a health claim relating to whole grains that General Mills submitted for approval in 1999. The claim reads: “Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol, may help reduce the risk of heart disease and certain cancers."
But the company went ahead with its latest claim without seeking FDA approval.
Perhaps the bloggers don’t realize the significance of the FDA’s decision; this is not about the threat of an authoritarian regime – it’s about insisting that food companies make scientifically verified claims. If those claims are about disease reduction, they will be treated as medicinal, and drug laws will apply. Those are the rules and companies risk the bad publicity that General Mills has seen if they break them.
There’s also a possibility that some people with high cholesterol will see eating breakfast as a clinical treatment, perhaps even offsetting a more pressing need to cut back on the French fries.
This judgment is a refreshing change for the FDA, as part of the Obama administration’s promised crackdown on dodgy parts of the food industry.
What’s surprising is that it is General Mills in the spotlight, and that the food giant has remained incredibly stubborn over its clear defiance of the law.
“The science is not in question,” it said in a statement. “…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."
General Mills should count itself lucky that it is not subject to European health claims regulations, which are currently undergoing a massive shake-up. Make no mistake, just as the FDA and the Federal Trade Commission (FTC) have indicated they will crack down on this kind of behavior, a similar crackdown is happening in Europe. There, under new rules implemented in 2006, companies making health claims have to match them to the available scientific evidence, not the other way round.
I hope the FDA stands its ground. General Mills should know better.
If other food companies can learn from their mistakes they should be able to avoid reading the kind of damaging headlines General Mills generated for its clumsy claim-making over their own bowl of breakfast cereal.
Caroline Scott-Thomas is a journalist specializing in the food industry. Prior to completing a Masters degree in journalism at Edinburgh's Napier University, she had spent five years working as a chef. If you would like to comment on this article, contact caroline.scott-thomas ‘at’ decisionnews.com.