A cereal or a drug?
Seizing boxes of Cheerios off store shelves?
That is what General Mills is trying to avoid. Following a warning from the Food and Drug Administration, the company says it will fix the overpromises on the cereal’s box.
Cheerios, the best selling cereal, claims eating it lowers cholesterol and reduces the risk of heart disease and cancer. The FDA issued a warning letter May 5, that says:
“The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA's home page at http://www.fda.gov. “
“We certainly don’t have any issues with the safety of Cheerios,” Stephen Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition, said in an interview Tuesday with Bloomberg News. “We just believe that the labeling on this particular product has gone beyond what the science supports.”
The agency has problems with the promises on the box such as:
- Can lower your cholesterol 4% in 6 weeks
- Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is…clinically proven to lower cholesterol. A clinical study showed that eating two 1 ½ cut servings daily of Cheerios cereal reduced bed cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”
Making these sorts of claims is reserved for drugs according to the FDA, and cannot be marked as such “without an approved new drug application”.
Making specific claims about cholesterol reduction makes the product “misbranded” says the FDA., which also takes exception to the General Mills Web site www.wholegrainnation.com.
Problems there include:
- “Heart-healthy diets rich in whole grain foods, can reduce the risk of heart diseases.”
The Web site statement does not meet the agency’s requirements for making a health claim. Preferable is a claim that says a diet low in saturated fat and cholesterol and high in fiber-containing fruit, vegetables, and grain products may reduce the risk of heart disease. General Mills leaves out any reference to fruits and vegetables and keeping levels of saturated fat and cholesterol low.
Cheerios was introduced to Americans in 1941, when it was called Cheeri Oats, says the General Mills Web site.
The FDA launched its probe after a complaint from the National Consumers League, a Washington-based consumer group.
General Mills had made the cholesterol claims for more than two years and the health claims have helped the marketing of Cheerios, says the CEO to Bloomberg, adding that sales rose 13 percent in the third quarter which ended in February.
The company says the science is there, but how the information is presented will be discussed with the FDA. #