In its drive to create a uniform and enforceable definition for “gluten-free” labeling of foods, the FDA (Food and Drug Administration) has announced that it has reopened the comment period for its proposal. It is also making available “a safety assessment of exposure to gluten for people with celiac disease. Comments on these additional data are welcome, the Agency added.

The FDA proposes a limit of 20ppm (parts per million) if a food maker or marketer wishes to claim it is gluten-free. As any amount lower than 20ppm is hard to detect, the FDA felt this was the right amount. 20ppm is a threshold level many other countries use, including the European Union.

Gluten is a protein found in barley, wheat and rye. Individuals with celiac disease cannot tolerate gluten. Approximately 1 in every 100 Americans has celiac disease. Celiac disease damages the small intestine and undermines the absorption of nutrients from food.

Michael Taylor, deputy commissioner for foods, said:

“Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance. We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”

The FDA invites people from local governments, consumers, the state, and the food industry to offer suggestions and comments about the gluten-free labeling docket number FDA-2005-N-0404 at www.regulations.gov. When in there, select “Submit a comment” from the top task bar, enter the docket number in the keyword space, and press “Search”.

You can also send comments by post to:
The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Make sure docket number FDA-2005-N-0404 is written on each page of the written comments.

Written by Christian Nordqvist