IOM: Improved Framework Needed For FDA Oversight of Drugs, Devices, Foods

Despite the common perception that foods present fewer risks to consumers than drugs, food based public health interventions—for example, supplementing milk with vitamin D and fortifying cereal with iron—may pose greater risks than many drugs because the reach of food is so vast. Even minor risks are significant when the majority of the population is exposed to them, the committee said.

FDA has been hampered in its ability to assess the number of health claims being made by food and supplement manufacturers in part because it lacks a process broadly accepted across the regulatory, food, and medical communities to evaluate biomarkers as valid and appropriate measurements to substitute for clinical outcomes, the report noted.

"Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medications, and this committee thinks that should in fact be the case," said committee chair John Ball, who is executive vice president of the American Society for Clinical Pathology, Chicago.