The results of the survey are in! Almost 57 percent of the 1,000 people who responded want “gluten-free” to mean no detectable gluten when the FDA finalizes its rule on gluten-free labeling of food.  Another 12 percent want it to mean less than 5 parts per million of gluten and another 9 percent want it to mean less than 10 parts per million of gluten. In total 78.8 percent (788/1000) of respondents want “gluten-free” to mean an amount lower than the current amount of less than 20 parts per million in the FDA’s proposed rule.

Results (1,000 respondents)

Question: When the FDA finalizes its gluten-free labeling rule, what would you like “gluten-free” to mean?

ChartExport[1]

Less than 100 parts per million of gluten: 29/1000

Less than 20 parts per million of gluten: 193/1000

Less than 10 parts per million of gluten: 91/1000

Less than 5 parts per million of gluten: 121/1000

No detectable gluten: 566/1000

Why these particular amounts were chosen as survey answer options

Less than 100 parts per million: In the European Union, foods containing over 20 parts per million and up to 100 parts per million of gluten are allowed to be labeled “very low gluten.”

Less than 20 parts per million: Under the FDA’s proposed rule for labeling of food as gluten free, products must contain less than 20 parts per million of gluten.

Less than 10 parts per million: Food products containing the Gluten-Free Certification mark from the Gluten-Free Certification Organization (Gluten Intolerance Group) must contain less than 10 parts per million of gluten.

Less than 5 parts per million: The lower limit of quantification for gluten using the standard sandwich R5 ELISA—the ELISA proposed by the FDA as the method of detection for gluten–is 5 parts per million of gluten. Also, foods containing the Celiac Sprue Association’s Recogniton Seal must contain less than 5 parts per million of gluten.

No Detectable Gluten: As close to zero as current assays for gluten can test. The standard sandwich R5 ELISA has a limit of detection of 3 parts per million of gluten.

The milligram amounts each of these levels represent

If a 1-ounce slice of “gluten-free” bread contains 100 parts per million of gluten it contains 2.835 milligrams of gluten.

If a 1-ounce slice of “gluten-free” bread contains 20 parts per million of gluten it contains 0.567 milligrams of gluten.

If a 1-ounce slice of “gluten-free” bread contains 10 parts per million of gluten it contains 0.283 milligrams of gluten.

If a 1-ounce slice of “gluten-free” bread contains 5 parts per million of gluten it contains 0.142 milligrams of gluten.

If a 1-ounce slice of “gluten-free” bread contains less than the limit of quantification for gluten (currently 3 parts per million) it contains less than 0.085 milligrams of gluten.

To put these amounts in perspective, a 1-ounce slice of “regular” white bread has been reported to contain 124,000 parts per million of gluten or 3,515.338 milligrams of gluten.

Issues to consider

  1. No detectable gluten is a “moving target.” As new and improved assays become available the limit of detection may decrease from 3 parts per million to 2 parts per million or even lower. Is this fair to manufacturers?
  2. Right now assays measure gluten in parts per million but there are assays that measure other “contaminants” in parts per billion. Eventually no detectable gluten could mean certain food groups, such as grain foods could no longer be labeled gluten free. Is this something individuals with celiac disease are willing to accept?
  3. Can gluten-free food manufacturers realistically meet a no detectable gluten limit?
  4. Will they want to meet this level or will it become too cost prohibitive?
  5. What will happen to the cost and availability of gluten-free food if no detectable gluten becomes the definition of gluten free?

When the FDA publishes findings from the safety assessment on gluten exposure in the Federal Register and opens a public comment period, please take the opportunity to voice your opinion.

This article is part one of a series I will be writing on issues related to gluten-free labeling. The next article in the series will address testing for gluten and the certification and recognition seal programs run by the Gluten Intolerance Group and the Celiac Sprue Association, respectively.

Copyright © February 2011 by Tricia Thompson, MS, RD

Survey Results: What Would You Like Gluten-Free to Mean?