FDA’s gluten free food labeling proposal

September 8, 2011

The Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Dear FDA,

Thank you for re-opening the discussion on “Gluten Free” food labeling. As the nation’s first and only retailer Gluten Free Endorsed by the Gluten Intolerance Group of North America, PCC Natural Markets represents a large faction of Gluten Free consumers in the greater Seattle area. We have reviewed the Proposed Rule (docket FDA-2005-N-0404) and would like to offer the following comments on the proposed guideline on gluten free labeling:

1) We do support the 20 ppm standard proposed by the FDA for labeling foods Gluten Free.

2) We strongly believe that there should be one uniform standard used by all food manufacturers when labeling foods Gluten Free, rather than a two-tiered approach.

3) We believe that labeling claims should always be backed up by actual testing of the foods that are labeled as being Gluten Free.

4) We would like Gluten Free Certification programs to continue certifying foods, giving consumers greater confidence.

5) We would like food manufacturers to be required to state whether or not foods labeled as Gluten Free were made on either a dedicated Gluten Free facility, or on a shared facility.

As the nation’s largest consumer-owned natural food retail co-operative, we have witnessed the growth of the Gluten Free food category, especially over the past 10 years and realize the challenges of establishing a uniform Gluten Free labeling standard. Not all consumers who avoid gluten have celiac disease; therefore not all Gluten Free consumers will have the same sensitivity to detectable traces of gluten in food. Yet, we still support the use of one uniform labeling standard for labeling Gluten Free foods, and do NOT support the use of a “two-tiered approach” to Gluten Free labeling, as mentioned in Option 6. A two-tiered approach allowing the use of terms such as “low gluten” would only confuse consumers who are already challenged and frustrated by their doctor’s orders to avoid foods containing gluten.

We do support the 20 ppm standard proposed by the FDA, which is backed up by prominent celiac researchers (reference #1); and because 20 ppm is already the established criteria used to define Gluten Free foods in Europe. We were very surprised to see that the FDA will not require testing to ensure that foods are below the 20 ppm standard prior to labeling them as Gluten Free. We realize that it may not be possible for the FDA to mandate this testing, but we encourage the FDA to make testing a requirement prior to labeling.

There is discussion (in the Federal Register Proposed Rule – 72 FR 2795 January 23, 2007) of foods labeled Gluten Free which contain greater than 20 ppm gluten being considered “misbranded.” Why not require testing to ensure Gluten Free foods are below 20ppm prior to the labeling of a food as Gluten Free? Currently, many organizations that certify foods as Gluten Free will test the finished product to ensure that it contains less than 20 ppm gluten. This is an example of a Good Manufacturing Practice that should be incorporated into the FDA’s Gluten Free labeling standard.

We hope that once the Proposed Rule goes into effect that food manufacturers will continue to be Certified Gluten Free by reputable organizations (such as Celiac Seal Association, Gluten Intolerance Group, National Foundation for Celiac Awareness). These organizations provide consumers with greater confidence in label claims, and hopefully will continue that work once the Federal Rule is passed. We also believe that if food manufacturers are testing to ensure that their foods are below 20 ppm (or any other more rigorous standard, such as 5 ppm) that they should be allowed to state this on their label.

We are concerned with the use of statements such as “all rice is gluten free” because of the fact that rice can become contaminated with gluten from sharing the same processing equipment as prohibited grains. Researchers have found traces of gluten in foods such as soybeans, buckwheat, and millet (reference #2) – grains which are not listed on the Federal Rule’s list of Prohibited Grains. In fact, the researchers of this study concluded that “the FDA may want to modify their proposed rule for labeling of food as gluten-free.” While it is true that many foods are naturally Gluten Free, it is also true that those foods can contain traces of gluten as a result of co-mingling with other grains. Food manufacturers should be required to state whether or not foods labeled as Gluten Free were made on either a dedicated Gluten Free facility, or on a shared facility. This type of labeling statement could also be applied to oats, which are known to become contaminated (co-mingled) with gluten on the farm, and also at the processing facility (reference #3).

At PCC Natural Markets, we offer free classes on shopping for Gluten Free products in our stores and we offer the following suggestions to assist our shoppers who are seeking Gluten Free foods:

  • Be able to read (and understand) the ingredients list, to confirm the Gluten Free status of a food.
  • Look for either a statement that the food was made on a dedicated Gluten Free facility, or if the product was made on a shared facility, then look for a product that is tested to ensure it is below 20 ppm gluten.
  • Look for Certified Gluten Free foods, for greater assurance that the food is indeed Gluten Free.

As the only retailer Gluten Free Endorsed by the Gluten Intolerance Group of North America, we strive to provide reliable information for our Gluten Free shoppers and look forward to seeing a new, reliable, and consistent standard applied to all foods carrying a Gluten Free claim on their package. Thank you for considering our comments on this critical issue that will impact in the lives of millions of Americans seeking foods that are uniformly gluten free.


Nick Rose, Nutrition Educator
Eli Penberthy, Public Affairs Specialist

PCC Natural Markets


1. Center for Celiac Research. University of Maryland School of Medicine Center for Celiac Research Supports FDA’s Proposed ’20 ppm’ Gluten-Free Definition. http://celiaccenter.org/ Accessed 8/29/11.
2. Thomson T, Lee AR, Grace T. Gluten contamination of grains, seeds, and flours in the United States: a pilot study. Journal of the American Dietetic Association 2010 Jun;110(6):937-940.
3. Koerner TB et al. Gluten contamination in the Canadian commercial oat supply. Food Additives and Contaminants 2011 Jun;29(6):705-710.

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