What could a cereal company possibly have in common with a pharmaceutical or medical device company? If you had asked that question a couple of weeks ago, people would have been hard-pressed to see a connection beyond “uh, well, they’re both companies.” But after the media explosion this week, most everyone could answer that question pretty quickly — They all have to watch their advertising claims… especially regarding public health.
In case you haven’t heard about this topic already or it has been clouded in your mind by media hype, I’ll summarize. The FDA sent a warning letter to General Mills’ Chairman of the Board and CEO Ken Powell on May 5th, 2009. In the letter, the FDA said that they reviewed the label and labeling of General Mills’ Cheerios Toasted Whole Grain Oat Cereal and found it in violation of the Federal Food, Drug, and Cosmetic (FD&C) Act and applicable 21 CFR regulations. Based on the claims made on the label, they determined that Cheerios was being “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.” By claiming to reduce your cholesterol level 4% in 6 weeks, Cheerios crossed the line into saying that their product is intended for use treating the disease hypercholesterolemia. Intentional or not, this marketing claim put the cereal into the class of being a drug promoted without FDA approval.
General Mills spokesperson Tom Forsythe responded to questions regarding the FDA’s warning letter by saying the cholesterol-lowering claim has been featured on the Cheerios box for more than two years and that the heart health claim was approved by the FDA 12 years ago. But what he failed to mention or understand was that Cheerios has kept pushing the envelope on their marketing claims over the past two years until they finally were slapped on the wrist by the FDA for overstepping the line.
Back in 1989, studies began to show that intake of oat bran may reduce cholesterol levels in the body. In 1996, Cheerios was able to meet the American Heart Association’s nutrition guidelines for its food certification program and they began to feature the AHA seal and checkmark on their packaging to publicize this endorsement. In 1997, the FDA announced that Cheerios, oatmeal, and oat products can lower the risk of heart disease when eaten as part of a diet low in saturated fat and cholesterol. In 1998, the FDA solidified this claim by allowing the phrase “can lower” to change to “in fact lower” cholesterol levels as part of a diet low in saturated fat and cholesterol.
If you look back at the Cheerios packaging over the last 2 years, you will see what I mean by Cheerios pushing the envelope on their health claims. Here is the progression on the wording on their packaging:
• All General Mills Cereals are Made with Whole Grain (banner); Three grams of soluble fiber daily from whole grain oat foods, like Cheerios, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios has one gram per cup. (small type)
• Oats Help to Naturally Lower Cholesterol (banner); Three grams of soluble fiber daily from whole grain oat foods, like Cheerios, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios has one gram per cup. (small type)
• Cheerios May Reduce Your Cholesterol (banner); As part of a heart-healthy diet, the soluble fiber in Cheerios may reduce your cholesterol. Three grams of soluble fiber daily from whole grain oat foods, like Cheerios, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios has one gram per cup. (small type)
• Clinically Proven to Help Reduce Cholesterol (banner); A study showed that two 1-1/2 cup servings daily for 6 weeks reduced bad cholesterol about 4% as part of a diet low in saturated fat and cholesterol. Three grams of soluble fiber daily from whole grain oat foods, like Cheerios, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios has one gram per cup. (small type)
• Join the Challenge — and Lower Your Cholesterol 4% in 6 Weeks (banner); Three grams of soluble fiber daily from whole grain oat foods, like Cheerios, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios has one gram per cup. (small type)
• You Can Lower Your Cholesterol 4% in 6 Weeks (banner); Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is the only leading cold cereal clinically proven to lower cholesterol. A clinical study showed that eating two 1-1/2 cup servings daily of Cheerios reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol. —- BAM! The FDA takes notice and generates a warning letter about this wording saying that General Mills is promoting Cheerios for conditions that cause it to be a drug.
What General Mills didn’t yet seem to understand (but I’m sure now does) is that even if they have done clinical testing and found that data to be true, a company can’t run around promoting it until they receive clearance from the FDA who validates the claim and offers guidance on what the can say to the public. Herbal and homeopathic remedies must always have asterisks next to their curative suggestions that declare “this statement has not been evaluated by the FDA.” The disclaimer must also announce that the product is not intended to “diagnose, treat, cure or prevent any disease,” because only an approved drug can legally make such a claim.
In the FDA warning letter, the FDA instructed General Mills that it would have 15 days to detail the specific steps it would correct the violations and specify the date by which it would complete the corrections with a statement of reason for any delay. The FDA sends out dozens of warning letters each year, so this is not disastrous news for General Mills, but they must quickly resolve the problem or face product seizes and other penalties — just like a pharmaceutical company would have to do.
And for those who think that the FDA is singling out the popular Cheerios brand for correction, just this past April it had warned Kellogg about its Frosted Mini-Wheats claim. Frosted Mini-Wheats asserted in their marketing that the product enabled children to be 20% more attentive than those who hadn’t eaten breakfast. A possible outcome of Kellogg’s own research studies, but not substantiated by the FDA and therefore in violation of the FD&C Act and applicable 21 CFR regulations.
The new FDA administration is sending a message to food manufacturers that they are watching labeling claims and are ready to enforce the Act, so they’d better mind their oats.