New report suggests ways for FDA to beef up its oversight,,,,
WEDNESDAY, May 12 (HealthDay News) -- U.S. consumers are being misled by the health claims made on the packaging of foods and supplements, according to a new report by the Institute of Medicine, because those claims do not undergo the same scientific rigor required for such claims on medications.
A box of cereal that proclaims the breakfast food will lower your cholesterol, for instance, has not had to pass the same government standards as the claims on the packaging of a cholesterol-lowering drug.
"There is evidence that things get on the market because the standard is lower," said Dr. John Ball, executive vice president of the American Society for Clinical Pathology and chairman of the committee that wrote the report, which was released Wednesday.
"Consumers probably assume that if the FDA said it's OK, it's OK," Ball said. "But in fact, the OK for drugs is a much higher OK than the OK for food supplements."
Faced with a barrage of health claims for foods, the FDA asked the committee to develop a way in which those claims could be better evaluated, Ball said.
Most health claims on food packaging, he said, are based on the supposed beneficial effects on biomarkers, which are a measure of a biological process, such as blood pressure or cholesterol. A cereal might be sold to consumers as being good for the heart when, in fact, that clinical outcome has not been tested.
Dr. Robert H. Sprinkle, an associate professor in the School of Public Policy at the University of Maryland, described food marketers' use of biomarkers in making health claims as "misappropriated" because "they may not mean much in the context in which they're cited."
For example, Sprinkle said, "our cereal does XYZ, and we want to say so ... and some experts think that's favorable, so we want to have you credit [it] with having that effect -- even though we don't really know if that effect is creditable here."
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.
"For food supplements, the standard is even lower," Ball said. "There is a presumption in favor of the supplement, and the FDA has to show that it's got a negative effect in order to be able to do anything about it."
"We are saying, 'You ought to have the same basic scientific standard for all the products,' " Ball said of the committee's report.
In addition, the FDA needs to do a better job tracking products once they are on the market, he said. "One of the things we did find [was that] even in post-marketing surveillance, where companies agreed to come forward with information, only about 10 percent of those agreements have been fully followed up," he said.
The bottom line for Ball is that the FDA needs more authority to regulate health claims being made -- a change that would require Congress to change the laws under which the agency operates.
As Sprinkle said: "A lot of what you see driving this report is revealed where the IOM says that Congress should give the FDA more authority and more money. But that recommendation is sure to be opposed vigorously, but, of course, quietly."
"So is this all about biomarkers?" he asked. "Well, yes and no."
The U.S. Food and Drug Administration has more on nutrition labeling on foods.
SOURCES: John Ball, M.D., executive vice president, American Society for Clinical Pathology, Chicago; Robert H. Sprinkle, M.D., Ph.D., associate professor, School of Public Policy, University of Maryland, College Park; May 12, 2010, report, Institute of Medicine, Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
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