April 18, 2007
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1601
Rockville, MD 20852
Submitted via Regulations.gov
Re: Docket Number: 2005N-0279
To Whom It May Concern:
The North American Millers' Association is the trade association representing the wheat, corn, oat and rye milling industry. NAMA’s 48 member companies operate 170 mills in 38 states and Canada. Their aggregate production of more than 160 million pounds per day is approximately 95 percent of the total industry capacity.
We appreciate having the opportunity to comment on the Food and Drug Administration (FDA) proposed definition of the term gluten-free. We recognize the tremendous amount of work that has gone into the writing of this proposed rule. Our comments will focus on oats in the proposed regulations.
As stated in the proposed rule published on January 23, 2007, guidance on whether oats should be consumed by individuals with celiac disease has been controversial for many years. NAMA appreciates FDA’s thoughtful consideration of the nutritional contribution of oats in the diets of celiac patients and therefore supports not including oats on the list of prohibited grains. Further, as FDA has acknowledged in the proposal, special efforts can result in “gluten-free” oat products. Specialized producers of oat products who are using rigorous methods to control the presence of wheat, barley and other “prohibited grains” (as defined by FDA) while growing, harvesting, transporting, milling and processing should be given the opportunity to promote the purity of their products in the marketplace.
NAMA supports the agency’s careful definition of the term gluten-free to apply only to those proteins from wheat, barley and rye that “may cause adverse health effects in persons with celiac disease.” However, as noted in the proposed rule, some peptides in oats are similar to those found in wheat and a small number of individuals react to them. NAMA supports FDA’s efforts to foster clear and consistent consumer understanding and industry usage of the term gluten-free through the proposed definition. In doing so, FDA recognizes that there continue to be areas of uncertainty regarding the reaction of individuals with celiac disease to the proteins in grains.
In conclusion, NAMA members support FDA’s decision to not include oats in the list of prohibited grains and to provide a mechanism for oat producers who take the necessary steps to limit the gluten content of oat containing products to communicate that benefit to consumers.
Sincerely,
Betsy Faga
President
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