Heightened Scrutiny of Food & Supplement Health Claims

Health claims made by food and nutritional supplement manufacturers should face the same level of regulatory scrutiny as those made by drug and medical device manufacturers, says a new report from the Institute of Medicine (IOM).

Food and nutritional supplement marketers often make health claims based on how individual ingredients in their products affect biomarkers (physiological characteristics that can be measured and evaluated objectively) such as cholesterol or glucose levels or tumor size. Thus, the manufacturer of a breakfast cereal that contains a cholesterol-lowering ingredient, such as fiber, might boast that its cereal has heart health benefits without clinical proof of improved outcomes.

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.

Commenting on the report, IOM member Harlan Krumholz, MD said, “This is a groundbreaking report that tells us we should really think carefully about the use of biomarkers and surrogates.”

SRxA’s Word on Health is pleased to hear that the food we eat will be given as much attention as the drugs we take, but hopes that the process can be somewhat faster!

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