An Institute of Medicine report recommending a framework for assessing biomarkers for food and supplement health claims could help the supplement industry because it "will set the stage for being able to validate more biomarkers," said Andrew Shao, senior VP of scientific and regulatory affairs with the Council for Responsible Nutrition.

FDA should apply the same standards for evaluating drug claims to health claims for supplements and food, according to IOM's May 12 report, "Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease."

"There are no scientific grounds for using different standards of evidence when evaluating the health benefits of food ingredients and drugs given that both can have significant impacts on the people's well-being," IOM said May 13 in a press release announcing the researchers' findings.

FDA contracted IOM to recommend a framework the agency can use when assessing the scientific biomarkers used in studies to support health and safety claims.

"FDA has been hampered in its ability to assess the proliferation of health claims being made by food and supplement manufacturers in part because it lacks a process broadly accepted across the regulatory, food and medical communities" to evaluate biomarkers, IOM said.

Shao commends the work in progress to establish the framework. "It's the starting point and we've got to start somewhere," he said.

He said there "were at least a handful of qualified health claim petitions that were outright rejected by FDA because the petitioners relied on studies that involved biomarkers but they weren't validated surrogate endpoints." FDA rejected the studies and did not review them.

"That's a big loss for the industry," he said, noting that for example, there is no health claim for the carotenoid lutein and its effect on macular degeneration. "Industry has really lost out on a lot because they're not able to use these studies to support a health claim," Shao pointed out.

The framework proposed by IOM's expert panel involves ensuring biomarkers can be measured adequately, that they are appropriate for their stated purpose and that they are linked to a clinical outcome.

The Natural Products Association said in a May 14 release if the framework is implemented, supplements and foods would be subject to the same "analytical validation, qualification and utilization analysis as pharmaceuticals and medical devices."

NPA pointed out May 14 the report was released "at a time where several major food manufacturers have come under scrutiny after putting unsubstantiated or incorrect health claims on their products."

John Robert Ball, executive VP of the American Society for Clinical Pathology in Chicago, chaired the committee.

"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," Ball said.

Panel Recommends New Authorities For FDA

The report also recommends Congress authorize the agency to conduct studies on consumers' knowledge of food and supplement health claims.

Further, the experts recommend Congress mandate that manufacturers make changes if more clarity is needed, and better communicate to consumers the science behind labeling claims.

"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," IOM observed.

The report says FDA needs the resources and authorities to take action when claims violate regulations or are the cause of confusion to consumers, pointing to a report Rep. Henry Waxman, D-Calif., issued, which suggested FDA's food and supplement claim enforcement declined by 50 percent from 2000 to 2004. However, IOM notes FDA recently has increased enforcement in the food labeling and supplement health claims areas.

The expert panel also said FDA "should take into account a nutrient's or food's source as well as any modifying effects of the food or supplement that serve as the delivery vehicle and the dietary patterns associated with consumption of the nutrient or food when reviewing health-related label claims and the safety of food and supplements." The expert panel suggested that Congress may need to "strengthen FDA authority" to do so.

Shao said the group strayed a bit from its charge. He added that FDA needs resources, but does not need new authorities.

Daniel Fabricant, VP of scientific and regulatory affairs for NPA, said that the report goes too far in discussing regulatory schemes, an area that was not part of its purview.

"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 the area of expertise nor within the committee's scope to review the regulatory authority of the agency beyond the viability of using biomarkers," NPA said in its release.

The report also discusses the supplement regulatory framework, saying the products are "widely presumed safe," yet FDA does not have the authority to require pre-market safety and efficacy approval.

"Because of the regulatory framework for dietary supplements, the FDA has little information about the safety and effectiveness of dietary supplements," the report states.

Fabricant argued the industry has its serious adverse event reporting requirements, which aim to provide the agency with supplement safety data. He called the report language "an attack."

However, a spokeswoman for IOM said that was not the report's intent. "Anyone who reads the report will find that it simply states what exactly [the Dietary Supplement Health and Education Act] says and makes no subjective comments about the law," said Christine Stencil, a media relations officer with IOM.

- Katie Stevenson ( ¹ k.stevenson@elsevier.com )

IOM Proposal Could Open Door For Biomarkers In Supplement Research

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