Consumers must demand more from the FDA

Peter Pitts Contributor
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A new report by the Institute of Medicine and the National Research Council says the U.S. Food and Drug Administration isn’t able to deal with the nation’s food supply problems. Scientists from the two groups called on Congress to grant the FDA more authority to prevent food-borne illnesses rather than simply react to them.

The report offers Congress — the commissioner of the report — some food for thought as it prepares to tackle FDA reform this year. The IOM concludes that in order for the FDA to better ensure food safety, legislative and organizational changes may be necessary. Most notably, it says, Congress should consider taking legislative action to provide the FDA with the additional authority it needs to fulfill its food safety mission. Within the
FDA, authority over field activities should shift from its Office of Regulatory Affairs to its Office of Foods. Such a change will ensure that responsibility lies with well-trained personnel with specialized expertise in food safety and risk-based principles of food safety management, says the IOM.

Thus far, government efforts to promote better food safety have been made with expanded recall powers and more numerous inspections. But more needs to be done.

American’s health also depends on having better information about the food they’re eating — particularly in today’s era of genetically modified foods with nutritional nanotechnology, probiotics, and other functions. Reformers must recognize this new reality and ensure that the FDA reform capitalizes on using food as a potent tool for better health.

Back in July 2003, the FDA-issued Task Force on Consumer Health Information for Better Nutrition Initiative report, of which I was a member, concluded that government efforts to fight poor nutrition – and the conditions and diseases like obesity and hypertension that go along with it – would be doomed unless the agency provided consumers with better information about their food.

“A better-informed public, supported by effective, science-based regulation of health information, would be expected to make better nutritional choices,” the 2003 report said.

The statement remains a sound hypothesis and a noble mission, but, unfortunately, the road to better health through better nutrition remains paved only with good intentions.

This needs to change.

Most lawmakers seem to think that shuffling the responsibilities of government agencies charged with regulating public health is the answer. Present FDA reform efforts have fallen prey to this brand of thinking. For instance, the recent Institute of Medicine/National Research Council report called for the creation of a new “single food agency” as the cure-all for the FDA’s food problems.

The debate over a single food agency simply distracts reformers from changes that could improve Americans’ health; like improved dissemination of nutritional information.

In 1990, Congress passed the Nutrition Labeling and Education Act (NLEA), which established the FDA-regulated Nutrition Facts Panel in order “to assist consumers with healthy dietary practices.” While reading food labels has become a routine aspect of every trip to the grocery store, the FDA has done little to advance the equally important educational component of the law.

The future of nutrition and diet/disease relationships is evolving very rapidly. Science is exploring opportunities for improving the health consequences of nutrition that range from a better understanding of the impact of general dietary patterns for the U.S. population as a whole to the specific understanding of how an individual’s genetic makeup interacts with food and the environment — “nutritional metabolomics” — increasing the ability to “design” foods and diets for individuals to maximize health.

As part of the NLEA, Congress gave FDA the option of establishing a different standard for health claims for dietary supplements labels as compared with that which Congress had provided for conventional foods. FDA determined that the best course of action was to use the same standard for both dietary supplements and conventional foods. This decision was motivated by public health considerations: All consumers eat conventional foods and most use dietary supplements; inconsistent standards would lead to consumer confusion and biased consumption choices. So, current regulations for health claims apply equally to dietary supplements and conventional foods.

In setting the rules for health claims, Congress provided for FDA to authorize health claims when the agency determined, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement (SSA), among experts qualified by scientific training and experience to evaluate such claims that the claim is supported by such evidence. Under existing regulations, health claims are put in place through a petition process by which FDA reviews the science in support of and against the claim, and determines whether to authorize the claim through notice-and-comment rulemaking.

The FDA has the authority but has chosen not to use it, instead falling back on the old excuse of “more data required.”  Do we really need more data to tell us the benefits of fruits and vegetables, tree nuts and fish oil?

Making foods “safer” is important and the IOM’s recommendations should be heeded, but delay in communicating about the health benefits of foods is a real disservice to public health. Lawmakers are rightly concerned about the FDA’s ability to ensure the safety of the nation’s food supply. But a safe food supply means little if consumers lack appropriate information on the food they’re eating. Reformers should act accordingly.

Peter Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.