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Docket    FDA-2005-N-0404    October 3, 2011

Thank you for the efforts made to make food safer for those with celiac disease. The Celiac Support Association, as the major US patient based organization for those with celiac disease, actively supports standardizing of the term gluten-free on a food label. Our members highly support a simple, straightforward identification of a gluten-free product suitable for the family members with celiac disease with a mandatory review at no more than five year intervals to assure food safety for those with celiac disease.

Members overwhelmingly support mandatory source labeling of ingredients containing or derived from rye (meaning any species belonging to the genus Secale); barley (meaning any species belonging to the genus Hordeum) and common oats (meaning any species belonging to the genus Avena). See attached member survey results.

The Celiac Support Association (CSA) supports a definition for voluntary use of the term gluten-free validated substantially lower than the proposed 20 parts per million (ppm). A lower compliance safety standard would be suitable for more celiacs, according to FDA’s own reports. The current preference of the membership is a gluten detection assay sensitive to 5 ppm. See attached member survey results. This definition would make certification programs, including the CSA Recognition Seal, unnecessary.

In 2004, CSA developed the first celiac certification program for gluten-free products. The program is for products “free of wheat, barley, rye, oats, their crosses and derivatives in product, processing and packaging.” The program was established to reflect the membership’s desire for a symbol of risk free assurance. The CSA program requires strict criteria for source ingredient validation, a Hazard Analysis Critical Control Points (HACCP) plan detailing company gluten-free practices and verification of absence of gluten below level of quantification (BLQ) status. Currently the verification assay of choice is the cross reactive R-Biopharm Ridascreen® Gliadin sensitive to 5 ppm, performed by the University of Nebraska Food Allergy Research and Resource Program (FAARP). The 5 ppm quantification calibration has been reliable, well respected and used in labs world-wide for many years. Seventy-six companies participate in the CSA Recognition Seal Program at this time. See attached list of participants.

Under FDA “Option 6”, as a compromise, a regulation with two gluten-free labeling options for companies is acceptable if one meets the FDA proposed gluten-free definition and the other option sets compliance at the proven attainable 5 ppm and eliminates crosses and derivatives. These two levels protect the companies who have made substantial investments in responding with products to the expressed needs of the US celiac gluten-free consumer, yet provide a venue for international trade and other products suitable to a wide range of consumers. See attached member survey results.

Based upon comments from the members of the Celiac Support Association, CSA supports a “gluten-free” claim on product labels defined:
     1.    to reflect the gluten absence level currently in standard practice in the US marketplace, which is closer to 5 ppm than 20 ppm. (see CSA Report of Gluten-free test results)
     2.    to meet the strict gluten-free needs of nearly all of us with celiac disease, rather than most of us.
     3.    and supported on the label with the listing of ingredients free of the gluten grain derivatives.
     4.    to stand alone as “gluten-free” without a caution statement, such as “made in a plant...”
     5.    to identify an inherently gluten-free product specially handled to be free of cross contamination.
     6.    if the Hazard Analysis Critical Control Points (HACCP) plan includes ingredient purity and to eliminate cross contamination in procurement, storage and processing. Products labeled gluten-free sent by the Celiac Support Association for testing to the University of Nebraska FAARP Lab now commonly result in levels Below Level of Quantization with the R-Biopharm Ridascreen standard assay sensitive to 5 ppm.
    7.    when a company retains adequate records, consistent with the FDA Food Safety Modernization Act (FSMA) requirements, to support such a claim.

CSA supports the consideration of replacing the term “prohibited” grains with “specific” grains throughout the proposed gluten-free definition regulation.

A safety assurance review of the definition in not more than five year increments after implementation would indicate a commitment to protect those with celiac disease since:

  • Refractory celiac disease is less common in the US than in Europe. Have the more than thirty years of a stricter US gluten-free diet been protective?
  • There is no statistically well established safe threshold level for gluten in people with celiac disease.
  • Advancing food processing methods may remove the amino acid sequences toxic to those with celiac disease.
  • Food analysis methods for gluten presence are not yet equally suitable for all processed foods and food additives.
  • Inherently gluten-free products may be cross-contaminated with gluten containing products.
  • Transglutaminase enzyme is becoming more common as a food additive in dairy and meat products. Implications of the use of this dietary enzyme in celiac diet has not been established.
  • The research on the tyrosine dimer is emerging.
  • The required labeling of Wheat, meaning any species belonging to the genus triticum,. has been immensely useful for those shopping for gluten-free products.
  • The Codex Alimentarius gluten-free definition for trade is set for implementation January 1, 2012.
  • An individual’s symptoms are poor indicators of damage to overall health.
  • Celiac disease is a cellular level autoimmune response.
  • Other gluten-induced health conditions are being identified.
  • A growing number of people are not aware of any specific symptoms when exposed to gluten.

The CSA office, governing board and members are ready to assist in the development of food safety regulations to meet the needs of those with celiac disease.
Also attached: 

  • Survey members were sent as email September 30, 2011-- preliminary results
  • Companies bearing the CSA Recognition Seal
  • Summary of Products tested through CSA for gluten. These products were tested as part of the normal process of helping members. Some products were tested to assist food company efforts to develop gluten-free products or companies pursuit of the CSA Recognition Seal or monitor manufacturing practices.
  • Presence of gluten in foods labeled “gluten-free” NSW Food Authority March 2008