Gluten Free FDA Definition

1
Gluten Free (FDA) Definition

• Gluten Free.FDA definition
• I. Introduction
• The Food and Drug Administration (FDA) is
  proposing to define the term "gluten-free" for
  voluntary use in the labeling of foods.  A
  definition for the term "gluten-free" established
  by FDA would assist those who have celiac disease
  (also known as celiac sprue or gluten-sensitive
  enteropathy) and their caregivers to more easily
  identify packaged foods that are safe for persons
  with celiac disease to eat.  This proposed action
  is in response to the Food Allergen Labeling and
  Consumer Protection Act of 2004, Title II of
  Public Law 108-282, enacted on August 2, 2004,
  which directs the Secretary of Health and Human
  Services to propose and later make final a rule
  that defines and permits the use of the food
  labeling term "gluten-free."
• II. Questions and Answers
• What is celiac disease?
• Celiac disease is a chronic inflammatory disorder
  of the small intestine in genetically susceptible
  individuals.  It is triggered by ingesting
  certain proteins, commonly referred to as
  "gluten" which is naturally present in some
  cereal grains. 
• What is the estimated prevalence of celiac
  disease in the U.S.?
• Experts estimate that the percentage of the
  general population in the United States who has
  celiac disease is as high as 1.
• Can celiac disease be cured?
• No, but health care professionals advise that it
  can be managed with diet.  Typically, individuals
  who have this disease are advised to avoid all
  sources of gluten in their diet.  Over time,
  strictly avoiding consumption of all gluten
  sources can improve the symptoms and reduce the
  associated health risks of celiac disease.
• What is gluten?
• The term "gluten" technically refers to a
  specific complex of proteins that forms when
  wheat flour is mixed with a liquid and physically
  manipulated, such as in the kneading of bread.

2
Gluten Free (FDA) Definition

• How is the term "gluten" used in the context of
  celiac disease?
• In the context of celiac disease, the term
  "gluten" is used to collectively refer to gluten
  in wheat, and to the proteins in other grains
  that have been demonstrated to cause harmful
• What is the FDA's proposed definition of the term
  "gluten"?
• FDA is proposing to define the term "gluten" to
  mean the proteins that naturally occur in a
  prohibited grain and that may cause adverse
  health effects in persons with celiac disease.
• What is the FDA's proposed definition for
  "prohibited grain"?
• FDA is proposing to define the term "prohibited
  grain" to mean any one of the following grains
• Wheat, meaning any species belonging to the genus
  Triticum
• Rye, meaning any species belonging to the genus
  Secale
• Barley, meaning any species belonging to the
  genus Hordeum
• Crossbred hybrids of wheat, rye or barley (e.g.,
  triticale, which is a cross between wheat and
  rye)
• Does the agency have a current definition for
  "gluten-free"?
• No. Currently, there is no FDA regulation that
  defines the term "gluten-free."  However, FDA has
  not objected to the use of the term "gluten-free"
  in the labeling of foods, provided that when such
  a claim is made, it is truthful and not
  misleading.
• Why is FDA proposing a regulation to define the
  term "gluten-free"?
• FDA is directed to define the term "gluten-free"
  to comply with a statutory mandate.  Title II of
  Public Law 108-282, also known as the Food
  Allergen Labeling and Consumer Protection Act of
  2004 (FALCPA), directs the Secretary of Health
  and Human Services to issue a proposed rule that
  will define and permit the use of the term
  "gluten free" on the labeling of foods by no
  later than two years after the law's enactment
  date (August, 2006), and a final rule by no later
  than four years after the law's enactment date
  (August, 2008).

3
Gluten Free (FDA) Definition

• How is the FDA proposing to define the term
  "gluten-free"?
• Barley, common wheat, rye, spelt, kamut,
  triticale
• Farina, vital gluten, semolina, malt vinegar
• Why did FDA not include oats as one of the
  "prohibited grains" in its proposed definition of
  the term "gluten-free"?
• FDA did not include oats as one of the
  "prohibited grains" in its proposed definition of
  the term "gluten free" for the following reasons
• There is no consensus among nutrition experts or
  authorities on the unconditional exclusion of
  oats from the diet of individuals with celiac
  disease.  For example, the following celiac
  disease experts/authorities do not support the
  unconditional exclusion of oats  The National
  Institutes of Health, the American Dietetic
  Association, and some celiac disease
  research/treatment centers. 
• Research data suggest that the majority of
  individuals with celiac disease can tolerate a
  daily intake of a limited amount (e.g., 50 grams)
  of oats that are free of gluten FDA proposes to
  define the term "gluten-free" to mean that a food
  bearing this claim in its labeling does not
  contain any one of the following
• An ingredient that is a prohibited grain
• An ingredient that is derived from a prohibited
  grain and that has not been processed to remove
  gluten in from wheat, rye, barley or their
  crossbred hybrids.
• Oats are reported to add variety, taste, satiety,
  dietary fiber, and other essential nutrients to
  the diet of individuals with celiac disease and
  may make their diet more appealing. 
• Allowing oats free of gluten from wheat, rye,
  barley or their crossbred hybrids, to bear a
  "gluten-free" labeling claim would make it easier
  for consumers to identify such oats in the
  marketplace and may serve as an incentive for
  more manufacturers to produce such oats.
• Why did FDA include "20 ppm or more gluten" as a
  criteria in its definition of "gluten-free"?
• The level is proposed based on the available
  analytic methods.  Data from peer-reviewed
  scientific literature demonstrate that current
  analytic technology can reliably and consistently
  detect gluten in wheat, rye, and barley at levels
  of 20 ppm in a variety of food matrices.
• What other criteria might be used to define
  "gluten-free"?
• The preamble to the proposed rule advises that
  FDA is planning to conduct a safety assessment
  for gluten, under which scientific data and
  methods would be used to estimate a "safe" level
  of gluten exposure. We intend to publish a notice
  in the Federal Register seeking comment on the
  draft safety assessment and its potential use in
  the final rule.

