Volume 6, Number 8 - August 2005

IN THIS ISSUE:

• FDA Policy on Food Labels Terms is Summarized

• FDA Explains "And/Or" Ingredient Labeling

• FDA Requests Input for "Gluten Free" on Food Labels

• FYI: Tips for 2006-Compliant Food Labels

Greetings! Food Consulting Company invites you to check out the newly improved online order system at www.foodlabels.com. Documents can now be submitted electronically as attachments to the online order form. The new online ordering system is the latest step to provide clients with efficient and expert food labeling help.

FDA Policy on Food Labels Terms is Summarized

Because of the many inquiries from clients regarding use of the terms -- natural, vegan and vegetarian, and whole grain and 100% whole grain -- Food Consulting Company requested clarification from FDA on the Agency's policy for use of the terms. No regulatory definition exists for any of the terms. An FDA spokesperson explained:

Natural -- FDA policy on the term is that the Agency will not restrict the use of the term "natural" on food labels except for those foods that contain artificial flavors, chemical preservatives, and added colors (from any source) as defined in 21CFR101.22. This is consistent with a Federal Register notice published on January 6, 1993, accessible on page 2407 (near the end) of the following link:  http://www.fda.gov/OHRMS/DOCKETS/98fr/1993-92-31504.pdf.

Vegan and Vegetarian -- FDA considers the terms to be types of diets. The Agency has not, and does not intend at this time, to develop regulatory definitions for those terms. The terms can be used on labels as long as they are truthful and not misleading.

Whole Grain and 100% Whole Grain -- The 2005 program priorities for FDA's Center for Food Safety and Applied Nutrition included a B-list goal to develop a strategy to initiate rulemaking on claims for whole grains. B-list goals are not necessarily accomplished the year they are listed and in fact FDA has not reported on any progress this fiscal year. For now, the terms can be used on labels as long as they are truthful and not misleading.

Commentary: Consumers who care about products labeled with the mentioned terms have expectations, and retailers often have their own criteria for products they will accept bearing these terms. Manufacturers put themselves at risk of unwanted FDA scrutiny of label claims and/or loss of retail shelf space if label claims do not match expectations. Food Consulting Company helps food labeling clients use the label terms so that the claims are consistent with consumer and retailer expectations, and ensures that all label statements are truthful and not misleading. Request help with label terms at www.foodlabels.com.

In a July 5, 2005, letter, FDA advises the soft drink industry to review ingredient statements and assure that the sweetening ingredients in the products are listed accurately; use of "and/or" ingredient labeling of nutritive sweeteners in soft drink products is not permitted.

From May 1997, to November 2004, FDA exercised enforcement discretion because of a pending proposed rule that would permit "and/or" labeling. By notice published in the Federal Register of November 26, 2004, the proposed rule was withdrawn as part of FDA's steps to reduce the Agency's regulatory backlog so that resources could focus on current public health issues.

Read FDA letter.

Read Federal Register notice of withdrawal:
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-26234.htm

Commentary: "And/or" ingredient labeling is sometimes, but rarely permitted. Food Consulting Company will develop or review ingredient statements for compliance with FDA regulations. For service, choose Full Label Compliance or Regulatory Research at http://www.foodlabels.com/orderpage.htm.

On August 19, 2005, FDA is holding a public meeting to gain stakeholder input to help define and permit the use of the term "gluten-free" on food labels. The Agency is requesting that comments address ten questions that are included in a meeting notice in the July 19, 2005, Federal Register. The questions relate to food manufacturing practices, gluten detection methods in use, and consumer issues regarding reduced levels of gluten in food.

See meeting notice and questions for comment:
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-14196.htm

Commentary: In July 2005, Food Label News reported on steps FDA is taking to establish the amount of gluten below which it would be unlikely to elicit harmful effects in celiac disease patients. See archive: http://www.foodlabels.com/archive/2005_07.htm

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