You can view the plans and comment online by May 5th, or you can submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the following docket number: FDA-2009-N-0083.
Here are the essential details of the planned study:
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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.
The data will 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. Participation in the study is voluntary…. Five thousand adults will complete the experiment.
My comment to the FDA was that I believe it’s a mistake to limit the study to people with internet access. There are many consumer groups – particularly among the elderly and lower-income families – who would be under-represented in an internet-only survey.
I tried to contact the FDA to find out which “celiac disease special interest organization” would be chosen to participate, and when the study is actually expected to start, but I haven’t had a response yet.
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It would be really nice if the link to the FDA worked. Please revise so all can see the plans.
Hi Kathy,
This is the correct link. It takes you to the Regulations.gov site, which is where all regulations (or rulemakings) issued by U.S. government agencies get posted, including all proposed rules (open for public comment) and final rules.
When you’ve followed the link, under “document details” there’s a heading for “Views.” You can select either the HTML view (to see it in your web browser) or the PDF view (if you have Adobe acrobat installed). Either choice will give you a copy of the proposal as it appeared in the Federal Register.
To comment, click on the little yellow bubble next to where it says “Add Comments” — right under “Views.”
I hope this helps.