4
Gluten Free (FDA) Definition

• How is FDA proposing to enforce "gluten-free"
  label claims?
• In the enforcement of FDA-regulated food labeling
  claims, the agency would deem the product to be
  misbranded on the basis of the result of one of
  the following 
• review of labels
• on-site inspections of food manufacturers
• analysis of food samples
• An ingredient that is derived from a prohibited
  grain and that has been processed to remove
  gluten, if the use of that ingredient results in
  the presence of 20 parts per  million (ppm) or
  more gluten in the food or
• 20 ppm or more gluten
• Will foods that meet the definition for
  "gluten-free" be required to bear a "gluten-free"
  claim?
• No. FDA is proposing to define the term
  "gluten-free" for voluntary use in the labeling
  of foods.  In other words, once a final federal
  definition of the term is in effect, if a
  manufacturer wishes to label his product as
  "gluten-free," it may do so at its own
  discretion, but only if the food bearing the
  label meets the proposed regulatory definition.
• Is the FDA proposing any synonyms for the term
  "gluten-free"?
• Yes. The following are proposed synonyms for the
  "gluten free" labeling claim
• "free of gluten"
• -"without gluten"
• "no gluten"
• Is the FDA proposing claims for foods which are
  naturally gluten-free?
• Yes.  FDA is proposing that with the exception of
  a food made from oats, any food that is naturally
  free of gluten may bear the claim "gluten free"
  provided both of the following requirements are
  met 

5
Gluten Free (FDA) Definition

• Are there potential benefits to industry in
  having a standardized definition for the term
  "gluten-free"?
• Yes. A standardized definition of the term
  "gluten-free" could assist food producers by
  providing them with a clearly codified definition
  of the term, thereby eliminating any uncertainty
  or misunderstandings as to how they may label
  their products.
• What are the potential benefits to consumers in
  having a standardized definition for the term
  "gluten-free"?
• A standardized definition for the term
  "gluten-free" can serve to protect the public
  health by providing consumers with celiac
  disease, and others who must avoid gluten in
  their diet, the assurance that the foods bearing
  this labeling meet a clear standard established
  and enforced by FDA as to the meaning of
  "gluten-free".
• How do I find more detailed information on this
  proposal?
• The proposal is on display at the Office of the
  Federal Register, and at
• The public also can learn about new FDA issues
  that are open for public comment through the
  agency's Dockets Management Page.
• Can I comment on this proposal?
• Yes, comments should be submitted in writing by
  April 23, 2007 to the Division of Dockets
  Management, Food and Drug Administration, 5630
  Fishers Lane, Room 1061, (HFA-305) Rockville, MD
  20852.
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  NutritionHypertext updated by cjm January 23,
  2007

6
Oats breakfast, Gluten-Free, Menu

• Recipe
• 1 cup, CHAI Boil
• 1 cup water Boil
• 1 cup, Oats, Old Fashioned (Boil/Directions)
• 1 tablespoon Cinnamon
• 1/8 Cup, Fruit Blueberry, cranberry
• Mix
• Option Yogurt (Vanilla), Soy Milk, Agave

7
Smoothies/Snack Gluten-Free, Menu

• Recipe
• 1 cup, Passion/or Green Tea
• 1 cup Orange Juice
• 1 Banana
• ½ cup Vanilla Yogurt
• 1/3 Acai- Frozen (Regular or Cherry)
• 1 cup (12oz.) Ice
• Blender
• Optimal Green powder, Rice Bran, CHIA, Agave

8
Salmon Lunch Gluten-Free, Menu

• Recipe
• 1 Lb. Salmon 3 portions each (5 oz./6oz.) thawed
  
• ¼ cup Lemon Juice
• 1/8 cup Lime Juice, Key West
• 1 cup Mango (Frozen)
• 3 cup Spinach (Fresh)
• ¼ tablespoon, Lemon Pepper (3 each)
• ¼ tablespoon, Jamaican Jerk (3 each)
• Pinch- Kosher Salt, Pepper
• Juice, 3 Salmon each portions spices
• Salmon, spices- saute/Covered Low
  2-minutes/flipped over salmon
• 3- minutes/Mango covered
• 1-minutes/Spinach
• Done
• Option Rice, Pasta