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Gluten-Free Labeling in the United States

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Grocery shopping has become challenging for me, because large sections of the grocery are off-limits. I have celiac disease (CD). CD is a systemic autoimmune disorder caused by exposure to gluten in genetically-susceptible people. Gluten is a protein found in wheat, rye, and barley. The immune response activated in celiac disease causes the body to attack gluten as if it is an antigen. Symptoms and other health problems associated with CD include including abdominal pain, bloating, diarrhea, psychiatric disorders, infertility, birth defects, osteoporosis, and life-threatening conditions such as intestinal cancer. According to the University of Chicago Celiac Disease Center, there are approximately 300 recognized symptoms of Celiac Disease. CD affects 1 in 133 people in the U.S. -- the number of people in the U.S. with CD could fill 4,400 Boeing 747 jets.

The only treatment for CD is adherence to a gluten-free diet. This means that I must avoid anything that contains or has come in contact with gluten (wheat, barley, or rye). The list of gluten-containing substances I must avoid is not limited to food. People with CD must find cosmetics, beauty products, cleaning supplies, and medications that are gluten-free. Exposure to gluten from these sources can also result in a CD immune response and its accompanying symptoms.

I learned quickly after my diagnosis that the easiest way to eat is to buy fresh food. You know, the food found on the perimeter of the grocery store. I have little use for the guts of the grocery store where all the tasty bagged, boxed, and canned foods live.

When I pick up an organic bunch of kale, I know what is in it. That is not true of food that comes in boxes, bags, and cans. Decoding the ingredients of processed products is tricky. In foods not labeled "gluten-free," I avoid anything that includes the ingredients "natural flavors," "artificial flavoring," or anything else that is vague. Then, I have to spend time Googling or using my gluten-free phone app to see if I can determine the gluten-free status of any other ingredients.

I am that lady standing in the aisle, probably in your way, basket on the floor, can in one hand, and an iphone in the other. Even if the product I am looking at has the words "gluten-free" on the label, I still have to wonder if it is gluten-free. I cannot just sigh with relief and toss it in my basket.


In the United States, there is no legal definition for the phrase "gluten-free." That is right; manufacturers can use that phrase as they choose without meeting any established, regulated standards. "Gluten-free" means whatever they say it means as long as, according to the U.S. Food and Drug Administration (FDA), it is not "misleading." There are instances of food products being sold with "gluten-free" labeling, and some products contain varying amounts of gluten, include "wheat" in the ingredients, and are exposed to gluten in the manufacturing process.

How can this be?

The FDA has failed to accurately define the term "major food allergen," establish safe gluten thresholds for food products, and meet its legal obligation under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCP) to create and implement final rules for gluten-free food labeling.

The phrase "major food allergen" under FALCP means:

(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g. crab, lobster, or shrimp), tree nuts (e.g. almonds, pecans, or walnuts), wheat, peanuts and soybeans.
(2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following: (A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived form such highly refined oil. -- 21 USC 321(qq) (2012)

The FALCP requires that manufacturers identify these allergens by their common names (i.e. wheat, milk, or soy) on labeling for easy identification by consumers.

In order for a product to be gluten-free, it must be free of all gluten: wheat, barley, and rye. Unfortunately, the current law does not meet that standard. The definition of major food allergen includes only wheat. It does not include rye and barley, both of which contain gluten. The FDA's definition of major food allergen must include the term "gluten" or the words "wheat, barley, and rye" to safely protect citizens with CD or other non-celiac gluten sensitivities.

Additionally, the FALCP charged the FDA to have final standards for gluten-free labeling in place by 2008, no later than four years after the enactment of FALCP. In 2007, following up on the mandate from FALCP, the FDA issued a proposed rule "Food Labeling: Gluten-Free Labeling of Foods." The proposed rule states that a food is gluten-free if the food does not contain any of the following:

(1) an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains;

(2) an ingredient derived from these grains and that has not been processed to remove gluten;

(3) an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten; or

(4) 20 ppm or more gluten. -- "Food Labeling; Gluten-Free Labeling of Foods," 72 Fed. Reg. 2795 (proposed January 23, 2007) (to be codified at 21 CFR Part 101).

The FDA's notice described the currently-adopted analytical methods for gluten detection as being able to reliably and consistently detect gluten at levels of 20 parts per million or more in a variety of foods. Participation by food manufacturers would be voluntary if they wish to market products as gluten-free. The comment period for these rules passed with no action. No final rules were issued by the FDA.

In 2011, the FDA reopened the comment period on the same proposed regulations for "Food Labeling; Gluten-Free Labeling of Foods." That comment period closed and, again, no action was taken. No final rules were issued by the FDA regarding the labeling of gluten-free foods.

Over a year later, on Dec. 14, 2012, the FDA issued a new proposed rule titled "Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of a Docket." The comment period on these proposed rules is open until Feb. 12, 2013, and an advisory committee meeting of the FDA is scheduled for March 7, 2013 from 8 a.m. to 5 p.m.

Have you ever shopped for a gluten-free cookbook for yourself or a friend? Do you know anyone with CD? It is likely that you do. Please consider supporting them by taking time to help prompt the FDA to do something with the power provided to it by Congress. Commenting on proposed government rules is a way for us to directly impact policy making. Your comments can directly impact and in some cases be included in the FDA's final rules. Let your voice be heard.

It has been five years since the statutory deadline for final rules on gluten-free labeling, and the FDA has taken no final action. Five years. It is time for the FDA to do something. Please go to the Federal Register and comment on the FDA's latest rule (Docket No. FDA-2012-N-0711) regarding the establishment of gluten thresholds for food.

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