Dear All:
FYI~
FDA is proposing to define the term "gluten-free" on food labeling, issued on Jan 23, 07.
The Food and Drug Administration (FDA) is proposing to define the term "gluten-free" for voluntary use in the labeling of foods.
- 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).
- How is the FDA proposing to define the term "gluten-free"? 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
- 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
- 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.
Best regards,
Jenny
