Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.


Public Meeting on Gluten-Free Food Labeling - Text Version of PowerPoint Presentation by Rhonda R. Kane

Public Meeting: Gluten-Free Labeling main page

Slide 1 - Gluten-Free Food Labeling Public Meeting

August 19, 2005

Rhonda R. Kane, M.S., R.D.
Consumer Safety Officer
Food Labeling & Standards Staff
Office of Nutritional Products, Labeling & Dietary Supplements
Center for Food Safety & Applied Nutrition (CFSAN)
Food & Drug Administration (FDA)

Slide 2 - Public Meeting Purpose

Assist FDA to comply with mandates of Section 206 of Public Law 108-282: Title II--Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (

  • Consult with appropriate experts and stakeholders to define and permit use of the term “gluten-free” in the labeling of foods
  • Issue a proposed rule on 8/2/06 and final rule on 8/2/08 to establish a definition for “gluten-free”

Slide 3 - Federal Register Notice on Public Meeting

  • Solicits comments on specific questions
  • Uses the following terms for the purpose of the Notice:
    • Gluten: proteins found in any grains that can cause harm to persons with celiac disease
    • Grains of concern: wheat, rye, barley and oats and their related species (e.g., durum, spelt, kamut) or crossbred hybrids (e.g., triticale)
    • Gluten-free foods: foods marketed in the U.S. that are represented/labeled to be free of gluten

Slide 4 - Categories of Questions

  • Definitions of “Gluten-Free”
  • Gluten-Free Product Development
  • Good Manufacturing Practices (GMPs) and Analytical Methods
  • Foods Marketed as “Gluten-Free”
  • Consumer Purchasing Practices

Slide 5 - Definitions of Gluten-Free

Question 1:

  • How do food manufacturers define “gluten-free”?
  • Does the food industry have a generally accepted definition of “gluten-free”?
  • Does any entity “certify” finished foods or raw ingredients to be “gluten-free,” and if, so how is that term defined and how is a food determined to satisfy that definition?

Slide 6 - Gluten-Free Product Development

Question 2:

  • How are “gluten-free” foods produced?
  • What methods are most commonly used to remove gluten from food?

Slide 7 - Gluten-Free Product Development

Question 3:

  • Is it technologically and economically feasible to produce:
    • “gluten-free” flour milled from grains other than those of concern (e.g., corn and millet)?
    • oat-based products that do not contain gluten from grains of concern other than oats (e.g., wheat)?
  • If so, what additional measures in the milling or manufacturing process would be needed to produce these products and what would be the incremental costs?

Slide 8 - GMPs and Analytical Methods

Question 4:

What measures are in place during the manufacturing, packaging or holding of “gluten-free” foods to prevent them from coming in contact with any grains of concern?

Slide 9 - GMPs and Analytical Methods

Question 5:

  • What analytical method(s) are used to evaluate “gluten-free” products?
  • How often are these analyses performed (e.g., test every batch of finished product or bulk containers of each ingredient)?
  • What is the cost of such testing?

Slide 10 - GMPs and Analytical Methods

Question 6 asks about test kits or analytical methods that detect gluten:

  • In what grains can the test kit/method detect gluten?
  • What specific mechanism is used to indicate the presence or absence of gluten?
  • What is the sensitivity or lowest level of detection of the test kit/method?

Slide 11 - GMPs and Analytical Methods

Question 6 asks about test kits or analytical methods that detect gluten (con’t):

  • Is the test kit/method qualitative or quantitative?
  • If the latter, what is the test kit’s/method’s limit of quantification?
  • What are the test kit’s/method’s false positive and negative rates?

Slide 12 - GMPs and Analytical Methods

Question 6 asks about test kits or analytical methods that detect gluten (con’t):

  • Is the effectiveness of the test kit/method affected by the nature of the processing of the “gluten-free” food or by the food matrix, and if so, how?
  • If the test kit/method has been validated, by whom and at what level (e.g., parts per million) of detection was it validated?

Slide 13 - GMPs and Analytical Methods

Question 6 asks about test kits or analytical methods that detect gluten (con’t):

  • If the test kit/method has not been validated, have the results of its performance or an evaluation of its performance been published in a peer reviewed scientific journal?
  • What is the cost of the test kit or the cost to perform the method of analysis?

Slide 14 - GMPs and Analytical Methods

Question 7:

  • What analytical methods are currently available or under development to detect the presence of oat proteins in food?
  • Which oat proteins are detected and what is the cost to conduct this analysis?
  • Have these methods been validated or published in a peer-reviewed scientific journal?

Slide 15 - Foods Marketed as “Gluten-Free”

Question 8 asks if research data or findings are available on:

What consumers with celiac disease (CD) or their caregivers believe the term “gluten-free” means (e.g., which specific grains or other ingredients should not be present in foods labeled as “gluten-free”)?

Slide 16 - Consumer Purchasing Practices

Question 9 asks if research data or findings are available on:

  • How do consumers with CD or their caregivers identify packaged foods that do not contain gluten?
  • How much time do these consumers devote to identifying such foods?

Slide 17 - Consumer Purchasing Practices

Question 10 asks if research data or findings are available on:

  • Are the packaged foods that consumers with CD or their caregivers currently purchase or consume primarily or exclusively those foods labeled “gluten-free”?
  • What types of “gluten-free” packaged foods are purchased or consumed by persons with CD or their caregivers?
  • Does a “gluten-free” label influence the purchasing decision of persons with CD or their caregivers when presented with products having identical ingredient lists?

Slide 18 - Notice Docket # 2005N-0279

  • Submit comments by 9/19/05
  • Note Docket # 2005N-0279 in correspondence
  • Send comments by:
    • Land mail to: FDA’s Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852
    • Internet to: (click “Docket Search,” enter “2005N-0279” in “Docket ID” window, and click “Find”)
    • E-mail to: (enter “Docket # 2005N-0279” in subject line of e-mail; accommodates attachments)

Page Last Updated: 01/30/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English