IOM CALLS FOR GREATER RIGOUR IN ASSESSMENT OF HEALTH CLAIMS

The US Institute of Medicine (IOM) has issued a report, sponsored by the US Food and Drug Administration (FDA), in which it recommends that the FDA should apply the same rigor to evaluating the science behind claims about the health benefits of foods and nutritional supplements as it devotes to assessing medicines and medical technology approvals. The IOM proposes that FDA use a three-stage framework which entails 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.It is noted that FDA needs the resources and authority to act on claims when they are found to cause confusion or to exceed regulatory limits - and that while FDA enforcement declined by 50% in the years 2000 - 2005, recent actions indicate that FDA is now engaging in heightened enforcement of food labelling, including health claims. Industry reaction to the IOM report has been mixed.   To quote the US Natural Products Association: "The IOM committee seems to have veered off course of their target. While the work on the biomarkers is of value, it seems unwise for the committee to present such broad statements regarding regulatory authority of the FDA on food claims, which is neither their area of expertise nor within the committee's scope to review the regulatory authority of the agency beyond the viability of using biomarkers."
(Source: IADSA Newsflash)