Science Board Recommendations Exceed CFSAN's Capabilities - Acheson

FDA's Center for Food Safety and Applied Nutrition is not prepared to do some of the consumer research the agency's Science Board recommends, says David Acheson, the agency's former food chief.

A Science Board subcommittee issued a ¹ report Aug. 11 that evaluates CFSAN's research and support programs and how well the center's work aligns with its regulatory responsibilities. The report recommends CFSAN expand its consumer research related to dietary supplements and other nutritional areas.

The subcommittee found research on labeling of supplements with nutrients that do not contain current daily recommended intake levels appears to be "neglected and/or not given high priority." Other neglected areas include consumer research on obesity and front-of-pack nutrition labeling.

"If regulatory measures are to have their intended consequences, it is important to study consumer views, both proactively and reactively," the report adds.

Acheson, a food safety consultant and FDA's former associate commissioner for foods, said "there's no significant infrastructure at FDA for doing that kind of work." But he acknowledged insights into consumer nutritional behavior are essential to understanding and changing it.

With a paucity of social scientists in CFSAN and other centers, FDA may not be the most suitable agency for conducting such research, said Acheson, now managing director of food and import safety with Leavitt Partners consultancy.

"It's a need, but does it make sense to create lots of little units doing work within a center that doesn't have enough money to do what it needs to do?" he said in an interview.

Coordinating with the National Institutes of Health, when appropriate, and other government entities might make more sense for FDA, Acheson added.

FDA is in the midst of developing a draft guidance on front-of-pack food labeling requirements following the failure of an industry labeling program and an agency enforcement sweep of food firms with violative labeling (² (Also see "FDA's Flurry Of Food Claim Warnings Sends Bold Enforcement Message" - Pink Sheet, 8 Mar, 2010.)).

The subcommittee also specifies a need for research into consumer and industry interest in folic acid fortification of cornmeal and corn flour. It notes the Centers for Disease Control and Prevention has shown interest in the fortification of those ingredients.

"Such a proposal raises many technical questions about the technology of fortification of such products," as well as about the effects on consumer folate intakes, according to the report.

Outside Options For Research

Subcommittee member Christine Bruhn, who researches consumer behavior regarding food safety, said the report's holistic view toward FDA and CFSAN responsibilities made it necessary to recommend enhanced consumer research.

The agency frequently is hamstrung as it awaits sign-offs by the Office of Management and Budget, which sometimes takes a year or more to approve research proposals, acknowledged Bruhn, a faculty member at the University of California, Davis.

Bruhn agreed with Acheson's suggestion that academic institutions could be corralled into performing consumer research more quickly and efficiently through CFSAN grants. She pointed out the report does not preclude that option.

"We did not look at the exact mechanism for getting this done, we just said the work needs to be done," Bruhn said. "And we do believe that the agency needs additional resources to accomplish its goals."

Prying Open CFSAN

Other Science Board recommendations likewise appear to depend on an influx of resources and tend toward opening CFSAN to more transparency and collaboration with industry.

For one, the center should be more transparent with its review of health claims. Because CFSAN often does not publish its research on health claims in scientific literature, stakeholders are left with incomplete information, according to the report.

"Guidance for development of health claims is of interest not only to industry but to food and nutrition scientists and others with a stake in the regulated products," the report says, adding there should be resources supporting submission and publication of such research.

The subcommittee emphasizes CFSAN generally must engage more in applied science relevant to industry.

"A thrust toward 'cutting-edge' science is laudable but ... CFSAN must provide the anticipatory, fundamental and applied regulatory research that is integral to its mission," according to the report.

At an Aug. 16 Science Board meeting in Bethesda, Md., subcommittee member John Floros said CFSAN's food science activities often appear to take place as if in a regulatory vacuum.

"What we saw in CFSAN is a lot of very good basic, bench-type research, but not very much extension of that basic research to regulations and understanding of how industry works with a hands-on approach to things," said Floros, head of Pennsylvania State University's Department of Food Science.

CFSAN acting Director Michael Landa said at the meeting the center plans to continue reviewing the recommendations and will respond to subcommittee members.

FDA's acting chief scientist, Jesse Goodman, acknowledged FDA's resource shortages are especially acute in the food center and there is limited outside food research suitable for CFSAN to leverage.

"I think even if you can't do everything, thinking about where you can have the most impact is important," Goodman said. "I think we just have to move forward and strengthen science at the FDA in general and try to bring that to CFSAN as well."

Congressional appropriators are recommending a fiscal 2011 budget of $261.5 million for CFSAN - an increase of $2.5 million from the current budget and on par with President Obama's request. However, in the event Congress passes a continuing resolution to keep the federal government operating past the end of fiscal 2010 on Sept. 30, CFSAN and other FDA units would continue temporarily under their current funding levels (³ (Also see "FDA Funding Not Set As Chances Grow For Omnibus Or Continuing Resolution" - Pink Sheet, 26 Jul, 2010.)).

- Dan Schiff ( ⁴ [email protected] )