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IOM Calls for Heightened Scrutiny of Food, Supplement Health Claims
Report Recommends Increased Authority, Resources for FDA
By News Staff
Faced with a proliferation of health claims being made by food and supplement manufacturers, the FDA's Center for Food Safety and Applied Nutrition asked the IOM in 2008 to recommend a framework for the evaluation of biomarkers. The IOM responded with a 267-page report that recommends the FDA apply the same rigor to evaluating the science behind the health claims of foods and nutritional supplements as it does to assessing new drug applications.
John Ball, M.D., chair of the IOM committee that produced the report and EVP of the American Society for Clinical Pathology, said in a news release that many consumers assume that the claims made by food and supplement marketers have the same degree of scientific backing as those for medications, but that is not the case. Without changes in the way biomarkers are used and assessed, he said, health care providers, regulators and consumers can't reliably collect or judge information about such claims.
In a preface to the report, Ball said there is neither rationale nor scientific basis for predicating regulatory decisions on different levels of scientific evidence for different substances.
"Science is science," he wrote. "That is, the same level of scientific evidence of benefit and risk should be required of foods as of drugs. 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 IOM's proposed biomarker evaluation process consists of three steps:
- validating that a biomarker can be accurately measured,
- ensuring that it is associated with the clinical outcome of concern and
- confirming that it is appropriate for the proposed use.
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Institute of Medicine: "Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease"
(May 12, 2010)