This page focuses on US government guidance on whole grain labeling. While we do not have information available on labeling in other countries, you can click here to read about nutrition guidance in other countries and about established definitions of whole grain, both in the US and internationally.
The Bottom Line
The US government has very few actual regulations for whole grain labeling. At this time, the FDA's prohibition of misleading and false labeling is one of the strongest forces in this area. The Whole Grains Council developed its Whole Grain Stamp program, with its clear designation of whole grain gram-content, to promote truth in whole grain labeling.
In line with common sense, we advise manufacturers to use the words "whole grain" in the name of a product only if the product contains more whole grain than refined grain (i.e., 51% or more of the grain is whole grain). We allow the use of the Whole Grain Stamp on products containing 8g or more of whole grain ingredients per serving – even if the product may contain more refined grain – because:
No scientific studies link the percent of whole grain in a product to its health benefits, while scores of studies link the amount of whole grain to better health. Every gram helps.
At a time when consumers typically eat a serving or less of whole grain daily, the addition of another 8g may increase their consumption by 50% – making the Stamp's minimum level a potent contributor to health.
Existing Regulations and Guidelines
The following government regulations and guidelines may be helpful to those labeling, manufacturing and selling whole grain products. Neither FDA nor USDA has established final regulations on whole grain labeling, and as can happen with a work in progress, some of these guidelines have not yet been harmonized with others.
- IOM report on School Meals (October 2009)
- FDA Draft Guidance on Whole Grain Label Statements (February 2006)
- USDA FSIS Statement of Interim Policy Guidance (October 2005)
- FDA Whole Grain Health Claims (1999 and 2003)
- FDA Standards of Identity for Whole Grain Products
- USDA FNS Interim Rules for Whole Grains in WIC (effective February 2008)
For the convenience of consumers and of companies producing whole grain products, we offer links to these key documents below. Scroll down and take a look!
Federal School Meal Requirements and Guidelines
We keep current information on federal school meal requirements and recommendations for whole grains over on our School Resources section. Click here to visit this page of our website.The October 2009 IOM Report is included in our School Resources.
FDA Draft Guidance
on Whole Grain Label Statements
February 15, 2006
FDA has jurisdiction over packaging of food products. This Draft Guidance explains current thinking of the FDA, but is nonbinding and does not carry regulatory force. FDA held a press conference in conjunction with its release, which further explains the Draft Guidance. Following release of this Draft Guidance, FDA held a 60-day comment period and is now considering final guidance. No timetable has been made public for a possible final guidance.
Download text of FDA Draft Guidance (112K PDF)
Download unofficial transcript of press conference (64K PDF)
Link to comments from industry & the public
USDA FSIS Statement of Interim Policy Guidance
October 14, 2005
USDA exercises pre-approval over packaging of products containing meat and poultry. This document details their current guidelines for labeling whole grain content in such products. Although this document is also called a "guidance" it differs from the FDA in that FSIS reserves the right to reject packaging that does not meet the standards outlined here. Again, these standards do NOT apply to all products – just to those containing meat and poultry.
Download USDA/FSIS Guidance (36K PDF)
Based on this Guidance, the use of the Whole Grain Stamp varies slightly when it appears on products containing meat and poultry. Click here to see the differences approved by FSIS.
FDA Whole Grain Health Claims
1999 and 2003
In 1999, FDA authorized the use of a health claim that can be used on whole grain foods. The claim has wording like this:
"Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease."
In 2003, a second related claim, with different requirements for fat content, was approved.
Limitations of FDA Whole Grain Health Claims
These claims have limitations and cannot be used on some whole grain foods, even if the foods are 100% whole grain.
Foods must contain at least 51% whole grain by total weight of ingredients, so products with high moisture levels and a variety of nongrain ingredients have difficulty qualifying. A whole grain raisin bread, for instance, may have 40% of its weight made up of moisture, with additional weight from raisins, and a small amount of oil or honey. The whole grain flour could easily be less than 51% of the total weight – even when the bread is made with NO refined grains whatsoever.
To qualify for this claim, whole grains must also contain 11% or more fiber. Whole grains vary widely in fiber content, and many have less than this level of fiber. Since qualifying foods must contain at least 51% whole grain, this means that each product overall must contain at least 5.6% (51%x11%) fiber. This level can be difficult for lower-fiber grains to reach, even when more than 51% of a product is whole grain.
Because of this, in early 2008, the FDA ruled that single-ingredient whole grain foods do not need to meet the fiber "test." This expansion of the claim allowed a bag of plain brown rice (3.5% fiber) to qualify for the Whole Grain Health Claim.
Multi-ingredient products made with lower-fiber grains such as brown rice or whole grain cornmeal (7.3% fiber), however, still won't qualify unless they contain a lot more than 51% whole grain: for whole cornmeal, about 77% of the weight of the product must be whole grain to qualify, and a brown-rice-based product cannot qualify even if whole grain is 99% of the overall weight.
So, as it stands today, the Whole Grain Health Claim still has severe limitations that put many grains and many types of foods at an unfair disadvantage.
FDA Standards of Identity
For certain foods, FDA has established what is called a Standard of Identity. This is a definition of the specific ingredients that must be used in making a food, in order for it to be labeled as that food.
In the area of whole grains, Standards of Identity exist for:
- whole wheat flour and graham flour (21 CFR 137.200)
- whole durum flour (21 CFR 137.225)
- whole wheat breads, rolls and buns (21 CFR 136.180)
- whole wheat macaroni products [pasta] (21 CFR 139.138)
Revisions in the WIC Food Packages, Interim Rule
This one's not really part of labeling whole grains, but it is a key government document, so we're including it on this page. This 68-page PDF explains the new WIC rules published in December 2007, which will for the first time include whole grains in the supplemental feeding program for Women, Infants and Children.
While specific products that can be purchased with WIC vouchers are approved state by state, the federal rules specify which whole grains are eligible for consideration.
Whole grains potentially eligible for inclusion in state WIC programs are:
a. 100% whole wheat breads meeting the FDA standard of identity for whole wheat bread.
b. Other whole grain breads that qualify for the FDA whole grain health claim and where the first ingredient is a whole grain.
c. Breakfast cereals that qualify for the FDA whole grain health claim and where the first ingredient is a whole grain, and that also meet requirements for iron and for limited sugar.
d. Brown rice, bulgur, oats and whole-grain barley with no added fats or oils.
e. Wheat and soft-corn tortillas where the first ingredient is whole wheat or whole corn.
The new rules are effective as of February 8, 2008; states must implement them by August 5, 2009. Download 423K PDF. See especially pages 68975-6, 68990-3, 69002-3, and 69012 for information specific to whole grains.