Published by the Institute of Medicine (IOM), the report also recommends that Congress should strengthen FDA authority in order to allow it to achieve these goals.
The report’s authors recommend that FDA adopt a consistent scientific process and framework for biomarker evaluation across all regulated areas, including drugs, medical devices, biologics, foods, and dietary supplements. This harmonization, they argue, is crucial to “consistently and transparently judge the appropriateness and validity of the scientific benchmarks used in studies that companies provide to support health and safety claims for their products”.
However, industry group Natural Products Association (NPA) says that the IOM committee have “veered off course” of their target in the report.
Foods carry risks too
According to the report, FDA should take into account all aspects of a food when evaluating the safety of health claims in order to ensure consumers are provided with all the information they need to make educated decisions about products. These include the source of a nutrient or food and any modifying effects of the food or supplement that serves as the delivery vehicle, as well as dietary patterns associated with consumption of the nutrient or food.
“Foods and drugs are regulated differently by the FDA. When the FDA reviews drugs, the safety and efficacy of the entire product is considered; however, when the agency considers foods, the safety of individual ingredients is evaluated rather than the food as a whole,” writes IOM.
“Despite the common perception that foods present fewer risks to consumers than drugs, in fact, food-based public health interventions—for example, supplementing milk with vitamin D and fortifying cereal with iron—may pose greater risks than many drugs because the reach of food is so vast. Even minor risks are significant when the majority of the population is exposed to them.”
The Natural Products Association said IOM’s work on the biomarkers is “of value”, but strongly disagreed with the report’s conclusions.
“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,” said the group.
“Despite the IOM committee’s views on the Dietary Supplement and Health Education Act, or DSHEA, the act has not ‘hobbled’ the FDA, but instead has actually provided the FDA with new enforcement authority over dietary supplements not previously available to the agency.”
The Grocery Manufacturers Association (GMA) took a more cautious and non-committal stance to the report, saying that it supports federal laws that require food labels to be a truthful, non-misleading characterization of the science, and should not overstate the findings.
“We welcome new science that aims to strengthen the evidence base. As the president has indicated, all regulatory action should be based in the very best science available,” it said.
On the other end of the spectrum, the outspoken consumer advocacy group Center for Science in the Public Interest (CSPI) backed IOM’s findings.
“Right now, FDA policies are riddled with loopholes that let companies make phony promises on weak scientific evidence,” it said.
”The IOM recommendations can be accomplished under current FDA authority. But if the FDA does not act, then Congress, as suggested by the IOM, should clarify the agency’s authority and mandate that the agency take action.”
Science is science
FDA had asked IOM to conduct this review back in 2008, when it was faced with hundreds of applications for review of food health claims based on stated effects on biomarkers. It requested IOM to study the evaluation process for biomarkers, focusing on biomarkers and surrogate endpoints in chronic disease.
The IOM committee proposed a three-part framework for FDA to assess the selections and use of biomarkers in both foods and drugs. This involves 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 states that Congress should grant the FDA authority to request studies and sufficient authority to act on the results of studies on consumer understanding of claims on foods and supplements.
“Few who are allergic to peanuts, eggs, or shellfish would argue that foods are less risky than drugs,” writes IOM. “The committee concludes that there is neither rationale nor scientific grounds for basing regulatory decisions on different levels of scientific evidence for different substances—science is science. In the interest of ensuring the public’s health, the proposed biomarker evaluation framework recognizes that scientific information is always evolving and yet allows for the introduction of new, life-saving health interventions.”
“Modern medicine depends on biomarkers. However, without improvements to the way biomarkers in general, and surrogate endpoints specifically, are used, health care practitioners, regulators, and consumers will not be able to collect or assess information about the foods they consume and drugs they use.”
The report, Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, can be accessed here.