On May 5th, the Food and Drug Administration sent a warning letter to General Mills stating that cholesterol-lowering claims the manufacturer was making about Cheerios cereal committed “serious violations” of federal law. According to the agency, the message — that consumers could lower their cholesterol 4% by eating Cheerious regularly for six weeks — touted the prevention and treatment of a disease, meaning Cheerios should be classified as a drug, and an unapproved one at that.
This came as a surprise to General Mills. After all, the cholesterol claim referred to a specific study and had been featured prominently on boxes and the company's website for more than two years.
“The science is not in question,” the company stated at the time.
But this was an FDA under a new administration galvanized by a recent spate of foodborne illnesses and massive product recalls. Reprimanding a major manufacturer seemed to signal a new direction for an agency frequently criticized for being too lax.
“This is the strongest action taken by the FDA against misleading health claims for foods in almost a decade,” said Bruce Silverglade, legal affairs director for the Washington, D.C.-based Center for Science in the Public Interest.
The FDA, under new commissioner Margaret Hamburg, and the Obama administration have continued to take progressive steps. Earlier this year, the President announced the creation of a food safety working group that would bring together various agencies with the goal of preventing outbreaks as early as possible. In July, the FDA issued a final rule on the prevention of Salmonella Enteriditis in shelled eggs — a ruling that was first proposed in 2004. Later that month, the agency issued safety guidance for tomatoes, melons and leafy greens, putting growers and other groups throughout the supply chain on alert. And then in early August the FDA announced that it would speed up its system for issuing warning letters to companies violating safety regulations. The new system, which started September 15th, gives offending companies 15 days to respond to an inspection report before a warning letter is sent.
The FDA is limited, in many ways, by its current mandate, which has the agency regulating 25% of all consumer goods with a staff and a system that many believe is inadequate. For more sweeping action, the agency will have to wait for the legislators: A food safety bill aimed at enhancing the agency's oversight capabilities passed a House of Representatives vote in late July, and has moved on to the Senate.