News reports about adulterated drugs seem to have been replaced by stories of contaminated food products. Cases of salmonella related to products that contain peanuts and pistachios are the latest examples. The US Food and Drug Administration has been blamed for failing to protect consumers, and commentators have cited outdated policies, inadequate staffing, and insufficient funds.
In February 2009, Rep. Rosa DeLauro (D-CT) proposed creating a separate Food Safety Administration to improve oversight of food products sold in the United States. But a recent FDA Warning Letter suggests that drawing a line between food and drug products might not be so simple.
On May 5, 2009, FDA advised General Mills that its Cheerios toasted whole-grain oat cereal was, in fact, an unapproved new drug. The Cheerios label contains claims such as “you can lower your cholesterol 4% in 6 weeks” that indicate that the cereal is intended to treat hypercholesterolemia and coronary heart disease. Although FDA set guidelines for health claims that link soluble fiber from whole grain oats with a reduced risk of coronary heart disease, the Cheerios label runs afoul of the guidelines because, among other things, it attributes a degree of risk reduction to the cereal. It seems that General Mills must either change its label or submit a new drug application.
At first, splitting FDA into two agencies that regulate food and drugs separately seems like a plausible idea, but the Cheerios incident shows that the line between the products can be fuzzy. Reorganizing FDA might be unnecessary anyway. I think that the food- and drug-safety initiatives that the agency described in its budget request (e.g., increasing the number of field tests of imported drugs) ought to be given a chance to succeed. And Senator Grassley’s (R-IA) Drug and Device Accountability Act of 2009, which would strengthen FDA by giving it more power and funds, would likely go a long way toward protecting consumers.