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Gluten Testing

FDA’s Gluten-Free Proposed Rule Q&A

On August 5, 2013, the FDA published its final ruling in the Federal Register on the definition of “Gluten Free” on food labels.  Prior to this final ruling, the term “Gluten Free” had been seen throughout the food industry from individual products on grocery store shelves to entire “gluten free” menus in the restaurant industry.  Typically, the food industry had been following the guidelines put forth in Codex Alimentarius, as the Codex standard was accepted in most other countries.  Now with the new final ruling from the FDA, the food industry has a strict guideline to follow when testing their product to determine if it is gluten free.  This is critical for millions of Americans who suffer from Celiac disease and avoid consuming food containing gluten.

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 definition of the term “gluten”?
A: FDA defines 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: Yes. The new ruling establishes the following requirements for a label to include the “Gluten Free” statement source:

  1. The food does not contain a gluten-containing grain
  2. The food does not contain an ingredient derived from a gluten-containing grain that has not been processed to remove gluten
  3. The food does not contain an ingredient derived from a gluten-containing grain that has been processed to remove gluten, if that ingredient results in the presence of 20 ppm or greater of gluten in the food
  4. The presence of gluten in the food product must be less than 20 ppm
Q: Why did the FDA create a regulation to define the term “gluten-free”?
A: FDA was 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 required 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 was delayed as the FDA sought comments from the food manufacturing industry and consumers. It became final on August 5, 2013
Q: How do I find more information on this?
A: It is available on the web: 72 FR 2795, with information on the final labeling at the Federal Register here.

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
  • Spices
  • 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 Laboratories 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 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.

Key Features:

  • Approved Methodology (AOAC 991.19 protocol)
  • High Sensitivity (LOD: 1 ppm)
  • Fully Validated
  • Quantitative or Qualitative
  • Versatility: Food Products and Environmental Sponges
  • Contact Us

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