The committee's job was to come up with a framework that the FDA could use to judge the appropriateness and validity of such claims. As Ball wrote in the report, "consumers wish to choose healthier diets, the food industry has an interest to market its products as healthy, and the FDA needs to minimize risks to the food supply and to inform consumers appropriately."
The first thing the FDA needs to do when faced with a health claim for a food product, Ball said, is to determine whether the particular biomarker that's being cited has anything to do with the disease about which the claim is being made. The next step would be to determine whether the product actually affects that biomarker.
If a manufacturer wants to say that its product is good for the heart because it lowers blood pressure, Ball explained, the first question would be whether blood pressure is a valid biomarker (which it is) and then whether it's a associated with the disease that the product claims to treat (which in this case it is).
After that, the FDA would have to determine if the claim is justifiable, he said.
"Are they making the claim that if you eat our food you'll prevent death?" Ball said. "That would be a different claim than if you eat our food there is a potential for reducing your blood pressure."
That can consume consumers, he said. People who look at just the front of the package see only the claim, but important data is in the nutritional panel on the box, he said.
Another problem, according to Ball, has been that for each of the areas FDA regulates -- food, food supplements, drugs and medical devices -- the scientific standard has been different. Food manufactures can make a claim for a health effect or for a decrease in risk as long as there is any degree of evidence, which is not the same standard required for a drug, he said.
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