FDA is Accepting Comments re: Gluten-Free

The FDA is finally getting serious about regulating gluten-free food labels! They have reopened comments on the rule that was proposed back in 2007. From August 3, 2011 – October 2, 2011 you can comment on the proposed rule.

Right now, in the USA, there is no one legal definition of “gluten-free.” I’ve found products that claim to be gluten-free, but in the fine print on the back disclose they were processed in the same facility as wheat. Calling the manufacturer reveals they did nothing to test to make sure the products were in fact free of gluten, just that the ingredients were “naturally gluten-free.”

Currently, products which naturally wouldn’t contain gluten can call themselves “gluten-free” without testing for contamination. This is a very serious problem for people who are using alternative flours, which have been found to contain up to 2,925 ppm of gluten!

Gluten can be introduced to a product which naturally wouldn’t be gluten-free everywhere in the process from growing in contaminated fields, to being handled by workers who just had a sandwich for lunch, to being shipped in contaminated containers, to being processed on equipment that also processes gluten-containing ingredients. Because of this, many alternative grains actually are contaminated with gluten in amounts much greater than the proposed 20 ppm.

Recent research shows that measurable damage to the small intestine of all celiac patients occurred at a level of 50 mg a day for three months. However, one patient in the study showed damage at the 10 mg level, and another had to drop out due to severe symptoms. It is currently generally accepted that 10 mg of daily gluten (which amounts to 1.1 lbs of “gluten-free” food at the 20 ppm level) does not cause observable damage or obvious reactions for most celiacs.

However, there are many individuals who do experience obvious symptoms at much lower levels of exposure, and the study was only three months long. Additionally, many people experience problems related to gluten without getting to the point of damage visible in a biopsy. My opinion is that 20 ppm is not low enough. In Australia the limit is 5 ppm, which seems much safer to me. Personally, I’d rather see a “Gluten-Lite” standard adopted at 20 ppm, with a “Gluten-Free” standard meaning that the product was produced in a gluten-free facility from start to finish, and the most sensitive tests of every batch did not detect any gluten.

Regardless of what the accepted level ends up being, it needs to be consistent and enforced. I’d much rather know what gluten-free means and take calculated risks with those products than deal with the current, unregulated gluten-free marketing craze.

If having a standard definition and labeling practice for gluten-free foods is important to you and have an opinion as to what that definition should be, please make a comment on the proposed rule.

If you’d rather submit your comments to the docket by mail, include docket number FDA-2005-N-0404 on each page of your written comments and use the following address:

The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

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