FDA Seeks Comments Regarding Gluten Free Labeling

Gluten Free Food Labeling - FDA is seeking public comments on the paperwork and regulatory burdens of a proposed survey, titled "Gluten-Free Labeling of Food Products Experimental Study" which is intended to " ... collect information from both consumers who have celiac disease or gluten intolerance and those who do not have either condition. The purpose of the study is to gauge perceptions of characteristics related to claims of 'gluten-free' and allowed variants (e.g., 'free of gluten,' 'without gluten,' 'no gluten'), in addition to other types of statements (e.g., 'made in a gluten-free facility' or 'not made in a facility that processes gluten-containing foods') on the food label. The study will also assess consumer understanding of 'gluten-free' claims on foods that are naturally free of gluten, and gauge consumer reaction to a product carrying a gluten claim concurrently with a statement about the amount of gluten the product contains ..."

Document Title: The title of the November 17, 2009 FDA Federal Register Notice is "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Gluten-Free Labeling of Food Products Experimental Study"

Organization: FDA Office of Policy

Summary: The following information is taken from the November 17, 2009 FDA Federal Register Notice

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Gluten-Free Labeling of Food Products Experimental Study--(OMB Control Number 0910-NEW)

Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393 (b)(2)), FDA is authorized to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the nation's food supply. FDA is planning to conduct an experimental study about gluten-free labeling of food products. The Gluten-Free Labeling of Food Products Experimental Study will collect information from both consumers who have celiac disease or gluten intolerance and those who do not have either condition. The purpose of the study is to gauge perceptions of characteristics related to claims of ``gluten-free'' and allowed variants (e.g., ``free of gluten,'' ``without gluten,'' ``no gluten''), in addition to other types of statements (e.g., ``made in a gluten-free facility'' or ``not made in a facility that processes gluten-containing foods'') on the food label. The study will also assess consumer understanding of ``gluten-free'' claims on foods that are naturally free of gluten, and gauge consumer reaction to a product carrying a gluten claim concurrently with a statement about the amount of gluten the product contains.

In a 60-day Federal Register notice, which published on March 6, 2009 (74 FR 9822), FDA stated that the data would be collected over the Internet from samples derived from two sources: (1) A membership list from a celiac disease special interest organization and (2) an online consumer panel. FDA will not utilize the membership list of a celiac disease special interest organization. Instead, FDA will obtain participants through the assistance of major celiac disease and research centers around the United States. Participation in the study is voluntary.

Also in the March 6, 2009, sixty-day Federal Register notice, FDA requested public comment on the proposed information collection provisions. FDA received 34 letters in response to the notice, each containing 1 or more comments.