More Details on FDA Gluten-Free Label Study

The biggest change in the Food and Drug Administration’s study of what consumers think about gluten-free labels is the way the agency will get volunteer participants.

Instead of using celiac support group membership lists, the FDA has asked major celiac disease centers around the US to publicise the study. The centers have been asked to invite those on their mailing lists to participate and to post flyers asking patients as well.

In another change, the FDA will add a paper version to provide greater access to the study to a more economically and geographically diverse group. Originally, the study was only going to be conducted on the Internet. The FDA estimated about 10,000 people will be screened, with about 7,000 completing the study.

The FDA wants to know what gluten-free consumers think of statements like “free of gluten,” “without gluten,” and “no gluten.” The study will also look at what consumers think when they see a gluten-free label on a food that is naturally gluten free, milk for example. Finally, the FDA is trying to gauge consumer reaction to products that are both labeled gluten free and have a statement about how much gluten the product contains.

Under the FDA’s proposed definition of the gluten free label, a food tested and found to have less than 20 parts per million of gluten could be labeled gluten free. The Food Allergen Labeling and Consumer Protection Act requires the FDA to come up with a definition for gluten-free labeling. An August 2008 deadline set in the law has long passed.

Changes in the way the consumer study will be done came as a result of public comments the FDA received.

Several comments noted that an Internet-only survey would make it more difficult for the elderly and those with lower incomes to participate so the FDA is adding a paper form. The agency will also select participants who have followed the gluten-free diet for varying periods of time in response to a comment that label reading needs and habits change with time.

In response to another comment, the FDA plans to include people who are avid label readers in its control group of those who do not follow the gluten-free diet.

It’s not clear when the study will get underway or when it will be completed. The FDA said it will publish the results.

If you are on a celiac center mailing list, you should receive an invitation to participate in the FDA gluten-free label study.

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