Until now, the Food and Drug Administration has enforced a very strict standard about what health benefits could be claimed on food labels. Before oatmeal could boast heart-healthy labels, for example, there had to be significant scientific consensus that oatmeal's fiber helps maintain low cholesterol levels.
Under the new program, to start Sept. 1, the FDA will allow certain foods to make "qualified health claims" — similar to what the courts have allowed for more loosely regulated dietary supplements.
Food makers will have to seek FDA approval first, and the FDA will respond by grading each potential claim: A for scientifically proven claims; B where the science is good but not conclusive; C when there's limited science to support a claim; and D when there's hardly any.
A-rated claims — such as "calcium prevents bone-weakening osteoporosis" — are the kind already permitted, and won't change.
Claims rated a "B," "C," or "D" would be considered qualified, and for the first time could be put on a food label right next to a short disclaimer that describes how much proof there is — or isn't.
"Americans shouldn't need a science degree to figure out how foods can fit into a healthy diet," said FDA Commissioner Mark McClellan, who said consumers already are bombarded with nutrition information that the claims rankings will help them sort out. "Information should be accurate, honest and easy to understand."
At the top of FDA's list to consider are claims that: eating several servings a week of salmon and certain other fish rich in omega-3 fatty acids may reduce the risk of heart disease, and that products made with vegetable oils are more heart-healthy than those made with solid fats.
It's advice often given by health groups, but that until now hadn't passed FDA scrutiny.
A congressman influential in passing a decade-old law that governs food labeling said the FDA is essentially violating that law — and will hurt consumers who trust provisional claims that later research discredits.
"FDA's decision is going to permit virtually unsupported health claims on foods," said Rep. Henry Waxman, D-Calif. "When consumers see a claim on a product and later learn it was a false claim, they're going to decide perhaps none of the labels on those food products mean anything."
At best, it means wishy-washy health advice will suddenly appear on foods, confusing consumers, said Bruce Silverglade of the consumer advocacy group Center for Science in the Public Interest, which is talking with Waxman about a possible legal challenge.
"This action represents the biggest rollback in food-labeling standards in 20 years," said Silverglade.
Why even allow low-rated claims?
Recent court rulings suggest FDA would be hard-pressed to continue limiting them when more loosely regulated dietary supplements often make more far-reaching claims about health effects, says the Grocery Manufacturers of America.
But the influential Consumer Federation of America said that court pressure is real, and that FDA crafted a program in response that appears to safeguard against abuse.
The budget-stretched FDA promised to give priority to claims expected to win a good B-rating, like the omega-3 heart benefit.
Other examples — some controversial — the food industry expects to seek: That the antioxidant lycopene, rich in cooked tomato products, can prevent prostate cancer; that low-fat dairy products lower blood pressure; that fiber prevents colon cancer; that compounds in grapes are heart-healthy.
McClellan thinks few manufacturers would bother advertising low-rated claims, instead doing better research or making a product healthier. "You'd have to do a lot better than a 'C' to attract consumers to your product," he said.