Food labels and gluten free diet

In Response: It is Time for Action by the United States Food and Drug Administration on Gluten-Free Labeling Rules

This commentary is in response to the research paper published in the Journal of Human Nutrition and Dietetics by researchers at The Center for Food Safety and Applied Nutrition at the United States Food and Drug Administration (the “FDA”). The FDA found, among other things, that the lack of rules in the United States regulating gluten-free labeling contributes to difficulty experienced by patients with coeliac disease and non-coeliac gluten sensitivities in adhering to a gluten-free diet. Yet, after being empowered in 2004 by the United States Congress, the FDA has been ineffective in enacting rules governing gluten-free claims on food labeling. The unsuccessful attempt is despite a statutory mandate under the Food Allergen Labeling and Consumer Protection Act of 2004 that such rules be in place no later than 2008.This commentary discusses the FDA rule-making history and lack of action on gluten-free labeling rules in the context of the FDA’s own research, which supports the need for final rules. The FDA agrees that final rules are necessary, but when will the FDA take action?

Coeliac disease, non-coeliac gluten sensitivity, and the adherence to a gluten-free diet are topics of increasing discussion in the scientific and lay media. The topic has been covered recently in the Journal of Human Nutrition and Dietetics by researchers at The Center for Food Safety and Applied Nutrition at the United States Food and Drug Administration (the “FDA”). (Verrill, et al., 2013).  (Verrill,et al., 2013).

The FDA researchers surveyed 1,583 adults with coeliac disease (“CD”) and 797 adults with non-coeliac gluten sensitivity (“NCGS”) all of whom adhere to a gluten-free diet (“GFD”) as treatment for their respective conditions. (Verrill, et al., 2013). The FDA researchers’ findings include that

  1. the United States’ lack of standards for use of gluten-free claims on food labels contributes to patients’ difficulty in adhering to a GFD;
  2. a “significant association between reading food labels and hav[ing] less difficulty following a GFD”; and
  3. a “positive association between using a [gluten-free] claim and difficulty following a GFD.” (Verrill, et al., 2013).

The FDA acknowledges that the lack of rules regarding gluten-free labeling contributes to patient difficulty in adhering to the GFD. (Verrill, et al., 2013).  It is observed that the “association between [gluten-free] claims and difficulty following a GFD could be explained by the potential confusion about the meaning of the claim or a mistrust of it.” (Verrill, et al., 2013).  The researchers state further that the “FDA’s rulemaking, which is underway to define the food labeling term [gluten-free], is expected to mitigate the confusion in this regard.” (Verrill, et al., 2013).

What the FDA does not state in this research paper is that the rules regarding gluten-free labeling on food products was required by the  United States Food Allergen Labeling and Consumer Protection Act of 2004 (“FALCP”) to be completed no later than 2008. Food Allergen Labeling and Consumer Protection Act of 2004, Pub. L. no. 108-282, 118 Stat. 910 (2004). Further, the FDA has not provided any indication that its rulemaking process will produce gluten-free standards in 2013 or the near future.

I have coeliac disease (“CD”). CD is a systemic autoimmune disorder caused by exposure to gluten in genetically susceptible people. (Fasano & Catassi, 2012). Gluten is a protein found in wheat, rye, and barley and the derivatives of each. The immune response activated in CD causes the body to attack gluten as if it is an antigen and cause symptoms including chronic diarrhea, weight loss, bloating, and chronic fatigue, among others. (Fasano & Catassi, 2012). Untreated CD can result in osteoporosis, neurologic disorders, and cancer. (Fasano & Catassi, 2012).

The only treatment for CD is adherence to a GFD. (Fasano & Catassi, 2012).

I learned quickly after my diagnosis that the easiest way to ensure that I am adhering to a GFD is to buy fresh food, rather than packaged food that is processed. I do occasionally purchase and consume processed foods out of convenience and necessity. When this happens I carefully examine the food label to determine if the food contains gluten. Often I contact manufacturers directly to inquire about the contents of the product or the company’s production practices to prevent cross-contamination. It is common for me to end those conversations and still wonder if the product is safe. When I am looking at products that claim on the label to be “gluten-free” I still have to wonder if the product is safely gluten-free.

