August 2, 2011
1. What action is FDA announcing today?
FDA is publishing a Federal Register (FR) notice to reopen for 60 days the public comment period on the agency's proposed rule on the gluten-free (GF) labeling of foods issued on January 23, 2007 (72 FR 2795). This FR notice announces the availability of and solicits comments on:
- FDA's safety assessment of gluten exposure in individuals with celiac disease;
- whether, and, if so, how, the assessment should affect FDA's proposed definition of the term GF in a final rule;
- and a number of related issues.
2. What is gluten?
"Gluten" is a term commonly used to refer to certain proteins that naturally occur in wheat, rye, barley, and crossbred hybrids of these grains that can cause harm to persons who have CD.
3. What is celiac disease (CD) and how prevalent is it in the United States?
CD is a type of inherited digestive disorder that involves an abnormal immune response to the consumption of gluten. Eating foods that contain gluten triggers the production of antibodies in persons who have CD, which then attack the lining of the small intestine, causing damage. With continual exposure to gluten over time, the body is not able to properly absorb nutrients from foods, which can lead to vitamin and mineral deficiencies. Persons with CD are also at higher risk of developing other serious health problems (e.g., growth retardation, short stature, infertility, and intestinal cancers). About 1 percent of the U.S. population is estimated to have CD.
4. What type of symptoms do people with CD experience if they consume gluten?
When people with CD eat foods containing gluten, they typically experience gastrointestinal symptoms like abdominal pain, bloating, vomiting, diarrhea and even constipation. However, others with CD may not immediately feel sick, even though damage to the lining of their small intestine may still occur.
5. How can the harmful health effects of gluten be prevented in those with CD?
Currently, there is no cure for CD. The only way those with CD can help prevent its harmful health effects is to adhere to a life-long GF diet.
6. Why is it important that FDA define the food labeling term GF?
Establishing a regulatory definition of the term GF will clarify the specific requirements that must be met in order for this claim to be used in the labeling of foods sold in the U.S. This action is necessary to ensure that individuals with CD are provided with truthful and accurate food labeling information. The adoption of a standard definition of GF will also promote fair competition among manufacturers that include this claim on their food labels, because they all must meet the same requirements.
7. How is FDA proposing to define the term GF for voluntary use in the labeling of foods?
FDA proposed to define the term GF for voluntary use in the labeling of foods to mean that the food does not contain any of the following:
- an ingredient that is a species of wheat, rye, barley, or a crossbred hybrid of these grains;
- an ingredient derived from these grains and that has not been processed to remove gluten;
- an ingredient derived from these grains and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 or more parts per million (ppm) gluten in the food; or
- 20 ppm or more gluten.
8. Why is FDA proposing to allow some amount of gluten in a food labeled GF?
Currently, analytical methods that can reliably and consistently detect gluten at levels lower than 20 ppm do not appear to be available. In addition, it may be difficult or infeasible for food manufacturers to meet a lower gluten threshold level or that meeting a lower level could increase their food product costs. As a result, fewer and/or more expensive GF-labeled foods would be available to individuals with CD, placing them at higher risk of developing serious health complications from CD and other related diseases.
FDA definitions for “free” claims recognize that it may not be possible to have a complete absence of a specified component or nutrient in a food. For example, FDA regulations allow: a food labeled “fat free” to contain < 0.5 gram of fat; a food labeled “cholesterol free” to contain < 2 milligrams cholesterol; and a food labeled “sodium free to contain < 5 milligrams sodium.
9. What approaches did FDA consider as a way to establish a gluten threshold level to define the term GF?
FDA identified two feasible approaches that could be used to establish a gluten threshold level to assist the agency in defining the term GF: an analytical methods-based approach, and a safety assessment-based approach. Under an analytical methods-based approach, a gluten threshold is determined by the sensitivity or ability of analytical method(s) used to detect gluten so that FDA can use those methods, when needed, to verify if a food labeled GF complies with the agency’s definition of GF. Under the safety assessment-based approach, a “safe” level of gluten is calculated using available scientific dose-response data to identify the point at which no or low adverse health effects are observed and then reducing that number by as much as 100-fold to account for knowledge gaps as well as limitations and uncertainties in the data.
10. What is the gluten threshold level for foods labeled GF as determined by an analytical methods-based approach?
Twenty ppm is the lowest level at which currently available analytical methods have been validated to reliably and consistently detect gluten. Therefore, based on this approach, FDA proposed to use < 20 ppm gluten as one of the criteria to define the term GF.
11. What were the findings of the safety assessment?
Based on the data and other variables included in the analysis, the safety assessment resulted in an estimate that a level of 0.01 ppm gluten in food would be protective of even the most highly sensitive individuals with CD. This estimation of risk to individuals with CD associated with very low levels of gluten exposure may be conservative and highly uncertain.
12. What is the gluten threshold level that other countries use to define the term GF and what gluten-detection analytical methods do they use?
Since the publication of the proposed rule in 2007, the Codex Alimentarius Commission revised its GF standard, establishing a 20 ppm or less gluten requirement and recommending the “ELISA R5 Mendez Method” for determining the gluten content of foods. This standard was adopted in 2009 in regulations by 27 countries currently comprising the Commission of European Communities.
14. If FDA adopts < 20 ppm gluten as a criterion to define the term GF and afterwards validated analytical methods become available that can detect gluten at lower levels, will FDA consider revising its regulatory definition of GF?
If FDA adopts the proposed < 20 ppm gluten threshold level as one of the criteria to define the term GF in the final rule, the agency will remain open to the feasibility and desirability of revising this criterion:
- as more sensitive methods to detect gluten become available or
- if FDA determines in the future that further research on CD indicates that the adoption of a lower gluten threshold level for GF-labeled foods is warranted to be adequately protective of Americans with CD.