Review of health claim standards recommended
by Keith Nunes
WASHINGTON — A new report issued by the Institute of Medicine said there are no scientific grounds for the Food and Drug Administration to use different standards of evidence when evaluating the health benefits of food ingredients and drugs. The I.O.M. recommended a new framework the agency may use to judge the appropriateness and validity of the scientific benchmarks used in studies that companies provide to support health and safety claims for their products.
The I.O.M. said the F.D.A. has been slowed in its ability to assess the proliferation of health claims being made by food and supplement manufacturers because it lacks a process accepted across the regulatory, food, and medical communities to evaluate biomarkers as valid measurements to substitute for clinical outcomes. As an example, the report said blood level of harmful cholesterol is often used as a biomarker for the risk of heart disease, and food companies make claims about the heart health benefits of their products based on their ability to lower cholesterol levels, even if the products have not been shown to actually decrease heart disease.
The committee is proposing a framework it said will give the F.D.A. a way to assess the selection and use of biomarkers across the food, device and drug areas. The proposed framework includes validating that a biomarker may be accurately measured, ensuring that it is associated with the clinical outcome of concern, and confirming that it is appropriate for the proposed use.
“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 John Ball, chair of the committee that wrote the I.O.M. report and executive vice-president of the American Society for Clinical Pathology, Chicago. “Without changes in the way biomarkers are used and assessed, however, health care providers, regulators, and consumers will not be able to reliably collect or judge information to support claims.”
The report also said Congress should enhance the F.D.A.’s ability to study how health-related information may be communicated more effectively to consumers to help them better understand the science behind claims they see on packaging. The typical consumer is not aware that claims for food ingredients and supplements are often made based on studies using biomarkers instead of actual health outcomes, and that this introduces a measure of uncertainty, according to the I.O.M.