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By Dave Fusaro, Editor-in-Chief | 05/29/2009
What are they, on drugs? There’s a pun in there, which you’ll get in a few lines.
May saw an interesting battle -- probably just the first shot, really – of a “new” FDA administration starting to flex its muscles and improve its stature as a guardian of the people’s safety, not a friend of industry.
And while the agency’s first victim is not without blame, the attack on General Mills Inc. isn’t entirely justified … although Big G does help to define “gone too far.”
The FDA sent a warning letter to General Mills on May 5 calling Cheerios an “unapproved new drug” because of its claims that it can lower cholesterol and otherwise contribute to heart health.
Wait, maybe I’m confused. Perhaps it was the FDA alleging the food industry is not doing enough for palliative health. No, that was 2007. In 2009, the food industry is going too far.
“Too far” apparently arrved when a new Cheerios package arrived in April boasting the cereal can lower your cholesterol by 10 percent in one month. That’s a substantially greater claim than the one used for much of 2008, that Cheerios can “lower your cholesterol 4% in six weeks.”
The 10 percent claim was based on brand-new research by Provident Clinical Research, presented April 20 at the Experimental Biology Meeting, which found Cheerios can help lower cholesterol by 10 percent in one month.
Actually, the FDA complaint only cites the “4% in six weeks” claim, a message the FDA has been scrutinizing for a while, people in the industry tell me, although the 10 percent claim pushed the regulators over the edge. The FDA’s letter says:
“These claims indicate that Cheerios is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios is intended for use in the treatment, mitigation, and prevention of coronary heart disease through lowering total and ‘bad’ (LDL) cholesterol … Because of these intended uses, the product is a drug [according to one section of the Code of Federal Regulations] also a new drug [under a different section] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore, under section 505(a) … it may not be legally marketed with the above claims in the United States without an approved new drug application.”
This Cheerios issue comes a month after the Federal Trade Commission complained Kellogg Co.’s national TV ads exaggerated claims that eating Frosted Mini-Wheats can improve children’s attentiveness in school by 20 percent. There was some proof to the claim, but only about half the children in the study showed any improved attentiveness, only 11 percent improved by 20 percent and all those measures were against children who ate no breakfast.
Kellogg agreed to stop marketing Frosted Mini-Wheats in those terms.
Attorney Leslie Krasny, a partner in the San Francisco office of Keller & Heckman, says the FDA complaint was more concerned with the location and prominence of the label statements made as part of the Cheerios health claims, plus incomplete health claim language used on the cereal’s web site. “But it’s a sign of a more aggressive FDA,” she adds.
Aggressive is good, especially when poor manufacturing practices can produce deadly peanut products or questionable imports from China. And these two cereal companies may have pushed the envelopes a bit. But this bolder, “new” FDA needs to keep some perspective. This country’s main food goals should be food safety first and a healthier populace second, two areas in which General Mills and Kellogg are leaders. Exaggerated marketing claims should be way down the list.