Dr Barbara Schneeman, PhD, director of the FDA's Office of Nutritional Products, Labeling and Dietary Supplements said during a press briefing yesterday that the guidance is intended to be consistent with the message of the Dietary Guidelines for Americans, published last year. These included the advice that Americans should consume upwards of three ounce-equivalents of whole grain products per day, although the precise recommendations vary with age, gender and lifestyle factors. At least half the grains consumed should be whole grains.
The FDA's document, available http://www.fda.gov/guidance online, gives definitions for what the agency understands to be whole grains - that is, cereal grains consisting of the intact, ground, cracked or flaked fruit of the grains whose starchy endosperm, germ and bran are present in the same relative proportions as in the intact grain.
When some of the bran and germ is removed during processing, this may result in a loss of fiber, vitamins and minerals.
Soybeans and seeds are specifically excluded from the whole grain definitions.
The definitions are intended to help manufacturers understand what the FDA considers appropriate for food labels making whole grain statements, and for consumers to have consistent guidance on what whole grain entails.
Schneeman said that the guidelines - which are in draft form - were drawn up taking into account definitions of whole grains from scientific literature and trade groups.
"We think of them as reflecting the current scientific position on the definition of whole grains," she said.
The FDA is open for comments and suggestions on the draft for the next 60 days.
One major point, however, is that the guidance supports manufactures making quantitive statements about the amount of whole grains in their products - such as '100 percent whole grain' or '10 grams of whole grains' - so long as such statements are not false or misleading, but that they should not imply that a particular level, such as 'excellent' or a 'good' source.
In fact, there are already more than 400 products on the market that make these claims, following the issue last January of stickers from the Whole Grain Council.
Some products are also making 'good' or 'excellent' source claims without the use of the labels.
Schneeman declined to make a definitive comment as to whether the manufacturers of these products would have to redesign their packaging and, if so when. Rather, she said that the FDA would have to do a case-by-case analysis of such claims.
"The goal is to help the industry give information that is truthful and not misleading," she said.
At the end of last year the Whole Grains Council and Oldways sent a letter to the FDA urging it to clarify its position on whole grains. In a response received on February 14, the FDA advised that food labels bearing the council's stamps could be misbranded.
However the council points out that the recommendations released yesterday are non-binding, and do not "establish legally enforceable responsibilities".
Cynthia Harriman, the council's director of food and nutrition strategies, said in December that the main problem in getting consumers to eat foods with whole grains is that they just cannot find them.
"Consumers know whole grains are healthy, that they probably should eat them, and they probably would, but they go into grocery stores and can't spot them."
The FDA currently permits foods containing at least 51 percent whole grains by weight and are low in total fat, saturated fat, and cholesterol to carry a health claim, which links them to a reduced risk of heart disease and certain cancers.
In a joint statement the council and food issues think tank Oldways said that they are please the FSA has announced its support for the whole grains recommendations contained within the dietary guidelines.
"This is a key step forward for public education campaigns to help consumers find legitimate whole grain products, and also to help them to become familiar with the wonderful tastes and textures of these health-promoting foods."
The guidelines were also welcomed by the Grocery Manufacturers Association, which said: "By clarifying what is a whole grain serving, the FDA's new draft guidance gives the food industry a tool to communicate the health benefits of whole grains to all consumers via the food label.
"Additionally, GMA has consistently emphasized the importance of providing consumers with the information they need to make the Dietary Guidelines a part of their lives. The food label is one of the best tools we have for communicating critical nutrition information, and we should take full advantage of this opportunity to help consumers incorporate whole grains into their diets."