The US Food and Drug Administration has written a warning letter to General Mills, the makers of the popular breakfast cereal Cheerios, explaining that they have reviewed the labelling of the product and found it contains “serious violations” of federal regulations.

The details of the FDA findings are in a letter dated May 5th, from W Charles Becoat, FDA Director for the Minneapolis District, to Ken Powell, Chairman and CEO of Minneapolis-based General Mills, who make Cheerios.

According to the FDA, General Mills is breaking federal regulations on two counts: they are marketing Cheerios like an “unapproved new drug” and misbranding the product by making “unauthorized health claims”.

The FDA letter to the food company states:

“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).”

The FDA said that the Cheerios product label promotes it like a drug intended for use in the “prevention, mitigation, and treatment of disease”. The letter drew particular attention to phrases that say the product lowers cholesterol by “4 per cent in 6 weeks”, that it can also reduce bad cholesterol by 4 per cent, and that it is “clinical proven” to lower cholesterol.

The letter does not address the veracity of the claims, it addresses the point that by making such claims then the product is really a drug and should go through the proper channels for obtaining drug approval.

For example, as the letter explains, the claims indicate that Cheerios is:

“Intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia.”

And by claiming that the product lowers total and bad cholesterol, then it is also claiming to treat heart disease, for which total and bad (LDL) cholesterol are known risk factors. This is what puts the product in the “new drug” category, and the letter quotes several sections of “the Act” to support their case.

The FDA said another reason that the product is considered to be a “new drug” was because under another section of “the Act”, it is “not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease“.

The letter acknowledged that General Mills had observed regulations correctly in respect of a health claim associating “soluble fiber from whole grain oats with a reduced risk of coronary heart disease”, but the two claims about lowering cholesterol are not part of that, and goes into great detail about the positioning on the packet label and how the words are shown to make its case.

The FDA said that even if the cholesterol-lowering claim could be argued to be part of an otherwise permissible claim, the wording disqualifies it from use in the soluble fiber health claim.

On the issue of misbranding, the FDA said that Cheerios bears “unauthorized health claims in its labeling” and cites text on the company’s website, which under the Act is considered to be part of the product labelling, as being faulty in this respect. The text says “heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease.”

According to the FDA, the claim does not meet the requirements of the Act which requires such assertions to state that “diets low in saturated fat and cholesterol and high in fiber-containing fruit, vegetable, and grain products may reduce the risk of heart disease”. The Cheerios labelling neither mentions fruits, vegetables and fiber, nor the need for the diet to be low in saturated fat and cholesterol.

Thus the label does not have enough information to “enable the public to understand the significance of the claim in the context of the total daily diet,” said the FDA letter.

The letter also refers to another labelling claim about reduction in cancer risk.

The FDA said the claim, which includes the statement “regular consumption of whole grains as part of, a low-fat diet reduces the risk for some cancers, especially cancers of the stomach and colon”, fails to meet the authorized format because, for example, like the other claim, it does not mention fruits and vegetables and fiber content and again denies the public the chance to see the overall context of the healthy diet.

The agency also takes issue with the added phrase “especially cancers of the stomach and colon” which goes beyond what an authorized claim is allowed to say. As the FDA letter explains:

“The claim authorized through the notification procedure does not emphasize the relationship between whole grain foods and stomach and colon cancer as compared to other cancers.”

General Mills has 15 days to reply with an explanation of how they intend to “correct the violations” and to ensure that “similar violations do not occur”.

Source: FDA warning letter, May 5.

Written by: Catharine Paddock, PhD