If you read a label and it says “gluten free” is it really gluten free? That’s a question asked in July, 2011 of the Food and Drug Administration by U.S. Senators Ron Leahy of Vermont and Ron Wyden of Oregon, both Democrats.
The U.S. Congress, in 2004, passed what is known as the Food Allergen Labeling and Consumer Protection Act which in part mandated that FDA issue rules on gluten free labeling within 2 years.
Now, nearly 7 years later, there is still no accepted, standardized limits for a clear definition of what “gluten free” means, and that’s what Senators Leahy and Wyden wrote to the FDA about. Here are excepts from their letter:
“The regulatory uncertainty surrounding FDA’s inaction has led to a proliferation of “gluten free” standards and labels provided by 3rd party groups. This creates confusion for consumers, and hesitancy amongst producers on what their requirements will be. For suffers of Celiac Disease, having accurate and standard labeling for these products is essential,” said Wyden’s office in a news release.
The Senators went on to say: “We ask that you (Margaret Hamburg, FDA Commissioner) provide us with an update on when FDA will promulgate a final rule, why FDA has taken so long to issue this rule, and if there are any legal or regulatory hurdles that have prevented the timely implementation of this legislation.”
According to the FDA’s proposed rule on what constitutes a “gluten free” food, the rule states that if the use of a prohibited ingredient (e.g., wheat, barley, rye) results in the presence of 20 parts per million (ppm) or more gluten in the food, or 20ppm or more gluten, the food cannot be labeled “gluten free.” But less than that, the food can be labeled “gluten free” although it can contain prohibited gluten.
The FDA has set the date of October 03, 2011 to receive comments from interested persons that wish to express their concerns/opinions/suggestions and you may do so by contacting the following person:
Rhonda R Kane, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy, College Park, MD 20740-3835, 240-402-2371, FAX 301-436-2636; e-mail: Rhonda.kane@fda.hhs.gov.
For a medical opinion on an acceptable level of gluten in a food product, please click here for a letter by Alessio Fasano, M.D., and the University of Maryland Center for Celiac Research.

