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  • Jefferson Adams
    Jefferson Adams

    Five Years Later: Still No FDA Rule on Gluten-free Food Labeling

    Reviewed and edited by a celiac disease expert.

    Celiac.com 02/15/2013 - If you think the FDA has dropped the ball on gluten-free food labeling, you are not alone.

    Photo: CC--mandbergIn 2004, the Food Allergen Labeling and Consumer Protection Act (FALCP) gave the FDA four years to create and implement final rules for gluten-free food labeling.

    The FALCP requires manufacturers to identify these allergens by their common names (i.e. wheat, milk, or soy) on labels so that consumers can easily identify them.

    In 2007, the FDA followed FALCP's mandate by issuing 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 proposed rule was based on the fact that currently-adopted analytical methods can reliably detect gluten at or above 20 parts per million in most foods. Also, under that rule, food manufacturers looking to market products as 'gluten-free' would voluntarily test those products prior to labeling.

    However, the FDA allowed the comment period for the proposed rule to pass with no action, and issued no final rule for gluten-free labeling.

    In 2011, the FDA announced a second comment period for their proposed rule, but that comment period also closed with the FDA taking no action.

    A full year and a half 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."

    They opened comment period on this proposed rule until Feb. 12, 2013, and scheduled an advisory committee meeting of the FDA for March 7, 2013 from 8 a.m. to 5 p.m.

    It has been eight years, since FALCP mandated the FDA to devise standards for gluten-free labeling, and five years since the legal deadline for final gluten-free rule, and the FDA has yet to accurately define the term "major food allergen," establish safe gluten thresholds for food products, and meet its statutory mandate to create and implement final rules for gluten-free food labeling.

    Until the FDA formally adopts a final rule for gluten-free labeling, there is no legal definition for what makes food "gluten-free" in the United States, and people with celiac disease will no clear assurance that when a product claims to be gluten-free, it is safe to consume.

    Please go to the Federal Register and comment on the FDA's latest ofrmulation of their rule (Docket No. FDA-2012-N-0711) regarding gluten-food.


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    The FDA does not work for the American people. It works for the food, drug and chemical companies that own it. Don't expect any action on what gluten-free means on a label, or the words natural, or anything else that would help people in their food choices.

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    Thanks for including a link to comment. Can't get it to work now but will keep trying. I am so tired of the "unknown" ingredients, such as maltodextrin and "natural flavors" that may or may not be a problem.

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    From a UK/EU viewpoint (we have benefited from improving labeling and availability for some time) the scenario you describe is unbelievable. But then again, US politicians often look like they're on another planet. Or they're even more in the pocket of big business than our own. Is it resistance from food companies? It's tempting to compare them to those nutters in the NRA.

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    This situation is disgraceful.

     

    Another problem for individuals with celiac disease, which will not be solved even by the gluten-free labels: the addition of transglutaminase without labeling to many foods, including low fat dairy products (yogurt and cheeses) as well as deli meats. It looks like it can even be added to foods labeled "organic" (and I am having trouble getting responses from some food manufacturers to my email inquiries about whether this is added or not to their product). I have heard from an expert on celiac (a MD and researcher) that transglutaminase may not be safe for celiac patients and may provoke reactions as well, even in the absence of gluten. This additive has been classified as "GRAS- generally recognized as safe" and it may be added without being listed on ingredient list. Finding safe food for celiac patients (indeed for everyone) is becoming more difficult. The FDA does a poor job of protecting the interests of the public.

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    Health Canada has passed legislation as of August 2012 (with 18 months to implement labeling prior to this date) manufacturers are required by law to identify allergens on all food ingredient labels,if the gluten (or any other allergen) has not been added but may have been processed in a facility with any allergen then the "may contain" statement must appear.This is not a voluntary requirement, it's mandatory! Shopping is so much easier now that I know I can trust what I'm buying. Proudly Canadian!

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    Does the celiac community agree with the 20ppm as an acceptable level for declaring gluten-free? It's ridiculous to say that gluten can't be detected with accuracy below 20ppm.

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    I wish this article had come out before Feb. 12th instead of now.

    Learning how to eat gluten free has been an interesting journey. I realized that labels were not always accurate very early on when I had reactions to so called gluten-free foods. Cooking from scratch, eating fruits/vegetables/grains, and buying organic meats goes a long way to nourishing my body without harmful or painful reactions.

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    Why are there no proposed regulations for personal care products? I was diagnosed 10 days ago and this has driven me to distraction. I want gluten-free toothpaste, lip gloss, lip balm, etc.

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  • About Me

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in science, scientific methodology, biology, anatomy, medicine, logic, and advanced research. He previously served as SF Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

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