FDA Proposal Would Allow Health Claim on Oat Products


Remember the rise and fall of oat bran?

Well, get ready for the second coming.

A government proposal, published last week, would allow food manufacturers to use health claims on product labels stating that diets high in oat bran and oatmeal "may reduce the risk of heart disease."

Quaker Oats Co. petitioned the U.S. Food and Drug Administration last March for approval to use the heart disease claim on products containing sizable portions of oats.

Health claims on food products were authorized by the 1990 passage of the Nutrition Labeling and Education Act. Since 1993, FDA has approved eight such statements after extensive review of substantiating scientific literature.

The previously approved health claims involve general regimens such as diets rich in fruit and vegetables, which may reduce the risk of some cancers. The proposed oat bran claim would be the first that associates a single food with health properties.

Oat bran rocketed to popularity in 1984 with the publication of several studies indicating that it played a role in lowering cholesterol levels. The studies were widely publicized and culminated in a best-selling book titled "The Eight Week Cholesterol Cure." Sales of oat bran, oatmeal and foods containing oats, whether or not nutritious, soared. The grain's popularity prompted several analysts to proclaim that oat bran was the major food trend of the 1980s.

The party ended abruptly in January 1990 with the publication of a controversial research study that seemed to indicate that an overall low-fat diet, and not oat bran alone, was responsible for cholesterol reductions. Subsequent studies have borne out that oat bran and oatmeal do have cholesterol-lowering properties and, when consumed regularly, could reduce an individual's risk of cardiovascular heart disease. The FDA, after 10 months of scientific review, concurred.

"FDA tentatively concludes that . . . there is significant scientific agreement to support the relationship between consumption of oat bran or oatmeal . . . and the risk of cardiovascular heart disease," according to the FDA proposal published in the Federal Register.

However, FDA also proposes that products carrying such a health claim must also provide more detailed language elsewhere on the product label stating that the effect of oatmeal or oat bran on heart disease is particularly evident "when these foods are consumed as part of a diet that is low in saturated fat and cholesterol."

"Oat bran and oatmeal are not magic bullets," the agency's proposal stated. "Diet is only one factor that influences whether a person will get a disease." The statement that heart disease, for instance, "depends on many factors" will be optional for those using the oat bran claims if the proposal becomes law.

Chicago-based Quaker Oats and other grain manufacturers hope the health claims will restart the oat bran-band wagon.

This time, however, there will be strict requirements for products to qualify for the oat bran-heart disease statement. An individual serving, for instance, would have to contain 20 grams of oatmeal and 1 gram of beta glucan soluble fiber, the active ingredient in inducing the cholesterol reductions. Steven L. Ink, Quaker Oats director of nutrition research, says the minimum requirement would be equivalent to one-third of a cup of dry or uncooked oatmeal.

"All [qualifying] products must be low in total fat and saturated fat as well. They will truly deliver a health benefit. Something with just a sprinkling of oat bran on it will not qualify [under the FDA's proposal]," Ink says. "We've been in the oatmeal business for over 100 years and don't benefit from a craze. We do benefit when solid nutrition information is provided on labels that consumers can bank on.

The FDA is accepting public comment on its oat bran and heart disease claim proposal until April 3. A final regulation will be issued later in the year.

Copyright © 2019, Los Angeles Times
EDITION: California | U.S. & World