Back in May, the FDA sent a warning letter to General Mills saying that its claim that with Cheerios “you can lower your cholesterol 4 percent in 6 weeks” classified the cereal as an unapproved drug. The FDA was concerned that the claim, which is printed on packs of Cheerios, goes beyond the FDA-approved soluble fiber heart health claim from 1997.
General Mills responded saying its percentage statement is permitted in accordance with the approved heart health claim. The FDA has not yet replied to this legal argument but did contact General Mills asking for evidence to support a revised health claim related to magnitude of effect.
General Mills submitted Cheerios specific studies backing up its claim in July. The FDA said in October that one of these studies “appears to provide data that soluble fiber from whole oats can lower LDL cholesterol by an average of 4 percent in 6 weeks.”
FDA request
But the FDA said this was not sufficient. To support a revised claim the agency said it would need to consider the totality of the publicly available evidence since the original claim was issued in 1997.
After conducted a review of the literature General Mills sent a letter to the FDA that was published on its website this week.
General Mills identified 10 studies that included oat products consistent with the FDA health claim, providing information on oat soluble fiber, and where the average net percentage reduction in total and LDL cholesterol was either provided or could be calculated.
Data strength
Commenting on the strength of the additional data, General Mills said: “Including the data available since 1997 provides further support that the results of the Cheerios studies are consistent with the scientific literature on the effects of soluble fiber on cholesterol levels reviewed by the FDA in approving the health claim, as well as the studies published since the 1997 final rule.”
General Mills will now have to wait for a response from the FDA regarding the submission of additional studies. The company is still waiting for a separate letter from the agency addressing its legal arguments and the revised sample labels proposed.
“Discussions with FDA continue, and we continue to look forward to reaching a resolution,” said General Mills in a statement.