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FDA taking comments again on proposed gluten-free rule

By MICHELE F. MIHALJEVICH
Indiana Correspondent

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) is reopening the comment period on its proposal to label gluten-free foods, the agency said last week.

Under the proposal, first announced in 2007, foods with gluten levels at or above 20 parts per million wouldn’t be allowed to be labeled as gluten-free. The labels of gluten-free foods would contain the phrase “prohibited grains.”

Earlier this year, several milling, baking and grain organizations wrote a letter to the FDA asking officials to reconsider and to use the phrase “gluten-containing grains” instead.

“There are numerous misperceptions about gluten and we do not want to fuel those unjustified claims that going gluten-free can help with weight loss, autism, ADD, MS, etc.,” the letter stated.
Gluten is a protein found in wheat, rye and barley. People with celiac disease cannot tolerate gluten, the FDA stated, adding about 1 percent of the U.S. population is estimated to have the disease.

The comment period started Aug. 3 and runs for 60 days. To make a comment electronically, go to www.regulations.gov and click on “submit a comment” on the top task bar, enter docket number FDA-2005-N-0404 in the “keyword” space and select “search.”

To submit comments by mail, write to: The Division of Dockets Management, HFA-305, FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Include docket number FDA-2005-N-0404 on each page of written comments.

8/10/2011