FDA misfires with Cheerios warning

The Food and Drug Administration has set its sights on Cheerios' claim that it can lower cholesterol in four to six weeks.

The Food and Drug Administration has set its sights on Cheerios' claim that it can lower cholesterol in four to six weeks. The government agency sent General Mills a warning letter this week that suggested the cereal maker should apply for a drug application if it wants to use such a claim, which the regulator asserted could only be made for drugs.

As usual, it seems as if the FDA is a little late in its reaction. The packaging on the Cheerios box making this claim is probably familiar to a number of Americans. That's because it has been in place for two years, according to General Mills. With all of the issues facing the undoubtedly understaffed and underfunded agency, it seems a cholesterol claim by a whole-grain cereal should be at the bottom of its list. Certainly the FDA shouldn't neglect its duties in holding marketers accountable, but this dispute could have been handled differently. For one thing, it appears to come out of the blue after two years of being very visible – on packaging sitting at the breakfast table.

A warning letter, one of the agency's strongest notification tactics, not only has the potential to confuse the public, but it also pits the agency against one of America's oldest and likely most-trusted brands. This is not a good place for the FDA to be, given its struggle to regain the trust of a public literally sickened after years of product recalls that have affected staples of American life, including pet food, salads, and peanut butter.

Instead of its public statement that it “found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act),” the agency should have told General Mills two years ago that it didn't like its marketing claims, and it ought to change them or risk serious action. Or, it could have put food makers on notice that it would be looking at claims that appear to cross the line toward “drug claims,” and give them a deadline to ensure they are in compliance.

President Obama has promised to provide an additional $300 million in funding to the FDA, and his selection for the top post at the government agency, Margaret Hamburg, has publicly vowed to restore the public's broken trust with the FDA. But the agency's continued bungling of its watchdog duties will do nothing to reassure the public.

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