Volume 8, Number 12 - December 2007

IN THIS ISSUE:

• Reader Q&A: Nutrition Facts Color

• FDA Takes Public Step to Revise Nutrition Labels

• Proposed Rule to Prohibit Omega-3 Nutrient Content Claims

• Food Labels Qualified Health Claims Update

• At Your Service: Label Help for Reformulated Products

Season's Greetings! We hope this holiday season includes a break from work along with joyful time with friends and family. Best wishes for a happy holiday season from Food Consulting Company.

Q.  Does the nutritional labeling have to be printed in black?   D. F., Manufacturer, Florida

A.  Per the Code of Federal Regulations, the Nutrition Facts panel must be in black or one color type printed on a white or neutral background with the intent that it is very easy to read. However... Read more: Reader Q&A page.

Submit a question for Reader Q&A (no charge).

FDA Takes Public Step to Revise Nutrition Labels

On November 2, 2007, FDA announced plans to revise the reference values and mandatory nutrients used in Nutrition Facts and Supplement Facts panels. To begin the process, FDA issued an Advance Notice of Proposed Rule Making (ANPRM) requesting comments on what new information should be used to calculate the percent daily values (DVs) and determine what nutrients should be mandatory on Facts panels.

In the ANPRM, FDA identifies new information as:

• revisions to the Dietary Guidelines for Americans

• Institute of Medicine's (IOM's) published reports on the Dietary Reference Intakes (DRIs) that update recommendations for the intake of vitamins, minerals, and macronutrients

• IOM report on the application of the DRIs

• IOM report on "Guiding Principles for Nutrition Labeling and Fortification"

The ANPRM details many questions for comment. Broad categories include:

• approach to setting DVs

• populations for which DVs are intended

• labeling of individual nutrients

• consumer and producer use and understanding of DVs

See ANPRM.

Commentary: This ANPRM encompasses many issues that have been covered by Food Label News over the years (prominence of calories, carbohydrate reporting, trans fats and other fat reporting, just to name a few.) Food Consulting Company has been asked if this ANPRM will result in mandatory label changes any time soon. The answer is no, not for several years. FDA's process to set regulations is multi-step and includes proposed rules, comment periods, final rules, and announcement of the uniform compliance date.

Proposed Rule to Prohibit Omega-3 Nutrient Content Claims

On November 27, 2007, in response to three notifications to FDA from industry (in 2004-2005), FDA issued a Proposed Rule to prohibit certain nutrient content claims for foods that contain omega-3 fatty acids: alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA). The claims of concern characterize the level of omega-3 content in products; under current FDA rules for nutrient content claims this is prohibited because there is no FDA-established Daily Value for omega-3 fatty acids.

The claims have been legally used for several years since, until now, FDA did not respond to the notifications with an FDA decision that use of the claims does not comply with nutrient content claim rules published in the Code of Federal Regulations. The proposed rule would prohibit use of the claims effective on the uniform compliance date for food labeling regulations that is applicable to the publication date of the Final Rule.

Also in the Proposed Rule FDA states the Agency's intention to take no regulatory action at this time regarding a particular nutrient content claim contained in one of the notifications for ALA omega-3 fatty acids; further, FDA expresses no opinion as to whether the particular ALA claim is supported by a statement that satisfies the legal requirements for use.

See Proposed Rule.

Commentary: In this Proposed Rule (for omega-3 fatty acids), FDA calls stakeholders' attention to the November 2, 2007, ANPRM that specifically addresses the issues surrounding reference values which are used as foundation for nutrient content claims.

Food Labels Qualified Health Claims Update

Food Consulting Company clients have expressed interest in the earlier Food Label News reports (September, October) about the measure "No funds in this Act may be used to authorize qualified health claims for conventional foods" that is included in the House version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2008.

As of December 1, 2007, the bill is still with the Senate. If the measure remains in the bill that the president eventually signs, FDA could announce that it is no longer accepting requests for qualified health claims for foods because of the Appropriations Act restriction.

Commentary: Despite objections from health advocacy groups, FDA has allowed qualified health claims in response to legal challenge that called use of such claims a right under the U.S. Constitution First Amendment right to free speech. It is unclear what the future holds for qualified health claims.

At Your Service:  As you reformulate products to eliminate trans fat, speed up your arrival to the marketplace by calling on Food Consulting Company to complete the label components for you. See Nutrition Facts and Ingredient/Allergen Statement services.

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