 Why?

In the United States there is no legal definition for the phrase “gluten-free.” In the United States manufacturers can use that phrase as they choose without meeting any regulated standards. Manufacturers may use the term “gluten-free” as long as, according to the FDA, it is not “misleading.”

 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 FALCP to create and implement final rules for gluten-free food labeling.

The United States Federal Food, Drug and Cosmetic Act does not specifically regulate gluten as it affects patients with CD, an autoimmune disorder. Rather, it regulates wheat as an allergen. 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 U.S.C. § 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. 21 U.S.C. § 343(w) (2012).

In order for a product to be gluten-free it must be safely 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. 21 U.S.C. § 321(qq) (2012). It does not include rye and barley, and the derivatives, all 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 NCGS.

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. Food Allergen Labeling and Consumer Protection Act of 2004, Pub. L. no. 108-282, 118 Stat. 910 (2004).  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). These standards are consistent with those adopted in European in 2012. (Verrill, et al., 2013).

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.” Food Labeling; Gluten-Free Labeling of Foods; Reopening of the Comment Period, 76 Fed. Reg. 46671 (proposed August 3, 2011) (to be codified at 21 CFR Part 101). 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 December 14, 2012, the FDA issued a notice titled “Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of a Docket.” This notice does not specifically include further comment or action on the proposed rules published on January 23, 2007 and again on December 12, 2012 to establish gluten-free labeling standards for food.

The comment period on the rule issued in December 2012 is open until February 12, 2013 and an advisory committee meeting of the FDA is scheduled for March 7, 2013 from 8:00 a.m. to 5:00 p.m. Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket, 77 Fed. Reg. 74485 (proposed December 14, 2012).

Today, nearly 1 in 133 people in the United States have CD. (Fasano, A. et al. 2003). It has been nearly a decade since the FDA was empowered by Congress to establish final rules on gluten-free labeling in the United States. The FDA has taken no final action. The FDA has acknowledged that the lack of standards for gluten-free labeling has created difficulty for patients with CD and NCGS to successfully adhere to the medically required GFD. The FDA has stated that “more research is needed in this area.” (Verrill, et al., 2013).  Yet, the FDA has not acted on rules it proposed over five years ago that could assist patients who must adhere to a GFD. It is time for the FDA to take action.

 

Whitney Caudill of Manchester College of Pharmacy, Indiana.

References:

  1. 21 U.S.C. § 321(qq) (2012).
  2. 21 U.S.C. § 343(w) (2012).
  3. Fasano A, Berti I, Gerarduzzi T, et al. (2003) Prevalence of celiac disease in at-risk and not-at-risk groups in the United States. Archives of Internal Medicine. 163, 268–292.
  4. Fasano, A., Catassi, C. (2012) Celiac Disease. N. Engl. J. Med. 367, 2419.
  5. Food Allergen Labeling and Consumer Protection Act of 2004, Pub. L. no. 108-282, 118 Stat. 910 (2004).
  6. Food Labeling; Gluten-Free Labeling of Foods, 72 Fed. Reg. 2795 (proposed January 23, 2007) (to be codified at 21 CFR Part 101).
  7. Food Labeling; Gluten-Free Labeling of Foods; Reopening of the Comment Period, 76 Fed. Reg. 46671 (proposed August 3, 2011) (to be codified at 21 CFR Part 101).
  8. Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket, 77 Fed. Reg. 74485 (proposed December 14, 2012).
  9. Verrill, L., Zhang, Y., Kane, R. (2013) Food label usage and reported difficulty with following a gluten-free diet among individuals in the USA with coeliac disease and those with noncoeliac gluten sensitivity. J. Hum. Nutr. Diet. doi:10.1111/jhn. 12032.

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