April 25, 2016
Center for Food Safety and Applied Nutrition (HFS-820)
Food and Drug Administration
5100 Paint Branch Pkwy.
College Park, MD 20740
Re: Gluten-Free Labeling of Fermented or Hydrolyzed Foods (FDA-2014-N-1021)
Dear Dr. D'Lima,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the Food and Drug Administration (FDA) on its proposed rule issued November 18, 2015. Representing over 90,000 registered dietitian nutritionists (RDNs),1 nutrition dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation’s health through food and nutrition across the lifecycle. Our members work provide individual counseling to patients and clients with celiac disease and with companies developing and labeling gluten-free products for individuals with gluten intolerances.
The Academy generally supports the FDA statement that "additional requirements for the ‘gluten-free’ labeling rule are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as 'gluten-free.'"
I. Academy Labeling Principles
The Academy has adopted a series of principles to guide policy recommendations for the labeling of foods, and we encourage the FDA to finalize its rule for the labeling of certain fermented or hydrolyzed foods in accordance with these principles:
- Label claims should be clear and understandable to consumers; consumers' nutrition literacy is key to promoting understanding.
- The label must be truthful and not misleading.
- Content on the label should help consumers make informed decisions to build a healthy diet.
- Labels should help to provide understanding about the healthfulness of overall food rather than a focus on particular nutrients.
- Label content should have consistent type and format so products can be read and consumers can make product comparisons.
- Labeling should enhance consistency among the various government nutrition recommendations.
- All claims should include labeling of accurate quantitative information about the dietary substance, including percent of Daily Value in a single serving of the products, when known, or the daily dietary intake necessary to achieve the claimed effect.
- Consumer research is imperative before making changes to the label.
- The label is only a source of information, and thus sustained support for educational programs and individual counseling by registered dietitian nutritionists is essential.
II. Labeling of Fermented and Hydrolyzed Foods
The Academy believes it is important to have a measurable, chemical definition of gluten for associated labeling, because individuals cannot "sense" gluten in foods by tasting, smelling, or feeling protein fragments. The measurable, chemical definition is critically important for individuals with celiac disease, because misbranding can cause serious health consequences. Simply labeling a food as "manufactured in premises that also handle gluten and wheat" or "no gluten ingredients" is not helpful for individuals with celiac disease, because it reduces their access to a large variety of foods in the marketplace. The Academy also believes it is important to test final products to ensure that they meet specified limit requirements for gluten. In addition, the Academy supports further research to substantiate support of the use of the current testing methodology for gluten in fermented or hydrolyzed foods and beverages. We note that the current design of the 'sandwich ELISA test' may not be able to be validated for proteins that are no longer intact, although the competitive ELISA requires only one epitope or antibody binding site.
The Academy questions whether the current corpus of research entirely supports the proposition that the removal of gluten-containing ingredients will eliminate symptoms in those with celiac disease or non-celiac gluten sensitivity. We are also concerned that the present inability to validate a testing methodology that ensures that foods and beverages using hydrolyzed and fermented gluten-containing ingredients do not cause symptoms of celiac disease or non-celiac gluten sensitivity leads to the conclusion that such products are not appropriately labeled as gluten-free. At the same time, we are concerned with the impacts from use of barley malt and hydrolyzed wheat protein in labeled gluten-free foods.
It is very important to retain source information for tracking and traceability. In the experience of those who work in related industries, many companies do not understand that it is not just their facility or final product that is held to meet regulations but the combination of all ingredients used in producing that item. Among the international community of food manufactures, it is important to be consistent in both science and standards. Having a different set of standards among the international community potentially places an undue burden on international labeling requirements necessitating assessment of the rationales for the different standards in finalizing the rule.
As with many nutrition issues, the lack of clear, consistent, and comprehensible education from recognizably qualified governmental entities and health care practitioners is problematic; guidance from FDA for education on gluten response is important.
The Academy appreciates the opportunity to comment on the proposed rule for Gluten-Free Labeling of Fermented or Hydrolyzed Foods. We are happy to discuss these recommendations in greater detail in the near future. Please contact either Jeanne Blankenship at 312/899-1730 or by email at firstname.lastname@example.org or Pepin Tuma at 202/775-8277, ext. 6001 or by email at email@example.com with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.