Volume 7, Number 3 - March 2006

IN THIS ISSUE:

• FDA on "Whole Grain" Statements on Food Labels

• FDA Proposes Study on Trans Fat Claims/Footnotes

• FDA Guidance Establishes Common Understanding

• FYI: Work Smart - Consider A Regulatory Support Plan

Dear Readers,

Each issue of Food Label News is a journey in continuing education for the Food Consulting Company staff. Every month staff members search various sources to find food label regulatory news and information that keeps our readers up-to-date and Food Consulting Company staff sharp on the regulatory issues. We do this so you can count on us to be your expert assistant for accurate, on-time food labeling help!  www.foodlabels.com

FDA on "Whole Grain" Statements on Food Labels

On February 17, 2006, FDA issued a draft guidance on "whole grain" label statements; stakeholders are asked to comment by April 18, 2006.

In part the guidance:

• defines whole grains as intact, ground, cracked or flaked cereal grains that contain the starchy endosperm, germ and bran in the same relative proportions as they exist in the intact state of the grain

• identifies amaranth, barley, buckwheat, bulgur, corn (including popcorn), millet, quinoa, rice, rye, oats, sorghum, teff, triticale, wheat, and wild rice as examples of cereal grains

• explains that legumes (e.g. soybeans, chickpeas), oilseeds (e.g., sunflower seeds), and roots (e.g., arrowroot) should not be considered whole grains

• states that factual statements about whole grains, such as "10 grams of whole grains," "1/2 ounce of whole grains," and "100% whole grain oatmeal," can be used on food labels as long as the statements are truthful and not misleading and do not imply a particular level of the ingredient, i.e., "high" or "excellent source"

• reminds that labels may bear a health claim based on an authoritative statement of a scientific body relating whole grains with a reduced risk of heart disease and certain cancers if the food meets certain qualifications

Read the guidance.

Commentary: The FDA guidance on whole grain label statements is not establishing new rules regarding the term; rather its purpose is to establish a common understanding of the existing regulations.

In response to numerous inquiries about using "whole grain" and related terms on food labels in the last year, Food Label News has reported on FDA's stand for these terms several times since August 2005. Food labelers may find the following Food Label News archived issues helpful: August 2005, December 2005, January 2006.

FDA Proposes Study on Trans Fat Claims/Footnotes

FDA is seeking comments on two proposed studies related to trans fat information on food labels. In separate studies, FDA will investigate:

• how consumers might interpret possible disclosure requirements (for example, about trans fat, either alone or in combination with saturated fat and cholesterol) to accompany nutrient content claims about trans fatty acids that could help consumers make heart-healthy food choices

• the communication effectiveness of possible footnotes that would help consumers interpret quantitative trans fat information on the Nutrition Facts panel (for example, an asterisk in the %DV column for trans fat that is tied to the same symbol at the bottom of the Nutrition Facts box with a statement such as "Intake of trans fat should be as low as possible.")

The findings of both studies will be used to help FDA formulate decisions and policies affecting labeling requirements for trans fat on foods.

See the studies.

Commentary: Currently, FDA does not allow nutrient content claims about trans fat content on food labels; however, the Agency does allow statements of fact that are truthful and not misleading. Creating FDA-acceptable statements can be tricky. For example, it is okay to use the statement "0g trans fat;" but it is not okay to say "zero grams of trans fat," with zero spelled out, because according to FDA regulations "zero" is reserved for use in FDA-defined nutrient content claims.

FDA Guidance Establishes Common Understanding

Periodically FDA issues guidance documents to describe the Agency's current thinking on a policy or regulatory issue. The guidance documents are developed for use by FDA staff, industry, and the public to establish common understanding of regulatory issues and related matters.

FDA is required to issue guidance documents whenever regulatory expectations are not readily apparent in newly published statutes or regulations. Also, members of the public can suggest that FDA draft a new guidance document or revise or withdraw an already existing guidance document.

Guidance documents do not establish legally enforceable rights or responsibilities; however, since they are expressions of FDA's thinking on existing regulations, alternative approaches by industry (other than those outlined in the guidance) must comply with the relevant statutes and regulations.

Learn more about FDA guidance.

Commentary: FDA recently issued two guidance documents that address food labeling issues that are of high interest to Food Consulting Company clients and Food Label News readers. The February 17, 2006, draft guidance for "whole grain" label statements is reported in this issue of Food Label News. The December 2005 guidance for requesting an "Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006" is reported in both December 2005 and January 2006 issues of Food Label News.

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