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(www.nationalacademies.org) from the Institute of Medicine, or IOM.
Food and nutritional supplement marketers often make health claims based on how individual ingredients in their products affect biomarkers (i.e., 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 soluble 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. 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(www8.nationalacademies.org) 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.
The report also calls for Congress to strengthen the FDA's authority and increase its resources to regulate claims made by food and supplement manufacturers. In addition, it calls on Congress to boost the agency's authority to require postmarket surveillance of drugs and devices if the products' initial approval is based on studies that used putative surrogate clinical endpoints.