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Volume 7, Number 1 - January 2006


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– Jay Highman, President & CEO
Nature's One, Inc.

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FDA Final Guidance - Extension to Use Existing Food Labels Stock

On December 30, 2005, FDA issued a revised final guidance for "Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006." According to the guidance, FDA:

  • has defined five factors it intends to consider for "extension" requests, including whether the declared label value for trans fat is 0.5g or less per serving.

  • believes firms would use existing labels for no longer than 12 months from the date the agency issues a letter back to the firm

  • will consider requests on a case-by-case basis

This final guidance does not address allergen labeling requirements that were also mandatory on January 1, 2006.

Read the revised final guidance on extension requests for trans fat labeling.

Commentary: Food Consulting Company reported and commented on the "extension option" in the October, 2005, issue of Food Label News. Access the archive at

Regardless of whether or not an extension is requested and then approved by FDA, manufacturers who have food labels that are not yet in compliance with January 1, 2006, requirements for trans fat and allergen labeling are obligated to get into compliance. Food Consulting Company can help companies overcome labeling obstacles; see

More on Food Labels Allergen Requirement

On December 14, 2005, FDA issued a revision of "Guidance for Industry-Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004." The revised guidance explains that the Food Allergen Labeling and Consumer Protection Act does not apply to major allergens that are unintentionally added to a food as a result of cross-contact.

Read the revised final guidance on food allergen labeling.

Commentary: For a quick overview of food allergen labeling requirements, see and read the article posted at

FDA Stand on Food Labels Claims for Whole Grains

In a November 8, 2005, letter, FDA denied a citizen petition that requested that FDA develop definitions for "excellent source," "good source," and "made with," as descriptors for the whole grain content of foods.

Currently, the terms requested in the petition are defined for use only as nutrient content claims for nutrients with established Daily Values.

In the letter, FDA identifies issues that need to be addressed prior to defining these terms as descriptors for whole grain content, including:

  • whether "whole grains" should be considered as a nutrient, a food ingredient, a food category, or something else

  • the regulatory implications about classification of label statements such as dietary guidance, nutrient content claims, or health claims

The denial letter explains that statements of fact such as "10g of whole grains per serving" and "100% whole grain oatmeal" are allowed, as long as the statements are truthful and not misleading.

Read the denial letter.

Commentary:  In December 2005, Food Label News reported on use of MyPyramid on food labels, including references to whole grain that state or imply a high or increased amount. Access the archive at

FYI:  On November 9, 2005, the Health Freedom Protection Act was introduced into the U.S. House of Representatives. The Act seeks to protect freedom of speech in the labeling and advertising of conventional foods and dietary supplements.
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