FDA’s Gluten-Free Proposed Rule Q&A
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 gluten allergies to more easily identify packaged foods that are safe to eat.
|Q:||What is gluten?|
|A:||In the context of the current legislation, 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
health effects in individuals who have celiac disease and gluten allergies. These prohibited
grains are wheat (including spelt and kamut), rye, barley, cross-bred hybrids and possibly
oats (currently not a prohibited grain).
|Q:||What is the FDA’s proposed definition of the term “gluten”?|
|A:||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
and gluten allergies.
|Q:||Does the agency have a current definition for “gluten-free”?|
|A:||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.
|Q:||Why is FDA proposing a regulation to define the term “gluten-free”?|
|A:||FDA is directed to define the term “gluten-free” to comply with a statutory mandate known
as the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). It requires a
proposed rule 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).
The final rule was to have been issued in August 2008, but it will be delayed as the FDA
seeks comments from the food manufacturing industry and consumers.
|Q:||How is the FDA proposing to define the term “gluten-free”?|
|A:||FDA proposes to define the term “gluten-free” to mean that a food bearing this claim in
its labeling does notcontain any one of the following:
|Q:||How do I find more information on this proposal?|
|A:||It is available on the web: 72 FR 2795 http://www.cfsan.fda.gov/~acrobat/fr070123.pdf.|
Common Foods That Contain Gluten
- Breads & Muffins
- Cakes & Pastries
- Pizza & Pastas
- Juice & Juice Products
- Soups, Sauces & Gravy Mixes
- Sausages & Luncheon Meats
- Breaded Meat, Poultry & Seafood
- Salad Dressings
- Condiments & Baked Beans
- Malted Products
- Creamed & Breaded Vegetables
- Imitation Bacon, Crab & other Seafood Products
- Spreads, Soft Cheeses & Dips
Gluten Allergen Analysis
ABC Research Corporation has skilled professional staff and modern analytical equipment in place to
provide accurate, timely analysis of a broad spectrum of food products.
Our Gluten Allergen Analysis will help you satisfy the FDA proposed rule for Gluten-Free Claims
of your product. We use the technological advanced ELISA method as outlined in the FDA?s Gluten?Free
Labeling Proposed Rule. ABC Research’s Gluten Allergen Analysis can be used for cooked, uncooked
and processed food products for the detection and quantification of gluten at very low concentrations with
a limit of detection (LOD) of 1ppm.
- Approved Methodology (AOAC 991.19 protocol)
- High Sensitivity (LOD: 1 ppm)
- Fully Validated
- Quantitative or Qualitative
- Versatility: Food Products and Environmental Sponges