FDA Offers Definition of Whole Grains


Until recently, the federal government had said very little about what constitutes a whole-grain food. That changed on February 17, when the Food and Drug Administration (FDA; Rockville, MD) issued a draft guidance document clarifying its views.


Whole-grain foods are one of the fastest-growing consumer product categories, with consumption of whole-grain bread rising by 18% since 2005, according to the Whole Grains Council (Boston). One key driver behind such sales has been last year’s release of the U. S. Department of Agriculture’s (Washington, DC) Dietary Guidelines for Americans, which recommend at least three servings of whole grains per day.

Until recently, the federal government had said very little about what constitutes a whole-grain food. That changed on February 17, when the Food and Drug Administration (FDA; Rockville, MD) issued a draft guidance document clarifying its views. “One of the most important decisions people can make about their health is the choice of foods they eat,” said Scott Gottlieb, MD, FDA’s deputy commissioner for medical and scientific affairs, on February 15. “A top priority at FDA is finding additional ways to clearly communicate the health benefits found in food.”


According to the guidance document, which is not legally binding, grains that contain an intact, ground, cracked, or flaked caryopsis (the bran, germ, and endosperm) may be considered whole grain if the main components of the caryopsis are present in the same proportions that exist in unprocessed grains.

Cereal grains such as barley, buckwheat, bulgur, corn, millet, rice, rye, oats, sorghum, and wheat may all be considered whole grains if they contain the caryopsis. For example, dehulled barley, which still contains the bran, germ, and endosperm, should be considered whole grain, but pearled barley, which lacks some of barley’s natural bran content, should not be considered whole grain.

The guidance document rules out legumes such as soybeans and chickpeas, as well as oilseed and root ingredients like sunflower seeds and arrowroot.


But the new guidance document also includes a word of caution about whole-grain labeling, warning that some common marketing practices may cause whole-grain products to be misbranded. Nutrient content–type claims may invite extra scrutiny.For example, statements like “contains 10 g of whole grains” or “100% whole grain” are acceptable on product labels, according to the guidance document, but statements like “an excellent source of whole grains” are not.

Labels may also bear health claims that link consumption of whole grains to a reduction in the risk of heart disease and certain cancers if the claims are based on authoritative statements by scientific bodies and meet the requirements of section 403(r)(3)(c) of the Food Modernization Act of 1997.


Although the guidance document has elucidated FDA’s views on whole grains, it has also created some uncertainty about permissible labeling practices. Organizations that advocate whole-grain consumption have greeted the new guidance document with qualified support.

Oldways (Boston), an organization formed to research and promote traditional food patterns, and the Whole Grains Council praised FDA’s efforts to encourage whole-grain consumption, but noted that the guidance document could create problems for the council’s Whole Grain Stamps program, which identifies foods as “good” or “excellent” sources of whole grains. The stamps currently appear on more than 600 whole-grain products.

“The Whole Grains Council and Oldways welcome this review,” says K. Dun Gifford, president of Oldways. “Consumer surveys are clear that consumers want to eat more whole grains but are bewildered by the clutter of whole-grains claims in advertisements and on packaging.” Gifford describes the stamps as simple descriptors that do not offer health claims.

“Consumers understand the health benefits of eating whole grains, and the buying trends of 2005 have proven this with broad increases across all categories,” Gifford adds. “For example, sales of whole grain pasta rose over 20%. It’s clear that people want to eat healthier, but are looking for help to reach their goals. That is the problem we are working to solve and why we created the Whole Grains Stamp.”

Cynthia Harriman, director of food and nutrition strategies for Oldways and the Whole Grains Council, notes that the stamp program reinforces FDA’s goals of creating uniform and consistent whole-grain terminology and helping consumers choose products consistent with the dietary guidelines.

“The Whole Grains Council and Oldways have followed these exact goals in developing and promoting the Whole Grain Stamps program, so we hope that any FDA reviews and final guidance will be carried out swiftly,” says Harriman.

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