They call it the Food and Drug Administration. So you might think the safety of food and drugs are tested to the same degree before they're allowed to go on the market.
They call it the Food and Drug Administration. So you might think the safety of food and drugs are tested to the same degree before they're allowed to go on the market. In fact, that's not the way it works. But perhaps it should, says Dr. John Ball, executive vice president or the American Society for Clinical Pathology in Chicago.
Ball chaired a committee organized by the Institute of Medicine that was asked to come up with a way to vet some of the biomarkers that are routinely used in safety studies. (For instance, do higher levels of "bad" cholesterol really translate into an increased risk of heart disease?)
But as the committee members contemplated a box of Cheerios, they started to consider a larger question: Was it okay for the box to tell consumers "You could lower your cholesterol 4 percent in 6 weeks"? And that led to an even bigger question: Is there any reason to hold health claims for foods and dietary supplements to a lesser standard than health claims made for drugs?
Their answer: No way. As Ball wrote in the preface to the committee's report, which was released last week: "There is neither rationale nor scientific basis for predicating regulatory decisions on different levels of scientific evidence for different substances: "science is science." That is, the same level of scientific evidence of benefit and risk should be required of foods as of drugs."
As for the notion that drugs should be subjected to extra scrutiny because they are inherently riskier than foods, the committee didn't buy it.
"Foods are encountered by a greater population than the target group who encounter drugs, and though drugs are subject to professional mediation (e.g., prescription and counseling), foods are not. As for risk, no one who is allergic to peanuts, eggs, or shellfish would argue that foods are less risky than drugs."
The report asks Congress to expand the FDA's authority to police unwarranted and untested claims made by food and supplement makers. You can read a summary of the committee's report on the Institute of Medicine Web site: www.iom.edu/Reports/2010/Evaluation-of-Biomarkers-and-Surrogate- Endpoints-in-Chronic-Disease.aspx.